Phase II Trial of Nab-Paclitaxel Compared With Docetaxel as First-Line Chemotherapy in Patients With Metastatic Breast Cancer: Final Analysis of Overall Survival

作者：Gradishar William J^*; Krasnojon Dimitry; Cheporov Sergey; Makhson Anatoly N; Manikhas Georgiy M; Clawson Alicia; Bhar Paul; McGuire John R; Iglesias Jose

来源：Clinical Breast Cancer, 2012, 12(5): 313-321.

DOI：10.1016/j.dbc.2012.05.001

• Dose
• Schedule
• Solvent
• Taxane
• Treatment-naive

Strategies for optimizing taxane treatment have focused on modification of dosing schedules. This randomized phase II study compared the efficacy and safety of weekly and every 3 weeks (q3w) nab-paclitaxel versus docetaxel q3w as first-line treatment for metastatic breast cancer (MBC). Weekly nab-paclitaxel at 150 mg/m2 demonstrated the best risk-to-benefit ratio and longest overall survival in this study.
Background: A randomized phase II study in first-line MBC demonstrated superior efficacy and safety of weekly nab-paclitaxel compared with docetaxel. Final ail-viva] analyses and updated safety results are reported. Patients and Methods: Three hundred two patients with no previous chemotherapy for MBC were randomized to receive nab-paclitaxel 300 mg/m(2) q3w, nab-paclitaxel 100 mg/m(2) or 150 mg/m(2) the first 3 of 4 weeks (qw 3/4), or docetaxel 100 mg/m(2) q3w. The trial was powered for analyses of antitumor activity and safety. Results: Treatment with nab-paclitaxel 150 mg/m(2) qw 3/4 resulted in a median overall survival (OS) of 33.8 months compared with 22.2, 27.7, and 26.6 months for nab-paclitaxel 100 mg/m(2) qw 3/4, nab-paclitaxel 300 mg/m(2) q3w, and docetaxel, respectively (overall P = .047). Patients receiving 150 mg/m(2) nab-paclitaxel had prolonged median OS compared with those in the 100 mg/m(2) nab-paclitaxel arm (hazard ratio, 0.575; P = .008). A trend toward a longer OS was noted in the 150 mg/m(2) nab-paclitaxel arm versus docetaxel arm (hazard ratio, 0.688). Grade 3 or 4 fatigue, neutropenia, and febrile neutropenia were less frequent in all nab-paclitaxel arms compared with docetaxel. Conclusions: Consistent with previously published efficacy results, these data suggest that 150 mg/m(2) qw 3/4 may represent the most clinically efficacious nab-paclitaxel dosing regimen for patients with no previous chemotherapy for MBC. A phase Ill trial confirming these results would be necessary and prudent before widespread adoption of the 150 mg/m(2) dose in clinical practice.

• 出版日期2012-10
• 单位西北大学