© 2005 European Society for Medical Oncology
Original article |
Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: a phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer)
1 Department of Medical Oncology, National Cancer Research Institute, Genova; 2 Clinical Trials Unit, NCI, Naples; 3 Istituto Nazionale Riposo e Cura per l'anziano, Oncologia, Roma; 4 Department of Oncology-Hematology, Azienda Ospedaliera S. Carlo, Potenza; 5 Department of Oncology, Ospedale Fatebenefratelli, Roma; 6 Medical Oncology Unit University Hospital of Padua, Padova; 7 UO Oncology, Molinette Hospital, Torino; 8 U.O. Oncologia Medica, USL 1, Ospedale Civile, Sanremo (IM), Italy
* Correspondence to: Dr L. Del Mastro, Department of Medical Oncology, National Cancer Research Institute, L.go Rosanna Benzi 10, 16132 Genova, Italy. Tel: +39-010-5600666; Fax: +39-010-5600850; Email: lucia.delmastro{at}istge.it
Background: First-line chemotherapy regimens suitable for elderly advanced breast cancer patients are still not defined.
Patients and methods: Women with stage III or IV breast cancer aged 
70 years were enrolled in a phase II study aimed to evaluate both activity and toxicity of weekly paclitaxel. Among 46 planned patients, at least 18 responses and not more than seven unacceptable toxic events are required for a favourable conclusion. Paclitaxel 80 mg/m2 was administered weekly for 3 weeks every 28 days.
Results: Unacceptable toxicity occurred in seven out of 46 patients evaluated for toxicity [15.2%; exact 95% confidence interval (CI) 7.6% to 28.2%] and was represented by one case of febrile neutropenia, one case of severe allergic reaction and five cases of cardiac toxicity. Among 41 patients evaluated for response, a complete response occurred in two (4.9%) patients and a partial response in 20 (48.8%), with an overall response rate of 53.7% (exact 95% CI 38.7% to 67.9%). The median progression-free survival was 9.7 months (95% CI 8.5–18.7) and median survival was 35.8 months (95% CI 19–not defined).
Conclusions: Weekly paclitaxel is highly active in elderly advanced breast cancer patients. Data on cardiovascular complications, however, indicate the need for a careful monitoring of cardiac function before and during chemotherapy.
Key words: breast cancer, cardiotoxicity, chemotherapy, elderly, phase II study, weekly paclitaxel
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