| Added by | amaraver |
|---|---|
| Group name | EquipeAM |
| Item Type | Journal Article |
| Title | Consolidation nivolumab and ipilimumab versus observation in limited-disease small-cell lung cancer after chemo-radiotherapy - results from the randomised phase II ETOP/IFCT 4-12 STIMULI trial |
| Creator | Peters et al. |
| Author | S. Peters |
| Author | J.-L. Pujol |
| Author | U. Dafni |
| Author | M. Dómine |
| Author | S. Popat |
| Author | M. Reck |
| Author | J. Andrade |
| Author | A. Becker |
| Author | D. Moro-Sibilot |
| Author | A. Curioni-Fontecedro |
| Author | O. Molinier |
| Author | K. Nackaerts |
| Author | A. Insa Mollá |
| Author | R. Gervais |
| Author | G. López Vivanco |
| Author | J. Madelaine |
| Author | J. Mazieres |
| Author | M. Faehling |
| Author | F. Griesinger |
| Author | M. Majem |
| Author | J. L. González Larriba |
| Author | M. Provencio Pulla |
| Author | K. Vervita |
| Author | H. Roschitzki-Voser |
| Author | B. Ruepp |
| Author | P. Mitchell |
| Author | R. A. Stahel |
| Author | D. De Ruysscher |
| Abstract | BACKGROUND: Concurrent chemotherapy and thoracic radiotherapy followed by prophylactic cranial irradiation (PCI) is the standard treatment in limited-disease small-cell lung cancer (LD-SCLC), with 5-year overall survival (OS) of only 25% to 33%. PATIENTS AND METHODS: STIMULI is a 1:1 randomised phase II trial aiming to demonstrate superiority of consolidation combination immunotherapy versus observation after chemo-radiotherapy plus PCI (protocol amendment-1). Consolidation immunotherapy consisted of four cycles of nivolumab [1 mg/kg, every three weeks (Q3W)] plus ipilimumab (3 mg/kg, Q3W), followed by nivolumab monotherapy (240 mg, Q2W) for up to 12 months. Patient recruitment closed prematurely due to slow accrual and the statistical analyses plan was updated to address progression-free survival (PFS) as the only primary endpoint. RESULTS: Of the 222 patients enrolled, 153 were randomised (78: experimental; 75: observation). Among the randomised patients, median age was 62 years, 60% males, 34%/65% current/former smokers, 31%/66% performance status (PS) 0/1. Up to 25 May 2020 (median follow-up 22.4 months), 40 PFS events were observed in the experimental arm, with median PFS 10.7 months [95% confidence interval (CI) 7.0-not estimable (NE)] versus 42 events and median 14.5 months (8.2-NE) in the observation, hazard ratio (HR) = 1.02 (0.66-1.58), two-sided P = 0.93. With updated follow-up (03 June 2021; median: 35 months), median OS was not reached in the experimental arm, while it was 32.1 months (26.1-NE) in observation, with HR = 0.95 (0.59-1.52), P = 0.82. In the experimental arm, median time-to-treatment-discontinuation was only 1.7 months. CTCAE v4 grade ?3 adverse events were experienced by 62% of patients in the experimental and 25% in the observation arm, with 4 and 1 fatal, respectively. CONCLUSIONS: The STIMULI trial did not meet its primary endpoint of improving PFS with nivolumab-ipilimumab consolidation after chemo-radiotherapy in LD-SCLC. A short period on active treatment related to toxicity and treatment discontinuation likely affected the efficacy results. |
| Publication | Annals of Oncology: Official Journal of the European Society for Medical Oncology |
| Volume | 33 |
| Issue | 1 |
| Pages | 67-79 |
| Date | 2022-01 |
| Journal Abbr | Ann Oncol |
| Language | eng |
| DOI | 10.1016/j.annonc.2021.09.011 |
| ISSN | 1569-8041 |
| Library Catalog | PubMed |
| Extra | PMID: 34562610 |
| Tags | Antineoplastic Combined Chemotherapy Protocols, Chemoradiotherapy, clinic, Female, Humans, Ipilimumab, limited disease, Lung Neoplasms, Male, Middle Aged, Nivolumab, randomised clinical trial, SCLC, small-cell lung cancer |
| Date Added | 2022/08/31 - 14:22:26 |
| Date Modified | 2022/08/31 - 14:22:39 |
| Notes and Attachments | Full Text (Attachment) PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
