|
Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 10683
© 2006 American Society of Clinical Oncology
A clinical phase II study of combination Cisplatinum and Vinorelbine followed by Docetaxel as first-line chemotherapy in metastatic breast cancer
N. S. El-Saghir,
Z. Otrock,
Z. Abdel Khalik,
H. Yassine,
M. Khalifeh,
N. Bitar,
M. Charafeddine,
R. Jalloul,
A. Dandashi and
A. Shamseddine
American University of Beirut, Beirut, Lebanon; Sahel General Hospital, Beirut, Lebanon; Makassed General Hospital, Beirut, Lebanon; Islamic Hospital, Beirut, Lebanon
10683
Background: Many chemotherapeutic options exist for metastatic breast cancer (MBC) but there is no standard regimen. We tested a sequential combination regimen using Cisplatinum and Vinorelbine (PVn) followed by Docetaxel as first-line chemotherapy in a phase II clinical trial. This is the first study using a non-anthracycline sequential combination chemotherapy of PVn with Docetaxelin MBC. Methods: Thirty-five patients were enrolled. Cisplatin 80 mg/m2, which was given on day 1 and Vinorelbine 30 mg/m2 on days 1 and 8 q3 weeks for 4 cycles. After the 4th cycle, responding patients received Docetaxel 75 mg/m2 every 21 days for a maximum of 4 cycles. Patients were evaluated every two cycles and those who had no response were offered other therapy. Patients who showed progression after 2 cycles of PVn were offered Docetaxel but were considered off protocol. Three patients were excluded from analysis because of death unrelated to treatment. Results: After a median follow up of 14 months (range 1–36), 32 patients (91.4%) completed the study. Overall response rate was 53.1%. Complete remission was seen in 5 pts (15.6%), partial response in 12 patients (37.5%), stable disease in 6 patients (18.75%), and progressive disease in 9 patients (28.1%). 20 patients (62.5%) were alive at 12 months. Median time to disease progression was 8 months (range 1–24). At 24 months 37.5% (12 patients) were alive. Response rates to PVn were not significantly improved by sequential addition of Docetaxel. A total of 183 cycles were administered with a median of 6 cycles per patient. Delay of chemotherapy because of Grade II neutropenia occurred in 41/183 cycles (22.4%). Febrile neutropenia was observed in 4 patients (2.2%). Grade II anemia was observed in 40/183 cycles (21.8%) and Grade III in 24/183 cycles (13.1%). Grade II nephrotoxicity occurred in 12 cycles (6.5%) and Grade III vomiting was observed in 31/183 cycles (16.9%). No treatment-related mortality has been reported. Conclusions: Sequential PVn-Docetaxel is a feasible and effective non-anthracycline option as first-line chemotherapy in patients with MBC. More effective Docetaxel may be better used upfront and followed by PVn. This regimen has acceptable toxicity as well.
No significant financial relationships to disclose.
|
