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Proffered Paper session - Breast cancer, early stage

118O - Extended therapy with letrozole as adjuvant treatment of postmenopausal patients with early-stage breast cancer: A randomised, phase III trial of the Gruppo Italiano Mammella

Date

17 Sep 2021

Session

Proffered Paper session - Breast cancer, early stage

Presenters

Lucia Del Mastro

Citation

Annals of Oncology (2021) 32 (suppl_5): S407-S446. 10.1016/annonc/annonc687

Authors

L. Del Mastro1, M. Mansutti2, G. Bisagni3, R. Ponzone4, A. Durando5, L. Amaducci6, F. Cognetti7, A. Frassoldati8, A. Michelotti9, S. Mura10, Y. Urracci11, G. Sanna12, S. Gori13, S. De Placido14, O. Garrone15, C. Barone16, C. Bighin1, F. Poggio1, M. Lambertini17, P. Bruzzi18

Author affiliations

  • 1 Breast Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy, 16132 - Genova/IT
  • 2 Oncologia, Azienda Sanitaria Universitaria Integrata di Udine - Ospedale Santa Maria della Misericordia, 33100 - Udine/IT
  • 3 Medical Oncology Department, Azienda unità Sanitaria Locale – IRCCS di Reggio Emilia, 42100 - Reggio Emilia/IT
  • 4 Gynecologic Oncology And Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, 10060 - Candiolo/IT
  • 5 Medical Oncology Department, Città della Salute e della Scienza ASO S. Anna, Torino, 10133 - Torino/IT
  • 6 Medical Oncology Department, Ospedale degli Infermi, 48018 - Faenza/IT
  • 7 Medical Oncology Department, Università La Sapienza, 00185 - Roma/IT
  • 8 Medical Oncology Department, Azienda Ospedaliera Universitaria S. Anna, 44121 - Ferrara/IT
  • 9 Medical Oncology Department, Ospedale Santa Chiara, 56126 - Pisa/IT
  • 10 Medical Oncology Department, Ospedale Civile SS Annunziata, 07100 - Sassari/IT
  • 11 Medical Oncology Department, Ospedale Businco, 09121 - Cagliari/IT
  • 12 Medical Oncology Department, Azienda Ospedaliera Universitaria Sassari, 07100 - Sassari/IT
  • 13 Medical Oncology Department, IRCCS Ospedale Sacro Cuore Don Calabria, 37024 - Negrar/IT
  • 14 Medical Oncology Department, Azienda Ospedaliera Universitaria Federico II, 80138 - Napoli/IT
  • 15 Breast Unit, Azienda Ospedaliera S. Croce e Carle, 12100 - Cuneo/IT
  • 16 Medical Oncology Department, Ospedale S. Lorenzo, ASL TO5, 1022 - Carmagnola/IT
  • 17 Department Of Medical Oncology, IRCCS Ospedale Policlinico San Martino, 16132 - Genova/IT
  • 18 Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, 16132 - Genova/IT
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Resources

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Abstract 118O

Background

The benefit of extended adjuvant therapy with aromatase inhibitors (AIs) in postmenopausal hormone-receptor positive breast cancer patients treated with tamoxifen for 2-3 years followed by an AI for 2-3 years is still controversial. We aimed to determine whether, after 2-3 years of tamoxifen, 5 years of letrozole is more effective than the standard duration of 2-3 years.

Methods

This is a prospective, open-label, phase 3 trial conducted in 64 Italian hospitals within the Gruppo Italiano Mammella (GIM). Stage I-III breast cancer patients, free of recurrence after 2-3 years of tamoxifen, were randomly allocated (1:1) with a centralized, interactive online system to receive 2-3 years (control arm) or 5 years (extended arm) of letrozole. Primary endpoint was disease-free survival (DFS) in the intention-to-treat population. Overall survival (OS) and safety were secondary endpoints.

Results

Between August 1, 2005, and October 24, 2010, we recruited 2056 patients. After a median follow-up of 11.7 years (IQR 9.5-13.1), 262 (25%) of 1030 patients in the control arm and 212 (21%) of 1026 patients in the extended arm experienced a DFS event. The 12-year DFS was 62% (95% CI 57-66) and 67% (62-71) in the control and extended arm, respectively (Hazard Ratio [HR] 0.78, 0.65-0.93; p=0.006). The effect did not change in a multivariate Cox model including nodal status, tumor size, grading, age, hormone receptor status, HER2 status, previous chemotherapy, and BMI (p=0·014). Overall, 263 (13%) deaths occurred, 147 in the control arm and 116 in the extended arm. The 12-year OS was 84% (82-87) in the control arm and 88% (86-90) in the extended arm (HR 0.77, 0.60-0.98; p=0.036). Arthralgia (31% vs 38%), myalgia (8% vs 12%), hypertension (1% vs 2%) and osteoporosis (5% vs 8%) were significantly more frequent in the experimental arm.

Conclusions

In post-menopausal breast cancer patients treated with 2-3 years of tamoxifen, extended treatment with 5 years of letrozole resulted in a significant and clinically meaningful improvement in both DFS and OS compared to the duration of 2-3 years of letrozole.

Clinical trial identification

EudraCT 2005-001212-44, NCT01064635.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Novartis; Italian Ministry of Health.

Disclosure

L. Del Mastro: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Genomic Health; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Ipsen; Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Celgene. M. Mansutti: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Celgene; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Roche. F. Cognetti: Financial Interests, Personal, Advisory Role: Genomic Health; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Glaxo Smith Kline; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Amgen; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Merck MSD; Financial Interests, Personal, Speaker’s Bureau: BMS; Financial Interests, Personal, Speaker’s Bureau: Astellas; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly. A. Frassoldati: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Eli Lilly. A. Michelotti: Financial Interests, Personal, Advisory Board: Eisai; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Teva; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Celgene; Financial Interests, Personal, Other, Travel grant: Ipsen. S. De Placido: Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Celgene; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Advisory Board: Seagen; Financial Interests, Personal, Advisory Board: Daiichii Sankyo; Financial Interests, Personal, Advisory Board: MSD. O. Garrone: Financial Interests, Personal, Other, Consulting fees: Novartis; Financial Interests, Personal, Other, Consulting fees: MSD; Financial Interests, Personal, Other, Consulting fees: Eisai; Financial Interests, Personal, Other, Consulting fees: Eli Lilly; Financial Interests, Personal, Other, Meeting support: Roche. C. Bighin: Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly. F. Poggio: Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Novartis. M. Lambertini: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Personal, Other, Honoraria: Takeda; Financial Interests, Personal, Other, Honoraria: Sandoz. All other authors have declared no conflicts of interest.

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