Bevacizumab Plus Atezolizumab After Progression on Atezolizumab Monotherapy in Pretreated Patients With NSCLC: An Open-Label,Two-Stage,Phase 2 Trial |
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| Affiliation: | 1. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;2. Research Institute for Future Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;3. Division of Hematology and Oncology, Chungbuk National University Hospital, Cheongju, Republic of Korea;4. Department of Digital Health, Samsung Advanced Institute of Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, Republic of Korea;5. Biomedical Statistics Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea;1. Department of Experimental Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia;2. Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia;3. Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia;4. Surgical Oncology Clinic, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia;5. Faculty of Medicine, University of Belgrade, Belgrade, Serbia;6. Clinic for Radiation Oncology and Diagnostics, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia;7. Faculty of Medicine, University of Nis, Nis, Serbia;8. Pulmonary Diseases Clinic, University Clinical Center Nis, Nis, Serbia;9. Clinic for Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade, Serbia;1. Supportive Care Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;2. Department of Family Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;3. Department of Clinical Research Design & Evaluation, Samsung Advanced Institute for Health Science & Technology, Sungkyunkwan University, Seoul, Republic of Korea;4. Department of Thoracic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;5. The Korea Central Cancer Registry, National Cancer Center, Goyang, Republic of Korea;6. Division of Cancer Registration and Surveillance, National Cancer Control Institute, National Cancer Center, Goyang, Republic of Korea;1. Department of Thoracic and Cardiovascular Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea;2. Department of Epidemiology and Medicine, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland;3. Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland;4. Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences & Technology (SAIHST), Sungkyunkwan University, Seoul, Republic of Korea;5. Center for Clinical Epidemiology, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea;6. Patient-Centered Outcomes Research Institute, Samsung Medical Center, Seoul, Republic of Korea;7. Department of Thoracic and Cardiovascular Surgery, Ewha Womans University School of Medicine, Mokdong hospital, Seoul, Republic of Korea;1. Clinical Trial Unit, Istituto Nazionale Tumori, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fondazione G. Pascale, Napoli, Italy;2. Medical Oncology 2, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padova, Italy;3. Department of Medical Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Dei Tumori, Milano, Italy;4. Thoracic Medical Oncology, Istituto Nazionale Tumori, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fondazione G. Pascale, Napoli, Italy;5. Medical Oncology Unit, AUSL of Romagna, S. Maria delle Croci Hospital, Ravenna, Italy;6. Oncology and Hematology Department, Guglielmo da Saliceto Hospital, Piacenza, Italy;7. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Dino Amdori, Meldola, Italy;8. Medical Oncology and Hematology, Mirano ULSS 3, Serenissima Regione Veneto, Mirano, Italy;9. Oncology Department, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy;10. Medical Oncology and Hematology, Department of Precision Medicine, Università degli Studi della Campania “Luigi Vanvitelli,” Napoli, Italy;11. Medical Oncology Unit, Senatore Antonio Perrino Hospital, Brindisi, Italy;12. Medical Oncology Unit, S. Chiara Hospital, Trento, Italy;13. Medical Oncology Unit, Degli Infermi Hospital in Rimini and Cervesi Hospital in Cattolica, Rimini, Italy;14. Medical Oncology Department, Policlinico Universitario Campus Bio Medico, Roma, Italy;15. Promise Department, Università of Palermo “La Maddalena Clinic for Cancer,” Palermo, Italy;p. Oncological Pneumology Unit, S. Camillo Forlanini Hospital, Roma, Italy;q. Medical Oncology Unit, Nuovo Ospedale di Prato—Santo Stefano, Prato, Italy;r. Division of Thoracic Oncology, European Institute of Oncology, Milano, Italy;s. Medical Oncology Unit, S. Maria della Misericordia Hospital, Perugia, Italy;t. Cellular Biology and Biotherapy, Istituto Nazionale Tumori, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fondazione G. Pascale, Napoli, Italy;u. Medical Statistics, Università degli Studi della Campania “Luigi Vanvitelli,” Napoli, Italy;v. Medical Oncology Unit, S. Giuseppe Moscati Hospital, Avellino, Italy;1. Thoracic Surgery Department, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People’s Republic of China;2. Key Laboratory of Minimally Invasive Therapy Research for Lung Cancer, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China;3. GCP Center, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China |
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| Abstract: | IntroductionVascular endothelial growth factor promotes an immunosuppressive tumor microenvironment that can be reverted by an antiangiogenic therapy. This two-stage, phase 2 study aimed to determine the treatment efficacy of adding bevacizumab to atezolizumab in patients with metastatic NSCLC whose disease had progressed after atezolizumab monotherapy.MethodsImmune checkpoint inhibitor–naive patients with NSCLC, without EGFR or ALK alterations, whose disease progressed after at least one line of platinum-based chemotherapy were eligible. The patients received atezolizumab 1200 mg once every 3 weeks until radiographic progression (stage I). Then, bevacizumab 15 mg/kg was combined with atezolizumab 1200 mg once every 3 weeks (stage II). The primary end point was the disease control rate (DCR) confined to stage II.ResultsA total of 42 and 24 patients were enrolled in stages I and II, respectively. Most patients had negative programmed death ligand-1 expression (71.4%) and received one or two lines of therapy (95.2%). In stage I, patients achieved a DCR of 35.7% (95% confidence interval [CI]: 21.6–52.0). In stage II, three (12.5%) and 18 (75.0%) of 24 patients had partial response and stable disease, respectively, leading to a DCR of 87.5% (95% CI: 67.6–97.3). For 24 patients enrolled in stage II, the median progression-free survival was 5.6 (95% CI: 4.1–7.1) months and the overall survival was 14.0 (95% CI: 10.7–17.4) months. Treatment-related adverse events occurred in 25% of the patients in stage II, but all were of grade 1 or 2.ConclusionsCombination of bevacizumab plus atezolizumab for patients with metastatic NSCLC whose disease had progressed after atezolizumab monotherapy was found to have a promising antitumor activity with good tolerability. |
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| Keywords: | Non–small cell lung cancer Atezolizumab Bevacizumab Immune checkpoint inhibitor Anti-angiogenic therapy |
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