Yuki Katsuya1, Hidehito Horinouchi2, Takashi Seto3, Shigeki Umemura4, Yukio Hosomi5, Miyako Satouchi6, Makoto Nishio7, Toshiyuki Kozuki8, Toyoaki Hida9, Tamie Sukigara10, Kenichi Nakamura10, Aya Kuchiba10, Yuichiro Ohe1. 1. Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. 2. Department of Thoracic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. Electronic address: hhorinou@ncc.go.jp. 3. Department of Thoracic Oncology, National Kyushu Cancer Center, 3-1-1 Notame, Minami-ku, Fukuoka, 811-1395, Japan. 4. Department of Thoracic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan. 5. Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, 3-18-22, Honkomagome, Bunkyo-ku, Tokyo, 113-0021, Japan. 6. Department of Thoracic Oncology, Hyogo Cancer Center, 13-70, Kitaoji-cho, Akashi-shi, Hyogo 673-8558, Japan. 7. Department of Thoracic Medical Oncology, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan. 8. Department of Thoracic Oncology and Medicine, National Hospital Organization Shikoku Cancer Center, 160 Kou Minami-Umemoto, Matsuyama-shi, Ehime 791-0280, Japan. 9. Department of Thoracic Oncology, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi 464-8681, Japan. 10. Clinical Research Support Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Abstract
INTRODUCTION: Thymic carcinoma (TC) is a rare cancer with a poor prognosis and limited treatment options, especially after relapse. METHODS: In this open-label, two-stage, multicentre, single-arm and phase II trial, the main eligibility criteria were unresectable or recurrent TC, an Eastern Cooperative Oncology Group-performance status of 0 or 1, progression after at least one chemo(radio)therapy and no history of autoimmune disease. Nivolumab was administered at a dose of 3 mg/kg every 2 weeks. The primary end-point was response rate (RR) as evaluated by central review using Response Evaluation Criteria In Solid Tumours (RECIST), version 1.1. The planned sample size was 15 for each stage, with a threshold RR of 5%, an expected RR of 20%, one-sided alpha of 5% and power of 80%. RESULTS: Between July 1 and August 16 2016, 15 patients were accrued in the first stage. Response was assessable in all patients, and 13 had squamous histology. Median follow-up time was 14.1 months (range: 2.4-17.5). The median number of nivolumab received was eight (range: 3-33). RR was 0% (95% confidential interval [CI]: 0-21.8). Eleven patients had stable disease (SD) including five patients with SD for 24 or more weeks. Median progression-free survival was 3.8 months (95% CI: 1.9-7.0). Two patients experienced immune-related serious adverse events (grade III aspartate aminotransferase (AST) increase and grade II adrenal insufficiency). Because the early termination criteria (less than one responder) were fulfilled during the first stage, the patient accrual was terminated. CONCLUSIONS: Despite the small number of patients, nivolumab was unable to produce tumour shrinkage by RECIST in previously treated unresectable or recurrent TC.
INTRODUCTION:Thymic carcinoma (TC) is a rare cancer with a poor prognosis and limited treatment options, especially after relapse. METHODS: In this open-label, two-stage, multicentre, single-arm and phase II trial, the main eligibility criteria were unresectable or recurrent TC, an Eastern Cooperative Oncology Group-performance status of 0 or 1, progression after at least one chemo(radio)therapy and no history of autoimmune disease. Nivolumab was administered at a dose of 3 mg/kg every 2 weeks. The primary end-point was response rate (RR) as evaluated by central review using Response Evaluation Criteria In Solid Tumours (RECIST), version 1.1. The planned sample size was 15 for each stage, with a threshold RR of 5%, an expected RR of 20%, one-sided alpha of 5% and power of 80%. RESULTS: Between July 1 and August 16 2016, 15 patients were accrued in the first stage. Response was assessable in all patients, and 13 had squamous histology. Median follow-up time was 14.1 months (range: 2.4-17.5). The median number of nivolumab received was eight (range: 3-33). RR was 0% (95% confidential interval [CI]: 0-21.8). Eleven patients had stable disease (SD) including five patients with SD for 24 or more weeks. Median progression-free survival was 3.8 months (95% CI: 1.9-7.0). Two patients experienced immune-related serious adverse events (grade III aspartate aminotransferase (AST) increase and grade II adrenal insufficiency). Because the early termination criteria (less than one responder) were fulfilled during the first stage, the patient accrual was terminated. CONCLUSIONS: Despite the small number of patients, nivolumab was unable to produce tumour shrinkage by RECIST in previously treated unresectable or recurrent TC.
Authors: Fabrizio Minervini; Laura Boschetti; Michael Gregor; Mariano Provencio; Virginia Calvo; Peter B Kestenholz; Savvas Lampridis; Davide Patrini; Pietro Bertoglio; L Filipe Azenha; Consolato M Sergi; Gregor J Kocher Journal: Gland Surg Date: 2021-11
Authors: Valentina Tateo; Lisa Manuzzi; Andrea De Giglio; Claudia Parisi; Giuseppe Lamberti; Davide Campana; Maria Abbondanza Pantaleo Journal: Int J Mol Sci Date: 2020-11-28 Impact factor: 5.923