17061 Background: Platinum-based doublets are used as treatment for advanced or metastatic non-small cell lung cancer (NSCLC), but chemotherapy must be tailored to decrease side effects. Oxaliplatin is more potent than cisplatin, requiring fewer DNA adducts to provide equivalent cytotoxicity in vitro studies. Oxaliplatin was active as a single agent and in combination with vinorelbine, paclitaxel, and gemcitabinein phase II studies of patients with NSCLC. 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 6 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints were progression-free and overall survival (PFS and OS), and safety. Results: Twenty-nine patients were treated; 15 (51.7%) were women, 25 (76%) were white, 17 (58.6%) were hispanic, 21 (72.4%) had adenocarcinomas, 24 (83%) had a PS ECOG 1, 93% had stage-IV disease and 28% had brain metastases. There were 10 partial responses in 27 evaluable patients for an ORR of 37% (90% confidence interval [CI], 21.7%–54.7%). Median PFS for 29 treated patients 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, 18.5%–60.8%) and 18-month OS was 16% (95% CI, 1.4%–45.7%). 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 2 reports of neutropenia; both were grade 1 or 2. Conclusions: These phase II findings suggest that the combination of oxaliplatin and docetaxel is active and well tolerated, and offers a feasible treatment alternative for patients with advanced or metastatic NSCLC. [Table: see text]
Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK -positive Non-Small Cell Lung Cancer
