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Oncology Pharmacy

Oncology Pharmacy Organisations
Specialist Journals
Specific Drugs
Oncology Pharmacy News
Latest Research Publications

Oncology Pharmacy Organisations (13 links)

    Link to Website
    Link to Directory
    Austrian Society of Oncology PharmacyASOP Austria
    Belgian Oncology Pharmacy PractitionersBOPP Belgium
    Board of Pharmacy Specialties - Oncology PharmacyBPS USA
    British Oncology Pharmacy AssociationBOPA UK
    Canadian Association of Pharmacy in OncologyCAPhO Canada
    German Society of Oncology PharmacyDGOP   Germany
    European Society of Oncology PharmacyESOP Europe
    Hematology/Oncology Pharmacy AssociationHOPA USA
    International Society of Oncology Pharmacy PractitionersISOPP International
    Polish Association of Oncology PharmacistsPSFO Poland
    French Society of Oncology PharmacySFPO France
    South African Association of Oncology PharmacistsSAOP   South Africa
    Association for Oncology PharmacyAFOP Switzerland

    Specialist Journals (4 links)

    See also: Oncology Journals

    Specific Drugs


    Everolimus (Afinitor)
    Gliadel implants
    Ipilimumab (Yervoy)
    Liposomal Daunorubicin
    Liposomal Doxorubicin

    Nilotinib (Tasigna)
    Obinutuzumab (Gazyva)
    Pamidronate (Aredia)
    Pazopanib (Votrient)

    Temsirolimus (Torisel)
    Vemurafenib (Zelboraf)

    Oncology Pharmacy News (1 links)


      Latest Research Publications

      Fajardo S, Zook F, Dotson E
      Specialty pharmacy for hematologic malignancies.
      Am J Health Syst Pharm. 2016; 73(11):797-809 [PubMed] Related Publications
      PURPOSE: The oral oncology medications used in the treatment of chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and non-Hodgkin's lymphoma are reviewed, and the specialty pharmacy services at three large academic medical centers are described.
      SUMMARY: More than one dozen oral oncology medications are being used for hematologic malignancies and afford patients increased convenience and the potential to improve their quality of life. These agents include ibrutinib, idelalisib, imatinib, dasatinib, nilotinib, bosutinib, ponatinib, thalidomide, lenalidomide, pomalidomide, panobinostat, ixazomib, and vorinostat. Despite the benefits of an autonomous-driven patient care plan, these high-risk, high-cost treatments are not without their challenges. Oral oncology medications are associated with significant barriers to adherence, including low health literacy, patient forgetfulness, complex administration instructions, troublesome adverse effects, and high copayments. Many outpatient cancer center pharmacies associated with large academic medical centers are now applying for specialty pharmacy designation. This affords the onsite dispensing pharmacy access to once-limited oral oncology medications that can be dispensed to clinic patients. In addition, the specialty pharmacy services offered within these cancer centers bridge an important gap in patient care and improve the care provided to oncology patients.
      CONCLUSION: As oral oncology agents continue to be approved by FDA, oncology treatment teams must establish a comprehensive plan for their management. Because of their pharmacologic expertise, access to patients' medical records, and unique position within ambulatory care oncology teams, pharmacists can play an important role in patient education, laboratory monitoring, medication adherence, and cost saving.

      Stein J, Mann J
      Specialty pharmacy services for patients receiving oral medications for solid tumors.
      Am J Health Syst Pharm. 2016; 73(11):775-96 [PubMed] Related Publications
      PURPOSE: Currently available oral oncology therapies are reviewed, and specialty pharmacy services for patients receiving these drugs are described.
      SUMMARY: Market introductions of new oral oncology drugs have increased substantially over the past decade, and 25-30% of all oncology agents in development are oral medications. Oral agents for treatment of breast cancer include capecitabine, lafatinib, and palbociclib. Several oral agents are used in treating patients with lung cancer driven by mutations of genes coding for anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR); currently available agents include the ALK inhibitors certinib and crizotinib and the EGFR inhibitors afatinib, erlotinib, and gefitinib. Four oral targeted therapies are used in the treatment of melanoma associated with the B-Raf proto-oncogene, BRAF: cobimetinib, dabrafenib, trametinib, and vemurafenib. Oral agents for treatment of prostate cancer include abiraterone acetate and enzalutamide. Oral agents for treatment of renal cell carcinoma include axitinib, everolimus, pazopanib, sorafenib, and sunitinib. Specialty pharmacy services for patients receiving oral oncology agents can include (1) providing patient counseling and education on adverse effects and self-management strategies, (2) processing prior-authorization requests and helping patients navigate copayment assistance programs, and (3) monitoring for medication toxicities and recommending dose adjustments as appropriate.
      CONCLUSION: Many oral oncology medications have been introduced over the past 10-15 years, with many others in clinical development. Due to the complexity of initiating and monitoring patients receiving these oral therapies, specialty pharmacy services are an essential component of many patients' cancer care.

      Jerjian TV, Glode AE, Thompson LA, O'Bryant CL
      Antibody-Drug Conjugates: A Clinical Pharmacy Perspective on an Emerging Cancer Therapy.
      Pharmacotherapy. 2016; 36(1):99-116 [PubMed] Related Publications
      Antibody-drug conjugates (ADCs) combine highly specific monoclonal antibodies with potent cytotoxic drugs. Their synergy allows for targeted delivery of toxic drugs to cancer cells while sparing systemic exposure. In this review, we focus on the history and clinical applications of ADCs approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer and highlight new ADCs in the drug development pipeline. Three ADCs have received FDA approval thus far. Gemtuzumab ozogamicin, although withdrawn from the U.S. market, may still be an effective treatment modality in subsets of patients with acute myeloid leukemia. Brentuximab vedotin and ado-trastuzumab emtansine have shown improved efficacy and safety data compared with standard chemotherapy for the treatment of advanced lymphoma and breast cancer, respectively. With a number of ADCs with promising preliminary data in the clinical trial pipeline, cancer therapy is moving forward from traditional chemotherapy to targeted treatment modalities driven by the specificity of monoclonal antibodies and advancing biotechnology.

