Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high‐risk follicular lymphoma: CALGB 50904 (Alliance)
Year: 2019
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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.
Source: Cancer
DOI: 10.1002/cncr.32289
Institutions: Emory University, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Winship Cancer Institute, The Ohio State University, Mayo Clinic, Duke University, Cleveland Clinic, Washington University in St. Louis, Alvin J. Siteman Cancer Center, Southeast Clinical Oncology Research Consortium, National Cancer Institute, Georgetown University, Georgetown University Medical Center, Georgetown Lombardi Comprehensive Cancer Center, Weill Cornell Medicine
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1141282278, Ozark Health Ventures LLC dba Cancer Research for the Ozarks (CRO), Alliance Statistics and Data Management Center, Washington University/ Siteman Cancer Center Lead Academic Site, G2056719604, G2117393317, G2184918994, G2215807464, G2406815399, G2435039520, G2448369161, G3053988604, G3591884900, Development of a comprehensive research program in mantle cell lymphoma in the ibrutinib era, G4185274752, G4732137494, G6105514657, Cancer Research Consortium of West Michigan (CRCWM), Lead Academic Participating Site for the Development and Conduct of NCTN Trials, G6880957883, NCTN Lead Academic Participating Sites Application, G7933848422, Alliance for Clinical Trials in Oncology Operations Center, Montana Cancer Consortium: An Inclusive and Collaborative Approach to Clinical Trial Accrual and Cancer Care Delivery Research across Montana, Idaho and Wyoming
OpenAlex ID: W2955112147