Cisplatin or carboplatin in combination with pemetrexed as adjuvant treatment for patients with completely resected stage 1b/2 non-small cell lung carcinoma demonstrated acceptable safety-related feasibility and tolerability, according to a study published online ahead of print in the journal Lung Cancer.1
In this multicenter, open-label, parallel-group, non-comparative phase 2 study, a total of 118 patients were treated with either pemetrexed (500 mg/m2) + cisplatin (75 mg/m2) or carboplatin (AUC5) for 4 cycles of 21 days. A total of 71.9% (46/64) of patients in the pemetrexed + cisplatin group and 88.9% (48/54) of patients in the pemetrexed + carboplatin group completed 4 cycles.
The study’s primary endpoint s were: treatment feasibility defined as 4 cycles completed with no cycle delay > 42 days and ≤ 2 dose reductions and no grade ≥ 3 toxicities at a follow-up of 30 days after last drug administration. Secondary endpoints were overall survival and safety.
Results showed that the study failed to meet the primary endpoint of feasibility (> 60% of patients). A total of 59.4% of patients in the cisplatin group (95% CI, 46.4 – 71.5) and 50% of patients in the carboplatin group (95% CI, 36.1 – 63.9).
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A post-hoc analysis considering only safety revealed feasibility in 81.3% (95% CI, 69.5 – 89.9) of patients in the cisplatin group and 90.7% (95% CI, 79.9 – 96.9) of patients in the carboplatin group.
Overall survival rates for both groups were 82% to 83% after 3 years and 80% to 83% after 5 years.
In regard to safety, treatment-related grade ≥ 3 adverse events were experienced by approximately 30% in each group.
- Schmid-Binder G, Engel-Riedel W, Reck M, et al. A randomized phase 2 study of pemetrexed in combination with cisplatin or carboplatin as adjuvant chemotherapy in patients with completely resected stage IB of II non-small-cell lung cancer [published online ahead of print November 7, 2015]. Lung Cancer. doi: 10.1016/j.lungcan.2015.11.007.