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

Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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%).

Limitations

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