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

doi:10.21037/jtd.2019.08.22

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

J Thorac Dis. 2019 Aug;11(8):3347-3359. doi: 10.21037/jtd.2019.08.22.

Authors

Yunpeng Yang¹, Jianhua Chang², Cheng Huang³, Yiping Zhang⁴, Jie Wang⁵, Yongqian Shu⁶, Jean Philippe Burillon⁷, Marcello Riggi⁷, Aurélie Petain⁸, Pierre Ferre⁸, Ying Liang¹, Li Zhang¹

Affiliations

¹ Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
² Fudan University Shanghai Cancer Center, Shanghai 200032, China.
³ Fujian Provincial Tumor Hospital, Fuzhou 350014, China.
⁴ Zhejiang Cancer Hospital, Hangzhou 310022, China.
⁵ Beijing Cancer Hospital, Beijing 100035, China.
⁶ Jiangsu Provincial People's Hospital, Nanjing 210029, China.
⁷ Institut de Recherche Pierre Fabre, Boulogne, France.
⁸ Institut de Recherche Pierre Fabre, Toulouse, France.

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.

Keywords: Chinese patients; Non-small cell lung cancer (NSCLC); cisplatin (CDDP); intravenous vinorelbine (intravenous VRL); oral vinorelbine (oral VRL).