A phase II randomized study comparing navelbine and capecitabine (Navcap) followed either by Navcap or by weekly docetaxel in the first-line treatment of HER-2/neu negative metastatic breast cancer.
Following the proven efficacy and tolerability of Navcap and Navcap followed by docetaxel in the treatment of MBC, a phase II randomized study was initiated to assess the ORR of both arms in the first-line setting of MBC. Patients with no prior chemotherapy for MBC and HER-2/neu negative were eligible. All patients received Navcap (V 25 mg/m2 on d1 and d8 and C 825 mg/m2 bid D1-14 q3w) for a total of 4 cycles. Patients progressing under Navcap were withdrawn and received docetaxel as second-line treatment. Patients responding or stable were randomized to 2 arms: 4 cycles of Navcap (A) or 12 weekly docetaxel (25 mg/m²/week) (B). From July 2004 to July 2008, a total of 106 patients were enrolled. Ninety-four patients were evaluable before randomization, with a clinical benefit of 58%. Twenty-one patients (22%) had disease progression and were therefore not randomized. Forty-one patients were randomized to arm A and 29 patients to arm B. ORRs were 56 and 71% in arms A and B, respectively. The median time to progression and overall survival were 10 and 35 months in arm A and 12 and 37 months in arm B. Adverse events were mild. Arm A: grade 3-4 neutropenia (10%), grade 3 anemia (5%). Arm B: grade 3 neutropenia (6%), grade 3 anemia (6.2%), and grade 2 alopecia (12%).


CONCLUSIONS
Both Navcap and Navcap followed by Docetaxel regimens were tolerated with manageable toxicity, offering consistent activities in terms of response rate for metastatic breast cancer patients.
Hematology and Medical Oncology Department, Hotel-Dieu de France University Hospital, Alfred Naccache Blvd, PO Box 166830 Beirut, Lebanon. mghosn.hdf@usj.edu.lb
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Ghosn
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Aftimos
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Farhat
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Kattan
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Hanna
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Haddad
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Nasr
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Chahine
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D014408:Biomarkers, Tumor / Q000032:analysis*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
D014408:Biomarkers, Tumor; D000069287:Capecitabine; D003841:Deoxycytidine; D000077143:Docetaxel; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D014747:Vinblastine; D000077235:Vinorelbine; C508053:ERBB2 protein, human