Evidence map›Paper›PMID 22915053›Full record

Trial reportCancer2013

A randomized phase 2 study of temozolomide and bevacizumab or nab-paclitaxel, carboplatin, and bevacizumab in patients with unresectable stage IV melanoma : a North Central Cancer Treatment Group study, N0775.

Lisa A Kottschade, Vera J Suman, Domingo G Perez, Robert R McWilliams, Judith S Kaur, Thomas T Amatruda, Francois J Geoffroy, Howard M Gross, Peter A Cohen, Anthony J Jaslowski and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00626405 (A Randomized Phase II Trial of Temozolomide), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT00626405 phase2completednot on this map

A Randomized Phase II Trial of Temozolomide (TMZ) and Bevacizumab or ABI-007 (ABX)/Carboplatin (CBDCA) and Bevacizumab in Patients With Unresectable Stage IV Malignant Melanoma

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2008 to 2012Enrolled95ConditionsMelanoma (Skin)Armsbevacizumab, carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, temozolomide
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 83 citations in OpenAlex.

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  19. Case report of aOncoTargets and therapy · 2017
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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

12 authors at 6 institutions in 1 country.

Lisa A KottschadeMayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. kottschade.lisa@mayo.edu
Vera J Suman
Domingo G Perez
Robert R McWilliams
Judith S Kaur
Thomas T Amatruda
Francois J Geoffroy
Howard M Gross
Peter A Cohen
Anthony J Jaslowski
Matthew L Kosel
Svetomir N Markovic
Mayo Clinic · USMetro-Minnesota Community Oncology Research Consortium · USDayton Clinical Oncology Program · USIowa Oncology Research Association · USMayo Clinic in Arizona · USRegional Cancer Center · US

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
SIOUX COMMUNITY CANCER CONSORTIUMU10CA035103 · NCI · UNIVERSITY OF SOUTH DAKOTA · PI MAZURCZAK, MIROSLAW · 1985 to 2014
$11.6M
MISSOURI VALLEY CANCER CONSORTIUM CCOPU10CA063849 · NCI · MISSOURI VALLEY CANCER CONSORTIUM, INC. · PI SOORI, GAMINI · 1994 to 2014
$11.3M
Illinois Oncology Research Association Community Clinical Oncology ProgramU10CA035113 · NCI · ONCOLOGY-HEMATOLOGY ASSOC-CENTRAL ILL · PI LE-LINDQWISTER, NGUYET A. · 1985 to 2014
$10.8M
DULUTH COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035269 · NCI · ESSENTIA INSTITUTE OF RURAL HEALTH · PI NIKCEVICH, DANIEL A · 1985 to 2014
$10.7M
IOWA ONCOLOGY RESEARCH ASSOCIATION CCOPU10CA035101 · NCI · IOWA ONCOLOGY RESEARCH ASSOCIATION · PI BEHRENS, ROBERT J. · 1985 to 2014
$10.1M
TOLEDO COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035415 · NCI · TOLEDO COMMUNITY HOSPITAL ONCOLOGY PROG · PI MOWAT, REX BRADLEY · 1985 to 2014
$9.9M
NCI NIH HHS CA-25224NCI NIH HHS CA-35090NCI NIH HHS CA-35101NCI NIH HHS CA-35103NCI NIH HHS CA-35113NCI NIH HHS CA-35267NCI NIH HHS CA-35269NCI NIH HHS CA-35415NCI NIH HHS CA-35448NCI NIH HHS CA-37404NCI NIH HHS CA-37417NCI NIH HHS CA-52352NCI NIH HHS CA-60276NCI NIH HHS CA-63848NCI NIH HHS CA-63849NCI NIH HHS N01 CA035431NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035101NCI NIH HHS U10 CA035103NCI NIH HHS U10 CA035113NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035269NCI NIH HHS U10 CA035415NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA035448NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA037417NCI NIH HHS U10 CA052352NCI NIH HHS U10 CA060276NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA063849
6 · The paper itself

Abstract

backgroundIncreasing evidence shows chemotherapy in combination with vascular endothelial growth factor (VEGF) inhibition is a clinically active therapy for patients with metastatic melanoma (MM).

methodsA phase 2 trial was conducted in chemotherapy-naive patients with unresectable stage IV MM who were randomized to temozolomide (200 mg/m(2) on days 1 through 5) and bevacizumab (10 mg/kg intravenously on days 1 and 15) every 28 days (Regimen TB) or nab-paclitaxel (100 mg/m(2) , or 80 mg/m(2) post-addendum 5 secondary to toxicity, on days 1, 8, and 15), bevacizumab (10 mg/kg on days 1 and 15), and carboplatin (area under the curve [AUC] 6 on day 1, or AUC 5 post-addendum 5) every 28 days (Regimen ABC). Accrual goal was 41 patients per regimen. The primary aim of this study was to estimate progression-free survival rate at 6 months (PFS6) in each regimen. A regimen would be considered promising if its PFS6 rate was > 60%.

resultsNinety-three eligible patients (42 TB and 51 ABC) were enrolled. The majority of patients had M1c disease (20 TB and 26 ABC). The median PFS and overall survival times with ABC were 6.7 months and 13.9 months, respectively. Median PFS time and median overall survival with TB were 3.8 months and 12.3 months, respectively. The most common severe toxicities (≥ grade 3) in both regimens were cytopenias, fatigue, and thrombosis. Among the first 41 patients enrolled onto each regimen, PFS6 rate was 32.8% (95% confidence interval: 21.1%-51.2%) for TB and 56.1% (90% confidence interval: 44.7%-70.4%) for ABC.

conclusionsThe addition of bevacizumab to nab-paclitaxel and carboplatin shows promising activity despite tolerability issues.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinDacarbazineFemaleHumansMaleMelanomaMiddle AgedNeoplasm StagingPaclitaxel130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedBevacizumabCarboplatinDacarbazinePaclitaxelTemozolomide

Identifiers

PMID22915053
PMCPMC4089063
OpenAlexW1993594227

What OpenQuestion holds

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Registered trials

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.