Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
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J Oncol Pharm Pract · Feb 2016
ReviewAssessment of adherence with oral anticancer agents in oncology clinical trials: A systematic review.
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. ⋯ 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.
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J Oncol Pharm Pract · Feb 2016
ReviewA review of a novel, Bruton's tyrosine kinase inhibitor, ibrutinib.
Ibrutinib, a Bruton's kinase inhibitor, was granted an accelerated approval by the US Food and Drug Administration in November, 2013, for the treatment of relapsed or refractory mantle cell lymphoma and subsequently for the treatment of relapsed refractory chronic lymphocytic leukemia in February, 2014. In the pivotal phase 2 study of 111 patients with relapsed or refractory mantle cell lymphoma, the overall response rate in patients who received ibrutinib 560 mg daily was 68%. The median progression-free survival was 13.9 months, and the overall survival was 58% at 18 months. ⋯ Ibrutinib, as a monotherapy, is an effective treatment modality as a salvage therapy for treatment of mantle cell lymphoma and chronic lymphocytic leukemia / small lymphocytic lymphoma, particularly in older patients (age ≥70 years) who are not a candidate for intensive chemotherapy and/or those with del (17 p). In patients with chronic lymphocytic leukemia and del (17 p), the current practice guideline recommends ibrutinib as an upfront treatment option. Current on-going trials will further define its role as upfront therapy and/or as a combination therapy in indolent B-cell lymphoid malignancies.