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 cell 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.
authors.affiliation: Department of Medicine, Indiana University Medical Center, Indianapolis 46202, USA.
authors.forename: L H
authors.initials: LH
authors.lastname: Einhorn
mesh_terms: D000328:Adult; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors*; D015996:Survival Rate; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D012264:Ribonucleotide Reductases; D002945:Cisplatin; D000093542:Gemcitabine