Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Mini Oral - Non-metastatic NSCLC and other thoracic malignancies

LBA85 - REACTION: A phase II study of etoposide and cis/carboplatin with or without pembrolizumab in untreated extensive small cell lung cancer

Date

18 Sep 2020

Session

Mini Oral - Non-metastatic NSCLC and other thoracic malignancies

Presenters

Benjamin Besse

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

B. Besse1, J. Menis2, P. Bironzo3, R. Gervais4, L. Greillier5, I. Monnet6, L. Livi7, R. Young8, C. Decroisette9, N. Cloarec10, G. Robinet11, R. Schott12, R. Califano13, F. De Marinis14, G.L. Banna15, M. Mauer16, A. Pochesci17, B. Hasan18, T. Berghmans19, A.C. Dingemans20

Author affiliations

  • 1 Dept Of Cancer Medicine, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 2 Medical Oncology, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 3 Oncology Department, Azienda Ospedaliera Universitaria San Luigi Gonzaga, 10043 - Orbassano/IT
  • 4 Pneumologie, Centre Francois Baclesse, 14076 - Caen/FR
  • 5 Multidisciplinary Oncology And Therapeutic Innovations Department, Hopital St. Marguerite Assistance Publique Hopitaux de Marseille, 13009 - Marseille/FR
  • 6 Pneumologie, CH Intercommunal de Créteil, 94010 - Créteil/FR
  • 7 Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, 50134 - Florence/IT
  • 8 Academic Unit Of Clinical Oncology, Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust, S10 2SJ - Sheffield/GB
  • 9 Pneumology, Le Centre Hospitalier Annecy Genevois, 74370 - Metz-Tessy/FR
  • 10 Oncology, CH Henri Duffaut, 84902 - Avignon/FR
  • 11 Pneumologie, C.H.U. Brest - Hôpital Morvan, 29609 - Brest/FR
  • 12 Medical Oncology, Centre Paul Strauss Centre de Lutte contre le Cancer, 67065 - Strasbourg/FR
  • 13 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 14 Director Thoracic Oncology Division, Vice Director Lung Cancer Program, European Institute of Oncology, IRCCS, Milan/IT
  • 15 Department Of Medical Oncology, Portsmouth Hospitals NHS Trust, PO63LY - Portsmouth/GB
  • 16 Statistics, EORTC, Brussels/BE
  • 17 Lung Cancer Group, EORTC, Brussels/BE
  • 18 Department Of Statistics, European Organisation for Research and Treatment of Cancer, 1200 - Brussels/BE
  • 19 Department Of Thoracic Oncology, Institute Jules Bordet, 1000 - Brussels/BE
  • 20 Pulmonology Department, Erasmus MC - University Medical Center, 3015 CE - Rotterdam/NL
More

Resources

Login to access the resources on OncologyPRO.

Abstract LBA85

Background

Anti-PD-L1 antibodies extend overall survival (OS) of patients with extensive disease Small Cell Lung Cancer (ED-SCLC) when combined with platinum-etoposide (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 = 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 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.

Clinical trial identification

NCT02580994.

Editorial acknowledgement

Legal entity responsible for the study

EORTC.

Funding

MSD.

Disclosure

B. Besse: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BeiGene; Research grant/Funding (institution): Blueprint Medicines; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Celgene; Research grant/Funding (institution): Cristal Therapeutics; Research grant/Funding (institution): Daiichi-Sankyo; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): GSK; Research grant/Funding (institution): Ignyta; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Inivata; Research grant/Funding (institution): Janssen; Research grant/Funding (institution): Merck KGaA; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Nektar; Research grant/Funding (institution): Onxeo; Research grant/Funding (institution): OSEI immunotherapeutics; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): PharmaMar; Research grant/Funding (institution): Roche-Genentech; Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Servier; Research grant/Funding (institution): Spectrum Pharmaceuticals; Research grant/Funding (institution): Takeda; Research grant/Funding (institution): Tiziana Pharma; Research grant/Funding (institution): Tolero Pharmace. J. Menis: Travel/Accommodation/Expenses: Bristol-Myers Squibb; Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: msd; Advisory/Consultancy: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim. L. Greillier: Honoraria (self): AbbVie; Honoraria (self): Novartis; Honoraria (self): MSD; Honoraria (self): AstraZeneca; Honoraria (self): roche; Honoraria (self): BMS; Honoraria (self): Boehringer Ingelheim; Honoraria (self): Pfizer; Honoraria (self): Takeda. C. Decroisette: Advisory/Consultancy: Roche; Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Pfizer. R. Califano: Honoraria (self), Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): Boehringer Ingelheim; Research grant/Funding (institution): AbbVie; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self): Bayer; Honoraria (self), Research grant/Funding (institution): Takeda; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Clovis; Shareholder/Stockholder/Stock options: The Christie Private Care. A-M.C. Dingemans: Non-remunerated activity/ies: AbbVie; Research grant/Funding (institution): Amgen; Honoraria (self): Pfizer; Honoraria (self): Roche; Honoraria (self): Boehringer Ingelheim; Research grant/Funding (institution): BMS; Honoraria (self): Takeda; Honoraria (self): Novartis; Honoraria (self): Eli Lilly; Honoraria (self): Pharma Mar. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings