title: Randomized phase II trial of cisplatin, etoposide, and radiation followed by gemcitabine alone or by combined gemcitabine and docetaxel in stage III A/B unresectable non-small cell lung cancer.
abstract: OBJECTIVE
  Southwest Oncology Group 9504 demonstrated the feasibility and potential benefit of docetaxel consolidation after etoposide, cisplatin, and radiotherapy in patients with locally advanced non-small cell lung cancer. Our study assessed consolidation with either gemcitabine alone or with docetaxel after identical chemoradiation as used in Southwest Oncology Group 9504.
  
  
  METHODS
  Patients with stage III non-small cell lung cancer and good performance status were included. Treatment consisted of concurrent cisplatin 50 mg/m on days 1 and 8 plus etoposide 50 mg/m on days 1 to 5 for two 28-day cycles plus radiotherapy (62 Gy, 2 Gy daily in 31 fractions over 7 weeks), followed by randomization to either gemcitabine 1000 mg/m on days 1 and 8 (G) or gemcitabine 1000 mg/m on days 1 and 8 plus docetaxel 75 mg/m on day 1 (GD) every 21 days for three cycles.
  
  
  RESULTS
  Eighty-three patients were entered, 81 received induction therapy, and 64 were randomized (32 in each arm). Grade 3 or four events, including neutropenia (56.3% vs. 28.1%, p = 0.03), anemia (18.8% vs. 3.1%, p = 0.05), and fatigue (15.6% vs. 6.3%, p = NS), were more frequent with GD compared with G. Among all patients, median survival from registration was 20.8 months (95% confidence interval: 16.4-33.8), and 2-year survival was 46.7% (95% confidence interval: 35.6-57.1). From randomization, median progression-free survival was 5.4 months for G and 13.4 months for GD, and median survival was 16.1 months for G and 29.5 months for GD. Two-year survival rates were 40.6% for G and 55.7% for GD.
  
  
  CONCLUSIONS
  The doublet, as expected, resulted in more toxicity, particularly myelosuppression and fatigue. Survival associated with the GD treatment arm of this trial exceeds that of previously reported trials.
authors.affiliation: Department of Radiation Oncology, Henry Ford Health Systems, 2799 W Grand Blvd, Detroit, MI 48202, USA. bmovsas1@hfhs.org
authors.forename: Benjamin
authors.initials: B
authors.lastname: Movsas
authors.forename: Corey J
authors.initials: CJ
authors.lastname: Langer
authors.forename: Helen J
authors.initials: HJ
authors.lastname: Ross
authors.forename: Luhua
authors.initials: L
authors.lastname: Wang
authors.forename: Robert M
authors.initials: RM
authors.lastname: Jotte
authors.forename: Steve
authors.initials: S
authors.lastname: Feigenberg
authors.forename: Feng
authors.initials: F
authors.lastname: Xu
authors.forename: Chao H
authors.initials: CH
authors.lastname: Huang
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Monberg
authors.forename: Coleman K
authors.initials: CK
authors.lastname: Obasaju
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018287:Carcinoma, Large Cell / Q000473:pathology / Q000628:therapy*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005047:Etoposide / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011879:Radiotherapy Dosage; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D005047:Etoposide; D002945:Cisplatin; D000093542:Gemcitabine