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R. Rossell
Author of
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-044 - Erlotinib vs Chemotherapy in EGFR Mut+ NSCLC: OS in Three Phase III Trials Adjusting for Post-Progression Treatment Crossover (ID 9462)
09:30 - 09:30 | Author(s): R. Rossell
- Abstract
Background:
In EURTAC, ENSURE and OPTIMAL, first-line erlotinib was associated with higher response rates and improved PFS versus chemotherapy in EGFR Mut+ NSCLC. OS benefit was not observed, possibly due to high crossover. We present statistical analyses of OS adjusting for crossover in the three studies.
Method:
Rank Preserving Structural Failure Time (RPSFT) analysis is a retrospective statistical methodology that estimates the effect of active treatment and then removes that effect from the control patients, during the period of active treatment. Separately, post-hoc OS analyses were conducted on non-randomized subgroups of patients who received a single line of therapy, chemotherapy only or erlotinib only; or a sequence, chemotherapy followed by TKI or erlotinib followed by chemotherapy. Impact of sequencing on OS was evaluated (Kaplan-Meier methodology).
Result:
RPSFT analyses (Table) show OS was numerically longer with erlotinib versus chemotherapy in EURTAC and ENSURE. OS was not longer with erlotinib in OPTIMAL, possibly due to low treatment adherence in the erlotinib arm, where >50% of patients refused chemotherapy or did not complete four cycles. In the non-randomized analyses, patients receiving erlotinib as the sole treatment had longer OS versus patients treated with only chemotherapy, in all three studies. Patients who received erlotinib followed by chemotherapy had longer OS versus patients who received chemotherapy followed by erlotinib in EURTAC and ENSURE. Patients who received chemotherapy followed by erlotinib in OPTIMAL had longer OS than patients who received erlotinib then chemotherapy, again possibly due to erlotinib patients refusing the full extent of post-progression chemotherapy.
Conclusion:
RPSFT analysis showed increased OS between erlotinib and chemotherapy in EURTAC and ENSURE versus the original ITT analysis. Similar impact in OPTIMAL was not apparent. Post-hoc analysis of non-randomized subgroups (patients treated with a single therapy) showed longer OS for erlotinib versus chemotherapy, notwithstanding caveats of such an approach.OS (RPSFT analysis) Study Treatment Group N Median OS, months HR (95% CI) EURTAC Erlotinib 86 22.9 0.64 (0.44, 0.95) Chemo 88 15.4 ENSURE Erlotinib 110 26.3 0.47 (0.32, 0.69) Chemo 107 17.1 OPTIMAL Erlotinib 82 22.7 1.78 (1.21, 2.64) Chemo 72 30.5 Influence of sequencing on OS in patients who crossed over (Kaplan-Meier analysis) Study Treatment Group N Patients crossing over, % Median OS, months EURTAC Erlotinib/chemo 49 57 24.9 Chemo/TKI 72 82 22.6 Erlotinib alone 37 17.2 Chemo alone 16 1.6* ENSURE Erlotinib/Chemo 69 63 27.0 Chemo/TKI 89 83 25.6 Erlotinib alone 41 23.2 Chemo alone 18 22.9 OPTIMAL Erlotinib/ Chemo 49 60 26.8 Chemo/TKI 52 72 31.4 Erlotinib alone 33 18.6 Chemo alone 20 11.2 *There were 5 deaths and 5 censored observations that occurred in the first two months
