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e-Poster Display Session

9P - Circulating tumour cells (CTCs) count and PD-L1 expression in untreated extensive small cell lung cancer patients treated in the REACTION trial, a phase II study of etoposide and cis/carboplatin with or without pembrolizumab (NCT02580994)

Date

09 Dec 2020

Session

e-Poster Display Session

Presenters

Jessica Menis

Citation

Annals of Oncology (2020) 31 (suppl_7): S1417-S1424. 10.1016/annonc/annonc389

Authors

J. Menis1, P. Bironzo2, G. Radj3, L. Greillier4, I. Monnet5

Author affiliations

  • 1 Istituto Oncologico Veneto IRCCS, Padova/IT
  • 2 Ospedale S. Luigi Gonzaga - Universita Di Torino, Torino/IT
  • 3 Centre Francois Baclesse (CLCC), Caen/FR
  • 4 Aix Marseille Univ, APHM, Marseille/FR
  • 5 Chi De Creteil, Creteil/FR
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Resources

Abstract 9P

Background

SCLC is characterized by large number of CTCs that have demonstrated prognostic value. We evaluated CTC count and PD-L1 expression on CTCs in the REACTION trial, a multicenter, open-label, randomized phase II trial.

Methods

In the REACTION 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 a total of 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. CTCs were collected with Streck tubes after registration and during the first 2 cycles of induction chemotherapy (at the discretion of the investigator), before randomization and every 2 cycles during treatment and at end of treatment.

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 = 0.84 (0.65, 1.09) and 1-sided p=0.194. Median OS (80% CI) was 12.3 months (10.2, 14.5) vs 10.4 (8.5, 11.6), HR = 0.73 (0.54, 1.0) and 1-sided p=0.097.

Conclusions

P combined with Pl-E was well tolerated, did not improve PFS but OS was significantly improved. CTC analysis are in finalization and results will be presented during the congress.

Clinical trial identification

NCT02580994.

Legal entity responsible for the study

European Organization for Research and Treatment of Cancer.

Funding

Merck Sharp & Dohme.

Disclosure

All authors have declared no conflicts of interest.

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