Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance).

BACKGROUND: This multicenter, randomized phase 2 trial evaluated complete responses (CRs), efficacy, and safety with ofatumumab and bendamustine and with ofatumumab, bendamustine, and bortezomib in patients with untreated, high-risk follicular lymphoma (FL). METHODS: Patients with grade 1 to 3a FL and either a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2 with 1 lymph node >6 cm or an FLIPI score of 3 to 5 were randomized to arm A (ofatumumab, bendamustine, and maintenance ofatumumab) or to arm B (ofatumumab, bendamustine, bortezomib, and maintenance ofatumumab and bortezomib). RESULTS: One hundred twenty-eight patients (66 in arm A and 62 in arm B) received treatment. The median age was 61 years, and 61% had disease >6 cm; 29% had an FLIPI score of 2, and 71% had an FLIPI score of 3 to 5. In arm A, 86% completed induction, and 64% completed maintenance. In arm B, 66% and 52% completed induction and maintenance, respectively. Dose modifications were required in 65% and 89% in arms A and B, respectively. Clinically significant grade 3 to 4 toxicities included neutropenia (A, 36%; B, 31%), nausea/vomiting (A, 0%; B, 8%), diarrhea (A, 5%; B, 11%), and sensory neuropathy (A, 0%; B, 5%). The estimated CR rates were 62% (95% confidence interval [CI], 50%-74%) and 60% (95% CI, 47%-72%) in arms A and B, respectively (P = .68). With a median follow-up of 3.3 years, the estimated 2-year progression-free survival (PFS) and overall survival (OS) rates were 80% and 97%, respectively, for arm A and 76% and 91%, respectively, for arm B. CONCLUSIONS: The CR rates, PFS, and OS were not improved with the addition of bortezomib to ofatumumab and bendamustine in patients with high-risk FL. Although grade 3 to 4 toxicities were similar, more patients treated with bortezomib required dose modifications and early discontinuation.

Workplace injury management: using new technology to deliver and evaluate physician continuing medical education.

OBJECTIVE: Physicians typically receive little continuing medical education (CME) about their role in workplace injury management as well as on workplace injuries and disease. Although new technologies may help educate physicians in these areas, careful evaluation is required, given the understudied nature of these interventions. The objective of this study is to evaluate two promising new technologies to deliver CME (online learning and videoconferencing) and to compare the effectiveness of these delivery methods to traditional CME interventions (large urban traditional conference lectures and small group local face-to-face outreach) in their impact on physician knowledge related to workplace injury management. METHODS: This study utilized a prospective, controlled evaluation of two educational programs for BC physicians: 1) The Diagnosis and Management of Lateral Epicondylitis; and 2) Is Return-to-Work Good Medicine? Each educational module was delivered in each of four ways (Outreach Visit, Videoconference Session, Conference Lecture, Online) and physicians self-selected their participation--both in terms of topic and delivery method. Questionnaires related to knowledge as well as learner attitude and satisfaction were administered prior (pre-test) and following (post-test) all educational sessions. RESULTS: 581 physician encounters occurred as a result of the educational interventions and a significant percentage of the physicians participated in the research per se (i.e. there were 358 completed sets of pre-test and post-test 'Knowledge' questionnaires). Overall the results showed that the developed training programs increased physicians' knowledge of both Lateral Epicondylitis and the physician's role in Return-To-Work planning as reflected in improved post-test performance when compared to pre-test scores. Furthermore, videoconferencing and online training were at least as effective as conference lectures and instructor-led small group outreach sessions in their impact on physician knowledge. CONCLUSIONS: Use of effective videoconferencing and online learning activities will increase physician access to quality CME related to workplace injury management and will overcome access barriers intrinsic to types of CME interventions based on instructor-student face-to-face interactions.