title: Phase II study of biweekly administration of docetaxel and irinotecan in patients with refractory or relapsed advanced non-small cell lung cancer.
abstract: We examined the safety and efficacy of the combination of docetaxel and irinotecan administered biweekly in patients with refractory or relapsed advanced non-small cell lung cancer (NSCLC). Patients with previously treated NSCLC of stage III or IV were eligible if they had a performance status of 2 or less, were 75 years or younger, and had adequate organ function. From May 2003 through February 2006, 35 patients (27 men and 8 women; median age 64 years; age range 41-75 years) were enrolled. Patients were treated every 4 weeks with docetaxel (33 mg/m(2) on days 2 and 16) plus irinotecan (50 mg/m(2) on days 1 and 15). None of the 35 patients achieved a complete response, but five achieved a partial response, for an overall response rate of 14.3% (95% confidence interval, 4.8-30.3%). The median survival time was 8 months (range 2-29 months). The median time to progression was 3 months (range 1-12 months). Grade 3 to 4 hematologic toxicities included leukopenia in 48.6% of patients, neutropenia in 54.3%, and anemia in 25.7%. No patients had grade 3 to 4 diarrhea or nausea and vomiting. Although one patient had grade 3 drug-induced interstitial pneumonia, all side effects were manageable, and there were no treatment-related deaths. In conclusion, the combination of docetaxel and irinotecan administered biweekly is a safe and effective treatment for refractory or relapsed NSCLC. However, the search for even more active regimens should be continued.
authors.affiliation: The First Department of Internal Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-8666, Japan. thirose-shw@umin.ac.jp
authors.forename: Takashi
authors.initials: T
authors.lastname: Hirose
authors.forename: Takao
authors.initials: T
authors.lastname: Shirai
authors.forename: Hiroo
authors.initials: H
authors.lastname: Ishida
authors.forename: Kohichi
authors.initials: K
authors.lastname: Ando
authors.forename: Tomohide
authors.initials: T
authors.lastname: Sugiyama
authors.forename: Sojiro
authors.initials: S
authors.lastname: Kusumoto
authors.forename: Takamichi
authors.initials: T
authors.lastname: Hosaka
authors.forename: Masanao
authors.initials: M
authors.lastname: Nakashima
authors.forename: Tohru
authors.initials: T
authors.lastname: Ohmori
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Adachi
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced / Q000473:pathology; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011838:Radiation-Sensitizing Agents; D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin