NSCLC: S-1 noninferior to docetaxel as 2nd, 3rd line therapy

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  • S-1 offers similar OS, PFS, and response rates as docetaxel for second- or third-line therapy for patients with advanced NSCLC, with less neutropenia and febrile neutropenia. 

Why this matters

  • Phase 2 S-1 monotherapy as second-line treatment for advanced NSCLC study overall response rate of 12.5% and median OS of 8.2 mo.

Study design

  • Randomized, open-label, multicenter, phase 3 noninferiority study.
  • 1129 patients with locally advanced or metastatic NSCLC and prior chemotherapy, including ≥1 platinum-based regimen, received S-1 (n=569) or docetaxel (n=560).
  • Funding: Taiho Pharmaceuticals Co., Ltd.

Key results

  • 1, 2, or 3 prior chemotherapy regimens: 350 patients in S-1 vs 357 docetaxel; 178 S-1 vs 169 docetaxel; and 49 S-1 vs 44 docetaxel.
  • Median OS 12.75 mo for S-1 vs 12.52 mo for docetaxel (HR, 0.945; 95% CI, 0.833-1.073) and median PFS 2.86 mo for S-1 vs 2.89 mo for docetaxel (HR, 1.033; 95% CI, 0.913-1.168).
  • Response rate 8.3% in S-1 group and 9.9% in docetaxel group (P=.3761).
  • In S-1, lower rates of neutropenia (14.9% vs 54.8%) and febrile neutropenia (0.9% vs 13.4%), but higher rates of diarrhea (35.9% vs 16.4%) and decreased appetite (50.4% vs 36.4%).


  • Docetaxel is no longer the only standard NSCLC second-line therapy.