Five-year follow-up of nivolumab treatment in Japanese patients with esophageal squamous-cell carcinoma (ATTRACTION-1/ONO-4538-07)

Taroh Satoh,Hiroki Hara,Atsushi Ohtsu,Yuichiro Doki,Kei Muro,Takahiro Tsushima,Ken Kato,Shuichi Hironaka,Hirofumi Yasui,Yuko Kitagawa,Yasuhiro Matsumura,Takashi Kojima,Yasuo Hamamoto,Keiko Minashi,Kensei Yamaguchi,Takashi Ura,Satoru Iwasa

doi:10.1007/s10388-021-00850-0

Abstract

BackgroundIn the phase II ATTRACTION-1 study, nivolumab demonstrated a promising antitumor activity among Japanese patients with treatment-refractory advanced esophageal cancer. Here, we report the follow-up results of ATTRACTION-1 of > 5 years.MethodsWe enrolled patients with esophageal cancer that was refractory or intolerant to a standard chemotherapy. Then, nivolumab (3 mg/kg) was administered every 2 weeks. The primary endpoint was a centrally assessed objective response rate.ResultsNivolumab was administered to 65 patients with esophageal squamous-cell carcinoma (ESCC). The centrally assessed objective response rate was 17.2%. The overall survival rates at 3 and 5 years were 10.9% and 6.3%, respectively. Three-year survivors tended to have more reduced target lesions. A total of 63.1% of the patients exhibited treatment-related adverse events, and no new safety signal was observed. Patients with select adverse events tended to have better overall survival than those without. No apparent chronological order was observed between the first response and the onset of select adverse events.ConclusionOur follow-up analysis of more than 5 years is currently the longest and is the first to demonstrate that nivolumab has long-term efficacy and safety for advanced ESCC.

Highlights

Esophageal cancer is one of the most common malignancies, with over 500,000 cases of new diagnosis and death worldwide in 2020 [1]
Nivolumab was approved in Japan in February 2020, for esophageal cancer that is refractory or intolerant to a standard chemotherapy, and nivolumab was further approved as a second-line treatment for esophageal cancer in South Korea, the United States, Taiwan, Brazil, and the European Union
All 65 patients were assessed for safety; one patient had multiple primary tumor sites, thereby excluded from the efficacy analysis

Summary

Introduction

Esophageal cancer is one of the most common malignancies, with over 500,000 cases of new diagnosis and death worldwide in 2020 [1]. In the Japanese phase II ATTRACTION-1 study, nivolumab exhibited a promising antitumor activity in patients with esophageal cancer that was refractory or intolerant to a standard chemotherapy [14]. In the subsequent phase III ATTRACTION-3 study, nivolumab significantly improved the overall survival (OS) compared with chemotherapy as a second-line therapy for esophageal cancer [15]. Through these findings, nivolumab was approved in Japan in February 2020, for esophageal cancer that is refractory or intolerant to a standard chemotherapy, and nivolumab was further approved as a second-line treatment for esophageal cancer in South Korea, the United States, Taiwan, Brazil, and the European Union. In the phase II ATTRACTION-1 study, nivolumab demonstrated a promising antitumor activity among Japanese patients with treatment-refractory advanced esophageal cancer. Conclusion Our follow-up analysis of more than 5 years is currently the longest and is the first to demonstrate that nivolumab has long-term efficacy and safety for advanced ESCC

Methods

Results

Conclusion