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

研究成果: Article査読

17 被引用数 (Scopus)

抄録

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.

本文言語English
ページ(範囲)811-816
ページ数6
ジャーナルAnti-Cancer Drugs
22
8
DOI
出版ステータスPublished - 09-2011
外部発表はい

All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 薬理学
  • 薬理学(医学)
  • 癌研究

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