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Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer
Yi-Long Wu1, Rafal Dziadziuszko1, Jin Seok Ahn1
1From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine (S.L.), the Department of Thoracic Surgery, Zhongshan Hospital, Fudan University (Q.W.), and the Department of Clinical Science, Roche (China) Holding (T.X.), Shanghai - all in China; the Department of Oncology and Radiotherapy and the Early Phase Clinical Trials Center, Medical University of Gdansk, Gdansk, Poland (R.D.); the Department of Hematology and Oncology, Samsung Medical Center (J.S.A.), and Asan Medical Center (D.H.L.), Seoul, and Seoul National University Bundang Hospital, Seongnam (J.-S.L.) - all in South Korea; the Department of Medical Oncology, International Center for Thoracic Cancers, Gustave Roussy, Villejuif, and Paris-Saclay University, Faculty of Medicine, Le Kremlin-Bicêtre - both in France (F.B.); the Cancer Institute Hospital, Japanese Foundation for Cancer Research (M.N.), and the Department of Thoracic Oncology, National Cancer Center Hospital (H.H.) - both in Tokyo; the Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf, Vienna (M.H.); the Thoracic Oncology Division, European Institute of Oncology, IRCCS, Milan (F.M.); the Pneumo-Oncology Unit, San Camillo Forlanini Hospital, Rome (M.R.M.); the Oncology and Medical Radiology Department, Dnipropetrovsk State Medical Academy, Dnipro, Ukraine (I.B.); PD Oncology (T.O.L.), Data and Statistical Sciences (A.C.), PD Safety Risk Management (T.R.), and Translational Medicine (J.N.), F. Hoffmann-La Roche, Basel, Switzerland; and the Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia (B.J.S.).
Background:
Platinum-based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK-positive non-small-cell lung cancer (NSCLC). Data on the efficacy and safety of adjuvant alectinib as compared with chemotherapy in patients with resected ALK-positive NSCLC are lacking.
Methods:
We conducted a global, phase 3, open-label, randomized trial in which patients with completely resected, ALK-positive NSCLC of stage IB (tumors ≥4 cm), II, or IIIA (as classified according to the seventh edition of the Cancer Staging Manual of the American Joint Committee on Cancer and Union for International Cancer Control) were randomly assigned in a 1:1 ratio to receive oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was disease-free survival, tested hierarchically among patients with stage II or IIIA disease and then in the intention-to-treat population. Other end points included central nervous system (CNS) disease-free survival, overall survival, and safety.
Results:
In total, 257 patients were randomly assigned to receive alectinib (130 patients) or chemotherapy (127 patients). The percentage of patients alive and disease-free at 2 years was 93.8% in the alectinib group and 63.0% in the chemotherapy group among patients with stage II or IIIA disease (hazard ratio for disease recurrence or death, 0.24; 95% confidence interval [CI], 0.13 to 0.45; P<0.001) and 93.6% and 63.7%, respectively, in the intention-to-treat population (hazard ratio, 0.24; 95% CI, 0.13 to 0.43; P<0.001). Alectinib was associated with a clinically meaningful benefit with respect to CNS disease-free survival as compared with chemotherapy (hazard ratio for CNS disease recurrence or death, 0.22; 95% CI, 0.08 to 0.58). Data for overall survival were immature. No unexpected safety findings were observed.
Conclusions:
Among patients with resected ALK-positive NSCLC of stage IB, II, or IIIA, adjuvant alectinib significantly improved disease-free survival as compared with platinum-based chemotherapy. (Funded by F. Hoffmann-La Roche; ALINA ClinicalTrials.gov number, NCT03456076.).
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