Evidence map›Paper›PMID 34022150›Full record

Trial reportThe Lancet. Global health2021

Safety and efficacy of rituximab in patients with diffuse large B-cell lymphoma in Malawi: a prospective, single-arm, non-randomised phase 1/2 clinical trial.

Stephen Kimani, Matthew S Painschab, Bongani Kaimila, Edwards Kasonkanji, Takondwa Zuze, Tamiwe Tomoka, Maurice Mulenga, Richard Nyasosela, Maria Chikasema, Asekanadziwa Mtangwanika and 13 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in The Lancet. Global health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 7 institutions in 2 countries.

Stephen KimaniDepartment of Medicine, Division of Hematology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; University of North Carolina Project-Malawi, Lilongwe, Malawi.
Matthew S PainschabDepartment of Medicine, Division of Hematology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; University of North Carolina Project-Malawi, Lilongwe, Malawi.
Bongani KaimilaUniversity of North Carolina Project-Malawi, Lilongwe, Malawi; University of Malawi, College of Medicine, Lilongwe Campus, Lilongwe, Malawi.
Edwards KasonkanjiUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Takondwa ZuzeUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Tamiwe TomokaDepartment of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; University of North Carolina Project-Malawi, Lilongwe, Malawi; University of Malawi, College of Medicine, Lilongwe Campus, Lilongwe, Malawi.
Maurice MulengaKamuzu Central Hospital, Malawi Ministry of Health, Lilongwe, Malawi.
Richard NyasoselaKamuzu Central Hospital, Malawi Ministry of Health, Lilongwe, Malawi.
Maria ChikasemaUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Asekanadziwa MtangwanikaUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Mena ChawingaUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Wilberforce MhangoUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Simon NicholasUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Fred ChimzimuUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Coxcilly KampaniUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Robert KrysiakUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Amy LillyDepartment of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Cara RandallDepartment of Pathology, Anatomy and Laboratory Medicine, West Virginia University, Morgantown, WV, USA.
Ryan SeguinUniversity of North Carolina Project-Malawi, Lilongwe, Malawi.
Katherine D WestmorelandDepartment of Medicine, Division of Hematology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; University of North Carolina Project-Malawi, Lilongwe, Malawi.
Nathan D MontgomeryDepartment of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; University of North Carolina Project-Malawi, Lilongwe, Malawi.
Yuri FedoriwDepartment of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; University of North Carolina Project-Malawi, Lilongwe, Malawi.
Satish GopalCenter for Global Health, National Cancer Institute, Rockville, MD, USA. Electronic address: satish.gopal@nih.gov.
University of Malawi · MWUniversity of North Carolina at Chapel Hill · USKamuzu Central Hospital · MWCenter for Global Health · USChristian Health Association of Malawi · MWLilongwe University of Agriculture and Natural Resources · MWWest Virginia University · US

Funding

Consortium for Advancing Management and Prevention of Cancer in People with HIVUM1CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Joseph A. Sparano · 2015 to 2026
$253.7M
UJMT – ORWH – Gazzetta, Issa-BoubeD43TW009340 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI William Checkley, Benjamin H. Chi · 2017 to 2026
$14.8M
Project 3U54CA190152 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAMANIA, BLOSSOM A, GOPAL, SATISH · 2014 to 2019
$4.2M
Cancer Care Quality Training ProgramT32CA116339 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ETHAN M. BASCH, Stephanie Brooke Wheeler · 2018 to 2026
$3.0M
Understanding Methotrexate Dosing, Pharmacokinetics, and Toxicities for Burkitt Lymphoma in MalawiK01TW011191 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI WESTMORELAND, KATHERINE DOUGLAS · 2019 to 2023
$768k
Safety, efficacy, and cost-effectiveness of rituximab for multicentric Castleman disease in MalawiK01TW011470 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI PAINSCHAB, MATTHEW SCOTT · 2019 to 2023
$720k
FIC NIH HHS D43 TW009340FIC NIH HHS K01 TW011191FIC NIH HHS K01 TW011470FIC NIH HHS L30 TW011802Intramural NIH HHS Z99 CA999999NCI NIH HHS L30 CA233709NCI NIH HHS T32 CA116339NCI NIH HHS U54 CA190152NCI NIH HHS UM1 CA121947
6 · The paper itself

Abstract

backgroundThere are no clinical trials involving patients with diffuse large B-cell lymphoma (DLBCL) in sub-Saharan Africa since antiretroviral therapy (ART) for HIV became widely available in this region. We aimed to establish the safety and efficacy of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with DLBCL in Malawi.

methodsThis prospective, single-arm, non-randomised phase 1/2 clinical trial was done at Kamuzu Central Hospital Cancer Clinic (Lilongwe, Malawi). Eligible patients were adults (aged 18-60 years) with newly diagnosed DLBCL, an Eastern Cooperative Oncology Group performance status of 0-2, a CD4 count of 100 cells per μL or higher (if HIV-positive), measurable disease by physical examination, an absolute neutrophil count of 1000 × 10

findingsBetween Aug 1, 2016, and July 31, 2019, 76 patients were screened, of whom 37 were eligible for the study and received R-CHOP. The median age of patients was 44 years (IQR 39-49) and 16 (43%) were women. Of all 37 patients, 20 (54%) had stage III or IV DLBCL, and the age-adjusted international prognostic index was 2 or higher in 25 (68%) patients. 27 (73%) patients were HIV-positive, with a median CD4 count of 208 cells per μL (IQR 144-422), and 21 (78%) patients were receiving ART at enrolment. Patients completed a median of six cycles (IQR 4-6). Grade 3 or 4 non-haematological toxic effects were reported in 12 (32% [95% CI 19-49]) patients, the most common of which was infection (nine [24%] patients). Of 16 (43%) deaths, ten were due to progression of DLBCL, four were due to treatment-related complications, and two were due to other causes, yielding a treatment-related mortality of 11% (95% CI 4-26%). Grade 3 or 4 neutropenia was observed in 26 (70%) patients, and grade 3 or 4 anaemia was observed in 11 (29%) patients. A total of 22 (59%) patients had a complete response. Overall survival was 68% (95% CI 50-80) at 12 months and 55% (37-70) at 24 months, and progression-free survival was 59% (42-73) at 12 months and 53% (35-68) at 24 months.

interpretationR-CHOP could be feasible, safe, and efficacious in patients with DLBCL in Malawi. This is the first completed clinical trial on DLBCL focused on sub-Saharan African populations. Given the paucity of data on treatment of DLBCL from this region, these results could inform emerging cancer treatment programmes in sub-Saharan Africa.

fundingThe University of North Carolina Lineberger Comprehensive Cancer Center.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDoxorubicinFemaleHumansLymphoma, Large B-Cell, DiffuseMalawiMaleMiddle AgedPrednisoneProspective StudiesRituximabTreatment OutcomeVincristineCyclophosphamideDoxorubicinPrednisoneR-CHOP protocolRituximabVincristine

Identifiers

PMID34022150
PMCPMC9338824
OpenAlexW3160104303

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Registered trials

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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.