RESUMO
BACKGROUND: A phase II study to evaluate the efficacy, tolerability and pharmacokinetics of oral or intravenous vinorelbine (VRL) plus cisplatin (CDDP) in Chinese patients with non-small cell lung cancer (NSCLC). METHODS: One hundred and thirty-one patients were randomised to oral VRL 60 mg/m2 (arm A) or intravenous VRL 25 mg/m2 (arm B) on days 1 and 8, plus CDDP 80 mg/m2 on day 1 (both arms). VRL was increased to 80 mg/m2 (arm A) or 30 mg/m2 (arm B) in cycles 2-4 in the absence of toxicity. Primary efficacy endpoint was objective response rate (ORR). VRL pharmacokinetics was evaluated for possible drug-drug interactions with CDDP. RESULTS: ORR was 25.8% in arm A and 23.1% in arm B. Disease control rate was 72.7% in arm A, 72.3% in arm B. Median overall survival was 16.1 months in arm A and 19.0 months in arm B. Median progression-free survival was 4.6 months in arm A and 4.9 months in arm B. Forty-three point nine percent and 86.2% of patients had grade 3/4 neutropenia in arms A and B, respectively; incidence of febrile neutropenia was low (6.1% and 9.2%, respectively). Frequency of grade 3/4 non-haematological adverse events was also low. VRL pharmacokinetics was not affected by co-administration of CDDP. CONCLUSIONS: Oral and intravenous VRL in combination with CDDP is effective and well-tolerated in Chinese patients with advanced NSCLC. VRL pharmacokinetics is unaffected by CDDP co-administration. Oral VRL could be an effective alternative to intravenous VRL as a first-line treatment for NSCLC, as it optimises treatment convenience while maintaining high efficacy.
RESUMO
BACKGROUND: This phase II trial was performed to assess the activity and safety of the cisplatin and vinorelbine combination in patients with advanced cervical carcinoma. PATIENTS AND METHODS: Forty-two patients with advanced cervical cancer were included in the study to receive vinorelbine at 30 mg/m2 on d 1 and d 8 and cisplatin 100 mg/m2 on day 1 every 4 weeks. RESULTS: Thirty-seven patients were evaluable for response and 40 patients for tolerance. Twenty-four patients (64.8%) achieved objective responses. The median duration of response was 17.5 months (range 2.5-57 months), median time to progression was 13.2 months (range 0.4-57 months) and median survival was 20.6 months (range 0.4-55 months). This regimen was well-tolerated; no WHO grade 4 neutropenia was observed, grade 3 nausea and vomiting occured in 50% of patients and grade 2 peripheral neuropathy in 5% of patients. CONCLUSION: Vinorelbine-cisplatin is an active and well-tolerated regimen in advanced cervical carcinoma.
