A phase II trial of carboplatin plus S-1 for elderly patients with advanced non-small-cell lung cancer with wild-type epidermal growth factor receptor: The Okayama Lung Cancer Study Group Trial 1202

Shoichi Kuyama, Nobuaki Ochi, Akihiro Bessho, Katsuyuki Hotta, Genyo Ikeda, Daizo Kishino, Toshio Kubo, Daijiro Harada, Nobukazu Fujimoto, Masamoto Nakanishi, Takahiro Umeno, Toshiaki Okada, Kenichi Chikamori, Tomoko Yamagishi, Kadoaki Oohashi, Eiki Ichihara, Nagio Takigawa, Mitsune Tanimoto, Katsuyuki Kiura

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Introduction S-1 is an oral fluoropyrimidine-based combination of tegafur, gimeracil, and oteracil potassium. Although the combination of S-1 with carboplatin is a first-line chemotherapy regimen for advanced non-small cell lung cancer (NSCLC), the efficacy and safety of the regimen in the elderly remain unknown. Methods The patient inclusion criteria were previously untreated advanced NSCLC, wild-type epidermal growth factor receptor, aged 70 years or more, and a performance status (PS) of 0–2. The patients received oral S-1 (40 mg/m2, twice daily) for 2 weeks and carboplatin (area under the curve: 5) on day 1 every 4 weeks as induction treatment. After four induction cycles, S-1 alone (40 mg/m2, twice daily) was administered for 2 weeks every 4 weeks as a maintenance therapy until disease progression. The primary endpoint was the overall response rate (ORR), which was expected to exceed 20%, and the secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the toxicity profile. The associations between clinical outcomes and expression of genes such as thymidylate synthase and thymidine phosphorylase in the tumors were evaluated. Results Thirty-three patients were enrolled between March 2013 and June 2015. The median age was 78 (range 70–89) years, and 51.5% had a PS of 0. The ORR was 30.3% (95% confidence interval (CI): 14.6–46.0) and the DCR 57.6% (95% CI: 40.7–74.4). Grade 3/4 toxicities included thrombocytopenia (42.4%), neutropenia (33.3%), and anemia (27.3%). There was one treatment-related death due to aspiration pneumonia following febrile neutropenia. The median PFS and OS were 134 days (95% CI: 79–173) and 479 days (95% CI: 250–571), respectively. Low thymidine phosphorylase expression was associated with the DCR (P < 0.01). Conclusion This study met the predesigned primary endpoint, and the regimen seems to be a favorable treatment option.

Original languageEnglish
Pages (from-to)188-194
Number of pages7
JournalLung Cancer
Volume112
DOIs
Publication statusPublished - Oct 1 2017

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Carboplatin
Epidermal Growth Factor Receptor
Non-Small Cell Lung Carcinoma
Lung Neoplasms
Confidence Intervals
Thymidine Phosphorylase
Disease-Free Survival
Aspiration Pneumonia
Febrile Neutropenia
Thymidylate Synthase
Survival
Therapeutics
Neutropenia
Thrombocytopenia
Area Under Curve
Disease Progression
Anemia
Potassium
Safety
Gene Expression

Keywords

  • Carboplatin
  • Elderly
  • Non-small cell lung cancer
  • S-1
  • Thymidine phosphorylase

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

A phase II trial of carboplatin plus S-1 for elderly patients with advanced non-small-cell lung cancer with wild-type epidermal growth factor receptor : The Okayama Lung Cancer Study Group Trial 1202. / Kuyama, Shoichi; Ochi, Nobuaki; Bessho, Akihiro; Hotta, Katsuyuki; Ikeda, Genyo; Kishino, Daizo; Kubo, Toshio; Harada, Daijiro; Fujimoto, Nobukazu; Nakanishi, Masamoto; Umeno, Takahiro; Okada, Toshiaki; Chikamori, Kenichi; Yamagishi, Tomoko; Oohashi, Kadoaki; Ichihara, Eiki; Takigawa, Nagio; Tanimoto, Mitsune; Kiura, Katsuyuki.

In: Lung Cancer, Vol. 112, 01.10.2017, p. 188-194.

Research output: Contribution to journalArticle

Kuyama, Shoichi ; Ochi, Nobuaki ; Bessho, Akihiro ; Hotta, Katsuyuki ; Ikeda, Genyo ; Kishino, Daizo ; Kubo, Toshio ; Harada, Daijiro ; Fujimoto, Nobukazu ; Nakanishi, Masamoto ; Umeno, Takahiro ; Okada, Toshiaki ; Chikamori, Kenichi ; Yamagishi, Tomoko ; Oohashi, Kadoaki ; Ichihara, Eiki ; Takigawa, Nagio ; Tanimoto, Mitsune ; Kiura, Katsuyuki. / A phase II trial of carboplatin plus S-1 for elderly patients with advanced non-small-cell lung cancer with wild-type epidermal growth factor receptor : The Okayama Lung Cancer Study Group Trial 1202. In: Lung Cancer. 2017 ; Vol. 112. pp. 188-194.
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title = "A phase II trial of carboplatin plus S-1 for elderly patients with advanced non-small-cell lung cancer with wild-type epidermal growth factor receptor: The Okayama Lung Cancer Study Group Trial 1202",
abstract = "Introduction S-1 is an oral fluoropyrimidine-based combination of tegafur, gimeracil, and oteracil potassium. Although the combination of S-1 with carboplatin is a first-line chemotherapy regimen for advanced non-small cell lung cancer (NSCLC), the efficacy and safety of the regimen in the elderly remain unknown. Methods The patient inclusion criteria were previously untreated advanced NSCLC, wild-type epidermal growth factor receptor, aged 70 years or more, and a performance status (PS) of 0–2. The patients received oral S-1 (40 mg/m2, twice daily) for 2 weeks and carboplatin (area under the curve: 5) on day 1 every 4 weeks as induction treatment. After four induction cycles, S-1 alone (40 mg/m2, twice daily) was administered for 2 weeks every 4 weeks as a maintenance therapy until disease progression. The primary endpoint was the overall response rate (ORR), which was expected to exceed 20{\%}, and the secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the toxicity profile. The associations between clinical outcomes and expression of genes such as thymidylate synthase and thymidine phosphorylase in the tumors were evaluated. Results Thirty-three patients were enrolled between March 2013 and June 2015. The median age was 78 (range 70–89) years, and 51.5{\%} had a PS of 0. The ORR was 30.3{\%} (95{\%} confidence interval (CI): 14.6–46.0) and the DCR 57.6{\%} (95{\%} CI: 40.7–74.4). Grade 3/4 toxicities included thrombocytopenia (42.4{\%}), neutropenia (33.3{\%}), and anemia (27.3{\%}). There was one treatment-related death due to aspiration pneumonia following febrile neutropenia. The median PFS and OS were 134 days (95{\%} CI: 79–173) and 479 days (95{\%} CI: 250–571), respectively. Low thymidine phosphorylase expression was associated with the DCR (P < 0.01). Conclusion This study met the predesigned primary endpoint, and the regimen seems to be a favorable treatment option.",
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TY - JOUR

T1 - A phase II trial of carboplatin plus S-1 for elderly patients with advanced non-small-cell lung cancer with wild-type epidermal growth factor receptor

