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Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer
Ying Cheng1, David R Spigel1, Byoung Chul Cho1
1From Jilin Cancer Hospital, Changchun (Y. Cheng), Department II of Thoracic Oncology (J.F.) and the Department of Radiation Oncology (A.S.), Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, and the Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou (Q.W.) - all in China; Sarah Cannon Research Institute (D.R.S.) and Tennessee Oncology (D.B.D.) - both in Nashville; Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (B.C.C.), and Chungbuk National University Hospital, Cheongju (K.H.L.) - both in South Korea; Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation, Moscow (K.K.L.); Cancer and Hematology Centers of Western Michigan, Grand Rapids (Y. Chen); National Cancer Center Hospital East, Kashiwa (Y.Z.), and Kyushu University Hospital, Fukuoka (Y.S.) - both in Japan; Hospital Vall d'Hebron and Vall d'Hebron Institute of Oncology, Barcelona (A.N.), and Hospital Universitario Virgen del Rocio, Seville (R.B.) - both in Spain; Hospitals of the City of Cologne, Cologne, Germany (E.L.B.); Chang Gung Medical Foundation-Linkou Branch, Taoyuan, Taiwan (J.W.-C.C.); Akdeniz University Medical Faculty, Antalya, Turkey (S.S.G.); Medical University of Gdansk, Gdansk, Poland (A.B.); National Cancer Hospital, Hanoi, Vietnam (N.T.T.H.); First Faculty of Medicine, Charles University, and General University Hospital, Prague, Czech Republic (M.Z.); AstraZeneca, Cambridge, United Kingdom (H.M.); AstraZeneca, Gaithersburg, MD (H.G., H.J.); and the Department of Radiation Oncology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam (S.S.).
Background:
Adjuvant therapy with durvalumab, with or without tremelimumab, may have efficacy in patients with limited-stage small-cell lung cancer who do not have disease progression after standard concurrent platinum-based chemoradiotherapy.
Methods:
In a phase 3, double-blind, randomized, placebo-controlled trial, we assigned patients to receive durvalumab at a dose of 1500 mg, durvalumab (1500 mg) plus tremelimumab at a dose of 75 mg (four doses only), or placebo every 4 weeks for up to 24 months. Randomization was stratified according to disease stage (I or II vs. III) and receipt of prophylactic cranial irradiation (yes vs. no). Results of the first planned interim analysis of the two primary end points of overall survival and progression-free survival (assessed on the basis of blinded independent central review according to the Response Evaluation Criteria in Solid Tumors, version 1.1) with durvalumab as compared with placebo (data cutoff date, January 15, 2024) are reported; results in the durvalumab-tremelimumab group remain blinded.
Results:
A total of 264 patients were assigned to the durvalumab group, 200 to the durvalumab-tremelimumab group, and 266 to the placebo group. Durvalumab therapy led to significantly longer overall survival than placebo (median, 55.9 months [95% confidence interval {CI}, 37.3 to not reached] vs. 33.4 months [95% CI, 25.5 to 39.9]; hazard ratio for death, 0.73; 98.321% CI, 0.54 to 0.98; P = 0.01), as well as to significantly longer progression-free survival (median 16.6 months [95% CI, 10.2 to 28.2] vs. 9.2 months [95% CI, 7.4 to 12.9]; hazard ratio for progression or death, 0.76; 97.195% CI, 0.59 to 0.98; P = 0.02). The incidence of adverse events with a maximum grade of 3 or 4 was 24.4% among patients receiving durvalumab and 24.2% among patients receiving placebo; adverse events led to discontinuation in 16.4% and 10.6% of the patients, respectively, and led to death in 2.7% and 1.9%. Pneumonitis or radiation pneumonitis with a maximum grade of 3 or 4 occurred in 3.1% of the patients in the durvalumab group and in 2.6% of those in the placebo group.
Conclusions:
Adjuvant therapy with durvalumab led to significantly longer overall survival and progression-free survival than placebo among patients with limited-stage small-cell lung cancer. (Funded by AstraZeneca; ADRIATIC ClinicalTrials.gov number, NCT03703297.).
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