      Wang Y, Wu H, Xu F
      Impact of Clinical Pharmacy Services on KAP and QOL in Cancer Patients: A Single-Center Experience.
      Biomed Res Int. 2015; 2015:502431 [PubMed] Free Access to Full Article Related Publications
      This study was to evaluate the efficacy of pharmaceutical intervention (PI) on chemotherapy knowledge-attitude-practice (KAP) and quality of life (QOL) in cancer patients. A prospective, randomized, controlled study was carried out at Oncology Ward in a tertiary hospital affiliated to Southern Medical University, China. Eligible patient was randomly assigned to pharmaceutical intervention (PI) group or control group. Each patient in PI group was given information booklets and was given 30 min face-to-face medication education and psychological counseling by clinical pharmacists, 2 sessions per week for 2 months. Patients in control group only received conventional treatment. All participants were asked to complete a structured Chemotherapy KAP Questionnaire and QOL Questionnaire at pre- and poststudy time. A total of 149 cancer patients (77 in PI group and 72 in control group) completed the study. The baseline scores of KAP and QOL in 2 groups were similar. At the end of study, only knowledge score was significantly increased; meanwhile no difference existed for attitude, practice, and QOL scores in control group; both KAP scores and QOL score were significantly increased in PI group. As for the between-group comparison, both KAP scores and QOL score in PI group were significantly higher than those in control group. In conclusion, pharmaceutical intervention has a positive role in increasing chemotherapy-related knowledge, improving patients' positive emotions, dealing with chemotherapy adverse reactions, and improving the quality of life of patients.

      Ashjian E, Salamin LB, Eschenburg K, et al.
      Evaluation of outpatient medication reconciliation involving student pharmacists at a comprehensive cancer center.
      J Am Pharm Assoc (2003). 2015 Sep-Oct; 55(5):540-5 [PubMed] Related Publications
      OBJECTIVE: To determine the number of discrepancies and medication-related problems found as a result of pharmacy-led medication reconciliation involving introductory pharmacy practice experience (IPPE) students at a comprehensive cancer center.
      SETTING: Outpatient infusion center of a National Cancer Institute (NCI)-designated and National Comprehensive Cancer Network (NCCN) cancer center.
      PRACTICE DESCRIPTION AND INNOVATION: Third-year IPPE students contacted and completed medication reconciliation for 510 hematology/oncology patients scheduled for infusion center appointments without a coupled provider visit. IPPE students discussed the findings of the medication reconciliations with their pharmacist preceptors, who updated the medication histories in the electronic medical record (EMR) and communicated with prescribers directly about identified medication-related problems. All medication reconciliation was documented using a standardized note template in the EMR.
      MAIN OUTCOME MEASURES: Number of medication discrepancies found, including medication additions, medication deletions, dose changes, and herbal product additions; medication-related problems-including drug-drug interactions, untreated indications (e.g., nausea, vomiting, pain, need for prophylactic medications), failure of patients to receive prescribed medications, and adverse drug reactions-were also documented.
      RESULTS: Medication reconciliation was completed for 510 patients through the student pharmacist/pharmacist preceptor-led intervention during a 1-year period between January 1, 2013, and December 31, 2013. A total of 88% of patients had at least one discrepancy identified in their medication history and corrected in the EMR. In addition, 11.4% of patients had a medication-related problem identified.
      CONCLUSIONS: Pharmacy-led medication reconciliation identified a large number of discrepancies among our hematology/oncology patients. This intervention allowed for correction of discrepancies in the EMR leading to improved accuracy of patient medication lists. In addition, it provided a valuable learning experience for student pharmacists.

      Nightingale G, Hajjar E, Guo K, et al.
      A pharmacist-led medication assessment used to determine a more precise estimation of the prevalence of complementary and alternative medication (CAM) use among ambulatory senior adults with cancer.
      J Geriatr Oncol. 2015; 6(5):411-7 [PubMed] Related Publications
      OBJECTIVES: The prevalence of complementary and alternative medication (CAM) use in senior adult oncology (SAO) patients is widely variable and little is known about whether polypharmacy (PP) and potentially inappropriate medication (PIM) use influences CAM use given the increased number of comorbidities and polypharmacy. One approach to optimize medication management is through utilization of pharmacists as part of a team-based, healthcare model.
      MATERIALS AND METHODS: Prevalence of CAM and factors influencing CAM use was examined in a secondary analysis of 248 patients who received an initial comprehensive geriatric oncology assessment between January 2011 and June 2013. Data was collected from electronic medical records. CAM was defined as herbal medications, minerals, or other dietary supplements, excluding vitamins. Patient characteristics influencing CAM use (e.g. comorbidities, PP and PIM use) were analyzed.
      RESULTS: Only 234 patients (evaluated by pharmacists) were included in the final analysis. Mean age was 79.9 years [range 61-98]; 64% women, 74% Caucasian, 87% with a solid tumor, mean comorbidities, 7.69. CAM prevalence was 26.5% (n=62) and median CAM use was 0 (range 0-10). The proportion of CAM use (1, 2, and 3) was 19.2%, 6.4%, and 0.4%, respectively. Associations with CAM use (versus no-CAM) were polypharmacy (P=0.045), vision impairment (P=0.048) and urologic comorbidities (P=0.021).
      CONCLUSIONS: A pharmacist-led comprehensive medication assessment demonstrated a more precise estimation of CAM prevalence in the ambulatory SAO population. CAM use was associated with polypharmacy, ophthalmic and urologic medical conditions. Integrating pharmacists into team-based (geriatric and oncology) care models is an underutilized yet viable solution to optimize medication use.

