4CPS-124 Effectiveness of maintenance therapy with oral vinorelbine for non-small-cell lung cancer

Background Combination of platinum with a third-generation agent, usually vinorelbine, is considered the standard first line in non-small-cell lung cancer (NSCLC). Purpose To analyse overall survival (OS) and progression-free survival (PFS) of maintenance therapy with oral vinorelbine after induction therapy with platinum plus vinorelbine (P/V) in patients with advanced or metastasic NSCLC. Material and methods Observational retrospective study that included patients who received maintenance therapy with oral vinorelbine, after an induction therapy with P/V from January 2011 to March 2017. Variables included were: sex, age, tumour histology, date of start and end of maintenance therapy, number of cycles of vinorelbine, progression date and death date. Data were obtained from clinic electronic history Cerner Millennium. The Kaplan-Meier method was used to analyse PFS and OS. We used STATA 14 ® for all statistical analyses. Results We included 56 patients, 47 males and nine females with a mean age of 61.3 years (range 40.3–76.9): 66.1% were diagnosed with adenocarcinoma, 30.4% squamous cell carcinoma and 3.6% large-cell carcinoma. Cisplatin-vinorelbine was the most used therapy (n=44), 10 patients received carboplatin-vinorelbine and two patients changed from cisplatin to carboplatin because of renal toxicity. The medium cycles of P/V was 4.4 (range 3–7) and the medium cycles of vinorelbine in maintenance was 4.2 (range 1–23). As of 30 April 2017 (data cut-off date), only four patients were still receiving maintenance treatment with oral vinorelbine. The median PFS measured from starting maintenance therapy was 2.6 months (95% CI: 1.9 to 3.0) and median OS was 11 months (95% CI: 7.4 to 14.4). The median PFS according to tumour histology was 2.2 months and 3 months in adenocarcinoma and squamous cell carcinoma, respectively. There were no statistically significant differences between both histologies (p=0.11). Conclusion Maintenance therapy with oral vinorelbine does not seem to provide advantages in PFS or OS compared to results found in the placebo group in the Paramount Trial (PFS and OS of 2.6 and 11 months, respectively). Our results are consistent with other non-comparative studies which evaluate maintenance therapy with vinorelbine. To confirm these results, further studies comparing maintenance with oral vinorelbine versus placebo in NSCLC are required. References and/or Acknowledgements 1. Paz-Ares L, et al. Lancet Oncol2012Mar;13(3):247–55. 2. Farhat FS, et al. Cancer Chemother Pharmacol2015Aug;76(2):235–42. 3. Bennouna J, et al. Clin Lung Cancer2014Jul;15(4):258–65. No conflict of interest