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Five-year follow-up of nivolumab treatment in Japanese patients with esophageal squamous-cell carcinoma (ATTRACTION-1/ONO-4538-07)
- Source :
- Esophagus
- Publication Year :
- 2021
-
Abstract
- Background In 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. Methods We 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. Results Nivolumab 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. 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.
- Subjects :
- 0301 basic medicine
Oncology
medicine.medical_specialty
Esophageal Neoplasms
medicine.medical_treatment
03 medical and health sciences
0302 clinical medicine
Japan
Surgical oncology
Esophageal squamous cell carcinoma
Internal medicine
medicine
Clinical endpoint
Carcinoma
Humans
Adverse effect
Chemotherapy
business.industry
Gastroenterology
Esophageal cancer
medicine.disease
Clinical trial
030104 developmental biology
Nivolumab
030220 oncology & carcinogenesis
Original Article
Immunotherapy
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 16129067
- Volume :
- 18
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Esophagus : official journal of the Japan Esophageal Society
- Accession number :
- edsair.doi.dedup.....5aa80aa5836efb54f17ec5a74b59a55b