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

Research output: Contribution to journalArticle

13 Citations (Scopus)

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 - 01-09-2011

Fingerprint

Non-Small Cell Lung Carcinoma
Japan
Lung
Confidence Intervals
Therapeutics
Disease-Free Survival
Stomatitis
Survival
Hyponatremia
Anorexia
Nausea
Anemia
Diarrhea
Survival Rate
Randomized Controlled Trials
Safety
Drug Therapy
Infection

All Science Journal Classification (ASJC) codes

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

Cite this

Nishiyama, Osamu ; Taniguchi, Hiroyuki ; Kondoh, Yasuhiro ; Takada, Kazuto ; Baba, Kenji ; Saito, Hiroshi ; Sugino, Yasuteru ; Yamamoto, Masashi ; Ogasawara, Toshihiko ; Kondo, Masashi ; Imaizumi, Kazuyoshi ; Hasegawa, Yoshinori ; Suzuki, Ryujiro ; Shimokata, Kaoru. / 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. In: Anti-Cancer Drugs. 2011 ; Vol. 22, No. 8. pp. 811-816.
@article{557fe7c6e984449b99299605244bd891,
title = "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",
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-na{\"i}ve 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.",
author = "Osamu Nishiyama and Hiroyuki Taniguchi and Yasuhiro Kondoh and Kazuto Takada and Kenji Baba and Hiroshi Saito and Yasuteru Sugino and Masashi Yamamoto and Toshihiko Ogasawara and Masashi Kondo and Kazuyoshi Imaizumi and Yoshinori Hasegawa and Ryujiro Suzuki and Kaoru Shimokata",
year = "2011",
month = "9",
day = "1",
doi = "10.1097/CAD.0b013e3283440231",
language = "English",
volume = "22",
pages = "811--816",
journal = "Anti-Cancer Drugs",
issn = "0959-4973",
publisher = "Lippincott Williams and Wilkins",
number = "8",

}

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, vol. 22, no. 8, pp. 811-816. https://doi.org/10.1097/CAD.0b013e3283440231

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

In: Anti-Cancer Drugs, Vol. 22, No. 8, 01.09.2011, p. 811-816.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II study of S-1 monotherapy as a first-line treatment for elderly patients with advanced nonsmall-cell lung cancer

T2 - The Central Japan Lung Study Group trial 0404

AU - Nishiyama, Osamu

AU - Taniguchi, Hiroyuki

AU - Kondoh, Yasuhiro

AU - Takada, Kazuto

AU - Baba, Kenji

AU - Saito, Hiroshi

AU - Sugino, Yasuteru

AU - Yamamoto, Masashi

AU - Ogasawara, Toshihiko

AU - Kondo, Masashi

AU - Imaizumi, Kazuyoshi

AU - Hasegawa, Yoshinori

AU - Suzuki, Ryujiro

AU - Shimokata, Kaoru

PY - 2011/9/1

Y1 - 2011/9/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=80051550619&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80051550619&partnerID=8YFLogxK

U2 - 10.1097/CAD.0b013e3283440231

DO - 10.1097/CAD.0b013e3283440231

M3 - Article

C2 - 21317767

AN - SCOPUS:80051550619

VL - 22

SP - 811

EP - 816

JO - Anti-Cancer Drugs

JF - Anti-Cancer Drugs

SN - 0959-4973

IS - 8

ER -