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Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer.
Mehta, Rita S; Barlow, William E; Albain, Kathy S; Vandenberg, Ted A; Dakhil, Shaker R; Tirumali, Nagendra R; Lew, Danika L; Hayes, Daniel F; Gralow, Julie R; Linden, Hannah H; Livingston, Robert B; Hortobagyi, Gabriel N.
Afiliación
  • Mehta RS; From 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 U
  • Barlow WE; From 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 U
  • Albain KS; From 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 U
  • Vandenberg TA; From 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 U
  • Dakhil SR; From 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 U
  • Tirumali NR; From 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 U
  • Lew DL; From 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 U
  • Hayes DF; From 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 U
  • Gralow JR; From 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 U
  • Linden HH; From 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 U
  • Livingston RB; From 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 U
  • Hortobagyi GN; From 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 U
N Engl J Med ; 380(13): 1226-1234, 2019 03 28.
Article en En | MEDLINE | ID: mdl-30917258
ABSTRACT

BACKGROUND:

We 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.

METHODS:

We 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.

RESULTS:

Of 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.

CONCLUSIONS:

The 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.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Inhibidores de la Aromatasa / Antagonistas del Receptor de Estrógeno / Fulvestrant / Anastrozol Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: N Engl J Med Año: 2019 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Protocolos de Quimioterapia Combinada Antineoplásica / Inhibidores de la Aromatasa / Antagonistas del Receptor de Estrógeno / Fulvestrant / Anastrozol Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: N Engl J Med Año: 2019 Tipo del documento: Article