Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: Aa report from the Central Japan Lung Study Group, CJLSG 0503 trial

Noriyasu Usami, Kohei Yokoi, Yoshinori Hasegawa, Hiroyuki Taniguchi, Joe Shindo, Masashi Yamamoto, Ryujiro Suzuki, Kazuyoshi Imaizumi, Masashi Kondo, Kaoru Shimokata

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Abstract

Background: The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). Methods: Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. Results: Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively). Conclusions: Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.

Original languageEnglish
Pages (from-to)583-587
Number of pages5
JournalInternational Journal of Clinical Oncology
Volume15
Issue number6
DOIs
Publication statusPublished - 01-12-2010

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gemcitabine
Carboplatin
Adjuvant Chemotherapy
Non-Small Cell Lung Carcinoma
Japan
Lung
Drug Therapy
Exanthema
Neutropenia
Area Under Curve
Demography

All Science Journal Classification (ASJC) codes

  • Surgery
  • Hematology
  • Oncology

Cite this

Usami, Noriyasu ; Yokoi, Kohei ; Hasegawa, Yoshinori ; Taniguchi, Hiroyuki ; Shindo, Joe ; Yamamoto, Masashi ; Suzuki, Ryujiro ; Imaizumi, Kazuyoshi ; Kondo, Masashi ; Shimokata, Kaoru. / Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer : Aa report from the Central Japan Lung Study Group, CJLSG 0503 trial. In: International Journal of Clinical Oncology. 2010 ; Vol. 15, No. 6. pp. 583-587.
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title = "Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer: Aa report from the Central Japan Lung Study Group, CJLSG 0503 trial",
abstract = "Background: The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). Methods: Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. Results: Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65{\%})/female (n = 7, 35{\%}), stage IB (n = 8, 40{\%}), IIA (n = 1, 5{\%}), IIB (n = 6, 30{\%}), IIIA (n = 5, 25{\%}). Seventeen patients (85{\%}, 95{\%} confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65{\%} and 40{\%} of the patients, respectively). Conclusions: Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.",
author = "Noriyasu Usami and Kohei Yokoi and Yoshinori Hasegawa and Hiroyuki Taniguchi and Joe Shindo and Masashi Yamamoto and Ryujiro Suzuki and Kazuyoshi Imaizumi and Masashi Kondo and Kaoru Shimokata",
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Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer : Aa report from the Central Japan Lung Study Group, CJLSG 0503 trial. / Usami, Noriyasu; Yokoi, Kohei; Hasegawa, Yoshinori; Taniguchi, Hiroyuki; Shindo, Joe; Yamamoto, Masashi; Suzuki, Ryujiro; Imaizumi, Kazuyoshi; Kondo, Masashi; Shimokata, Kaoru.

In: International Journal of Clinical Oncology, Vol. 15, No. 6, 01.12.2010, p. 583-587.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II study of carboplatin and gemcitabine as adjuvant chemotherapy in patients with completely resected non-small cell lung cancer

T2 - Aa report from the Central Japan Lung Study Group, CJLSG 0503 trial

AU - Usami, Noriyasu

AU - Yokoi, Kohei

AU - Hasegawa, Yoshinori

AU - Taniguchi, Hiroyuki

AU - Shindo, Joe

AU - Yamamoto, Masashi

AU - Suzuki, Ryujiro

AU - Imaizumi, Kazuyoshi

AU - Kondo, Masashi

AU - Shimokata, Kaoru

PY - 2010/12/1

Y1 - 2010/12/1

N2 - Background: The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). Methods: Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. Results: Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively). Conclusions: Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.

AB - Background: The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). Methods: Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m2 on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. Results: Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively). Conclusions: Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.

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