ESMO 2019 — Nivolumab prolongs survival versus chemotherapy in second-line treatment of metastatic oesophageal squamous cell carcinoma


  • Jo Whelan
  • Oncology Conference reports
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Takeaway

  • 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.

Key results

  • 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.

Study design

  • 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.

Limitations

  • It is not clear whether the results are generalisable to non-Asian populations.

Expert commentary

  • “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.