title: Phase I/II study of paclitaxel and radiotherapy in non-small cell lung cancer.
abstract: To establish the maximum tolerated dose of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) as a radiosensitizing agent and to determine its optimal therapeutic dose when combined with conventionally fractionated radiotherapy in the treatment of non-small cell lung cancer, a phase I/II study was undertaken in 16 treatment-naive patients. Beginning at 40 mg/m2/wk with doses escalated in 10 mg/m2 increments until dose-limiting toxicity was encountered, paclitaxel was administered over 3 hours to successive three-patient cohorts. Radiotherapy (2 Gy/d x 5 d/wk; maximum total dose, 50 Gy) was delivered after the paclitaxel infusion. Treatment continued for 5 successive weeks. All 16 patients are evaluable for response and toxicity. Hematologic toxicity was low, with red blood cells and platelets remaining stable and leukocyte decreases (mean, 60%) attributed to radiotherapy. Nonhematologic toxicity included grade 2/3 esophagitis and neurologic sequelae. Responses were noted at all paclitaxel dose levels, including two complete and five partial responses, but the median time to progression was only 5 months. Paclitaxel may be combined safely with radiotherapy without major toxicity, and the radiosensitizing effect of paclitaxel was evident at all doses.
authors.affiliation: Oncology Department, City Hospital, Ravenna, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Marangolo
authors.forename: E
authors.initials: E
authors.lastname: Emiliani
authors.forename: G
authors.initials: G
authors.lastname: Rosti
authors.forename: M
authors.initials: M
authors.lastname: Giannini
authors.forename: B
authors.initials: B
authors.lastname: Vertogen
authors.forename: F
authors.initials: F
authors.lastname: Zumaglini
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000633:toxicity; D002289:Carcinoma, Non-Small-Cell Lung / Q000532:radiotherapy / Q000628:therapy*; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D004941:Esophagitis / Q000139:chemically induced; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000209:etiology; D008175:Lung Neoplasms / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000633:toxicity; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage*; D011878:Radiotherapy / Q000009:adverse effects; D011879:Radiotherapy Dosage
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011838:Radiation-Sensitizing Agents; D017239:Paclitaxel