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Summary: 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 (175mg/m2 for 3h) 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. [Copyright &y& Elsevier]

Summary: Introduction:: The primary tumour type most likely to metastasize to the brain is lung cancer. In heavily pre-treated patients, limited therapeutic option is available and the results of availability therapies reported in literature are disappointing. The present phase II study was designed to assess the efficacy and safety of temozolomide (TMZ) as palliative treatment for brain metastases (BrM) in NSCLC patients pre-treated with WBRT and at least one line of chemotherapy for metastatic brain disease. Material and methods:: Temozolomide was administered orally at 150mg/mq/day for five consecutive days for the first cycle, doses were increased to 200mg/mq/day for 5 days every 28 days for subsequent cycles if no grade 3/4 haematological toxicity was observed. Eligibility criteria included cytological or histological confirmed NSCLC; BrM, recurrent or progressing after WBRT and at least one line of chemotherapy. A total of 30 consecutive patients entered the study and received the allocated treatment. Results:: Three patients (10%) achieved an objective response (OR) of BrM with two complete remission. Stable disease and progressive disease were achieved in 3 (10%) and 24 patients (80%), respectively. A correlation between response to TMZ and sensitivity to the previous first line chemotherapy was reported. Time to progression and overall survival were examined both for responder patients and for all included patients. For long-term survivors, we considered the patients who survived >12 months after the start of TMZ. According to this definition, three patients resulted long-term survivors: 2 with OR and 1 with stable brain disease. No grades 3 or 4 toxicity occurred. The total of treatment-related adverse events were mild or moderate (G1-2) in intensity. No patients discontinued TMZ as a result of treatment-related toxicity. Discussion:: The results of the present trial clearly demonstrates that TMZ is active and safe in BrM NSCLC patients previously treated with WBRT and at least one line of chemotherapy. [Copyright &y& Elsevier]