title: A phase II trial of gemcitabine and ifosfamide in non-small cell lung cancer.
abstract: The novel nucleoside agent gemcitabine has demonstrated antitumor activity against a variety of solid tumors and is associated with low toxicity. A phase I trial in Germany of gemcitabine combined with the alkylating agent ifosfamide has shown encouraging activity against non-small cell lung cancer (NSCLC). The efficacy and toxicity of this combination was further evaluated in a phase II trial of chemotherapy-naive patients with NSCLC (mostly stage IV disease). Gemcitabine was administered at a dose of 1,000 mg/m2 on days 1, 8, and 15 followed by a 1-week rest, while ifosfamide was given at a dose of 1,500 mg/m2 on day 8 and days 9 through 12. Fifty-one of 56 patients were evaluable for response. Eleven partial responses were seen, for an overall objective response rate of 22%. The 6- and 9-month survival rates are 62% and 41%, respectively. Grade 3 and 4 neutropenia occurred in 35.8% and 24.5% of patients, respectively, but the incidence of infection was low. These results indicate that the combination of gemcitabine and ifosfamide is active against NSCLC and has a mild toxicity profile, and suggest that further evaluation of this combination is warranted.
authors.affiliation: Department of Thoracic Oncology, Grosshansdorf Hospital, Hamburg, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Gatzemeier
authors.forename: C
authors.initials: C
authors.lastname: Manegold
authors.forename: W
authors.initials: W
authors.lastname: Eberhard
authors.forename: H J
authors.initials: HJ
authors.lastname: Wilke
authors.forename: F
authors.initials: F
authors.lastname: Chomy
authors.forename: P
authors.initials: P
authors.lastname: Chomy
authors.forename: D
authors.initials: D
authors.lastname: Khayat
authors.forename: J
authors.initials: J
authors.lastname: Blatter
authors.forename: S
authors.initials: S
authors.lastname: Seeber
authors.forename: P
authors.initials: P
authors.lastname: Drings
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage* / Q000009:adverse effects; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors*; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D003841:Deoxycytidine; D012264:Ribonucleotide Reductases; D007069:Ifosfamide; D000093542:Gemcitabine