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Nivolumab with carboplatin, paclitaxel, and bevacizumab for first-line treatment of advanced nonsquamous non-small-cell lung cancer.
Sugawara, S; Lee, J-S; Kang, J-H; Kim, H R; Inui, N; Hida, T; Lee, K H; Yoshida, T; Tanaka, H; Yang, C-T; Nishio, M; Ohe, Y; Tamura, T; Yamamoto, N; Yu, C-J; Akamatsu, H; Namba, Y; Sumiyoshi, N; Nakagawa, K.
Afiliación
  • Sugawara S; Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.
  • Lee JS; Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Korea.
  • Kang JH; Department of Medical Oncology, The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea.
  • Kim HR; Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
  • Inui N; Department of Pulmonary Medicine, Hamamatsu University Hospital, Shizuoka, Japan.
  • Hida T; Department of Thoracic Oncology, Aichi Cancer Center, Aichi, Japan.
  • Lee KH; Department of Internal Medicine, Chungbuk National University Hospital, Chungcheongbuk-do, Korea.
  • Yoshida T; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Tanaka H; Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
  • Yang CT; Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
  • Nishio M; Department of Thoracic Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan.
  • Ohe Y; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Tamura T; Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.
  • Yamamoto N; Internal Medicine III, Wakayama Medical University, Wakayama, Japan.
  • Yu CJ; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
  • Akamatsu H; Internal Medicine III, Wakayama Medical University, Wakayama, Japan.
  • Namba Y; Clinical Science, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
  • Sumiyoshi N; Oncology Clinical Development Planning 1, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
  • Nakagawa K; Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan. Electronic address: nakagawa@med.kindai.ac.jp.
Ann Oncol ; 32(9): 1137-1147, 2021 09.
Article en En | MEDLINE | ID: mdl-34139272
BACKGROUND: This international, randomized, double-blind phase III study (ONO-4538-52/TASUKI-52) evaluated nivolumab with bevacizumab and cytotoxic chemotherapy as first-line treatment for nonsquamous non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Between June 2017 and July 2019, this study enrolled treatment-naïve patients with stage IIIB/IV or recurrent nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations. They were randomly assigned in a 1 : 1 ratio to receive nivolumab or placebo in combination with carboplatin, paclitaxel, and bevacizumab every 3 weeks for up to six cycles, followed by nivolumab/placebo with bevacizumab until progressive disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) assessed by an independent radiology review committee (IRRC). RESULTS: Overall, 550 patients from Japan, Korea, and Taiwan were randomized; of these patients, 273 and 275 received the nivolumab and placebo combinations, respectively. In the present preplanned interim analysis with a median follow up of 13.7 months, the IRRC-assessed median PFS was significantly longer in the nivolumab arm than in the placebo arm (12.1 versus 8.1 months; hazard ratio 0.56; 96.4% confidence interval 0.43-0.71; P < 0.0001). The PFS benefit was observed across all patients with any programmed death-ligand 1 (PD-L1) expression levels including PD-L1-negative patients. The IRRC-assessed objective response rates were 61.5% and 50.5% in the nivolumab and placebo arms, respectively. The incidence of treatment-related adverse events of grade 3 or 4 was comparable between the two arms; treatment-related adverse events leading to death were observed in five and four patients in the nivolumab and placebo arms, respectively. CONCLUSION: The TASUKI-52 regimen should be considered a viable new treatment strategy for treatment-naïve patients with advanced nonsquamous NSCLC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Pulmón de Células no Pequeñas / Neoplasias Pulmonares Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2021 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido