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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. | Austin Authors: | Peters, S ;Pujol, J-L;Dafni, U;Dómine, M;Popat, S;Reck, M;Andrade, J;Becker, A;Moro-Sibilot, D;Curioni-Fontecedro, A;Molinier, O;Nackaerts, K;Mollá, A Insa;Gervais, R;Vivanco, G López;Madelaine, J;Mazieres, J;Faehling, M;Griesinger, F;Majem, M;Larriba, J L González;Pulla, M Provencio;Vervita, K;Roschitzki-Voser, H;Ruepp, B;Mitchell, Paul L R ;Stahel, R A;Le Pechoux, C;De Ruysscher, D | Affiliation: | Medicine, Royal Marsden Hospital, London, United Kingdom Department of Medical Oncology and Hematology, University Hospital Zürich, Zürich, Switzerland Coordinating Office, European Thoracic Oncolocy Platform, Bern, Switzerland Department of Pulmonology, Respiratory Oncology Unit, KU Leuven, Leuven, Belgium Department of Pulmonology, Amsterdam University Medical Center, Amsterdam, the Netherland Klinikum Esslingen, Germany Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Grosshansdorf, Germany Hospital Universitario Fundacion Jimenez Díaz (IIS-FJD), Madrid, Spain Medical Oncology, Hospital Virgen De La Salud, Toledo, Spain Thoracic Oncology Unit, Hopital Arnaud de Villeneuve, Montpellier, France National and Kapodistrian University of Athens & Frontier Science Foundation-Hellas, Athens, Greece Pius-Hospital Oldenburg, Germany Medical Oncology, Hospital Clínico Universitario De Valencia, Valencia, Spain Medical Oncology, Hospital Universitario Cruces, Barakaldo, Spain Hospital De La Santa Creu I Sant Pau, Barcelona, Spain Hospital Clínico San Carlos, Madrid, Spain Hospital Puerta de Hierro, Madrid, Spain Thoracic Oncology Unit, Centre Hospitalier Universitaire Grenoble-Alpes , Grenoble, France Department of Respiratory Disease, Centre Hospitalier - Le Mans, Le Mans, France Medical Oncology, Centre François Baclesse, Caen, France Thoracic Oncology Unit, Centre Hospitalier Universitaire Caen Normandie, Caen, France ThoracicOncology, Centre Hospitalier Universitaire Toulouse, France Frontier Science Foundation-Hellas, Athens, Greece Department of Radiation Oncology, Gustave Roussy, Villejuif, France Olivia Newton-John Cancer Wellness and Research Centre Department of Oncology, Centre Hospitalier Universitaire Vaudois (CHUV) and Lausanne University, Lausanne, Switzerland Coordinating Office, European Thoracic Oncolocy Platform, Bern, Switzerland. Maastricht University Medical Center, Department of Radiation Oncology (Maastro), GROW School for Oncology, Maastricht, Netherlands.. |
Issue Date: | 2022 | Date: | 2021-09-22 | Publication information: | Annals of Oncology : Official Journal of the European Society for Medical Oncology 2022; 33(1): 67-79 | Abstract: | 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 25-33%. 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 12months. 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. 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% PS 0/1. Up to 25/May/2020 (median follow-up 22.4months), 40 PFS events were observed in the experimental arm, with median PFS 10.7months (95%CI 7.0-Not Estimable(NE)) versus 42 events and median 14.5months (8.2-NE) in the observation, HR=1.02 (0.66-1.58), 2-sided p=0.93. With updated follow-up (03/June/2021; median: 35months), 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. Grade≥3 adverse events were experienced by 62% pts in experimental and 25% in observation arm, with 4 and 1 fatal, respectively. 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. | URI: | https://ahro.austin.org.au/austinjspui/handle/1/27569 | DOI: | 10.1016/j.annonc.2021.09.011 | Journal: | Annals of Oncology | PubMed URL: | 34562610 | Type: | Journal Article | Subjects: | Ipilimumab Limited disease Nivolumab Randomised clinical trial SCLC Small cell lung cancer |
Appears in Collections: | Journal articles |
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