Efficacy
After a median follow up of 45.2 months, the primary endpoint was not met. The median RFS in the intention to treat population was 38.9 months in the cisplatin/pemetrexed group vs 37.3 months in the cisplatin/vinorelbine group (HR=0.98; 95% CI, 0.81 to 1.20; p=0.474).r
The 3 year recurrence-free survival was 51.1% in the cisplatin/pemetrexed group (95% CI, 45.8% to 56.0%) vs 50.2% (95% CI, 45.0% to 55.2%) in the cisplatin/vinorelbine group.
The 3 year OS was 87.2% in the cisplatin/pemetrexed group (95% CI, 83.8% to 90.2%) and 83.5% in the cisplatin/vinorelbine group (95% CI, 79.2% to 87.0%).
In the post-hoc subgroup analysis by EGFR mutation status, the RFS in the EGFR wildtype group was 65.2 months in the cisplatin/pemetrexed group (95% CI 33.1 to no upper limit) and 39.9 months in the cisplatin/vinorelbine group (HR=0.87; 95% CI, 0.69 to 1.09).
The RFS in the EGFR mutated group was 24.1 months in the cisplatin/pemetrexed group and 30.4 months in the cisplatin/vinorelbine group (HR=1.38; 95% CI, 0.95 to 1.99). Based on preliminary data, known EGFR mutated patients requiring adjuvant chemotherapy should preferably receive cisplatin/vinorelbine.
JIPANG r |
Cisplatin/Vinorelbine |
Cisplatin/Pemetrexed |
Median RFS - overall population |
37.3 months |
38.9 months |
Median RFS - EGFR mutated |
30.4 months |
24.1 months |
Median RFS - EGFR wildtype |
39.9 months |
65.2 months |
3 year RFS |
50.2% |
51.1% |
3 year OS |
87.2% |
83.5% |
Kaplan Meier curve for RFS and OS in eligible patientsr
© J Clin Oncol 2020
Kaplan Meier curve for RFS in (A) patients with EGFR wildtype NSCLC and (B) patients with EGFR mutant NSCLCr
© J Clin Oncol 2020