Phase II study of IV Vinflunine (VFL) as second line treatment of patients (pts) with advanced non-small-cell lung cancer (NSCLC) previously treated with a platinum based regimen. Final results

Abstract

7139 Background: Pts with NSCLC who progress on or after 1st line therapy but continue to have a good performance status (PS) may be offered 2nd line chemotherapy. VFL (Javlor) is a novel fluorinated vinca-alkaloid derivative synthesised using superacidic chemistry which has shown high activity in experimental tumour models. Methods: The aim of this trial was to determine the response rate and safety of VFL (320 mg/m2 q 3 weeks) as a single agent in pts with advanced NSCLC, who failed to a previous platinum-based regimen. Results: Sixty-three pts have been treated, 47 males, 16 females, median (m) age 60 years; Karnofsky PS 100 %: 14 pts, 90 %: 21 pts and 80 %: 28 pts. Prior platinum combinations included taxanes (31 % pts), vincas (31 % pts) and other (38 % pts). The total number of cycles administered was 221 (m: 5 [1 - 9]). Of the 62 evaluable pts, 38 (61 %, [95 % CI: 49–73 %]) achieved disease control: 5 pts (8 %, [95 % CI: 1–15 %]) partial response (independent radiological review) lasting 5.8 months (mo) [95 % CI: 4.6–7.9] and 33 pts (53 %, [95 % CI: 41–66 %]) stabilisation. Progression free survival (PFS) was established at 2.6 mo [95 % CI: 1.4–3.8]. In terms of tolerance, grade (G) 3/4 neutropenia was observed in 15.8 % of cycles (25.4 % of pts) and 10.4 % cycles (23.8 % of pts) respectively; G3 anaemia and thrombocytopenia were rare. Two pts suffered from febrile neutropenia and 2 other from neutropenic infection. G ≥3 non-haematological toxicities observed were: myalgia 5 % cycles (15.9 % of pts), fatigue 1.9 % cycles (6.4 % of pts), stomatitis 1.4 % cycles (4.8 % of pts); constipation was present in 2.3 % cycles (7.9 % of pts), abdominal pain and arthralgia were observed in 1.4 % cycles (4.8 % of pts). Neither grade G3/4 peripheral neuropathy nor phlebitis was observed. Conclusions: In NSCLC patients previously treated with platinum containing regimens VFL achieved encouraging efficacy in terms of disease control and PFS. Toxicity was manageable and reversible. Based on these results a phase III is currently ongoing. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Institut de Recherche Pierre Fabre (IRPF), France