Evidence map›Paper›PMID 30917258›Full record

Trial reportThe New England journal of medicine2019

Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer.

Rita S Mehta, William E Barlow, Kathy S Albain, Ted A Vandenberg, Shaker R Dakhil, Nagendra R Tirumali, Danika L Lew, Daniel F Hayes, Julie R Gralow, Hannah H Linden and 2 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00075764 (Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer), which is not on this map. Cited by 57 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 1 pooled it
14.1field-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.

NCT00075764 phase3completednot on this map

Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2004 to 2018Enrolled695ConditionsBreast CancerArmsanastrozole, fulvestrant
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 1 synthesis or guideline pooled it, 126 citations in OpenAlex.

  1. Pooled it
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  3. Thymidine kinase activity levels in serum can identify HR+ metastatic breast cancer patients with a low risk of early progression (SWOG S0226).Biomarkers : biochemical indicators of exposure, response, and susceptibility to chemicals · 2023
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  20. Effects ofPharmacogenomics · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 2 countries.

Rita S MehtaFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
William E BarlowFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Kathy S AlbainFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Ted A VandenbergFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Shaker R DakhilFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Nagendra R TirumaliFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Danika L LewFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Daniel F HayesFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Julie R GralowFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Hannah H LindenFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Robert B LivingstonFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Gabriel N HortobagyiFrom the Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange (R.S.M.); the SWOG Statistics and Data Management Center (W.E.B., D.L.L.) and Seattle Cancer Care Alliance and University of Washington Medical Center (J.R.G., H.H.L.) - both in Seattle; Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); London Health Sciences Centre and the National Cancer Institute of Canada Clinical Trials Group, London, ON, Canada (T.A.V.); the Cancer Center of Kansas and Wichita National Cancer Institute Community Oncology Research Program (NCORP), Wichita (S.R.D.); Kaiser Permanente NCORP, Portland, OR (N.R.T.); the University of Michigan, Ann Arbor (D.F.H.); the University of Arizona Cancer Center, Tucson (R.B.L.); and the University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.).
Kaiser Permanente Center for Health Research · USLondon Health Sciences Centre · CALoyola University Chicago · USSeattle Cancer Care Alliance · USThe University of Texas MD Anderson Cancer Center · USUniversity of Arizona Cancer CenterUniversity of California, Irvine Medical Center · USUniversity of Michigan–Ann Arbor · USUniversity of Washington Medical Center · USWichita Clinic · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MEGAN OTHUS · 2014 to 2026
$115.2M
Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Christine Hui · 1994 to 2026
$57.9M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP) UG1UG1CA233329 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI KELLY K HUNT, CHELSEA Camille PINNIX · 2019 to 2026
$11.1M
National Community Oncology Research ProjectUG1CA189808 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 2014 to 2018
$8.6M
UT MD Anderson Cancer Center Network Lead Academic Participating Site (LAP)U10CA180858 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI HUNT, KELLY K, PINNIX, CHELSEA CAMILLE · 2014 to 2018
$5.6M
SWOG GRANT APPLICATION FOR LOYOLA UNIVERSITYU10CA046282 · NCI · LOYOLA UNIVERSITY CHICAGO · PI STIFF, PATRICK J · 1988 to 2013
$5.4M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
SOUTHWEST ONCOLOGY GROUP CA13612U10CA013612 · NCI · UNIVERSITY OF ARIZONA · PI CRANMER, LEE D · 1985 to 2013
$4.5M
NCI NIH HHS CA13612NCI NIH HHS CA180888, CA180819, CA180863, CA189808, CA180801,NCI NIH HHS N01 CA013612NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA062203NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180858NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189952NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA233160NCI NIH HHS UG1 CA233328NCI NIH HHS UG1 CA233329
6 · The paper itself

Abstract

backgroundWe previously reported prolonged progression-free survival and marginally prolonged overall survival among postmenopausal patients with hormone receptor-positive metastatic breast cancer who had been randomly assigned to receive the aromatase inhibitor anastrozole plus the selective estrogen-receptor down-regulator fulvestrant, as compared with anastrozole alone, as first-line therapy. We now report final survival outcomes.

methodsWe randomly assigned patients to receive either anastrozole or fulvestrant plus anastrozole. Randomization was stratified according to adjuvant tamoxifen use. Analysis of survival was performed by means of two-sided stratified log-rank tests and Cox regression. Efficacy and safety were compared between the two groups, both overall and in subgroups.

resultsOf 707 patients who had undergone randomization, 694 had data available for analysis. The combination-therapy group had 247 deaths among 349 women (71%) and a median overall survival of 49.8 months, as compared with 261 deaths among 345 women (76%) and a median overall survival of 42.0 months in the anastrozole-alone group, a significant difference (hazard ratio for death, 0.82; 95% confidence interval [CI], 0.69 to 0.98; P = 0.03 by the log-rank test). In a subgroup analysis of the two strata, overall survival among women who had not received tamoxifen previously was longer with the combination therapy than with anastrozole alone (median, 52.2 months and 40.3 months, respectively; hazard ratio, 0.73; 95% CI, 0.58 to 0.92); among women who had received tamoxifen previously, overall survival was similar in the two groups (median, 48.2 months and 43.5 months, respectively; hazard ratio, 0.97; 95% CI, 0.74 to 1.27) (P = 0.09 for interaction). The incidence of long-term toxic effects of grade 3 to 5 was similar in the two groups. Approximately 45% of the patients in the anastrozole-alone group crossed over to receive fulvestrant.

conclusionsThe addition of fulvestrant to anastrozole was associated with increased long-term survival as compared with anastrozole alone, despite substantial crossover to fulvestrant after progression during therapy with anastrozole alone. The results suggest that the benefit was particularly notable in patients without previous exposure to adjuvant endocrine therapy. (Funded by the National Cancer Institute and AstraZeneca; ClinicalTrials.gov number, NCT00075764.).

Indexed as

AdultAgedAged, 80 and overAnastrozoleAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBreast NeoplasmsCross-Over StudiesEstrogen Receptor AntagonistsFemaleFollow-Up StudiesFulvestrantHumansKaplan-Meier EstimateMiddle AgedNeoplasm MetastasisAnastrozoleAromatase InhibitorsEstrogen Receptor AntagonistsFulvestrant

Identifiers

PMID30917258
PMCPMC6885383
OpenAlexW2925092419

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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.