Abstract 223P
Background
Adjuvant treatment with novel tyrosine-kinase inhibitors (TKI) improves survival in EGFR-mutated and ALK-rearranged completely resected lung cancer. However, it is debatable whether novel generation TKIs should be administered in combination with platinum based chemotherapy (PCT) or alone. To clarify the role of PCT in these patients the overall benefits offered by PCT in EGFRm and ALKr resected NSCLC alone or in combination with novel generation TKIs were tested in an individual patients’ data (IPD) meta-analysis of randomized trial.
Methods
An IPD meta-analysis of phase III trials investigating novel generation TKIs after surgical resection with or without PCT was conducted. IPD was extracted using the IPDfromKM method from available Kaplan Meier curves estimated from the intention to treat analysis. The primary endpoint of the study was to compare disease-free survival (DFS) in EGFRm and ALKr patients treated with novel generation TKIs with or without PCT administration. Hazard ratios (HR) and relative 95% confidence intervals (95% CI) were estimated with Cox regression analyses.
Results
Three reports from 2 studies (ALINA, ADAURA)were ultimately included in this analysis. We extracted IPD from 939 patients, of which 266 had TKI alone, 203 had TKI plus PCT, 334 had chemotherapy alone and 136 had placebo. Overall, death or recurrence was observed in 30 versus 22 patients after TKI alone or TKI plus PCT with a 2yr-DFS of 91.9% and 89% respectively. The HR for DFS was 1.52 (95%CI 0.87–2.66), p=0.145. In the patients undergoing adjuvant PCT, recurrences or death were observed in 153 patients. 2-yr DFS were 54.7% and 58.3% in the patients undergoing either PCT or placebo. HR for recurrence or death was 1.11 (95%CI 0.81–1.51), p=0.53. PCT improved DFS in patients in stage IIIA compared to placebo (p=0.0007).
Conclusions
Our analysis showed that PCT in addition to novel generation TKIs seems not to provide survival advantages over TKIs monotherapy in the adjuvant setting.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.