#OncoAlert Now online at JCO @ASCO_pubs, results from the randomized phase III trial of adjuvant cis/pem vs cis/vinorelbine in resected stage II-IIIA #NSCLC. #LCSM
ascopubs.org/doi/full/10.12…
#OncoAlert Enrolled 804 patients with nonsquamous stage II-IIIA. 1:1 randomization [stratified by sex, age, stage, institution, EGFR status] to 4 21-day cycles of either standard cisplatin 80mg/m2 + vinorelbine 25mg/m2 days 1 and 8 or to cisplatin 75mg/m2 + pemetrexed 500mg/m2.
#OncoAlert Primary endpoint of superior DFS was NOT met. After median f/u of 45.2 months, median RFS 37.3m with standard cis/vinorelbine versus 38.9m with cis/pem (HR 0.98). Median OS not reached but HR 0.98 and 3y OS rate 83.5% in control and 87.2% in experimental. #LCSM
#OncoAlert Surprised by the #EGFR subset. In EGFR wild type, RFS favored cis/pem (65.2m vs. 39.9m); in EGFR mutant, RFS favored cis/vinorelbine (30.4m vs. 24.1m), though neither significant. Surprised by the low absolute RFS in #EGFR. Inadequate staging (i.e. no MRI)? #LCSM
#OncoAlert Tolerability favored cis/pem over cis/vinorelbine. G3+ febrile NTP rate 0.3% vs. 11.6%, G3+ anemia rate 2.8% vs. 9.3%, G3+ fatigue 2.3% vs 4.5%. Completion of 4 cycles achieved by 87.9% of cis/pem arm and 72.7% of cis/vino arm (bit higher than I would have guessed).
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