G/GEJ cancer: nivolumab + SOX/CapeOX does well in ATTRACTION-4

  • Boku N & al.
  • Ann Oncol
  • 1 Feb 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Nivolumab combined with S-1 plus oxaliplatin (SOX) or capecitabine plus oxaliplatin (CapeOX) showed encouraging efficacy in unresectable advanced or recurrent HER2-negative gastro/gastroesophageal junction (G/GEJ) cancer.
  • Almost all patients reduced or delayed their dose because of treatment-related adverse events (TRAEs).

Why this matters

  • Chemotherapy may modulate the immune system, which may, in turn, boost the immune effects of nivolumab. 
  • The study was part 1 of 2. Part 2 will compare nivolumab plus chemotherapy with placebo plus chemotherapy.

Study design

  • Open-label study at 13 centers in Japan and South Korea (ATTRACTION-4); 39 patients were randomly assigned to receive nivolumab plus SOX or nivolumab plus CapeOX.
  • Funding: Ono Pharmaceutical and Bristol-Myers Squibb.

Key results

  • 95.2% of patients in nivolumab/SOX and 94.4% of patients in nivolumab/CapeOX reduced or delayed chemotherapy because of TRAEs.
  • The objective response rate (ORR) was similar in both groups (66.7% in nivolumab/SOX, 70.6% in nivolumab/CapeOX).
  • Corresponding ORR was 57.1% and 76.5%, respectively, when assessed centrally.
  • Median OS was not reached in any group. Median OS was 13.9 months overall, 11.9 months for the nivolumab/SOX group, and 11.2 months for the nivolumab/CapeOX group.

Limitations

  • Small study.
  • Asian population.

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