Francesco Perrone1, Michelino De Laurentiis2, Sabino De Placido3, Michele Orditura4, Saverio Cinieri5, Ferdinando Riccardi6, Angela Stefania Ribecco7, Carlo Putzu8, Lucia Del Mastro9, Emanuela Rossi10, Vincenza Tinessa11, Anna Maria Mosconi12, Francesco Nuzzo2, Francesca Di Rella2, Adriano Gravina2, Giovanni Iodice2, Gabriella Landi2, Carmen Pacilio2, Valeria Forestieri3, Rossella Lauria3, Agnese Fabbri13, Toni Ibrahim14, Ermelinda De Maio15, Sandro Barni16, Stefania Gori17, Vittorio Simeon18, Laura Arenare19, Gennaro Daniele19, Maria Carmela Piccirillo19, Nicola Normanno20, Andrea de Matteis2, Ciro Gallo18. 1. Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy. Electronic address: f.perrone@istitutotumori.na.it. 2. Clinical and Experimental Senology, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy. 3. Department of Medical and Surgical Clinics, Università Federico II, Napoli, Italy. 4. Oncoematology Unit, Università Degli Studi Della Campania "Luigi Vanvitelli", Napoli, Italy. 5. Oncology, Ospedale A.Perrino, Brindisi, Italy. 6. Medical Oncology, Ospedale Cardarelli, Napoli, Italy. 7. Oncology, Ospedale S.Maria Annunziata Bagno a Ripoli, Firenze, Italy. 8. Medical Oncology, Azienda Ospedaliera Universitaria, Sassari, Italy. 9. IRCCS Ospedale Policlinico San Martino, Genova, Italy; Department of Internal Medicine (DIMI), Università di Genova, Italy. 10. Medical Oncology, A.O. San Giuseppe Moscati, Avellino, Italy. 11. Medical Oncology, Ospedale Rummo, Benevento, Italy. 12. Medical Oncology, Ospedale Santa Maria Della Misericordia, S.Andrea Delle Fratte, Perugia, Italy. 13. Department of Medical Oncology, Ospedale Belcolle, Viterbo, Italy. 14. Osteoncology and Rare Tumors Center, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola FC, Italy. 15. Oncology, Azienda Usl Toscana Nord Ovest, Livorno, Italy. 16. Medical Oncology - Ospedale di Treviglio Caravaggio BG, Italy. 17. Medical Oncology, IRCCS, Ospedale Sacro Cuore Don Calabria, Negrar VR, Italy. 18. Medical Statistics, Università Degli Studi Della Campania "Luigi Vanvitelli", Napoli, Italy. 19. Clinical Trial Unit, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy. 20. Cellular Biology and Biotherapies, Istituto Nazionale Tumori, IRCCS, Fondazione G.Pascale, Napoli, Italy.
Abstract
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 receivedtriptorelin 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 withtriptorelin, ZL significantly improves DFS, while worsening compliance and toxicity, as compared with T. (NCT00412022).
RCT Entities:
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).
Authors: Kristin M D'Silva; Sara Jane Cromer; Elaine W Yu; Michael Fischer; Seoyoung C Kim Journal: J Bone Miner Res Date: 2020-11-02 Impact factor: 6.741
Authors: Olivia Pagani; Prudence A Francis; Gini F Fleming; Barbara A Walley; Giuseppe Viale; Marco Colleoni; István Láng; Henry L Gómez; Carlo Tondini; Graziella Pinotti; Angelo Di Leo; Alan S Coates; Aron Goldhirsch; Richard D Gelber; Meredith M Regan Journal: J Clin Oncol Date: 2019-10-16 Impact factor: 44.544
Authors: Komal Waqas; Joana Lima Ferreira; Elena Tsourdi; Jean-Jacques Body; Peyman Hadji; M C Zillikens Journal: J Bone Oncol Date: 2021-03-18 Impact factor: 4.072