A randomised, multicentre open-label phase II study to evaluate the efficacy, tolerability and pharmacokinetics of oral vinorelbine plus cisplatin versus intravenous vinorelbine plus cisplatin in Chinese patients with chemotherapy-naive unresectable or metastatic non-small cell lung cancer

Yunpeng Yang, Jianhua Chang, Cheng Huang, Yiping Zhang, Jie Wang, Yongqian Shu, Jean Philippe Burillon, Marcello Riggi, Aurélie Petain, Pierre Ferre, Ying Liang, Li Zhang

Abstract

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.