Phase II trial of gemcitabine plus cisplatin in non-small cell lung cancer

A Hoosier Oncology Group Study

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Abstract

Although non-small cell lung cancer accounts for a majority of lung cancer cases in the United States, overall response rates of only 20% have been obtained with cisplatin-based therapy. However, new agents such as the nucleoside analog gemcitabine have demonstrated single-agent response rates of approximately 20%. The synergistic growth inhibition of several tumor cell lines seen in vitro with cisplatin and gemcitabine has led to clinical trials incorporating this drug combination. Recent phase I trials revealed that administration of gemcitabine 1,000 mg/m2 weekly X 3, with cisplatin 100 mg/m2 on day 15, every 28 days, was well tolerated. This regimen was used in the present Hoosier Oncology Group phase II trial of patients with advanced non-small tell lung cancer, except that cisplatin was administered on day 1. Five patients had stage IIIB and 25 had stage IV disease, with a mean Karnofsky performance status of 90. Toxicity observed was primarily hematologic, notably, granulocytopenia and thrombocytopenia. Responses were seen in 10 of 27 patients, for an overall response rate of 37%. Median overall survival was 8.4 months; it was 10.2 months for patients with stage IV disease. These favorable results and manageable side effects suggest that future trials incorporating gemcitabine and cisplatin are indicated.

Original languageEnglish
JournalSeminars in Oncology
Volume24
Issue number3 SUPPL. 8
StatePublished - 1997

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gemcitabine
Non-Small Cell Lung Carcinoma
Cisplatin
Lung Neoplasms
Karnofsky Performance Status
Agranulocytosis
Drug Combinations
Tumor Cell Line
Nucleosides
Thrombocytopenia
Clinical Trials
Survival
Growth

ASJC Scopus subject areas

  • Oncology

Cite this

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title = "Phase II trial of gemcitabine plus cisplatin in non-small cell lung cancer: A Hoosier Oncology Group Study",
abstract = "Although non-small cell lung cancer accounts for a majority of lung cancer cases in the United States, overall response rates of only 20{\%} have been obtained with cisplatin-based therapy. However, new agents such as the nucleoside analog gemcitabine have demonstrated single-agent response rates of approximately 20{\%}. The synergistic growth inhibition of several tumor cell lines seen in vitro with cisplatin and gemcitabine has led to clinical trials incorporating this drug combination. Recent phase I trials revealed that administration of gemcitabine 1,000 mg/m2 weekly X 3, with cisplatin 100 mg/m2 on day 15, every 28 days, was well tolerated. This regimen was used in the present Hoosier Oncology Group phase II trial of patients with advanced non-small tell lung cancer, except that cisplatin was administered on day 1. Five patients had stage IIIB and 25 had stage IV disease, with a mean Karnofsky performance status of 90. Toxicity observed was primarily hematologic, notably, granulocytopenia and thrombocytopenia. Responses were seen in 10 of 27 patients, for an overall response rate of 37{\%}. Median overall survival was 8.4 months; it was 10.2 months for patients with stage IV disease. These favorable results and manageable side effects suggest that future trials incorporating gemcitabine and cisplatin are indicated.",
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AB - Although non-small cell lung cancer accounts for a majority of lung cancer cases in the United States, overall response rates of only 20% have been obtained with cisplatin-based therapy. However, new agents such as the nucleoside analog gemcitabine have demonstrated single-agent response rates of approximately 20%. The synergistic growth inhibition of several tumor cell lines seen in vitro with cisplatin and gemcitabine has led to clinical trials incorporating this drug combination. Recent phase I trials revealed that administration of gemcitabine 1,000 mg/m2 weekly X 3, with cisplatin 100 mg/m2 on day 15, every 28 days, was well tolerated. This regimen was used in the present Hoosier Oncology Group phase II trial of patients with advanced non-small tell lung cancer, except that cisplatin was administered on day 1. Five patients had stage IIIB and 25 had stage IV disease, with a mean Karnofsky performance status of 90. Toxicity observed was primarily hematologic, notably, granulocytopenia and thrombocytopenia. Responses were seen in 10 of 27 patients, for an overall response rate of 37%. Median overall survival was 8.4 months; it was 10.2 months for patients with stage IV disease. These favorable results and manageable side effects suggest that future trials incorporating gemcitabine and cisplatin are indicated.

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