title: Long-term follow-up of a phase I/II trial of dose escalating three-dimensional conformal thoracic radiation therapy with induction and concurrent carboplatin and paclitaxel in unresectable stage IIIA/B non-small cell lung cancer.
abstract: BACKGROUND
  We conducted a modified phase I/II trial investigating the incorporation of three-dimensional conformal thoracic radiation therapy (TCRT) into the treatment paradigm of induction and concurrent carboplatin and paclitaxel in patients with unresectable stage IIIA/B non-small cell lung cancer.
  
  
  METHODS
  Patients received 2 cycles of induction carboplatin (area under the curve of 6) and paclitaxel (225 mg/m) on days 1, and 22. On day 43 concurrent TCRT and weekly x6 of carboplatin (area under the curve = 2) and paclitaxel (45 mg/m) was initiated. The TCRT dose was escalated from 60 to 74 Gy in 4 cohorts (60, 66, 70, and 74 Gy), and the 74 Gy cohort was expanded into a phase II trial.
  
  
  RESULTS
  Sixty-two patients were enrolled; the median age 57 years (range, 36-82), 39 were male (63%), 61 (98%) had a performance status of 0 or 1, 28 (45%) had stage IIIA disease, 21 (34%) had >5% weight loss, and the median forced expiratory volume 1 = 2.10 liters (range, 1.02-3.75). With a median follow-up for survivors of approximately 9 years (range, 7-11 years) the median progression-free survival, time to tumor progression, and overall survival (OS) (with 95% confidence intervals) were 10 (8.5-17), 15 (9-50), and 25 months (18-37), respectively. The 5-year progression-free survival and OS rates were 21% (12-32%) and 27% (17-39%), respectively. The 10-year OS rate was 14% (7-25%).
  
  
  CONCLUSIONS
  The long term survival rate compares favorably to other treatment approaches for stage III non-small cell lung cancer.
authors.affiliation: Division of Hematology/Oncology, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7305, USA. thomas_stinchcombe@med.unc.edu
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Stinchcombe
authors.forename: Carrie B
authors.initials: CB
authors.lastname: Lee
authors.forename: Dominic T
authors.initials: DT
authors.lastname: Moore
authors.forename: M Patricia
authors.initials: MP
authors.lastname: Rivera
authors.forename: Jan
authors.initials: J
authors.lastname: Halle
authors.forename: Steven
authors.initials: S
authors.lastname: Limentani
authors.forename: Julian G
authors.initials: JG
authors.lastname: Rosenman
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D020266:Radiotherapy, Conformal; D012074:Remission Induction; D015996:Survival Rate; D013997:Time Factors
chemical_list: D016190:Carboplatin; D017239:Paclitaxel