      Weil E, Oxencis C
      Pharmacist collaborative practice agreement for the management of anemia in malignant disease with erythropoiesis-stimulating agents.
      Support Care Cancer. 2015; 23(8):2507-13 [PubMed] Related Publications
      PURPOSE: Erythropoiesis-stimulating agents (ESAs) reduce transfusions and increase hemoglobin levels in patients with anemia of malignant disease. A medication guideline and pharmacist collaborative practice agreement (CPA) were developed and implemented to standardize ESA prescribing workflow. The use of ESAs in malignant diseases, in accordance with institutional guidelines, was evaluated to ensure safe and effacious use.
      METHODS: An observational study was conducted on all ESA doses given throughout a health system's cancer clinics prior to and after implementation of an ESA guideline and pharmacist CPA. The primary outcome measured was ESA therapy initiated in accordance with guidelines before and after the intervention. Secondary outcomes evaluated were nurse and pharmacist satisfaction, vitals recorded prior to dose, and transfusion rates in patients receiving ESA therapy before and after the intervention.
      RESULTS: In the pre-implementation group, criteria for initiation were not met by any of the 39 patients; prior to therapy, 5.1 % of patients had not had hemoglobin drawn, 23 % of patients had no iron studies completed, and 29.4 % of myelodysplastic syndrome (MDS) patients had no erythropoietin levels drawn. In the post-implementation group, prior to therapy, all patients had hemoglobin levels drawn, 16.67 % did not have iron studies completed, and all MDS patients had erythropoietin levels drawn appropriately. Chemotherapy-induced anemia (CIA) patients in the pre-implementation group had 71.4 % compliance with receiving chemotherapy within 8 weeks of ESA dose, and the post-implementation group had 100 % compliance.
      CONCLUSION: An ESA guideline and pharmacist CPA aligned prescribing practices with the NCCN and ASCO guidelines and improved staff satisfaction.

      Trump D
      Commentary on: "Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): A multicentre, randomised, double-blind, phase 3 trial." Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR, CA184-043 Investigators. Departments of Urology and Immunology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA, Electronic address: kwon.eugene@mayo.edu; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Brady Urological Institute, Baltimore, MD, USA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; Institut Gustave Roussy, University of Paris-Sud, Villejuif, France; Institut Gustave Roussy, Villejuif, France; VU University Medical Centre, Amsterdam, Netherlands; Vienna General Hospital, Medical University Vienna, Vienna, Austria; Institut Bergonié, Bordeaux, France; CHU Caremeau, Nimes, France; Centro Médico Austral, Buenos Aires, Argentina; Centre Jean Perrin, Clermont-Ferrand, France; St John of God Hospital, Subiaco, WA, Australia; University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; Hospital de Caridade de Ijuí, Ijuí, Brazil; Nottingham University Hospital, Nottingham, UK; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania; Hospital Británico de Buenos Aires, Buenos Aires, Argentina; Herlev Hospital, Herlev, Denmark; Odense University Hospital, Odense, Denmark; University of Texas MD Anderson Cancer Center, Houston,
      Urol Oncol. 2016; 34(5):249-50 [PubMed] Related Publications
      BACKGROUND: Ipilimumab is a fully human monoclonal antibody that binds cytotoxic T-lymphocyte antigen 4 to enhance antitumour immunity. Our aim was to assess the use of ipilimumab after radiotherapy in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel chemotherapy.
      METHODS: We did a multicentre, randomised, double-blind, phase 3 trial in which men with at least one bone metastasis from castration-resistant prostate cancer that had progressed after docetaxel treatment were randomly assigned in a 1:1 ratio to receive bone-directed radiotherapy (8Gy in one fraction) followed by either ipilimumab 10mg/kg or placebo every 3 weeks for up to four doses. Non-progressing patients could continue to receive ipilimumab at 10mg/kg or placebo as maintenance therapy every 3 months until disease progression, unacceptable toxic effect, or death. Patients were randomly assigned to either treatment group via a minimisation algorithm, and stratified by Eastern Cooperative Oncology Group performance status, alkaline phosphatase concentration, haemoglobin concentration, and investigator site. Patients and investigators were masked to treatment allocation. The primary endpoint was overall survival, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT00861614.
      FINDINGS: From May 26, 2009, to Feb 15, 2012, 799 patients were randomly assigned (399 to ipilimumab and 400 to placebo), all of whom were included in the intention-to-treat analysis. Median overall survival was 11.2 months (95% CI: 9.5-12.7) with ipilimumab and 10.0 months (8.3-11.0) with placebo (hazard ratio [HR] = 0.85, 0.72-1.00; P = 0.053). However, the assessment of the proportional hazards assumption showed that it was violated (P = 0.0031). A piecewise hazard model showed that the HR changed over time: the HR for 0-5 months was 1.46 (95% CI: 1.10-1.95), for 5-12 months was 0.65 (0.50-0.85), and beyond 12 months was 0.60 (0.43-0.86). The most common grade 3-4 adverse events were immune-related, occurring in 101 (26%) patients in the ipilimumab group and 11 (3%) of patients in the placebo group. The most frequent grade 3-4 adverse events included diarrhoea (64 [16%] of 393 patients in the ipilimumab group vs seven [2%] of 396 in the placebo group), fatigue (40 [11%] vs 35 [9%]), anaemia (40 [10%] vs 43 [11%]), and colitis (18 [5%] vs 0). Four (1%) deaths occurred because of toxic effects of the study drug, all in the ipilimumab group.
      INTERPRETATION: Although there was no significant difference between the ipilimumab group and the placebo group in terms of overall survival in the primary analysis, there were signs of activity with the drug that warrant further investigation.
      FUNDING: Bristol-Myers Squibb.

      King AC, Ma MQ, Chisholm G, Toale KM
      Once daily versus twice daily enoxaparin for acute pulmonary embolism in cancer patients.
      J Oncol Pharm Pract. 2016; 22(2):265-70 [PubMed] Related Publications
      BACKGROUND: Venous thromboembolism (VTE) is a condition in which a thrombus occludes the vasculature. The incidence of VTE in cancer patients is three times higher than that of the general population. Enoxaparin 1 mg/kg subcutaneously (SC) twice daily and enoxaparin 1.5 mg/kg SC once daily are both FDA-approved dosing regimens for the treatment of pulmonary embolism (PE). The objectives of this study were to assess outcomes of cancer patients treated with once or twice daily enoxaparin for acute PE. Primary outcomes included recurrent or worsening PE and secondary outcomes included mortality or signs of clinically overt, major bleeding.
      METHODS: This study was a retrospective chart review of adult cancer patients treated at The University of Texas MD Anderson Cancer Center from 2011 to 2013 who received either 1 mg/kg twice daily or 1.5 mg/kg once daily enoxaparin for acute PE upon discharge.
      RESULTS: Among 48 patients in each the twice daily and once daily group, six recurrent PEs occurred. The incidence of recurrent PE was higher in the once daily group (n = 4) versus twice daily group (n = 2). More major bleeding events occurred in the once daily group than the twice daily group (15% vs. 6%). Mortality at 6 months was higher in the twice daily group versus once daily group (13% vs. 6%).
      CONCLUSION: Cancer patients receiving once daily enoxaparin for the treatment of acute PE may be at increased risk of recurrent PE and clinically overt bleeding. Larger randomized trials are needed to confirm the results of this study.

