title: Phase I study to determine the MTD of paclitaxel given three times per week during concurrent radiation therapy for stage III non-small cell lung cancer.
abstract: OBJECTIVE
  To evaluate the toxicity and the maximum tolerated dose (MTD) of paclitaxel concurrently with three-dimensional (3D) conformal radiotherapy for patients with locally advanced non-small cell lung cancer (LANSCLC) after 2-3 cycles of induction chemotherapy.
  
  
  METHODS
  Patients with histologically proven stage III non-small cell lung cancer (NSCLC) were eligible. Induction chemotherapy regimen included cisplatin (40 mg/m2) on days 1 and 2, and vinorelbine (25 mg/m2) on days 1 and 8 every 3 weeks for 2 or 3 cycles, followed a month later by continual three-dimensional (3D) conformal radiotherapy (60 Gy in 30 fractions for 6 weeks) delivered concurrently with paclitaxel dose escalating from the lowest level, 15 mg/m2, twice weekly, 6 weeks in all, to the highest level, 15 mg/m2, three times a week, 6 weeks in all.
  
  
  METHODS
  The MTD was defined as the highest safely tolerated dose at which no more than one patient out of six experiences dose-limiting toxicity, with the next higher dose having at least two out of six patients experience dose-limiting toxicity (DLT).
  
  
  RESULTS
  Twenty-three patients were enrolled in this study. The maximum tolerated dose of paclitaxel during 3D-conformal radiotherapy was not reached at 15 mg/m2, three times a week, 6 weeks in all, a level which has been recommended for Caucasian patients with LANSCLC without induction chemotherapy. The overall response rate of induction chemotherapy alone was 47.8% (0% complete remission, 47.8% partial remission, 39.1% stable disease, 13% progressive disease) and that of induction chemotherapy plus concurrent treatment was 78.3% (18/23), including 8.7% (2/23) complete remissions. None of the patients died as a result of toxicity. The median survival time was 23.0 months.
  
  
  CONCLUSIONS
  15 mg/m2 of paclitaxel, three times a week, concurrently with 3D-conformal radiotherapy for patients with locally advanced NSCLC after 2 or 3 cycles of induction chemotherapy is a safe and effective dose, according to our preliminary study.
authors.affiliation: Department of Radiation Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing, China.
authors.forename: Anhui
authors.initials: A
authors.lastname: Shi
authors.forename: Tongtong
authors.initials: T
authors.lastname: An
authors.forename: Guangying
authors.initials: G
authors.lastname: Zhu
authors.forename: Rong
authors.initials: R
authors.lastname: Yu
authors.forename: Gang
authors.initials: G
authors.lastname: Xu
authors.forename: Xuyi
authors.initials: X
authors.lastname: Liu
authors.forename: Bo
authors.initials: B
authors.lastname: Xu
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel