The randomised, multicentre, open-label, phase II RENO trial was conducted with the objective of establishing a standard chemotherapy regimen in the setting of chemo-radiotherapy of locally advanced NSCLC. A total of 134 patients with inoperable stage III NSCLC received either oral vinorelbine plus cisplatin or etoposide plus cisplatin.
Although the analysis revealed no differences regarding both PFS (primary endpoint; 11.4 vs. 11.8 months with vinorelbine and etoposide, respectively) and response (ORR, 64 % vs. 66.7 %, respectively), vinorelbine showed a better safety profile. Grade-3/4 events were significantly reduced in the vinorelbine arm (19.7 % vs. 62.6 %; p < 0.001) due to higher tolerability with regard to both haematological and non-haematological events. The latter included oesophagitis, pneumonia, and sepsis. The RENO trial is currently maturing to assess the impact of these regimens on overall survival.
- Provencio M et al., Randomized phase II trial (RENO): efficacy results of oral vinorelbine or etoposide combined with cisplatin in chemo-radiotherapy treatment of locally advanced NSCLC (LA-NSCLC). SLCG 10/02. J Clin Oncol 34, 2016 (suppl; abstr 8538)