In this phase II, multicentre trial, patients with metastatic breast cancer (MBC) were treated with a combination of gemcitabine, epirubicin and paclitaxel (GET). The primary objective of this study was to determine the tolerability and activity in terms of complete responce (CR) and overall response rate of the GET combination in this patient population. Patients with no prior treatment for MBC, and at least one bidimensionally measurable lesion received gemcitabine 1000 mg m(-2) intravenously (i.v.) over 30 min on days 1 and 4, followed by epirubicin i.v. at 90 mg m(-2) on day 1, and paclitaxel 175 mg m(-2) over 3 h on day 1, every 21 days, up to eight courses. From May 1999 to June 2000, 48 patients were enrolled from seven Italian institutions. A total of 297 chemotherapy courses were administered with a median of six cycles patient(-1) (range 1-8). Seven patients (15%) obtained CR and 27 patients (56%) had partial responce, for an overall response rate of 71% (95% CI: 58.3-83.7). After a median follow-up of 23.7 months (range 7.0-34.4), median progression-free survival was 10.5 months (95% CI: 9.2-11.7), and median overall survival 25.9 months. The main haematological toxicity consisted of grade 3 or 4 neutropenia that occurred in 62% of cycles (22% grade 4 and 40% grade 3). The GET combination is active and well tolerated as first-line chemotherapy for MBC.

Muiticentric phase II trial of gemcitabine plus epirubicin plus paclitaxel as first-line chemotherapy in metastatic breast cancer / Cappuzzo, F; Mazzoni, F; Gennari, A; Donati, S; Salvadori, B; Orlandini, C; Cetto, Gl; Molino, A; Galligioni, E; Mansutti, M; Tumolo, S; Lucentini, A; Valduga, F; Bartolini, S; Crinò, L; Conte, Pierfranco. - In: BRITISH JOURNAL OF CANCER. - ISSN 0007-0920. - STAMPA. - 90:(2004), pp. 31-35. [10.1038/sj.bjc.6601518]

Muiticentric phase II trial of gemcitabine plus epirubicin plus paclitaxel as first-line chemotherapy in metastatic breast cancer

CONTE, Pierfranco
2004

Abstract

In this phase II, multicentre trial, patients with metastatic breast cancer (MBC) were treated with a combination of gemcitabine, epirubicin and paclitaxel (GET). The primary objective of this study was to determine the tolerability and activity in terms of complete responce (CR) and overall response rate of the GET combination in this patient population. Patients with no prior treatment for MBC, and at least one bidimensionally measurable lesion received gemcitabine 1000 mg m(-2) intravenously (i.v.) over 30 min on days 1 and 4, followed by epirubicin i.v. at 90 mg m(-2) on day 1, and paclitaxel 175 mg m(-2) over 3 h on day 1, every 21 days, up to eight courses. From May 1999 to June 2000, 48 patients were enrolled from seven Italian institutions. A total of 297 chemotherapy courses were administered with a median of six cycles patient(-1) (range 1-8). Seven patients (15%) obtained CR and 27 patients (56%) had partial responce, for an overall response rate of 71% (95% CI: 58.3-83.7). After a median follow-up of 23.7 months (range 7.0-34.4), median progression-free survival was 10.5 months (95% CI: 9.2-11.7), and median overall survival 25.9 months. The main haematological toxicity consisted of grade 3 or 4 neutropenia that occurred in 62% of cycles (22% grade 4 and 40% grade 3). The GET combination is active and well tolerated as first-line chemotherapy for MBC.
2004
90
31
35
Muiticentric phase II trial of gemcitabine plus epirubicin plus paclitaxel as first-line chemotherapy in metastatic breast cancer / Cappuzzo, F; Mazzoni, F; Gennari, A; Donati, S; Salvadori, B; Orlandini, C; Cetto, Gl; Molino, A; Galligioni, E; Mansutti, M; Tumolo, S; Lucentini, A; Valduga, F; Bartolini, S; Crinò, L; Conte, Pierfranco. - In: BRITISH JOURNAL OF CANCER. - ISSN 0007-0920. - STAMPA. - 90:(2004), pp. 31-35. [10.1038/sj.bjc.6601518]
Cappuzzo, F; Mazzoni, F; Gennari, A; Donati, S; Salvadori, B; Orlandini, C; Cetto, Gl; Molino, A; Galligioni, E; Mansutti, M; Tumolo, S; Lucentini, A; Valduga, F; Bartolini, S; Crinò, L; Conte, Pierfranco
File in questo prodotto:
File Dimensione Formato  
6601518.pdf

Open access

Tipologia: Versione pubblicata dall'editore
Dimensione 109.01 kB
Formato Adobe PDF
109.01 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/615772
Citazioni
  • ???jsp.display-item.citation.pmc??? 4
  • Scopus 23
  • ???jsp.display-item.citation.isi??? 21
social impact