title: Enduring challenge in the treatment of nonsmall cell lung cancer with clinical stage IIIB: results of a trimodality approach.
abstract: BACKGROUND
  Stage IIIb (T4/N3) non-small-cell lung cancer (NSCLC) is considered an inoperable disease and treatment is an enduring challenge. Surgery after induction therapy seems to improve locoregional control. We report the results of a phase II prospective trimodality trial (chemotherapy and concomitant radiotherapy plus surgery) in patients with stage IIIb NSCLC.
  
  
  METHODS
  From November 1992 to June 2000, 39 patients (37 men and 2 women, mean age 65 years) with clinical stage IIIb (34 T4N0 to 2, 4 T2 to 3N3, 1 T4N3, excluding T4 for malignant pleural effusion) entered the study. They received intravenous infusions of cisplatin 20 mg/m(2) and 5-fluorouracil 1,000 mg/m(2) (days 1 to 4 and 25 to 28) combined with a total dose of 50.4 Gy radiotherapy delivered over 4 weeks (1.8 Gy daily). Upon clinical restaging responders underwent surgery.
  
  
  RESULTS
  All patients were available for clinical restaging. No complete response was observed. Twenty-one patients had partial response (53.8%), 16 had stable disease (41%), and 2 had progressive disease (5.2%). Hematologic toxicity was moderate. Twenty-two patients (56.4%), 21 with partial response and 1 with stable disease, underwent surgery with no perioperative death. A radical resection was possible in 21 cases. Nine lobectomies, 3 bilobectomies, and 9 pneumonectomies were performed. Complications occurred in 5 patients (23.6%). Fourteen of the patients who underwent surgery (66.6%) showed a pathologic downstaging. A complete pathologic response was obtained in 9 cases (49%). Overall 5-year survival (Kaplan-Meier) was 23%. Resected versus non-resected patients showed a significant difference: 38% versus 5.6% (p = 0.028, log rank).
  
  
  CONCLUSIONS
  This trimodal approach for stage IIIb NSCLC appears safe and effective. It provides good therapeutic results with acceptable morbidity in surgical cases.
authors.affiliation: Department of Surgical Sciences, Catholic University, Rome, Italy. mimgaleta@yahoo.com
authors.forename: Domenico
authors.initials: D
authors.lastname: Galetta
authors.forename: Alfredo
authors.initials: A
authors.lastname: Cesario
authors.forename: Stefano
authors.initials: S
authors.lastname: Margaritora
authors.forename: Venanzio
authors.initials: V
authors.lastname: Porziella
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Macis
authors.forename: Rolando M
authors.initials: RM
authors.lastname: D'Angelillo
authors.forename: Lucio
authors.initials: L
authors.lastname: Trodella
authors.forename: Silvia
authors.initials: S
authors.lastname: Sterzi
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Granone
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000009:adverse effects; D011183:Postoperative Complications; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D016019:Survival Analysis; D015996:Survival Rate
chemical_list: D002945:Cisplatin; D005472:Fluorouracil