This phase II study combined paclitaxel (Taxol; Bristol Myers Squibb Company, Princeton, NJ) 135 mg/m2 by 3-hour infusion on day 1 and vinorelbine 25 mg/m2 on days 1 and 8 (in the first 14 patients) or on days 1 and 3 (in the subsequent 20 patients). The courses were repeated every 3 weeks. The second vinorelbine dose (on days 3 or 8) was reduced or omitted according to the toxicities encountered. Thirty-four patients have been treated to date; 21 had received one prior regimen of chemotherapy, 11 had two prior regimens, and two had three prior regimens. Only two patients (6\%) had not been exposed to anthracyclines. One hundred twenty-six courses have been administered: 52 with vinorelbine given on days 1 and 8, and 74 with vinorelbine administered on days 1 and 3. The most frequent toxicity was grade 4 neutropenia, which occurred in 64\% of the courses; 13 episodes of febrile neutropenia have been reported in eight patients. Filgrastim was administered in 43\% of the courses because of febrile neutropenia or delayed recovery (> 72 hours) from grade 4 neutropenia. Mucositis was observed in 18\% of the courses (12\% grade 1, 3\% grade 2, and 3\% grade 3). The dose of vinorelbine was reduced or omitted in 86\% of courses with the days 1 and 8 schedule, and in 48\% of courses with the days 1 and 3 schedule. Among 28 evaluable patients, two complete and 10 partial responses have been observed (response rate, 43\%, 95\% confidence interval, 19\% to 51\%). Median duration of response is 5+ months (range, 1 to 15 months). In conclusion, this combination is active and has acceptable toxicities in anthracycline-pretreated breast cancer patients. The delivered dose intensity of vinorelbine is higher with the schedule adopted later in the study, with vinorelbine given on days 1 and 3.
|Data di pubblicazione:||1996|
|Titolo:||Paclitaxel in combination with vinorelbine in pretreated advanced breast cancer patients.|
|Autore/i:||A., Michelotti; A., Gennari; B., Salvadori; P. G., Giannessi; E., Baldini; C., Tibaldi; M. D., Prato; Conte, Pierfranco|
|Codice identificativo ISI:||WOS:A1996VP85200008|
|Codice identificativo Scopus:||2-s2.0-0029805051|
|Codice identificativo Pubmed:||8893898|
|Citazione:||Paclitaxel in combination with vinorelbine in pretreated advanced breast cancer patients / A., Michelotti; A., Gennari; B., Salvadori; P. G., Giannessi; E., Baldini; C., Tibaldi; M. D., Prato; Conte, Pierfranco. - In: SEMINARS IN ONCOLOGY. - ISSN 0093-7754. - STAMPA. - 23(1996), pp. 38-40.|
|Tipologia||Articolo su rivista|
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