      Wilbur K, Babiker A, Al-Okka M, et al.
      Risk communication with Arab patients with cancer: a qualitative study of nurses and pharmacists.
      BMJ Open. 2015; 5(4):e006890 [PubMed] Free Access to Full Article Related Publications
      OBJECTIVES: To explore pharmacist and nurse views and experiences in educating patients regarding their treatment safety and tolerability as well as the roles of other professions in this regard.
      DESIGN: In this qualitative study, six focus group discussions were conducted.
      SETTING: The National Center for Cancer Care and Research in Qatar.
      PARTICIPANTS: Eleven pharmacists and 22 nurses providing direct patient care.
      RESULTS: Concepts related to three key themes were drawn from the seeding questions and included factors for determining the level of risk they communicated: the specific treatment regimen in question; the patient; and their assessment of the patient. Patient-related considerations arose from additional subthemes; both nurses and pharmacists described aspects related to the perceived psychological health status of the patient, as well as anticipated comprehension, as ascertained by demonstrated education and language abilities. In all discussions, it was noted that physician and family non-disclosure of cancer diagnosis to the patient profoundly influenced the nature of information they provided. While a high level of cohesion in safety communication prioritisation among these two health disciplines was found, a number of pharmacists asserted a more formal role compared to informal and repeated teaching by nurses.
      CONCLUSIONS: Nurses and pharmacists in this Middle East healthcare environment were not reluctant to discuss treatment side effects with patients and draw on similar professional judgements in prioritising treatment risk information. We found that they did not always recognise each other's informal educational encounters and that there are opportunities to explore increased collaboration in this regard to enhance the patient care experience.

      Dao BD, Ho H, Quintal LN
      Combination pertuzumab, trastuzumab, and taxane for metastatic breast cancer after first progression: a single institution's experience.
      J Oncol Pharm Pract. 2016; 22(2):261-4 [PubMed] Related Publications
      BACKGROUND: The addition of pertuzumab to trastuzumab and taxane therapy was shown to be an effective first-line treatment for patients with HER2-positive metastatic breast cancer.
      OBJECTIVE: Describe the progression-free survival of pertuzumab, trastuzumab, and taxane therapy for previously treated HER2-positive metastatic breast cancer.
      METHODS: This case-series reviews 19 patients with metastatic breast cancer receiving treatment with pertuzumab, trastuzumab, taxane after progression and exposure to previous lines of HER2-directed therapy. Progression-free survival and adverse effects such as changes in ejection fraction and episodes of neutropenic fever were assessed.
      RESULTS: The median progression-free survival of pertuzumab, trastuzumab, taxane therapy for previously treated metastatic breast cancer was 4.1 months. The mean baseline left ventricular ejection fraction change experienced by patients was -1%. Neutropenic fever events were not encountered.
      CONCLUSIONS: Pertuzumab, trastuzumab, and taxane therapy seems to confer progression-free survival benefit for previously treated metastatic breast cancer. The use of the dual anti-HER2 antibodies, pertuzumab and trastuzumab, in addition to cytotoxic chemotherapy agents for previously treated metastatic breast cancer should be further evaluated.

      Nightingale G, Hajjar E, Swartz K, et al.
      Evaluation of a pharmacist-led medication assessment used to identify prevalence of and associations with polypharmacy and potentially inappropriate medication use among ambulatory senior adults with cancer.
      J Clin Oncol. 2015; 33(13):1453-9 [PubMed] Related Publications
      PURPOSE: The use of multiple and/or inappropriate medications in seniors is a significant public health problem, and cancer treatment escalates its prevalence and complexity. Existing studies are limited by patient self-report and medical record extraction compared with a pharmacist-led comprehensive medication assessment.
      PATIENTS AND METHODS: We retrospectively examined medication use in ambulatory senior adults with cancer to determine the prevalence of polypharmacy (PP) and potentially inappropriate medication (PIM) use and associated factors. PP was defined as concurrent use of five or more and less than 10 medications, and excessive polypharmacy (EPP) was defined as 10 or more medications. PIMs were categorized by 2012 Beers Criteria, Screening Tool of Older Person's Prescriptions (STOPP), and the Healthcare Effectiveness Data and Information Set (HEDIS).
      RESULTS: A total of 248 patients received a geriatric oncology assessment between January 2011 and June 2013 (mean age was 79.9 years, 64% were women, 74% were white, and 87% had solid tumors). Only 234 patients (evaluated by pharmacists) were included in the final analysis. Mean number of medications used was 9.23. The prevalence of PP, EPP, and PIM use was 41% (n = 96), 43% (n = 101), and 51% (n = 119), respectively. 2012 Beers, STOPP, and HEDIS criteria classified 173 occurrences of PIMs, which were present in 40%, 38%, and 21% of patients, respectively. Associations with PIM use were PP (P < .001) and increased comorbidities (P = .005).
      CONCLUSION: A pharmacist-led comprehensive medication assessment demonstrated a high prevalence of PP, EPP, and PIM use. Medication assessments that integrate both 2012 Beers and STOPP criteria and consider cancer diagnosis, prognosis, and cancer-related therapy are needed to optimize medication use in this population.

