Three-year follow-up of ATTRACTION-3: A phase III study of nivolumab (Nivo) in patients with advanced esophageal squamous cell carcinoma (ESCC) that is refractory or intolerant to previous chemotherapy
| Autor: | Chueh-Chuan Yen, Eva Holtved, Keisho Chin, Shigenori Kadowaki, Chih-Hung Hsu, Yuko Kitagawa, Myung-Ju Ahn, Yasuo Hamamoto, Yasuhiro Matsumura, Yuichiro Doki, Yutaro Kubota, Byoung Chul Cho, Akira Takazawa, Sung-Bae Kim, Ken Kato, Ioannis Xynos, Masanobu Takahashi, Morihito Okada, Chen Yuan Lin |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Oncology
Cancer Research Chemotherapy medicine.medical_specialty Taxane business.industry medicine.medical_treatment Esophageal squamous cell carcinoma 03 medical and health sciences Safety profile 0302 clinical medicine Refractory 030220 oncology & carcinogenesis Internal medicine Overall survival Medicine In patient Nivolumab business 030215 immunology |
| Zdroj: | Chin, K, Kato, K, Cho, B C, Takahashi, M, Okada, M, Lin, C-Y, Kadowaki, S, Ahn, M-J, Hamamoto, Y, Doki, Y, Yen, C-C, Kubota, Y, Kim, S-B, Hsu, C-H, Holtved, E, Xynos, I, Matsumura, Y, Takazawa, A & Kitagawa, Y 2021, ' Three-year follow-up of ATTRACTION-3: A phase III study of nivolumab (Nivo) in patients with advanced esophageal squamous cell carcinoma (ESCC) that is refractory or intolerant to previous chemotherapy ', Journal of Clinical Oncology, vol. 39, no. Suppl. 3, pp. 204-204 . < https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.3_suppl.204 > |
| Popis: | 204 Background: Previous results from the ATTRACTION-3 phase 3 trial demonstrated a significant improvement in overall survival and a favorable safety profile compared with taxane chemotherapy (CT) in previously-treated ESCC patients. To our knowledge, no long-term efficacy and safety data of this immune checkpoint inhibitor has been reported in ESCC. Herein, we report the three-year survival data of Nivo in ESCC. Methods: In ATTRACTION-3, 419 patients with unresectable advanced or recurrent ESCC refractory or intolerant to 1 prior fluoropyrimidine/platinum-based CT were randomized in a 1:1 ratio to receive Nivo (N = 210) or the investigator’s choice of CT (paclitaxel or docetaxel) (N = 209) until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS). A subgroup analysis of OS according to the best overall response (BOR) was performed. The onset of treatment-related adverse events of special interest over time in the Nivo arm was also evaluated. Results: As of data cut-off on 25 May 2020, 3 years after the last patient was enrolled, the median OS (mOS) was 10.91 months with Nivo versus 8.51 months with CT [hazard ratio (HR) 0.79; 95% confidence interval (CI) 0.64-0.97]. The OS rates of patients with Nivo and CT were 20.2 % and 13.5 % at 24 months, and 15.3% and 8.7% at 36 months, respectively. In the subgroup analysis of OS by BOR, mOS in CR/PR patients were 19.91 and 15.41 months (HR 0.84, 95%CI 0.46-1.54) and that in SD patients were 17.38 and 9.36 months (HR 0.45, 95%CI 0.26-0.78) in the Nivo and CT arm, respectively. Furthermore, mOS in PD patients were 10.91 and 6.18 months (HR 0.56, 95%CI 0.33-0.95) in the Nivo and CT arm, respectively. No new safety signals were detected during the three-year follow-up. Time to onset of the event of special interest was within the range of events previously observed in other indications. Conclusions: At three-year follow up, Nivo continued to show improved OS over CT in pretreated patients with advanced ESCC patients. Nivo showed a longer mOS than CT regardless of BOR. During the three-year follow-up, no new safety signals were observed. Clinical trial information: NCT02569242. |
| Databáze: | OpenAIRE |
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