T2 - The Okayama Lung Cancer Study Group Trial 1202

AU - Kuyama, Shoichi

AU - Ochi, Nobuaki

AU - Bessho, Akihiro

AU - Hotta, Katsuyuki

AU - Ikeda, Genyo

AU - Kishino, Daizo

AU - Kubo, Toshio

AU - Harada, Daijiro

AU - Fujimoto, Nobukazu

AU - Nakanishi, Masamoto

AU - Umeno, Takahiro

AU - Okada, Toshiaki

AU - Chikamori, Kenichi

AU - Yamagishi, Tomoko

AU - Oohashi, Kadoaki

AU - Ichihara, Eiki

AU - Takigawa, Nagio

AU - Tanimoto, Mitsune

AU - Kiura, Katsuyuki

PY - 2017/10/1

Y1 - 2017/10/1

N2 - Introduction S-1 is an oral fluoropyrimidine-based combination of tegafur, gimeracil, and oteracil potassium. Although the combination of S-1 with carboplatin is a first-line chemotherapy regimen for advanced non-small cell lung cancer (NSCLC), the efficacy and safety of the regimen in the elderly remain unknown. Methods The patient inclusion criteria were previously untreated advanced NSCLC, wild-type epidermal growth factor receptor, aged 70 years or more, and a performance status (PS) of 0–2. The patients received oral S-1 (40 mg/m2, twice daily) for 2 weeks and carboplatin (area under the curve: 5) on day 1 every 4 weeks as induction treatment. After four induction cycles, S-1 alone (40 mg/m2, twice daily) was administered for 2 weeks every 4 weeks as a maintenance therapy until disease progression. The primary endpoint was the overall response rate (ORR), which was expected to exceed 20%, and the secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the toxicity profile. The associations between clinical outcomes and expression of genes such as thymidylate synthase and thymidine phosphorylase in the tumors were evaluated. Results Thirty-three patients were enrolled between March 2013 and June 2015. The median age was 78 (range 70–89) years, and 51.5% had a PS of 0. The ORR was 30.3% (95% confidence interval (CI): 14.6–46.0) and the DCR 57.6% (95% CI: 40.7–74.4). Grade 3/4 toxicities included thrombocytopenia (42.4%), neutropenia (33.3%), and anemia (27.3%). There was one treatment-related death due to aspiration pneumonia following febrile neutropenia. The median PFS and OS were 134 days (95% CI: 79–173) and 479 days (95% CI: 250–571), respectively. Low thymidine phosphorylase expression was associated with the DCR (P < 0.01). Conclusion This study met the predesigned primary endpoint, and the regimen seems to be a favorable treatment option.

AB - Introduction S-1 is an oral fluoropyrimidine-based combination of tegafur, gimeracil, and oteracil potassium. Although the combination of S-1 with carboplatin is a first-line chemotherapy regimen for advanced non-small cell lung cancer (NSCLC), the efficacy and safety of the regimen in the elderly remain unknown. Methods The patient inclusion criteria were previously untreated advanced NSCLC, wild-type epidermal growth factor receptor, aged 70 years or more, and a performance status (PS) of 0–2. The patients received oral S-1 (40 mg/m2, twice daily) for 2 weeks and carboplatin (area under the curve: 5) on day 1 every 4 weeks as induction treatment. After four induction cycles, S-1 alone (40 mg/m2, twice daily) was administered for 2 weeks every 4 weeks as a maintenance therapy until disease progression. The primary endpoint was the overall response rate (ORR), which was expected to exceed 20%, and the secondary endpoints included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the toxicity profile. The associations between clinical outcomes and expression of genes such as thymidylate synthase and thymidine phosphorylase in the tumors were evaluated. Results Thirty-three patients were enrolled between March 2013 and June 2015. The median age was 78 (range 70–89) years, and 51.5% had a PS of 0. The ORR was 30.3% (95% confidence interval (CI): 14.6–46.0) and the DCR 57.6% (95% CI: 40.7–74.4). Grade 3/4 toxicities included thrombocytopenia (42.4%), neutropenia (33.3%), and anemia (27.3%). There was one treatment-related death due to aspiration pneumonia following febrile neutropenia. The median PFS and OS were 134 days (95% CI: 79–173) and 479 days (95% CI: 250–571), respectively. Low thymidine phosphorylase expression was associated with the DCR (P < 0.01). Conclusion This study met the predesigned primary endpoint, and the regimen seems to be a favorable treatment option.

KW - Carboplatin

KW - Elderly

KW - Non-small cell lung cancer

KW - S-1

KW - Thymidine phosphorylase

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U2 - 10.1016/j.lungcan.2017.08.010

DO - 10.1016/j.lungcan.2017.08.010

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VL - 112

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JO - Lung Cancer

JF - Lung Cancer

SN - 0169-5002

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