      Hewett YG, Uprety D, Shah BK
      Idelalisib- a PI3Kδ targeting agent for B-cell malignancies.
      J Oncol Pharm Pract. 2016; 22(2):284-8 [PubMed] Related Publications
      Idelalisib, the first in-class phosphotidlyinositol 3-kinase delta (PI3Kδ) inhibitor, was approved by the US Food and Drug Administration in July 2014. It simultaneously received breakthrough therapy designation in combination with rituximab for the treatment of relapsed chronic lymphocytic leukemia (CLL) as well as accelerated approval as monotherapy for the treatment of relapsed follicular lymphoma and relapsed small lymphocytic lymphoma. In a pivotal phase III study of 220 patients with relapsed CLL, the overall response rate of patients who received rituximab plus idelalisib was 81%. The median progression-free survival (PFS) was 5 months with rituximab plus placebo group, but was not reached in the idelalisib arm. At 24 weeks, the PFS in patients receiving idelalisib was 93%. In a phase II trial of 125 patients with relapsed or refractory indolent non-Hodgkin lymphoma who received idelalisib 150 mg twice daily, the response rate was 57%. Complete response was seen in 6% of patients. The median duration of response was 12.5 months, and median PFS was 11 months. Idelalisib is a promising new therapy for relapsed indolent B-cell malignancies.

      Ashjian E, Redic K
      Multiple myeloma: Updates for pharmacists in the treatment of relapsed and refractory disease.
      J Oncol Pharm Pract. 2016; 22(2):289-302 [PubMed] Related Publications
      There have been a number of recent advances in the treatment of patients with relapsed and refractory multiple myeloma. However, despite additional FDA-approved therapies including carfilzomib and pomalidomide as well as clinical trials investigating new combinations of existing treatments, multiple myeloma remains an incurable disease. New therapies currently in the drug development pipeline for relapsed and refractory disease include additional proteasome inhibitors (oprozomib, marizomib, ixazomib), histone deacetylase inhibitors (panobinostat, ricolinostat, quisinostat), monoclonal antibodies (daratumumab, elotuzumab, SAR650984), Bruton's tyrosine kinase inhibitors (ibrutinib), a selective inhibitor of nuclear export, and others. This review will focus on these newly developing therapies as well as the ever expanding role of the pharmacist in supportive care for patients with relapsed and refractory multiple myeloma.

      Debruyne PR, Johnson PJ, Pottel L, et al.
      Optimisation of pharmacy content in clinical cancer research protocols: Experience of the United Kingdom Chemotherapy and Pharmacy Advisory Service.
      Clin Trials. 2015; 12(3):257-64 [PubMed] Related Publications
      BACKGROUND: Clarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in such protocols have the potential to delay research and jeopardise both patient safety and collection of credible data. The Chemotherapy and Pharmacy Advisory Service was established by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical research protocols. This article reports the scope of Chemotherapy and Pharmacy Advisory Service, its methodology of mandated protocol review and pharmacy-related guidance initiatives and its current impact.
      METHODS: Over a 6-year period (2008-2013) since the inception of Chemotherapy and Pharmacy Advisory Service, cancer clinical trial protocols were reviewed by the service, prior to implementation at clinical trial sites. A customised Review Checklist was developed and used by a panel of experts to standardise the review process and report back queries and inconsistencies to chief investigators. Based on common queries, a Standard Protocol Template comprising specific guidance on drug-related content and a Pharmacy Manual Template were developed. In addition, a guidance framework was established to address 'ad hoc' pharmacy-related queries. The most common remarks made at protocol review have been summarised and categorised through retrospective analysis. In order to evaluate the impact of the service, chief investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from chief investigators have been collated and acceptance rates determined.
      RESULTS: A total of 176 protocols were reviewed. The median number of remarks per protocol was 26, of which 20 were deemed clinically relevant and mainly concerned the drug regimen, support medication, frequency and type of monitoring and drug supply aspects. Further analysis revealed that 62% of chief investigators responded to the review. All responses were positive with an overall acceptance rate of 89% of the proposed protocol changes.
      CONCLUSION: Review of pharmacy content of cancer clinical trial protocols is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the majority of suggestions were effectively incorporated in the final protocols. The refinement of existing and development of new pharmacy-related guidance documents by Chemotherapy and Pharmacy Advisory Service might aid in better and safer clinical research.

      Dede RJ, Pruemer JM
      Comparing venous thromboembolism prophylactic strategies for ambulatory multiple myeloma patients on immunomodulatory drug therapy.
      J Oncol Pharm Pract. 2016; 22(2):248-55 [PubMed] Related Publications
      PURPOSE: Patients with multiple myeloma have an increased incidence of venous thromboembolism. The risk for venous thromboembolism further increases when these patients are placed on immunomodulatory drug therapy. This study aims to determine the incidence of venous thromboembolism in patients with multiple myeloma receiving immunomodulatory drug therapy in the ambulatory setting at UC Health and to investigate adherence with guidelines developed by The National Comprehensive Cancer Network for venous thromboembolism prevention in this patient population.
      METHODS: A retrospective chart review of patients with multiple myeloma initiated on immunomodulatory drug therapy between January 2000 and January 2014 was conducted.
      RESULTS: Sixty-two cases met inclusion criteria and were included for analysis. The National Comprehensive Cancer Network guidelines were followed in 33.9% of cases. The rate of venous thromboembolism was 4.8% in guideline adherent cases and 12.2% in guideline nonadherent cases (p = 0.65). The overall incidence of venous thromboembolism was 9.7%. No patients on a low-molecular-weight-heparin agent or warfarin developed a venous thromboembolism, 7.9% patients on aspirin therapy developed a venous thromboembolism, and 23.1% patients on no pharmacologic thromboprophylaxis developed a venous thromboembolism (p = 0.26).
      CONCLUSION: Ambulatory patients with multiple myeloma who are considered for immunomodulatory drug therapy should be placed on pharmacologic thromboprophylaxis based on individual venous thromboembolism and bleeding risk factors. This study identified the need for increased adherence to national guidelines for venous thromboembolism prevention in patients with multiple myeloma receiving immunomodulatory drug therapy so as to increase the quality of care provided at UC Health.

      Mainor CB, Duffy AP, Atkins KL, et al.
      Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia in pregnancy.
      J Oncol Pharm Pract. 2016; 22(2):374-7 [PubMed] Related Publications
      BCR-ABL inhibitors administered in conjunction with chemotherapy have significantly improved outcomes in Philadelphia chromosome-positive acute lymphoblastic leukemia but, for patients diagnosed during pregnancy, data on risks to the fetus are limited. We report a woman treated with chemotherapy and imatinib mesylate who delivered a healthy baby at 30 weeks, and we discuss available data.

      Ojeda-Uribe M, Merieau S, Guillon M, et al.
      Secondary thrombotic microangiopathy in two patients with Philadelphia-positive hematological malignancies treated with imatinib mesylate.
      J Oncol Pharm Pract. 2016; 22(2):361-70 [PubMed] Related Publications
      Drug-mediated thrombotic microangiopathy may cause life-threatening medical emergencies. Novel targeted therapies have dramatically changed the prognosis of a number of oncological diseases. Tyrosine kinase inhibitors of the Breakpoint Cluster Region-Abelson (BCR-ABL) oncoprotein are used in patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. Imatinib mesylate, which was the first anti-BCR-ABL tyrosine kinase inhibitor, has demonstrated a high tolerance profile and efficacy in these patients for many years. Good results have also been observed in patients with gastrointestinal stromal tumors. In this study, we describe two patients with Philadelphia chromosome-positive hematological malignancies who presented with secondary thrombotic microangiopathy that was most likely linked to the use of imatinib. Other potential causes of thrombotic microangiopathy were discarded, and the predisposing role of some comorbidities and potential short or long-term drug-drug interactions was assessed. The clinical and biological data were more indicative of atypical secondary hemolytic uremic syndrome in one of the cases and of secondary thrombotic microangiopathy with renal and cardiac impairment in the other, which is also categorized as secondary hemolytic uremic syndrome. The outcome was favorable after imatinib discontinuation and the treatment of severe cardiac and renal failures.

      Bergsbaken JJ, Eickhoff JC, Buss BA, et al.
      Assessment of adherence with oral anticancer agents in oncology clinical trials: A systematic review.
      J Oncol Pharm Pract. 2016; 22(1):105-13 [PubMed] Related Publications
      BACKGROUND: Despite recommendations for adherence reporting in clinical trials involving an oral anticancer agent, the frequency and methods of adherence reporting are inconsistent. The purpose of this systematic review is to determine the frequency and type of adherence measures used in oncology and hematology clinical trials of oral anticancer agents and their association with study characteristics including quality, cancer type, stage and treatment type.
      DESIGN: PubMed was searched of all randomized controlled clinical trials assessing self-administered pharmacological interventions in patients with cancer and published over two years, between 1 January 2011 and 31 December 2012 were evaluated.
      RESULTS: We identified 70 publications in the PubMed database, comprising 45,118 total patients. Adherence reporting was present in 14 of 70 trials (20%); quantitative reporting was present in three of 70 trials (4%). Method of adherence assessment varied and included medication count, medication diaries and patient self-report. There was no association between adherence reporting and study quality or other study characteristics, although there was a trend towards increased reporting in breast cancer studies, with 46% of the studies reporting adherence (p = 0.0621). In a preliminary analysis, hematology studies (mean Jadad score 2.19 ± 1.47) were found to have significantly lower quality when compared to non-hematology trials (mean Jadad score 3.39 ± 1.37, p = 0.0034).
      CONCLUSION: This systematic review demonstrates adherence reporting in clinical trials of oral anticancer agents is infrequent. When reported, adherence was not associated with overall study quality or other study characteristics. Given the potential effects of non-adherence on study power and validity, adherence reporting should be encouraged in oncology and hematology clinical trials.

      de Souza CM, Visacri MB, Ferrari GB, et al.
      Nausea, vomiting and quality of life of patients with cancer undergoing antineoplastic treatment: an evaluation by pharmacists.
      Int J Pharm Pract. 2015; 23(5):357-60 [PubMed] Related Publications
      OBJECTIVE: This study aims to evaluate the frequency and severity of nausea and vomiting using two different instruments and relate them to quality of life (QOL) in patients with cancer receiving antineoplastic treatment.
      METHODS: Severity of chemotherapy-induced nausea and vomiting (CINV) was measured by Common Terminology Criteria for Adverse Events (CTCAE) and a numerical scale. QOL was assessed using the Functional Assessment of Cancer Therapy-General questionnaire.
      KEY FINDINGS: Of the 50 patients studied, 60.0% reported nausea (40.0% CTCAE grade 1; 66.7% moderate intensity on numerical scale) and 30.0% reported vomiting (46.7% CTCAE grades 1 and 2, each; 66.7% moderate intensity on numerical scale). CINV did not influence overall QOL.
      CONCLUSION: The frequency of CINV was high. There was no association between nausea/vomiting and overall QOL.

      Musri FY, Mutlu H, Kıvrak Salim D, et al.
      Sorafenib-induced severe urticaria in a patient with hepatocellular cancer.
      J Oncol Pharm Pract. 2016; 22(2):350-3 [PubMed] Related Publications
      Sorafenib which is used in the treatment of renal, thyroid and hepatocellular cancers is a multi-targeted tyrosine kinase inhibitor. Though sorafenib is associated with some side effects, it is known that sorafenib is generally well tolerated compared to other tyrosine kinase inhibitors. In the present case, hepatocellular cancer was diagnosed seven months ago. The disease was in stage IIIB at the time of diagnosis. Sorafenib was initiated with a dose of 400 mg twice daily because of disease progression after two cycles of doxorubicin. The reactions on the skin of the arms and the body of the patient occurred in the eighth week of treatment. Skin biopsy was performed and urticaria was diagnosed after pathologic examination. No other disorders or drugs which may cause urticaria were detected in the patient. Skin reactions disappeared one week after sorafenib discontinuation without any further intervention.

      Kaminski KS, Beach CL, Peden DB, et al.
      Successful use of palifermin following severe anaphylaxis to pegaspargase in a pediatric patient with acute lymphoblastic leukemia.
      J Oncol Pharm Pract. 2016; 22(2):354-6 [PubMed] Related Publications
      Palifermin and pegaspargase are Escherichia coli-derived drug products. Hypersensitivity reactions, including anaphylaxis, are frequently reported with pegaspargase. In high-risk acute lymphoblasic leukemia (ALL), patients undergoing allogeneic hematopoietic stem cell transplant may be treated with palifermin as a supportive care measure for mucositis prophylaxis. However, no literature exists documenting the cross-reactivity between palifermin and pegaspargase. We report a case in which a child with very high-risk ALL having experienced severe anaphylaxis with pegaspargase was later successfully treated with palifermin during stem cell transplant conditioning.

