New cytotoxic agents with activity against breast cancer have been recently introduced in clinical practice with positive impact in survival. Among these agents, paclitaxel as single agent has produced response rates of 29–62%. Many clinical trials are in progress to evaluate the most promising associations of paclitaxel with other new agents; gemcitabine has demonstrated activity in metastatic breast cancer (MBC) with response rates ranging from 12% to 29% (in pretreated pts) and from 14% to 37% (as first-line therapy) when used as a single agent. Phase II studies of gemcitabine plus paclitaxel in pretreated patients with MBC have shown impressive response rates ( 50%). Recent clinical trials have demonstrated the feasibility, safety and activity of a biweekly administration of paclitaxel and gemcitabine in MBC and according to these data, a phase II study was started in order to assess this schedule in a subset of patients pretreated with anthracyclines. In a phase II study, paclitaxel (135 mg/mq) was given on day 1, followed by gemcitabine (2000 mg/mq) also on day 1, of a 14-day course. Treatments with colony-stimulating factors were allowed in order to respect the dose-density of the schedule. Twenty-two patients were recruited and their characteristics were: median age 53, PS 0–1 in 18 pts (82%) and 2 in 4 pts (18%), pre-treatment with anthracyclines in adjuvant and advanced setting. All the patients were evaluable for toxicity and activity. The treatment was feasible and well tolerated: grade 4 toxicity was very rare and occurred in only three cases (2 pts with neutropenia and one with thrombocytopenia); grade 3 toxicity was more frequent but promptly reversible (the most recurrent was anemia in 24% of cases); no febrile neutropenia was observed. We observed 13 (58%) objective responses, three complete responses (13%), 10 (45%) partial responses and five (23%) stable disease. Progression was documented in 4 pts (18%). This study confirms the evidence that the biweekly association of paclitaxel and gemcitabine is a safe and active regimen in anthracycline-pretreated patients with MBC and suggests the necessity to investigate whether the combination of gemcitabine and paclitaxel is better than paclitaxel alone in this subset of patients.

Phase II study evaluating the activity and toxicity of biweekly schedule of gemcitabine and paclitaxel in anthracycline-pretratted breast cancer / Spinelli, GIAN PAOLO; DI SERI, Marisa; Mezi, Silvia; A., Oliveti; F., Tomao; F., Petricola; S., Rosati; S., Ricciardi; D., Coletta; A., Romiti; Frati, Luigi; Tomao, Silverio. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - STAMPA. - 15:(2004), p. 24. ((Intervento presentato al convegno 6th National Congress of Medical Oncology tenutosi a Bologna.

Phase II study evaluating the activity and toxicity of biweekly schedule of gemcitabine and paclitaxel in anthracycline-pretratted breast cancer

SPINELLI, GIAN PAOLO;DI SERI, Marisa;MEZI, Silvia;F. Tomao;FRATI, Luigi;TOMAO, SILVERIO
2004

Abstract

New cytotoxic agents with activity against breast cancer have been recently introduced in clinical practice with positive impact in survival. Among these agents, paclitaxel as single agent has produced response rates of 29–62%. Many clinical trials are in progress to evaluate the most promising associations of paclitaxel with other new agents; gemcitabine has demonstrated activity in metastatic breast cancer (MBC) with response rates ranging from 12% to 29% (in pretreated pts) and from 14% to 37% (as first-line therapy) when used as a single agent. Phase II studies of gemcitabine plus paclitaxel in pretreated patients with MBC have shown impressive response rates ( 50%). Recent clinical trials have demonstrated the feasibility, safety and activity of a biweekly administration of paclitaxel and gemcitabine in MBC and according to these data, a phase II study was started in order to assess this schedule in a subset of patients pretreated with anthracyclines. In a phase II study, paclitaxel (135 mg/mq) was given on day 1, followed by gemcitabine (2000 mg/mq) also on day 1, of a 14-day course. Treatments with colony-stimulating factors were allowed in order to respect the dose-density of the schedule. Twenty-two patients were recruited and their characteristics were: median age 53, PS 0–1 in 18 pts (82%) and 2 in 4 pts (18%), pre-treatment with anthracyclines in adjuvant and advanced setting. All the patients were evaluable for toxicity and activity. The treatment was feasible and well tolerated: grade 4 toxicity was very rare and occurred in only three cases (2 pts with neutropenia and one with thrombocytopenia); grade 3 toxicity was more frequent but promptly reversible (the most recurrent was anemia in 24% of cases); no febrile neutropenia was observed. We observed 13 (58%) objective responses, three complete responses (13%), 10 (45%) partial responses and five (23%) stable disease. Progression was documented in 4 pts (18%). This study confirms the evidence that the biweekly association of paclitaxel and gemcitabine is a safe and active regimen in anthracycline-pretreated patients with MBC and suggests the necessity to investigate whether the combination of gemcitabine and paclitaxel is better than paclitaxel alone in this subset of patients.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/410613
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