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Cancer. 2019 Oct 1;125(19):3378-3389. doi: 10.1002/cncr.32289. Epub 2019 Jun 7.

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

Author information

1
Department of Hematology and Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.
2
Comprehensive Cancer Center, Ohio State University, Columbus, Ohio.
3
Alliance Statistics and Data Center, Mayo Clinic College of Medicine, Rochester, Minnesota.
4
Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.
5
Department of Clinical Pathology, Cleveland Clinic, Cleveland, Ohio.
6
Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.
7
Southeast Clinical Oncology Research Consortium, NCI Community Oncology Research Program, Winston-Salem, North Carolina.
8
Lombardi Comprehensive Cancer Center, Georgetown University Hospital, Washington, DC.
9
Department of Medicine and Meyer Cancer Center, Weill Cornell Medicine, New York, New York.

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.

KEYWORDS:

bendamustine; bortezomib; follicular lymphoma; ofatumumab

PMID:
31174236
PMCID:
PMC6744328
[Available on 2020-10-01]
DOI:
10.1002/cncr.32289

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