Evidence map›Paper›PMID 20606091›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303).

Hedy Lee Kindler, Donna Niedzwiecki, Donna Hollis, Susan Sutherland, Deborah Schrag, Herbert Hurwitz, Federico Innocenti, Mary Frances Mulcahy, Eileen O'Reilly, Timothy F Wozniak and 5 more

Open access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 433 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
433citing papers in PubMed, 9 pooled it
38.5field-weighted citation impact, top 1% 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

433 citing papers in PubMed, 9 syntheses or guidelines pooled it, 839 citations in OpenAlex.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
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  6. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
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373 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

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

15 authors at 7 institutions in 1 country.

Hedy Lee KindlerUniversity of Chicago Cancer Research Center, Chicago, IL 60637-1470, USA. hkindler@medicine.bsd.uchicago.edu
Donna Niedzwiecki
Donna Hollis
Susan Sutherland
Deborah Schrag
Herbert Hurwitz
Federico Innocenti
Mary Frances Mulcahy
Eileen O'Reilly
Timothy F Wozniak
Joel Picus
Pankaj Bhargava
Robert J Mayer
Richard L Schilsky
Richard M Goldberg
Cancer Research Center · USUniversity of North Carolina at Chapel Hill · USChristiana Care Health System · USMemorial Sloan Kettering Cancer Center · USDana-Farber Cancer Institute · USDuke Medical Center · USUniversity of Chicago · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
MEDICAL CENTER OF DELAWARE CCOPU10CA045418 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GRUBBS, STEPHEN S. · 1987 to 2014
$14.5M
ECOG Clinical TrialsU10CA017145 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B · 1985 to 2013
$6.1M
CANCER &LEUKEMIA GROUP BU10CA032291 · NCI · DANA-FARBER CANCER INSTITUTE · PI BURSTEIN, HAROLD J. · 1985 to 2013
$5.8M
WUSM CANCER AND LEUKEMIA GROUP BU10CA077440 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L · 1998 to 2013
$4.4M
CANCER AND LEUKEMIA GROUP B GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
MEMORIAL HOSPITAL AND CANCER AND ACUTE LEUKEMIA GROUP BU10CA077651 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI HUDIS, CLIFFORD A · 1998 to 2013
$3.2M
CANCER AND LEUKEMIA GROUP BU10CA047577 · NCI · DUKE UNIVERSITY · PI CRAWFORD, JEFFREY · 1988 to 2013
$2.2M
CANCER AND LEUKEMIA GROUP BU10CA047559 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SHEA, THOMAS C. · 1991 to 2013
$1.8M
NCI NIH HHS CA17145NCI NIH HHS CA21115NCI NIH HHS CA31946NCI NIH HHS CA 32291NCI NIH HHS CA33601NCI NIH HHS CA41287NCI NIH HHS CA45418NCI NIH HHS CA47559NCI NIH HHS CA47577NCI NIH HHS CA77440NCI NIH HHS CA77651NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032291NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA045418NCI NIH HHS U10 CA047559NCI NIH HHS U10 CA047577NCI NIH HHS U10 CA077440NCI NIH HHS U10 CA077651
6 · The paper itself

Abstract

purposeThe combination of gemcitabine plus bevacizumab produced a 21% response rate and a median survival of 8.8 months in a multicenter phase II trial in patients with metastatic pancreatic cancer. These encouraging data led Cancer and Leukemia Group B (CALGB) to conduct a double-blind, placebo-controlled, randomized phase III trial of gemcitabine/bevacizumab versus gemcitabine/placebo in advanced pancreatic cancer patients. PATIENTS AND

methodsEligible patients had no prior therapy for advanced disease, Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, no tumor invasion of adjacent organs, and no increased bleeding risk. The primary end point was overall survival. Patients were stratified by performance status, extent of disease, and prior radiotherapy. Patients received gemcitabine at 1,000 mg/m(2) over 30 minutes on days 1, 8, and 15 every 28 days and bevacizumab at 10 mg/kg or placebo on days 1 and 15 every 28 days.

resultsBetween June 2004 and April 2006, 602 patients were enrolled onto the study and 535 were treated. Median overall survival was 5.8 months for gemcitabine/bevacizumab and 5.9 months for gemcitabine/placebo (P = .95). Median progression-free survival was 3.8 and 2.9 months, respectively (P = .07). Overall response rates were 13% and 10%, respectively. Patients with a performance status of 0, 1, and 2 survived a median of 7.9, 4.8, and 2.4 months, respectively. The only statistically significant differences in grades 3 and 4 toxicity occurred for hypertension (10% v 3%; P < .001) and proteinuria (5% v 1%; P = .002); venous thrombosis grade > or = 3 was equivalent in both arms (14% and 15%, respectively).

conclusionThe addition of bevacizumab to gemcitabine does not improve survival in advanced pancreatic cancer patients.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansMaleMiddle AgedPancreatic NeoplasmsPlacebosAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabDeoxycytidineGemcitabinePlacebos

Identifiers

PMID20606091
PMCPMC2917317
OpenAlexW2128095147

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.