Paclitaxel and epirubicin followed by cyclophosphamide, methotrexate and 5-fluorouracil for patients with stage IIIC breast cancer with ten or more involved axillary lymph nodes.

OBJECTIVE: The aim of this study was to evaluate the feasibility of a combination of epirubicin and paclitaxel followed by intravenous (iv) cyclophosphamide, methotrexate, and 5-fluorouracile (CMF) as adjuvant treatment of breast cancer patients with 10 or more metastatic axillary lymph nodes. METHODS: Forty-four patients entered this multicenter study and received 4 cycles of epirubicin (E 120 mg/m2 day 1, q3 weeks) and paclitaxel (T 135 mg/m2 day 1, q3 weeks), followed by 4 cycles of iv CMF (days 1 and 8, q4 weeks). Patients with positive hormonal receptors received sequentially tamoxifen associated with LH-RH analogue if premenopausal. The endpoints were the evaluation of the feasibility of this schedule and disease free survival (DFS). RESULTS: Median age of patients was 55; median number of positive axillary nodes was 14 (range, 10-47). Hormonal receptor status was positive in 57% of patients. The combination of epirubicin and paclitaxel was well tolerated; NCI grade 3/4 events were: leucopenia in 27% of patients, neutropenic fever in 5 patients, anemia in 7%, thrombocytopenia in 7%, nausea in 18%, vomiting in 14%, and neurotoxicity in 4%. CMF regimen caused a few cases of grade 3/4 hematologic toxicity. No cardiac toxicity was recorded. With a median follow-up of 59 months, 18 (41%) patients relapsed. Sites of relapse were mainly bone, skin/soft tissues, liver, and lung. Median DFS was 78 months, with a 5-year rate of 60%. CONCLUSIONS: The combination of paclitaxel at low dose and epirubicin followed by CMF is a feasible regimen, which seems to be effective in high-risk node positive breast cancer patients and requires further investigations.

Clinical benefit of gemcitabine-cisplatin in advanced non-small cell lung cancer elderly patients.

BACKGROUND: Cisplatin-based chemotherapy seems to improve the control of non-small cell lung cancer (NSCLC)-related symptoms, but assessment of symptomatic gain in these patients is often difficult. This study was designed to test a method for the assessment of clinical benefit in elderly advanced NSCLC patients, after weekly cisplatin-gemcitabine chemotherapy. PATIENTS AND METHODS: Evaluation of clinical benefit was the primary end-point. Clinical benefit derived from the evaluation of eight parameters: PS, cough, dyspnea, pain and hemoptysis were considered primary parameters. Weight loss, asthenia and anorexia were secondary parameters. RESULTS: Twenty-nine patients aged > 65 years, symptomatic at study entry, were enrolled. Responses were calculated according to the intent-to treat principle. Fifteen patients were considered as clinical benefit responders for an overall clinical benefit response rate of 52% (95% C.I. = 33.5% to 70%). The median duration of clinical benefit was 9 months (range 2-36). Tumour objective responses, according to WHO criteria, were 14, for an overall response rate of 48% (95% C.I. = 31% to 65%). Ten patients (34%) obtained both clinical benefit and tumour response. The median survival-time was 10 months (range 1-36). Chemotherapy was well-tolerated with low incidence of WHO grade III-IV toxicities. CONCLUSION: Evaluation of clinical benefit in advanced, symptomatic, elderly NSCLC patients is feasible and could be used together with tumor response and quality of life questionnaires to assess the efficacy of chemotherapy. It could reasonably be extended to non-elderly NSCLC patients. Our results suggest that weekly cisplatin-gemcitabine seems to be able to improve the principal NSCLC-related symptoms in elderly patients.