1. A phase-III prevention trial of low-dose tamoxifen in postmenopausal hormone replacement therapy users: the HOT study
- Author
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Decensi, A., Bonanni, B., Maisonneuve, P., Serrano, D., Omodei, U., Varricchio, C., Cazzaniga, M., Lazzeroni, M., Rotmensz, N., Santillo, B., Sideri, M., Cassano, E., Belloni, C., Muraca, M., Segnan, N., Masullo, P., Costa, A., Monti, N., Vella, A., Bisanti, L., D'Aiuto, G., Veronesi, U., Schitulli, Francesco, Deliso, Maria, Omodei, Umberto, Ramazzotto, Francesca, Corini, Silvia, Pecorelli, Sergio, Daldos, Cristina, Melis, Gianbenedetto, Pilloni, Monica, Artioli, Fabrizio, Guerzoni, Roberta, Sciacchitano, Salvatore, Grasso, Daniela, Torrioli, Donatello, Bravi, Stefano, Corrado, Gemma, Biamonte, Rosalbino, Segnan, Nereo, Ponti, Antonio, Marti, Elvira, Gonzales, Galina, Campagnoli, Carlo, Massobrio, Marco, Ambrogio, Simona, Gallo, Mario, Sismondi, Piero, Biglia, Nicoletta, Uicic, E, Bottini, Alberto, Allevi, Giovanni, Andreis, Daniele, Rosselli del Turco Marco, Muraca Maria Grazia, Zeccarelli, Maurizia, Iossa, Anna, Brancato, Beniamino, Belluardo, Donatella, Valenzano, Mario, Bogliolo, Stefano, Fortunato, Tiziana, Pardi, Giorgio, Ferrari, Maria, Waldis, Francesca, Veronesi, Umberto, Bonanni, Bernardo, Cazzaniga, Massimiliamo, Lazzeroni, Matteo, Serrano, Davide, Varricchio Maria Clara, Feroce, Irene, Rotmensz, Nicole, Maisonneuve, Patrick, Santillo, Barbara, Bazolli, Barbara, Goldhirsch, Aron, Sideri, Mario, Di Pace Raffaella, Moroni, Simona, Zamperini, Paola, Viale, Giuseppe, Cassano, Enrico, Latronico, Antuono, Meneghetti, Lorenza, Di Nubila Brunella, Pizzamiglio, Maria, D’Aiuto, Giuseppe, Oliviero, Pasquale, Oliviero, Giovanna, Riccone, Giuseppina, Gustavino, Claudio, Centurioni Maria Grazia, Ferrando, Liliana, De Maria Enrica, Zandonini, Gianfranco, Mangioni, Costantino, Giussani Maria Elena, Di Carlo Costantino, Nappi, Carmine, Mapelli, Carlo, Infantino, Carmelo, Bacchi Modena Alberto, Sgarabotto Maria Paola, Valitutto, Simona, Costa, Alberto, Scoccia, Elisabetta, Genazzani, Andrea, Gambacciani, Marco, Pepe, Antonia, Vacca, Francesca, Monti, Nadia, Tumolo, Salvatore, Cascinu, Stefano, Michiara, Maria, Ravaioli, Alberto, Desiderio, Franco, Fabbri, Carla, Pini, Emanuela, Vella, Alessandro, Fabi Linda Maria, Corrado, Nunziata, Bastianelli, Carlo, Rapiti, Stefania, Colafrancesco, Francesca, Ferrazzi, Enrico, Bombelli Maria Vittoria, Ciminera, Nadia, Cetin, Irene, Quaranta, Stefano, Incoronato, Pasquale, Gioffréwalter, Tripodi, Alessia, Vescio, Filippo, Pacquola Maria Grazia, Piccione, Emilio, Pietropolli, Adalgisa, Belloni, Carlo, Piol, Francesca, Sangiorgi, Barbara, Masullo, Pietro, Di Feo Gemma, Speranza, Mariangela, Ronsini, Salvatore, and Bisanti, Luigi
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Oncology ,medicine.medical_specialty ,breast cancer ,chemoprevention ,hormone replacement therapy and low dose ,tamoxifen ,Drug-Related Side Effects and Adverse Reactions ,Hormone Replacement Therapy ,medicine.medical_treatment ,Breast Neoplasms ,Hormone replacement therapy (HRT) ,Placebo ,Breast cancer ,Internal medicine ,menopausal symptoms ,Clinical endpoint ,Medicine ,Humans ,Drug Dosage Calculations ,skin and connective tissue diseases ,Adverse effect ,Climacteric ,Gynecology ,business.industry ,Hormone replacement therapy (menopause) ,Hematology ,Middle Aged ,medicine.disease ,Menopause ,Postmenopause ,Tamoxifen ,Chemoprevention ,Hormone replacement therapy and low dose ,Female ,Follow-Up Studies ,Relative risk ,business ,medicine.drug - Abstract
Postmenopausal hormone replacement therapy (HRT) relieves menopausal symptoms and may decrease mortality in recently postmenopausal women, but increases breast cancer risk. Low-dose tamoxifen has shown retained activity in phase-II studies.We conducted a phase-III trial in 1884 recently postmenopausal women on HRT who were randomly assigned to either tamoxifen, 5 mg/day, or placebo for 5 years. The primary end point was breast cancer incidence.After 6.2 ± 1.9 years mean follow-up, there were 24 breast cancers on placebo and 19 on tamoxifen (risk ratio, RR, 0.80; 95% CI 0.44-1.46). Tamoxifen showed favorable trends in luminal-A tumors (RR, 0.32; 95% CI 0.12-0.86), in HRT users5 years (RR, 0.35; 95% CI 0.15-0.82) and in women completing at least 12 months of treatment (RR, 0.49; 95% CI 0.23-1.02). Serious adverse events did not differ between placebo and tamoxifen, including, respectively, coronary heart syndrome (6 versus 4), cerebrovascular events (2 versus 5), VTE (2 versus 5) and uterine cancers (3 versus 1). Vasomotor symptoms were 50% more frequent on tamoxifen.The addition of low-dose tamoxifen to HRT did not significantly reduce breast cancer risk and increased climacteric symptoms in recently postmenopausal women. However, we noted beneficial trends in some subgroups which may deserve a larger study.
- Published
- 2013