Evidence map›Paper›PMID 21826527›Full record

Trial reportBreast cancer research and treatment2011

SWOG S0215: a phase II study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer.

Robert B Livingston, William E Barlow, Joseph J Kash, Kathy S Albain, Julie R Gralow, Danika L Lew, Lawrence E Flaherty, Melanie E Royce, Gabriel N Hortobagyi

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Breast cancer research and treatment, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00041067 (Docetaxel), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT00041067 phase2completednot on this map

Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2002 to 2012Enrolled76ConditionsBreast CancerArmsfilgrastim, trastuzumab, docetaxel, vinorelbine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
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

9 authors at 8 institutions in 1 country.

Robert B LivingstonArizona Cancer Center, Hematology/Oncology Section, Tucson, AZ, 85724-5024, USA. living@azcc.arizona.edu
William E Barlow
Joseph J Kash
Kathy S Albain
Julie R Gralow
Danika L Lew
Lawrence E Flaherty
Melanie E Royce
Gabriel N Hortobagyi
Cancer Research And Biostatistics · USArizona Oncology · USEdward Hospital · USLoyola University Chicago · USSeattle Cancer Care Alliance · USThe University of Texas MD Anderson Cancer Center · USUniversity of New Mexico · USWayne State University · US

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
GREENVILLE, SOUTH CAROLINA CCOPU10CA067663 · NCI · PRISMA HEALTH - UPSTATE · PI GIGUERE, JEFFREY K · 1995 to 2014
$11.7M
WESTERN ONCOLOGY RESEARCH CONSORTIUMU10CA045377 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI CONLIN, ALISON K · 1987 to 2013
$9.9M
NORTHWEST COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035281 · NCI · TACOMA GENERAL HOSPITAL · PI KEECH, JOHN A · 1985 to 2013
$9.2M
NM MINORITY-BASED COMMUNITY CLINICAL ONC. PROGRAMU10CA086780 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI ROYCE, MELANIE E · 2000 to 2014
$8.8M
OZARKS REGIONAL COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045560 · NCI · ST. JOHN'S REGIONAL HEALTH CENTER · PI CARLSON, JAY W · 1987 to 2014
$8.2M
Montana Cancer Consortium CCOPU10CA067575 · NCI · MONTANA CANCER CONSORTIUM · PI MARCHELLO, BENJAMIN T. · 1995 to 2013
$6.5M
TUMOR INSTITUTE CCOPU10CA045461 · NCI · BAY AREA TUMOR INSTITUTE · PI FEUSNER, JAMES · 1989 to 2014
$6.3M
NCI NIH HHS CA11083NCI NIH HHS CA12644NCI NIH HHS CA14028NCI NIH HHS CA20319NCI NIH HHS CA35128NCI NIH HHS CA35281NCI NIH HHS CA37981NCI NIH HHS CA45377NCI NIH HHS CA45461NCI NIH HHS CA45808NCI NIH HHS CA46282NCI NIH HHS CA46368NCI NIH HHS CA52654NCI NIH HHS CA58861NCI NIH HHS CA58882NCI NIH HHS CA67663NCI NIH HHS CA86780NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035281NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037981NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045461NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA052654NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA067663NCI NIH HHS U10 CA086780
6 · The paper itself

Abstract

SWOG trial S0102 showed significant activity of the combination of docetaxel and vinorelbine in HER2-negative metastatic breast cancer (MBC). For HER2-positive patients, additional benefit may occur with the addition of trastuzumab due to its synergy with docetaxel and vinorelbine. Patients with HER2-positive MBC, but without prior chemotherapy for MBC or adjuvant taxane, were eligible. Docetaxel (60 mg/m²) was given intravenously on Day 1, vinorelbine (27.5 mg/m²) intravenously on Days 8 and 15, and filgrastim (5 µg/kg) on Days 2-21 of a 21-day cycle. In addition, patients received weekly infusions of trastuzumab (2 mg/kg) after an initial bolus of 4 mg/kg. The primary outcome was 1 year overall survival (OS), with secondary outcomes of progression-free survival (PFS), response rate, and toxicity. Due to slow accrual (February 2003-December 2006), enrollment was stopped after 76 of 90 planned patients. There have been 32 deaths and 51 progressions among the 74 eligible patients who received treatment. The estimated 1 year OS was 93% (95% CI 84-97%) with a median of 48 months. One-year PFS was 70% (95% CI 58-79%) with a median of 20 months. Response rate for measurable disease was 84%. No deaths were attributed to treatment. Grade 4 toxicities were reported for 19% with neutropenia the most common (15%). The most common grade 3 toxicities (33%) were leucopenia (14%) and fatigue (10%). The combination of trastuzumab, docetaxel, and vinorelbine is effective as first-line chemotherapy in HER2-positive MBC with minimal toxicity. One-year survival estimates are among the highest reported in this population.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDocetaxelErb-b2 Receptor Tyrosine KinasesFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansKaplan-Meier EstimateMiddle AgedNeoplasm StagingRecombinant ProteinsTaxoidsAntibodies, Monoclonal, HumanizedDocetaxelErb-b2 Receptor Tyrosine KinasesFilgrastimGranulocyte Colony-Stimulating FactorRecombinant ProteinsTaxoidsTrastuzumabVinblastineVinorelbine

Identifiers

PMID21826527
PMCPMC3513946
OpenAlexW2010476765

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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.