- Nivolumab improved median survival by 2.5 months compared with chemotherapy, with a 23% reduction in the risk of death.
- Patients treated with nivolumab had a markedly lower risk of grade 3-4 adverse events compared with chemotherapy, and their quality of life scores were higher.
Why this matters
- Current chemotherapy options for second-line treatment of metastatic oesophageal squamous cell carcinoma (ESCC) offer poor long-term survival.
- Median overall survival was 10.9 months (95% CI 9.2-13.3) in the nivolumab arm and 8.4 months (95% CI 7.2-9.9) with chemotherapy (HR 0.77, 95% CI 0.62-0.96, P=0.02). This was the final survival analysis (minimum follow-up 17.6 months).
- Benefit was seen regardless of tumour PD-L1 status.
- Survival at 18 months was 31% and 21% with nivolumab and chemotherapy, respectively.
- Only 18% of patients in the nivolumab arm experienced grade 3-4 treatment-related adverse events, compared with 63% in the chemotherapy arm.
- Exploratory analysis showed improved health-related quality of life in the nivolumab arm versus chemotherapy.
- Patients (n=419) had unresectable advance or recurrent ESCC and were refractory or intolerant to ≥1 fluoropyrimidine or platinum-based therapy. Enrolment was regardless of PD-L1 status.
- They were randomised 1:1 to either nivolumab (240 mg every 2 weeks) or investigator’s choice of paclitaxel or docetaxel.
- The primary endpoint was overall survival (OS).
- The trial was international, but 94% of patients were of Asian race.
- Funding: Ono Pharmaceutical Co, Bristol-Myers Squibb.
- It is not clear whether the results are generalisable to non-Asian populations.
- “The evidence now shows that PD-L1-based treatment works in this setting; we look forward to seeing the data in first line treatment.” Dr Ian Chau MD FRCP, Royal Marsden Hospital, London, who was not involved in the study.