Evidence map›Paper›PMID 26410620›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2015

A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naïve patients with metastatic melanoma.

E M Hersh, M Del Vecchio, M P Brown, R Kefford, C Loquai, A Testori, S Bhatia, R Gutzmer, R Conry, A Haydon and 13 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00864253 (An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma), which is not on this map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 5% 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.

NCT00864253 phase3completednot on this map

An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

TypeinterventionalSponsorCelgeneRan2009 to 2014Enrolled529ConditionsMalignant MelanomaArmsABI-007, Dacarbazine
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.

  1. Pooled it
  2. Systemic treatments for metastatic cutaneous melanoma.The Cochrane database of systematic reviews · 2018
    Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 16 institutions in 6 countries.

E M HershDepartment of Medicine, Arizona Cancer Center, Tucson, USA ehersh@azcc.arizona.edu.
M Del VecchioDepartment of Medical Oncology, Fondazione IRCCS National Tumor Institute, Milan, Italy.
M P BrownCancer Clinical Trials Unit, Royal Adelaide Hospital and School of Medicine, University of Adelaide, Adelaide.
R KeffordSydney West Cancer Trials Centre/Westmead Hospital and Melanoma Institute Australia, University of Sydney, North Sydney, Australia.
C LoquaiDepartment of Dermatology, University of Mainz, Mainz, Germany.
A TestoriMelanoma and Muscle Cutaneous Sarcoma Division, European Institute of Oncology, Milan, Italy.
S BhatiaDepartment of Medicine, Seattle Cancer Care Alliance, Seattle, USA.
R GutzmerDepartment of Dermatology and Oncology, Hannover Medical School, Hannover, Germany.
R ConryDivision of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, USA.
A HaydonDepartment of Medical Oncology, Alfred Hospital, Melbourne, Australia.
C RobertDemartology Unit, Department of Medicine, The Gustave Roussy Cancer Institute, Villejuif, France.
S ErnstDepartment of Medical Oncology, London Health Sciences Center-London Regional Cancer Program, London, Canada.
J HomsiDepartment of Medical Oncology, Banner MD Anderson Cancer Center, Gilbert, USA.
J J GrobDepartment of Dermatology, Timone Hospital, APHM and Aix-Marseille University, Marseille, France.
K KendraDepartment of Internal Medicine, Division of Medical Oncology, Ohio State University Comprehensive Cancer Center, Columbus.
S S AgarwalaDepartment of Hematology and Oncology, St Luke's Cancer Center and Temple University, Bethlehem.
M LiBiometrics and Data Operations/Translational Medicine/Biometrics and Data Operations/Clinical Research & Development/Global Medical Affairs, Celgene Corporation, Summit, USA.
A ClawsonBiometrics and Data Operations/Translational Medicine/Biometrics and Data Operations/Clinical Research & Development/Global Medical Affairs, Celgene Corporation, Summit, USA.
C BrachmannBiometrics and Data Operations/Translational Medicine/Biometrics and Data Operations/Clinical Research & Development/Global Medical Affairs, Celgene Corporation, Summit, USA.
M KarnoubBiometrics and Data Operations/Translational Medicine/Biometrics and Data Operations/Clinical Research & Development/Global Medical Affairs, Celgene Corporation, Summit, USA.
I EliasBiometrics and Data Operations/Translational Medicine/Biometrics and Data Operations/Clinical Research & Development/Global Medical Affairs, Celgene Corporation, Summit, USA.
M F RenschlerBiometrics and Data Operations/Translational Medicine/Biometrics and Data Operations/Clinical Research & Development/Global Medical Affairs, Celgene Corporation, Summit, USA.
A HauschildDepartment of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.
Aix-Marseille Université · FRArizona Oncology · USBanner MD Anderson Cancer CenterEuropean Institute of Oncology · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITInstitut Gustave Roussy · FRJohannes Gutenberg University Mainz · DELondon Health Sciences Centre · CAMedizinische Hochschule Hannover · DESeattle Cancer Care Alliance · USSt. Luke's University Health Network · USThe Alfred Hospital · AUThe Ohio State University · USThe University of Adelaide · AUThe University of Sydney · AUUniversity of Alabama at Birmingham · US

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
NCI NIH HHS P30 CA015704
6 · The paper itself

Abstract

backgroundThe efficacy and safety of nab-paclitaxel versus dacarbazine in patients with metastatic melanoma was evaluated in a phase III randomized, controlled trial. PATIENTS AND

methodsChemotherapy-naïve patients with stage IV melanoma received nab-paclitaxel 150 mg/m(2) on days 1, 8, and 15 every 4 weeks or dacarbazine 1000 mg/m(2) every 3 weeks. The primary end point was progression-free survival (PFS) by independent radiologic review; the secondary end point was overall survival (OS).

resultsA total of 529 patients were randomized to nab-paclitaxel (n = 264) or dacarbazine (n = 265). Baseline characteristics were well balanced. The majority of patients were men (66%), had an Eastern Cooperative Oncology Group status of 0 (71%), and had M1c stage disease (65%). The median PFS (primary end point) was 4.8 months with nab-paclitaxel and 2.5 months with dacarbazine [hazard ratio (HR), 0.792; 95.1% confidence interval (CI) 0.631-0.992; P = 0.044]. The median OS was 12.6 months with nab-paclitaxel and 10.5 months with dacarbazine (HR, 0.897; 95.1% CI 0.738-1.089; P = 0.271). Independently assessed overall response rate was 15% versus 11% (P = 0.239), and disease control rate (DCR) was 39% versus 27% (P = 0.004) for nab-paclitaxel versus dacarbazine, respectively. The most common grade ≥3 treatment-related adverse events were neuropathy (nab-paclitaxel, 25% versus dacarbazine, 0%; P < 0.001), and neutropenia (nab-paclitaxel, 20% versus dacarbazine, 10%; P = 0.004). There was no correlation between secreted protein acidic and rich in cysteine (SPARC) status and PFS in either treatment arm.

conclusionsnab-Paclitaxel significantly improved PFS and DCR compared with dacarbazine, with a manageable safety profile.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntineoplastic Agents, AlkylatingDacarbazineDisease-Free SurvivalFemaleHumansMaleMelanomaMiddle AgedPaclitaxelSkin NeoplasmsYoung Adult130-nm albumin-bound paclitaxelAlbuminsAntineoplastic Agents, AlkylatingDacarbazinePaclitaxelBRAFchemotherapy-naïvedacarbazinemetastatic melanomanab-Paclitaxel

Identifiers

PMID26410620
PMCPMC6279094
OpenAlexW2173572264

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.