      Gunaldi M, Duman BB, Afsar CU, et al.
      Risk factors for developing cardiotoxicity of trastuzumab in breast cancer patients: An observational single-centre study.
      J Oncol Pharm Pract. 2016; 22(2):242-7 [PubMed] Related Publications
      BACKGROUND: Trastuzumab is a recombinant humanized monoclonal antibody used to treat human epidermal growth factor receptor 2 positive breast cancer, with recognized associated cardiotoxicity. In this retrospective observational study, we investigated associated cardiotoxicity on clinical outcomes using trastuzumab in women referred to our clinic.
      MATERIALS AND METHODS: The study was made up of 111 women with human epidermal growth factor receptor 2-overexpressing breast cancer who received trastuzumab in the Medical Oncology Department, between 2010 and 2013.
      RESULTS: A > 10% reduction of the baseline fraction of the left ventricular ejection fraction was observed in 18 (16.21%) women. Two individuals (1.8%) suffered from symptomatic heart failure, seven women showed cardiac symptoms and nine women showed asymptomatic decline of left ventricular ejection fraction. Risk factors for cardiotoxicity in the group included: postmenopausal status (p = 0.01), hypertension (p = 0.002), obesity (p = 0.0001), previously diagnosed coronary artery disease (p = 0.0001) and smoking (p = 0.03).
      CONCLUSION: The aforementioned factors pose a risk for cardiotoxicity. We found postmenopausal status, hypertension, obesity, previous coronary artery disease and smoking to be associated with an increased risk of cardiac dysfunction in women using trastuzumab. While administering trastuzumab to women who have these conditions, one must be aware of the risk of cardiotoxicity of trastuzumab.

      Nguyen AD, Heil EL, Patel NK, et al.
      A single-center evaluation of the risk for colonization or bacteremia with piperacillin-tazobactam- and cefepime-resistant bacteria in patients with acute leukemia receiving fluoroquinolone prophylaxis.
      J Oncol Pharm Pract. 2016; 22(2):303-7 [PubMed] Related Publications
      Fluoroquinolone prophylaxis is indicated to prevent neutropenic fever in patients with acute leukemia. However, fluoroquinolone use has been associated with development of multi-drug-resistant Pseudomonas aeruginosa and extended spectrum β-lactamase producing gram-negative bacilli. Due to a presumed risk of multi-drug resistance associated with fluoroquinolone prophylaxis, patients admitted to our hospital with neutropenic fever receive empiric carbapenem therapy until cultures are negative for 72 h or identification of an organism. Our study seeks to identify the incidence of multi-drug-resistant organism colonization and bacteremia among patients who receive fluoroquinolone prophylaxis and to evaluate duration of empiric carbapenem therapy. A retrospective review of adult patients with acute leukemia receiving a fluoroquinolone as outpatient infection prophylaxis, admitted to our tertiary cancer center for treatment of neutropenic fever was completed. Surveillance and blood cultures were reviewed for antibiotic resistance. Duration of empiric carbapenem therapy was reviewed. One hundred patients and 177 admissions for neutropenic fever were included. Six patients harbored a piperacillin-tazobactam-resistant organism found during routine surveillance. Among these patients, two bacteremias were identified, one of which was a piperacillin-tazobactam-resistant organism. Five bacteremias were identified among 83 patients with negative surveillance cultures. Among the bloodstream infections, five organisms isolated were fluoroquinolone resistant. No cefepime-resistant organism was isolated on surveillance or bloodstream cultures. Adherence to the institution guideline of narrowing antibiotics after 72 h of negative cultures occurred in only 13% of neutropenic fever cases. The average duration of carbapenem therapy in 177 neutropenic fever episodes was 4.4 days. Our findings show that among our patient population, there is a low risk of bacteremia with a piperacillin-tazobactam-resistant or cefepime-resistant organism. However, prompt de-escalation of carbapenem therapy needs to be reiterated within hospital practice.

      Tanriverdi O, Ogunc H
      A case report of three patients with metastatic gastric cancer on hemodialysis who were treated with cisplatin-fluorouracil regimen.
      J Oncol Pharm Pract. 2016; 22(2):345-9 [PubMed] Related Publications
      Gastric carcinoma is the first cause of death worldwide. In previous studies that included best supportive care and chemotherapy comparison, chemotherapy survival time was four to five months more than best supportive care. This time was reported as seven to nine months in cisplatin and fluorouracil therapy. We aimed to call attention to non-progression survival time which was being longer with cisplatin and fluorouracil therapy in three metastatic gastric carcinoma patients who were on hemodialysis due to chronic renal impairment related to diabetic nephropathy. We determined that this regimen was well tolerated with hemodialysis, and the median time to progression was eight months (range 7-10). This time was similar to the time results of previous studies. In our hypothesis, hemodialysis may increase the time to progression significantly and we aimed to discuss the hypothetical relation between dialysis membrane and circulating tumor cells.

