A phase II study of cisplatin and vinorelbine in patients with metastatic breast cancer.

BACKGROUND: To evaluate the efficacy and safety of the combination of cisplatin and vinorelbine in metastatic breast cancer. PATIENTS AND METHODS: Cisplatin (80 mg/m(2) day 1) and vinorelbine (25 mg/m(2) days 1 and 8) were administrated every 3 weeks to 52 patients (mean age 57 years; range 35-75 years) with metastatic breast cancer. Thirty-two patients were previously untreated for metastatic disease. Treatment was repeated for a maximum of six cycles. RESULTS: Objective responses were obtained in 27 patients (52.9%; complete response 9.8%). The response rate was similar in pretreated and untreated patients (50% and 54.7%, respectively; P = 0.7). ECOG performance status was good (grade 0 or 1) in 55.7% of patients at baseline assessment and in 90.3% at the end of treatment (P = 0.0001). Median time to progression was 8.5 months (8.5 months in first-line and 8.7 months in second-line patients). Median survival was 16.6 months (21.2 months in first-line and 16.1 months in second-line patients). Grade 3/4 toxicity included neutropenia (44% in first-line, 60% in second-line patients), nausea (17.3%), anemia (17%), asthenia (3.8%) and thrombocytopenia (1.9%). There were no cases of febrile neutropenia or treatment-related deaths. Alopecia did not develop in any of the patients. CONCLUSIONS: Cisplatin plus vinorelbine is active and tolerable in metastatic breast cancer, in untreated and pretreated patients.

The combination of metoclopramide, methylprednisolone and ondansetron against antiblastic-delayed emesis: a randomised phase II study.

The aim of the study was to verify whether the combination of an antiserotoninergic, metoclopramide, and a steroid could improve the complete control (CC) of delayed emesis, a contraversial issue, 105 patients undergoing highly-emetogenic chemotherapy, receiving Ondansetron (O) 8 mg + Dexamethasone 20 mg i.v. for the prevention of acute emesis, were randomly treated p.o for three further days with a) Metoclopramide 10 mg x 3 b) the same as a) + Methylprednisolone 4 mg c) the same as b) + O 8 mg x 3. CC (acute+delayed emesis) over three cycles was: a) 0.b) 12.5%, c) 38.5% (p = 0.02). Days with nausea/vomiting: 59%, 51%, 29.7% of the total observed period, respectively (b vs c p = 0.0000). CC of acute emesis was similar in the first cycle (about 85%), remained unchanged in the following cycles (c) and decreased to 30% and 68% in the third cycle (a and b) (p = 0.01). The three drug combination significantly improved complete control of acute and delayed emesis over successive chemotherapy cycles.

[Effectiveness of sequential administration of G-CSF and GM-CSF after antineoplastic chemotherapy in patients with advanced tumors: results of a randomized trial]. / Efficacia della somministrazione sequenziale di G-CSF e GM-CSF dopo chemioterapia antitumorale in pazienti in fase avanzata: risultati di uno studio randomizzato.

Recent in vitro data have shown that growth factors are more effective when used in combination. This synergy between cytokines, when translated in a clinical setting, should permit a reduction of dosage, and therefore of toxicity. We sought to determine whether the sequential administration of low doses of G-CSF followed by low doses of GM-CSF could be effective both in protecting from neutropenia, and in reducing side effects. A randomized single blind phase III study was carried out. Patients considered to be eligible for the study were designated to receive a minimum of 3 chemotherapy cycles for treatment of metastatic or locally advanced cancer. Patients were randomized to receive, from the 8th day to the 13th day of cycle, G-CSF, 2.5 micrograms/kg/day s.c., or G-CSF, 2.5 micrograms/kg/day s.c. for the first 3 days, followed by GM-CSF, 2.5 micrograms/kg/day s.c. for the last 3 days. The number of delays in relation to the number of cycles, the number of patients whose therapies were deferred, and the total number of days of delay in relation to the total number of days of observation were significantly different, with far fewer delays in the group treated with the G-GM sequence. Our study confirms that the sequential administration of G-CSF and GM-CSF is highly synergistic. This synergy allows clinicians to administer chemotherapy treatments to pre-treated and/or elderly patients, with minimal risk of toxicity and no need for delays or dosage reduction.