TY - JOUR
T1 - Efficacy and safety of oxaliplatin and docetaxel in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC)
AU - Raez, Luis E.
AU - Santos, Edgardo S.
AU - Lopes, Gilberto
AU - Rosado, Manuel F.
AU - Negret, Lawrence M.
AU - Rocha-Lima, Caio
AU - Tolba, Kalhed
AU - Farfan, Nancy
AU - Hamilton-Nelson, Kara
AU - Silva, Orlando
AU - Roman, Eloy
PY - 2006/9/1
Y1 - 2006/9/1
N2 - Background and aims: Platinum-based doublets are recommended as treatment for advanced or metastatic non-small-cell lung cancer (NSCLC); however, chemotherapy must be tailored to limit side effects. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC. Methods: Patients with stage IIIB or IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m2, oxaliplatin 130 mg/m2, and pegfilgrastim 6 mg every 21 days for up to six cycles. Primary endpoint was overall response rate (ORR), secondary endpoints were progression-free (PFS) and overall survival (OS), and safety. Results: Twenty-nine patients were treated; 93% had stage IV disease and 28% had brain metastases. In 27 evaluable patients with follow-up, there were 10 partial responses for an ORR of 37% (90% confidence interval [CI], 22-55%). Median PFS was 4.6 months (95% CI, 2.6-6.5 months); 12-month PFS was 14.8% (95% CI, 3.4-34.0%). Median OS was 10.9 months (95% CI, 8.9-16.8 months); 12-month OS was 40% (95% CI, 19-61%) and 18-month OS was 16% (95% CI, 1-46%). In 29 treated patients, there were no unusual or unexpected adverse events. The most common grade 3 and 4 toxicities were anemia (14% of patients) and hyperglycemia (10%); there were only two reports of neutropenia; both were grade 1 or 2. Conclusion: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and should be further investigated as a feasible treatment alternative for patients with advanced or metastatic NSCLC.
AB - Background and aims: Platinum-based doublets are recommended as treatment for advanced or metastatic non-small-cell lung cancer (NSCLC); however, chemotherapy must be tailored to limit side effects. A phase II study was conducted to evaluate the efficacy and safety of oxaliplatin combined with docetaxel for NSCLC. Methods: Patients with stage IIIB or IV, chemotherapy-naive NSCLC received docetaxel 70 mg/m2, oxaliplatin 130 mg/m2, and pegfilgrastim 6 mg every 21 days for up to six cycles. Primary endpoint was overall response rate (ORR), secondary endpoints were progression-free (PFS) and overall survival (OS), and safety. Results: Twenty-nine patients were treated; 93% had stage IV disease and 28% had brain metastases. In 27 evaluable patients with follow-up, there were 10 partial responses for an ORR of 37% (90% confidence interval [CI], 22-55%). Median PFS was 4.6 months (95% CI, 2.6-6.5 months); 12-month PFS was 14.8% (95% CI, 3.4-34.0%). Median OS was 10.9 months (95% CI, 8.9-16.8 months); 12-month OS was 40% (95% CI, 19-61%) and 18-month OS was 16% (95% CI, 1-46%). In 29 treated patients, there were no unusual or unexpected adverse events. The most common grade 3 and 4 toxicities were anemia (14% of patients) and hyperglycemia (10%); there were only two reports of neutropenia; both were grade 1 or 2. Conclusion: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and should be further investigated as a feasible treatment alternative for patients with advanced or metastatic NSCLC.
KW - Advanced disease
KW - Chemotherapy
KW - Docetaxel
KW - First-line therapy
KW - Non-small-cell lung cancer
KW - Oxaliplatin
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U2 - 10.1016/j.lungcan.2006.05.023
DO - 10.1016/j.lungcan.2006.05.023
M3 - Article
C2 - 16844257
AN - SCOPUS:33746886649
SN - 0169-5002
VL - 53
SP - 347
EP - 353
JO - Lung Cancer
JF - Lung Cancer
IS - 3
ER -