title: Phase I/II study of paclitaxel + carboplatin for refractory or recurrent non-small cell lung cancer.
abstract: A gene-drug correlation analysis was previously performed in lung cancer cell lines using the NC160 program. On the basis of this work, a phase I/II pilot study of weekly paclitaxel and carboplatin (CBDCA) was subsequently planned for refractory or recurrent non-small cell lung cancer (NSCLC). Safety and antitumor effects were evaluable in all 30 patients registered for this study. Seven patients were stage IIIB and 23 were stage IV. At level 5 (paclitaxel 100 mg/m2 and CBDCA AUCS), toxicities were not dose-limiting factors, but three out of the initial six cases had infusion skips. Our recommended dose was paclitaxel 100 mg/m2 and CBDCA AUC5. The response rate was 50% (9/18)(95% CI: 27-73%) in step 5. The median survival time was 12 months. This combination showed a promising clinical activity with mild toxicity and should be selected for the investigational arm of phase III trials to be compared with either docetaxel or pemetrexed.
authors.affiliation: Department of Pulmonary Medicine/Infection and Oncology, Nippon Medical School, Tokyo, Japan. agemma@nms.ac.jp
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
authors.forename: Masahiro
authors.initials: M
authors.lastname: Seike
authors.forename: Seiji
authors.initials: S
authors.lastname: Kosaihira
authors.forename: Yuji
authors.initials: Y
authors.lastname: Minegishi
authors.forename: Rintaro
authors.initials: R
authors.lastname: Noro
authors.forename: Michiya
authors.initials: M
authors.lastname: Nara
authors.forename: Yukio
authors.initials: Y
authors.lastname: Hosomi
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Okano
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kokubo
authors.forename: Akinobu
authors.initials: A
authors.lastname: Yoshimura
authors.forename: Masahiko
authors.initials: M
authors.lastname: Shibuya
authors.forename: Shoji
authors.initials: S
authors.lastname: Kudoh
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects
chemical_list: D016190:Carboplatin; D017239:Paclitaxel