Abstract
| Original language | English |
|---|---|
| Journal | European Journal of Cancer |
| DOIs | |
| Publication status | Published - 2019 |
Fingerprint
Keywords
- Adjuvant endocrine treatment
- Aromatase inhibitors
- Breast cancer
- Phase 3
- Premenopausal patients
- Zoledronic acid
Cite this
Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer. / Perrone, Francesco; De Laurentiis, Michelino; De Placido, Sabino; Orditura, Michele; Cinieri, Saverio; Riccardi, Ferdinando; Ribecco, Angela Stefania; Putzu, Carlo; Del Mastro, Lucia; Rossi, Emanuela; Tinessa, Vincenza; Mosconi, Anna Maria; Nuzzo, Francesco; Di Rella, Francesca; Gravina, Adriano; Iodice, Giovanni; Landi, Gabriella; Pacilio, Carmen; Forestieri, Valeria; Lauria, Rossella; Fabbri, Agnese; Ibrahim, Toni; De Maio, Ermelinda; Barni, Sandro; Gori, Stefania; Simeon, Vittorio; Arenare, Laura; Daniele, Gennaro; Piccirillo, Maria Carmela; Normanno, Nicola; de Matteis, Andrea; Gallo, Ciro.
In: European Journal of Cancer, 2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer
AU - Perrone, Francesco
AU - De Laurentiis, Michelino
AU - De Placido, Sabino
AU - Orditura, Michele
AU - Cinieri, Saverio
AU - Riccardi, Ferdinando
AU - Ribecco, Angela Stefania
AU - Putzu, Carlo
AU - Del Mastro, Lucia
AU - Rossi, Emanuela
AU - Tinessa, Vincenza
AU - Mosconi, Anna Maria
AU - Nuzzo, Francesco
AU - Di Rella, Francesca
AU - Gravina, Adriano
AU - Iodice, Giovanni
AU - Landi, Gabriella
AU - Pacilio, Carmen
AU - Forestieri, Valeria
AU - Lauria, Rossella
AU - Fabbri, Agnese
AU - Ibrahim, Toni
AU - De Maio, Ermelinda
AU - Barni, Sandro
AU - Gori, Stefania
AU - Simeon, Vittorio
AU - Arenare, Laura
AU - Daniele, Gennaro
AU - Piccirillo, Maria Carmela
AU - Normanno, Nicola
AU - de Matteis, Andrea
AU - Gallo, Ciro
PY - 2019
Y1 - 2019
N2 - Aim: The aim of the study is to analyse whether letrozole (L) and zoledronic acid plus L (ZL) are more effective than tamoxifen (T) as adjuvant endocrine treatment of premenopausal patients with breast cancer with hormone receptor–positive (HR+) tumours. Patients and methods: In a phase 3 trial, 1065 premenopausal patients with HR + early breast cancer received triptorelin to suppress ovarian function and were randomly assigned (1:1:1) to adjuvant T, L or ZL for 5 years. Cancer recurrence, second breast or non-breast cancer and death were considered events for the intention-to-treat disease-free survival (DFS) analysis. Results: With a 64-month median follow-up and 134 reported events, the disease-free rate at 5 years was 85.4%, 93.2% and 93.3% with T, L and ZL, respectively (overall P = 0.008). The hazard ratio for a DFS event was 0.52 (95% confidence interval [CI], 0.34 to 0.80; P = 0.003) with ZL vs T, 0.72 (95% CI, 0.48 to 1.07; P = 0.06) with L vs T and 0.70 (95% CI, 0.44 to 1.12; P = 0.22) with ZL vs L. With 36 deaths, there was no significant difference in overall survival (P = 0.14). Treatment was stopped for toxicity or refusal in 7.3%, 7.3% and 16.6% patients, and in the safety population, grade 3–4 side-effects were reported in 4.2%, 6.9% and 9.1% patients treated with T, L or ZL, respectively. Conclusion: HOBOE study shows that in premenopausal patients with early breast cancer undergoing ovarian function suppression with triptorelin, ZL significantly improves DFS, while worsening compliance and toxicity, as compared with T. (NCT00412022)
AB - Aim: The aim of the study is to analyse whether letrozole (L) and zoledronic acid plus L (ZL) are more effective than tamoxifen (T) as adjuvant endocrine treatment of premenopausal patients with breast cancer with hormone receptor–positive (HR+) tumours. Patients and methods: In a phase 3 trial, 1065 premenopausal patients with HR + early breast cancer received triptorelin to suppress ovarian function and were randomly assigned (1:1:1) to adjuvant T, L or ZL for 5 years. Cancer recurrence, second breast or non-breast cancer and death were considered events for the intention-to-treat disease-free survival (DFS) analysis. Results: With a 64-month median follow-up and 134 reported events, the disease-free rate at 5 years was 85.4%, 93.2% and 93.3% with T, L and ZL, respectively (overall P = 0.008). The hazard ratio for a DFS event was 0.52 (95% confidence interval [CI], 0.34 to 0.80; P = 0.003) with ZL vs T, 0.72 (95% CI, 0.48 to 1.07; P = 0.06) with L vs T and 0.70 (95% CI, 0.44 to 1.12; P = 0.22) with ZL vs L. With 36 deaths, there was no significant difference in overall survival (P = 0.14). Treatment was stopped for toxicity or refusal in 7.3%, 7.3% and 16.6% patients, and in the safety population, grade 3–4 side-effects were reported in 4.2%, 6.9% and 9.1% patients treated with T, L or ZL, respectively. Conclusion: HOBOE study shows that in premenopausal patients with early breast cancer undergoing ovarian function suppression with triptorelin, ZL significantly improves DFS, while worsening compliance and toxicity, as compared with T. (NCT00412022)
KW - Adjuvant endocrine treatment
KW - Aromatase inhibitors
KW - Breast cancer
KW - Phase 3
KW - Premenopausal patients
KW - Zoledronic acid
U2 - 10.1016/j.ejca.2019.05.004
DO - 10.1016/j.ejca.2019.05.004
M3 - Article
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
ER -