      Delpeuch A, Leveque D, Gourieux B, Herbrecht R
      Impact of clinical pharmacy services in a hematology/oncology inpatient setting.
      Anticancer Res. 2015; 35(1):457-60 [PubMed] Related Publications
      BACKGROUND/AIM: Clinical pharmacists are contributing to safe medication use by providing comprehensive management to patients and medical staff. However, little is known regarding their impact in oncology. The aim of this study was to document and evaluate the role of clinical pharmacy services in a hematology/oncology department.
      PATIENTS AND METHODS: A prospective, descriptive, observational study was carried out from May 2012 to May 2013. Medication reviews concerning hospitalized adult cancer patients were performed twice a week. Medication problems, pharmaceutical interventions and acceptance rate by the oncologists were recorded by a clinical pharmacist.
      RESULTS: A total of 4,393 prescriptions (including chemotherapy and support) of 489 adult cancer patients (mean age=63 years) were analyzed. The pharmacist identified 552 drug-related problems (12.6% of the prescriptions) primarily related to anti-infective agents (59.5%). Medication problems included inappropriate medications (20.6%), untreated indications (14.8%), inappropriate administrations (14.1%), underdosing (11.7%), drug-drug interactions (14.3%), lack of monitoring (9.6%), overdosing (8.9%), administration omissions (3.5%) and side-effects (2.5%). Interventions (n=552) led to treatment discontinuation (26.2%), drug dosing adjustments (21.5%), drug additions (16.9%), alternate routes of administration (11.7%), replacement of a drug by another one (10.7%), therapeutic drug monitoring (10.3%) and optimizing administration (2.6%). Most (96%) of the interventions were accepted and implemented by the medical staff.
      CONCLUSION: The integration of clinical pharmacy services resulted in drug-specific interventions in 12.6 % of the prescriptions of hospitalized adult patients with cancer. Medication problems mostly concerned anti-infective agents. The intervention acceptance rate by oncologists was high. The outcome of care in the hematology/oncology inpatient setting remains to be measured.

      Skledar SJ, Doedyns A, Yourich B
      Building an outpatient cancer center pharmacy program across a tristate region.
      Am J Health Syst Pharm. 2015; 72(2):126-32 [PubMed] Related Publications
      PURPOSE: The transition to a hybrid model of oncology pharmacy services including remote order verification across a regional network of cancer centers is described.
      SUMMARY: Five years ago the University of Pittsburgh Medical Center (UPMC) began a major expansion of its cancer care services, gradually integrating 19 community-based physician practice sites into its tristate oncology network as affiliated hospital-based clinics (HBCs). The network expansion was achieved through a stepwise process including (1) development of oncology medication protocols, (2) interdisciplinary efforts to modify oncology care workflows, (3) implementation of a hybrid practice model to optimize the use of clinical pharmacy resources, and (4) focused staff training programs. Under the hybrid practice model, first checks of antineoplastic medication orders, premedication orders, and laboratory values are performed by either onsite or remote pharmacists, with all second checks performed remotely. In 2013, network pharmacists implemented large numbers of medication therapy interventions to improve chemotherapy and biological response modifier dosing (n = 641) and nonchemotherapy medication use (n = 1082); other documented interventions included patient counseling to help optimize the use of erythropoietin-stimulating agents and other medications (n = 441) and anticoagulation-related dosing adjustments and patient education (n = 102).
      CONCLUSION: Nineteen ambulatory care centers were successfully integrated into the UPMC oncology network as affiliated HBCs through a stepwise process that included workflow modifications, staff training, and a hybrid pharmacy services model that ensures a two-pharmacist check of antineoplastic orders in accordance with regulatory and quality standards.

      Avery M, Williams F
      The importance of pharmacist providing patient education in oncology.
      J Pharm Pract. 2015; 28(1):26-30 [PubMed] Related Publications
      The world's increasing diversity requires health care professionals to adjust delivery methods of teaching to accommodate different cultural values and beliefs. The ability to communicate effectively across languages and various cultural practices directly affects patient education outcomes. Pharmacist should be aware of varying modalities and considerations when counseling a patient diagnosed with cancer and undergoing chemotherapy. In more recent years, the medical profession has seen an increase in patient outcomes due to using the multidisciplinary team approach and has benefited by implementing Medication Therapy Management (MTM) programs at various institutions. For the clinical pharmacist, this would mean documentation for these services should be precise and accurate based on the specific patients needs. There are several factors involved in the care and therapy of the patient with cancer. Clinical oncology pharmacist should be aware of the ever-changing role in oncology and be able to implement new practices at their facility for better patient outcomes.

      Tonyali O, Sumbul AT, Ozturk MA, et al.
      A case of rectal adenocarcinoma presented with palatine tonsil metastasis.
      J Oncol Pharm Pract. 2016; 22(2):341-3 [PubMed] Related Publications
      The most common metastatic sites of colorectal cancer are liver, lung, peritoneum and lymph nodes. Metastasis of colorectal carcinoma to palatine tonsil is rarely seen. To our knowledge, only 11 patients were documented in English literature. Atypical metastases can sometimes lead to misdiagnosis. Precise diagnosis of atypical metastases requires a careful physical examination, good imaging method and comprehensive pathological evaluation. Here, we report a case of rectal adenocarcinoma presented with palatine tonsil metastasis.

      Land JD, Chen AH, Atkinson BJ, et al.
      Proteinuria with first-line therapy of metastatic renal cell cancer.
      J Oncol Pharm Pract. 2016; 22(2):235-41 [PubMed] Related Publications
      BACKGROUND: Vascular endothelial growth factor receptor inhibitors, mammalian target of rapamycin inhibitors, and tyrosine kinase inhibitors are approved for metastatic renal cell cancer. Proteinuria can occur, but there is limited data regarding the incidence, monitoring, and management in metastatic renal cell cancer patients.
      OBJECTIVE: Our primary objective was to describe the incidence and severity of proteinuria in metastatic renal cell cancer patients treated in the first-line setting with pazopanib, bevacizumab, or everolimus.
      METHODS: We conducted a retrospective review of patients with metastatic renal cell cancer enrolled from January 2011-April 2013 in a phase II trial. Baseline and toxicity data were extracted from the electronic medical record. Descriptive statistics were used.
      RESULTS: In all, 129 patients were eligible for analysis. The overall incidence of proteinuria was 81%, with most events being Grade 1 or 2. The incidence of proteinuria was 80% (n = 35) for pazopanib, 64% (n = 25) for bevacizumab, and 96% (n = 44) for everolimus. At peak proteinuria, 80% (n = 28), 64% (n = 16), and 80% (n = 35) of patients on pazopanib, bevacizumab, and everolimus, respectively, were managed with continued monitoring at the same dose. The overall incidence of Grades 3 and 4 events was 24% (n = 6) and found in the bevacizumab group.
      CONCLUSION: A high incidence of proteinuria with minor severity within each class was demonstrated. It may be reasonable to continue therapy at the same dose for Grade 1 or 2 proteinuria. Treatment modification or discontinuation of therapy may be warranted with Grade 3 or 4 proteinuria.

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