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Background: Induction chemotherapy followed by surgical resection or definitive radiotherapy for patients affected by stage IIIA N2 bulky non-small cell lung cancer (NSCLC) has been investigated in several trials. Patients and Methods: In this present study, 52 patients with stage IIIA N2 bulky NSCLC with cytologically or histologically confirmed mediastinal lymph node involvement received paclitaxel 175 mg/mq on day 1, carboplatin AUC 5 on day 1 and gemcitabine 1,000 mg/mq on day 1 and 8 every 3 weeks for three cycles as induction chemotherapy. Results: Objective response (4 complete remission and 36 partial remission) was achieved in 40/52 patients. No early or toxic deaths were observed. Twenty-two patients were surgically explored. Fifteen were excluded for resection for biopsy-proven residual tumour in mediastinal nodes. Complete surgical resection was performed in 15 patients with confirmed pathological downstaging. Pathological complete response was achieved in 4 patients. No surgery-related mortality or significant morbidity was reported. Adjuvant radiotherapy was delivered in 15 patients, and 30 patients received definitive radiotherapy. Conclusion: In the present study, the combination of paclitaxel, carboplatin and gemcitabine has been a safe and active regimen in poor-prognosis stage IIIA N2 bulky NSCLC.

Introduction: Lung cancer is the leading cause of tumour-related deaths in the elderly population but the optimal management of advanced NSCLC in older patients has not been defined to date. The present phase II study was planned to evaluate the efficacy and toxicity of the combination of carboplatin and paclitaxel in elderly patients with advanced NSCLC. Patients and methods: Patients (>70 years old) who had pathologically been proven to have a NSCLC and measurable lesions were treated with paclitaxel (175 mg/m2for 3 h) and carboplatin [area under the concentration-time curve (AUC = 5)] on day 1 every 3 weeks. Results: Forty patients were enrolled into the study. The median age was 74 years (range, 70-78 years). Approximately 85% of the patients had stage IV and 80% had a performance status (PS) of 0-1. Nine of the 40 (22.5%; 90% CI 17.6-28.1) included patients had a partial response; one patient (2.5%; 90% CI 1.7-3.2) achieved a complete response. The overall response rate was 25% (90% CI 15.3-38.6). In addition stable disease was observed in 13 patients (32.5%; 90% CI 24.3-40.7). The median survival was 7.8 months (95% confidence interval, 5.1-11.8 months). The actual 1-year survival was 18% (95% confidence interval, 12-29%). The median time to disease progression was 4.1 months (95% CI 2.8-8.5). Overall, 37.5% of patients experienced grade 3-4 neutropenia of any duration with only two patients (5%) developing neutropenic fever. Grade 3 or 4 non-haematological toxicity was uncommon apart alopecia. Conclusions: In the present phase II study the combination of paclitaxel and carboplatin has demonstrated to be active and safe in an age-selected population. © 2005 Elsevier Ireland Ltd. All rights reserved.