Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance).
Kristie A Blum, Mei-Yin Polley, Sin-Ho Jung, Travis J Dockter, Sarah Anderson, Eric D Hsi, Nina Wagner-Johnston, Beth Christian, Jim Atkins, Bruce D Cheson and 2 more
Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registry
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
3 · Its place in the literature
Who cites it
3 citing papers in PubMed, 10 citations in OpenAlex.
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
5 · Who and what money
Authors and funding
12 authors at 9 institutions in 1 country.
Kristie A BlumDepartment of Hematology and Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.ORCID 0000-0003-4229-2569
Mei-Yin PolleyAlliance Statistics and Data Center, Mayo Clinic College of Medicine, Rochester, Minnesota.
Sin-Ho JungDepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.
Travis J DockterAlliance Statistics and Data Center, Mayo Clinic College of Medicine, Rochester, Minnesota.
Sarah AndersonAlliance Statistics and Data Center, Mayo Clinic College of Medicine, Rochester, Minnesota.
Eric D HsiDepartment of Clinical Pathology, Cleveland Clinic, Cleveland, Ohio.
Nina Wagner-JohnstonSiteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.
Beth ChristianComprehensive Cancer Center, Ohio State University, Columbus, Ohio.
Jim AtkinsSoutheast Clinical Oncology Research Consortium, NCI Community Oncology Research Program, Winston-Salem, North Carolina.
Bruce D ChesonLombardi Comprehensive Cancer Center, Georgetown University Hospital, Washington, DC.
John P LeonardDepartment of Medicine and Meyer Cancer Center, Weill Cornell Medicine, New York, New York.
Nancy L BartlettSiteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.
Mayo Clinic · USWashington University in St. Louis · USCleveland Clinic · USCornell University · USDuke University · USEmory University · USGeorgetown University · USSoutheast Clinical Oncology Research Consortium · USThe Ohio State University · US
Funding
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Metro-Minnesota Community Oncology Research Consortium (MMCORC)UG1CA189863 · NCI · PARK NICOLLET INSTITUTE · PI JOLEEN M HUBBARD, Yan Ji · 2014 to 2026
$43.2M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
Cancer Research Consortium of West Michigan (CRCWM)UG1CA189860 · NCI · COREWELL HEALTH · PI KATHLEEN YOST BUTLER · 2014 to 2026
$29.1M
Iowa-Wide Oncology Research Coalition (I-WORC)UG1CA189816 · NCI · IOWA ONCOLOGY RESEARCH ASSOCIATION · PI Seema Harichand, Arshin Sheybani · 2014 to 2026
$14.9M
Ozark Health Ventures, LLC dba Cancer Research for the Ozarks (CRO)UG1CA189822 · NCI · OZARK HEALTH VENTURES, LLC · PI Jay W Carlson · 2014 to 2026
$14.2M
VCU Massey Comprehensive Cancer Center NCI Community Oncology Research ProgramUG1CA189869 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI HARRY D BEAR, Khalid Matin · 2014 to 2026
$14.1M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Montana Cancer Consortium NCORPUG1CA189872 · NCI · MONTANA CANCER CONSORTIUM · PI Jeffrey Warren Allen, John M. Schallenkamp · 2014 to 2026
backgroundThis 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).
methodsPatients 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).
resultsOne 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.
conclusionsThe 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.
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.
Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance). · full record | OpenQuestion