title: Concurrent radio-chemotherapy in N2 non small cell lung cancer: interim analysis.
abstract: OBJECTIVE
  In recent years many authors have been focused on N2 non-small cell lung cancer patients to determine whether the rate of resectability and long term survival can be improved by a combined preoperative treatment, with significant results. Following these experiences, we planned an induction therapy trial to assess the impact on downstaging, resectability and survival of concurrent radio-chemotherapy on N2 non-small cell lung cancer patients.
  
  
  METHODS
  Between January 1990 and August 1995, 82 N2 non-small cell lung cancer patients (44 IIIA and 38 IIIB) received preoperative chemo-radiotherapy with a single cycle of Carboplatin (90 mg/m2 per day for days 1-4), concurrent with radiotherapy (daily radiation dose of 180 cGray for a total of 5040). After surgery, all patients received multi-drug chemotherapy with Carboplatin 300 mg/m2 per day on day 1 and VP-16 100 mg/m2 per day on days 1, 2 and 3, for a total of 6 monthly cycles. Patients with unresectable tumors underwent to this multi-drug chemotherapy, directly.
  
  
  RESULTS
  Two patients were excluded from the study. When the remaining 80 patients had a 'clinical' re-staging, 41 (51.3%) showed a major response, 36 (45%) had minimal or none response, and 3 (3.7%) had progression of disease. Forty-one patients were judged to be resectable, 11 staged IIIB, and 30 IIIA; 2 patients of the IIIB group refused surgery. Of the 39 operated cases, 37 were completely resected (resectability rate: 94.8%). We report one perioperative death due to respiratory failure and two major complications. The overall actuarial 5 year survival is 24.5%. Downstaging was observed in 22 patients (56.4%), with three patients (7.7%) having no evidence of tumor in the specimen, 16 (41%) having sterilization of all lymph nodes, and three (7.7%) having sterilization of mediastinal nodes but positive N1 nodes. The 5-year actuarial survival is 53% for patients who had complete resection and 0% for patients with no resection (P = 0.0000).
  
  
  CONCLUSIONS
  The following conclusions are possible: preoperative radiotherapy and chemotherapy with Carboplatin is well tolerated by patients, does not increase postoperative complications and produces an high rate of response. There is an high resection rate for patients who respond to the therapy. Patients with major response who undergo complete surgical resection had statistically significant improved survival compared with patients whose disease was not resected.
authors.affiliation: Department of General Thoracic Surgery, Agostino Gemelli Hospital, Catholic University of Rome, Italy. ste.si@iol.it
authors.forename: P
authors.initials: P
authors.lastname: Granone
authors.forename: S
authors.initials: S
authors.lastname: Margaritora
authors.forename: A
authors.initials: A
authors.lastname: Cesario
authors.forename: P
authors.initials: P
authors.lastname: Bonatti
authors.forename: D
authors.initials: D
authors.lastname: Galetta
authors.forename: A
authors.initials: A
authors.lastname: Picciocchi
mesh_terms: D000206:Actuarial Analysis; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy; D011300:Preoperative Care; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin