Phase II study of S-1 monotherapy as a first-line treatment for elderly patients with advanced nonsmall-cell lung cancer: The Central Japan Lung Study Group trial 0404

Osamu Nishiyama, Hiroyuki Taniguchi, Yasuhiro Kondoh, Kazuto Takada, Kenji Baba, Hiroshi Saito, Yasuteru Sugino, Masashi Yamamoto, Toshihiko Ogasawara, Masashi Kondo, Kazuyoshi Imaizumi, Yoshinori Hasegawa, Ryujiro Suzuki, Kaoru Shimokata

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Abstract

Although S-1 has been shown to have activity against advanced nonsmall-cell lung cancer (NSCLC), its efficacy for elderly patients remains unclear. This phase II study evaluated the efficacy and safety of S-1 as a first-line treatment for elderly patients. Chemotherapy-naïve patients aged 70 years or older with stages IIIB to IV or postoperative NSCLC and performance status 1 or lower were eligible. Patients received S-1 approximately equivalent to 80 mg/m/day for 2 weeks followed by a 1-week rest period every 3 weeks. The primary end point was the response rate. Secondary end points were toxicity, disease control rate, progression-free survival, and overall survival. Twenty-nine patients were eligible. The median age was 78 years (range, 70-85 years). The overall response rate and the disease control rate were 27.6 [95% confidence interval (CI), 11.3-43.9%] and 65.5% (95% CI: 48.2-82.8%), respectively. The median progression-free survival time was 4.0 months (95% CI: 4.0-9.8 months). The median overall survival was 12.1 months (95% CI: 13.8-25.5 months) and the 1-year survival rate was 53.6%. No grade 4 toxicities were observed. The only hematological toxicity of grade 3 was anemia in 6.9% of patients. The grade 3 nonhematological toxicities included hyponatremia, anorexia, nausea, oral mucositis, and diarrhea in 3.4% of patients and infection in 6.9% of patients. S-1 monotherapy was effective and well tolerated as a first-line treatment for elderly patients with advanced NSCLC. The results of this study warrant further investigations of this regimen, including a randomized controlled trial.

Original languageEnglish
Pages (from-to)811-816
Number of pages6
JournalAnti-Cancer Drugs
Volume22
Issue number8
DOIs
Publication statusPublished - 09-2011

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Cancer Research

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    Nishiyama, O., Taniguchi, H., Kondoh, Y., Takada, K., Baba, K., Saito, H., Sugino, Y., Yamamoto, M., Ogasawara, T., Kondo, M., Imaizumi, K., Hasegawa, Y., Suzuki, R., & Shimokata, K. (2011). Phase II study of S-1 monotherapy as a first-line treatment for elderly patients with advanced nonsmall-cell lung cancer: The Central Japan Lung Study Group trial 0404. Anti-Cancer Drugs, 22(8), 811-816. https://doi.org/10.1097/CAD.0b013e3283440231