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REACTION: A phase II study of etoposide and cis/carboplatin with or without pembrolizumab in untreated extensive small cell lung cancer
Besse, B. Menis, J. Bironzo, P. Gervais, R. Greillier, L. Monnet, I. Livi, L. Young, R. Decroisette, C. Cloarec, N.
Besse, B.
Menis, J.
Bironzo, P.
Gervais, R.
Greillier, L.
Monnet, I.
Livi, L.
Young, R.
Decroisette, C.
Cloarec, N.
Citations
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Abstract
Background: Anti-PD-L1 antibodies extend overall survival (OS) of patients with
extensive disease Small Cell Lung Cancer (ED-SCLC) when combined with platinumetoposide
(Pl-E) from cycle 1. We evaluated the benefit of first-line pembrolizumab
(P) combined with Pl-E from cycle 3 in the subgroup of chemo-sensitive ED-SCLC.
Methods: REACTION is a multicenter, open-label, randomized phase II trial. Patients
with ED-SCLC, unselected for PD-L1, with PS 0/1 and controlled brain metastases who
achieved an objective response after 2 X Pl-E were randomized 1:1 to experimental
arm (EXP) P in combination with 4 X Pl-E then P up to 35 cycles vs. 4 X Pl-E in the
control (CTRL) arm. Cross-over to P-Pl-E was allowed for CTRL. Primary endpoint was
progression free survival (PFS) from randomization. With a 1-sided alpha 10%, the
study was powered at 90% level to detect a Hazard Ratio (HR) of 0.575 in PFS.
Results: Between Feb 7, 2018 and Oct 31, 2019, 125 patients were recruited (61 in
EXP arm vs 64 in CTRL arm) with 119 (58 vs 61) eligible and receiving at least one dose
of treatment (Per Protocol [PP] population). Median age was 65 vs 63.5 years with the
majority being male (72 vs 56%), PS 1 (62 vs 60%), and rare brain metastases (8 vs
11%). Most patients had partial response (PR) to the induction chemo (98% in each
arm). 19 patients crossed over to P-E-Pl. Among 124 patients who started treatment,
grade _3 adverse events were observed in 43 vs 36%, while only 2 patients (1 in each
arm) had grade 5 toxicity. Among PP patients, 107 PD or deaths were observed. The
response rate was 61% (67 vs 56%). Median follow-up time with respect to OS was
14.2 months in EXP and 14.0 months in CTRL arm. Median PFS (80% CI) was 4.7
months (4.5, 5.3) vs 5.4 (4.9, 5.5), HR ¼ 0.84 (0.65, 1.09) and 1-sided p¼0.194. Median OS (80% CI) was 12.3 months (10.2, 14.5) vs 10.4 (8.5, 11.6), HR ¼ 0.73 (0.54,1.0) and 1-sided p¼0.097.Conclusions: P combined with Pl-E was well tolerated but did not improve PFS over
Pl-E in chemo-sensitive patients with ED-SCLC. The OS however showed P combined
with Pl-E significantly improved OS at 1-sided 10% level.
Description
Date
2020
Publisher
Collections
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From UNPAYWALL
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Keywords
Type
Meetings and Proceedings
Citation
Besse B, Menis J, Bironzo P, Gervais R, Greillier L, Monnet I, et al. LBA85 REACTION: A phase II study of etoposide and cis/carboplatin with or without pembrolizumab in untreated extensive small cell lung cancer. Annals of Oncology. 2020;31:S1211-S2.