638P - Two year survival and safety update for esophageal squamous cell carcinoma treated with nivolumab (ATTRACTION-01/ONO-4538-07)

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Oesophageal Cancer
Gastrointestinal Cancers
Presenter Yuko Kitagawa
Citation Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369
Authors Y. Kitagawa1, Y. Doki2, K. Kato3, T. Ura4, T. Kojima5, T. Tsushima6, S. Hironaka7, H. Hara8, T. Kudo9, S. Iwasa10, K. Muro4, Y. Hamamoto11, H. Yasui12, K. Minashi13, K. Yamaguchi14, A. Ohtsu15
  • 1Department Of Surgery, Keio University School of Medicine, 160-8582 - Tokyo/JP
  • 2Department Of Gastrointestinal Surgery, Graduate School of Medicine, Osaka University, 565-0871 - Suita/JP
  • 3Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 4Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 5Department Of Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 6Divison Of Gi Oncology, Shizuoka Cancer Center, 411-877 - Shizuoka/JP
  • 7Clinical Trial Promotion Department, Chiba Cancer Center, 260-8717 - Chiba/JP
  • 8Department Of Gastroenterology, Saitama Cancer Center Hospital, Saitama/JP
  • 9Frontier Science For Cancer And Chemotherapy, Osaka University Graduate School of Medicine, 565-0871 - Suita/JP
  • 10Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo/JP
  • 11Keio Cancer Center, Keio University School of Medicine, 160-8582 - Tokyo/JP
  • 12Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-0933 - Shizuoka/JP
  • 13Clinical Trial Promotion Department, Chiba Cancer Center Hospital, 260-8717 - Chiba/JP
  • 14Department Of Gastroenterology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 15The Director Of A Hospital, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP



Nivolumab (Nivo) monotherapy has demonstrated clinical activity and safety for esophageal cancer refractory or intolerant to standard chemotherapy (Lancet oncology, online March 14, 2017, http://doi.org/10.1016/S1470-2045(17)30181-X). We report updated results base on a minimum follow-up of 2-years.


Patients aged ≥ 20 years with ECOG PS 0-1 were enrolled and treated with Nivo (3 mg/kg, IV, Q2W) until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) evaluated by independent review committee according to RECIST 1.1. Other endpoints included safety, overall survival (OS), progression-free survival (PFS) and duration of response (DOR).


Between February 25, 2014 and November 14, 2014, 65 patients with esophageal squamous-cell carcinoma were enrolled; median age of 62 years (range 49-80); male/female, 54/11; ECOG PS 0/1, 29/36; median number of 3.0 (range 1-8) prior regimens. The primary endpoint of ORR was 17.2% (11/64 patients, CR/PR: 1/10, 95% confidence interval [CI] 9.9, 28.2) as of May 17, 2015. Median OS and PFS were 10.8 and 1.5 months. With a minimum follow-up of 2-years (cutoff date November 17, 2016), 6 patients remained on treatment with Nivo. The ORR was 17.2% (CR/PR: 3/8) and median DOR was 11.17 months (95% CI 3.02, -). The Kaplan-Meier estimated 1-, 1.5- and 2-years OS rate were 45.3% (95% CI 32.9, 56.9), 25.0% (15.2, 36.0) and 17.2% (9.2, 27.3). One, 1.5- and 2-years PFS rate were 10.3% (95% CI: 4.2, 19.4), 8.6% (3.2, 17.3) and 8.6% (3.2, 17.3). Adverse events (AEs) were reported in 56 (86.2%) of 65 patients including grade 3 − 4 AEs reported in 19 patients (29.2%). The most common AEs were diarrhea (21.5%), decreased appetite (18.5%), lung infection (13.8%) and cough (12.3%). Seven patients (10.8%) discontinued the study treatment due to drug-related AEs, while no treatment-related death was reported.


Nivo suggest a durable, long-term survival benefit with 17.2% of patients alive at 2-years. These data support ongoing phase III study (NCT 02569242) assessing Nivo monotherapy compared with docetaxel or paclitaxel.

Clinical trial identification


Legal entity responsible for the study

Ono Pharmaceutical Co., Ltd


Ono Pharmaceutical Co., Ltd, Bristol-Myers Squibb


Y. Kitagawa: Ono Pharmaceutical Co.,Ltd. and Bristol-Myers Squibb (Honoraria, Grants, research supports). Y. Doki: Ono Pharmaceutical Co.,Ltd. (advisory doard), Ono Pharmaceutical Co.,Ltd. (Honoraria, Grants, research supports). K. Kato: Ono Pharmaceutical Co.,Ltd., Shionogi, MSD. T. Kojima: Institution (Ono Pharmaceutical Co.,Ltd., Shionog, MSD, Taiho, Merck Serono, AstraZeneca) S. Hironaka: Advisory Board (MBL), Honoraria (Yakult Honsha, Eli lilly). H. Hara: Advisory role (Ono, Chugai Pharma), “Honoraria (Chugai, Taiho, Merck Serono, Yakult Honsha, Lilly) Reserch funding (AstraZeneca, Chugai, Merck Serono, MSD, Ono, Taiho, Takeda, Boehringer Ingelheim, Dainippon Sumitomo, Daiichi Sankyo, Lilly). T. Kudo: Bayer (research supports). S. Iwasa: corporate-sponsored research (Novartis, Merck Serono, Lilly, Daiichi Sankyo, Bristol-Myers Squibb). K. Muro: Shionogi, MSD, Daiichi Sankyo, Kyowa Hakko Kirin, Gilead Sciences, honoraria for lectures. (Chugai, Takeda, Eli Lilly Japan, Merck Serono, Taiho, Yakult honsha). K. Yamaguchi: Ono Pharmaceutical Co., Ltd (research supports). All other authors have declared no conflicts of interest.