title: Phase II study of gemcitabine-cisplatin-paclitaxel triplet as induction chemotherapy in inoperable, locally-advanced non-small cell lung cancer.
abstract: OBJECTIVE
  Our objective was to determine the activity in terms of response rate, surgical resectability, and the tolerability of the new three-drug combination gemcitabine-cisplatin-paclitaxel (GCP) in unresectable stage IIIA(N2) and IIIB non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Forty-two chemo-naive patients with stage IIIA(N2)-IIIB NSCLC, median age of 59 years, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the ability to tolerate pneumectomy, received gemcitabine (Gem) 1000 mg/m(2) IV days 1 and 8, cisplatin (CDDP) 50 mg/m(2) IV days 1 and 8, paclitaxel 125 mg/m(2) 1h infusion IV days 1 and 8, every 21 days for 3 cycles. After induction chemotherapy, patients were evaluated for surgery or definitive radiotherapy.
  
  
  RESULTS
  Grade 3-4 neutropenia was the main hematologic toxicity, occurring in 28% of patients. Grade 3-4 thrombocytopenia was observed in only 11% of cases. No neutropenic fever or bleeding episodes were recorded. Severe non-hematologic toxicity was uncommon. Thirty (71%, 95% CI: 57.2-84.7%) of the 42 eligible patients had objective responses (1 complete and 29 partial responses). After induction chemotherapy, 21 patients (50%) went to surgery. Complete resection was obtained in 16 patients (38%). Viable tumor was present in 18 of 21 resection specimens. In three cases only necrotic tumor cells were identified, for a pathological complete response of 7%. With a median follow-up of 13.9 months, median time to progression was 17.4 months, median survival 21.7 months and estimated 1-year survival 92%.
  
  
  CONCLUSIONS
  GCP combination is active and well tolerated in locally-advanced, non-resectable NSCLC. The activity profile, in terms of response and surgical resection rate, is comparable to that obtained with standard doublets.
authors.affiliation: Division of Medical Oncology, Bellaria Hospital, Via Altura 3, 40139 Bologna, Italy. federico.cappuzzo@ausl.bo.it
authors.forename: Federico
authors.initials: F
authors.lastname: Cappuzzo
authors.forename: Filippo
authors.initials: F
authors.lastname: De Marinis
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Nelli
authors.forename: Cesare
authors.initials: C
authors.lastname: Calandri
authors.forename: Antonio
authors.initials: A
authors.lastname: Maestri
authors.forename: Giovanni
authors.initials: G
authors.lastname: Benedetti
authors.forename: Maria Rita
authors.initials: MR
authors.lastname: Migliorino
authors.forename: Enrico
authors.initials: E
authors.lastname: Cortesi
authors.forename: Francesca
authors.initials: F
authors.lastname: Rastelli
authors.forename: Olga
authors.initials: O
authors.lastname: Martelli
authors.forename: Michele
authors.initials: M
authors.lastname: Andruccetti
authors.forename: Stefania
authors.initials: S
authors.lastname: Bartolini
authors.forename: Lucio
authors.initials: L
authors.lastname: Crinò
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine