| Added by | standudu |
|---|---|
| Last modified by | amaraver |
| Group name | EquipeAM |
| Item Type | Journal Article |
| Title | A Randomized Non-Comparative Phase II Study of Anti-Programmed Cell Death-Ligand 1 Atezolizumab or Chemotherapy as Second-Line Therapy in Patients With Small Cell Lung Cancer: Results From the IFCT-1603 Trial |
| Creator | Pujol et al. |
| Author | Jean-Louis Pujol |
| Author | Laurent Greillier |
| Author | Clarisse Audigier-Valette |
| Author | Denis Moro-Sibilot |
| Author | Lionel Uwer |
| Author | José Hureaux |
| Author | Florian Guisier |
| Author | Delphine Carmier |
| Author | Jeannick Madelaine |
| Author | Josiane Otto |
| Author | Valérie Gounant |
| Author | Patrick Merle |
| Author | Pierre Mourlanette |
| Author | Olivier Molinier |
| Author | Aldo Renault |
| Author | Audrey Rabeau |
| Author | Martine Antoine |
| Author | Marc G. Denis |
| Author | Alexandra Langlais |
| Author | Franck Morin |
| Author | Pierre-Jean Souquet |
| Abstract | INTRODUCTION: This randomized phase II trial aimed at evaluating the engineered programmed cell death ligand 1 (PD-L1) antibody atezolizumab in SCLC progressing after first-line platinum-etoposide chemotherapy. METHODS: Patients were randomized 2:1 to atezolizumab (1200 mg intravenously every 3 weeks) until progression or unacceptable toxicity, or conventional chemotherapy (up to 6 cycles of topotecan or re-induction of initial chemotherapy). Patients were not selected based on PD-L1 tissue expression. The primary endpoint was objective response rate at 6 weeks. A two-stage design with 2:1 randomization and O'Brien-Fleming stopping rules was used. The null hypothesis was rejected if more than 12 of 45 patients were responders. RESULTS: Overall, 73 patients were randomized (atezolizumab n = 49; chemotherapy n = 24). At 6 weeks, 1 of 43 eligible atezolizumab patients achieved an objective response (2.3%, 95% confidence interval [CI]: 0.0-6.8), whereas 8 others had stable disease (20.9% disease control rate; 95% CI: 8.8-33.1). Among eligible chemotherapy patients (n = 20), 10% achieved an objective response (65% disease control rate). Median progression-free survival was 1.4 months (95% CI: 1.2-1.5) with atezolizumab and 4.3 months (95% CI: 1.5-5.9) with chemotherapy. Overall survival did not significantly differ between groups. Median overall survival was 9.5 months versus 8.7 months for the atezolizumab and the chemotherapy group, respectively (adjusted hazard ratioatezolizumab : 0.84, 95% CI: 0.45-1.58; p = 0.60). Two atezolizumab patients (4.2%) experienced grade 3 fatigue, and two others grade 1 dysthyroidism. Among 53 evaluable specimens, only 1 (2%) had positive immunohistochemical PD-L1 staining (SP142 clone). CONCLUSIONS: Atezolizumab monotherapy in relapsed SCLC failed to show significant efficacy. No unexpected safety concerns were observed. |
| Publication | Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer |
| Volume | 14 |
| Issue | 5 |
| Pages | 903-913 |
| Date | May 2019 |
| Journal Abbr | J Thorac Oncol |
| Language | eng |
| DOI | 10.1016/j.jtho.2019.01.008 |
| ISSN | 1556-1380 |
| Short Title | A Randomized Non-Comparative Phase II Study of Anti-Programmed Cell Death-Ligand 1 Atezolizumab or Chemotherapy as Second-Line Therapy in Patients With Small Cell Lung Cancer |
| Library Catalog | PubMed |
| Extra | PMID: 30664989 |
| Tags | Atezolizumab, Chemotherapy, clinic, Programmed cell death ligand 1, SCLC |
| Date Added | 2019/05/16 - 11:44:18 |
| Date Modified | 2020/01/20 - 11:49:50 |
| Notes and Attachments | PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
