Abstract 56P
Background
Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. Vinorelbine (VNR) is an established treatment for advanced NSCLC, both as a single agent and in combination with platin chemotherapy. Four previous phase II, open-label clinical trials evaluated the efficacy and safety of oral VNR as monotherapy in NSCLC patients. Here, we aim to assess the efficacy and safety of oral VNR using pooled data.
Methods
This analysis included individual data of 4 phase II, open-label trials, focusing only on patients receiving oral VNR as monotherapy administered as standard weekly doses administration. Patients received VNR at the dose of 60 mg/m² weekly at cycle 1 (3weeks per cycle), followed by an increase to 80 mg/m² weekly for the subsequent cycles, until disease progression or toxicity. Main outcomes were overall response rate [ORR], disease control rate [DCR], progressive free survival [PFS] and overall survival [OS]), and tolerance.
Results
A total of 247 patients were included, and 244 were treated. The patient characteristics were: 75.7% of male patients, 81.4% of them had a stage IV, and 37.2% had squamous histology. The ECOG PS (Eastern Cooperative Oncology Group Performance Status) was 0, 1, ≥2, in respectively 40.9%, 45.7%, and 12.6% of patients. There were 108 patients (43.7%) with ≥ 3 organs involved. Overall, 243 patients received oral VNR for a total of 1176 cycles, representing a median number of 4 cycles per patient, and 73% of patients had dose escalation at cycle 2. ORR was 8.9% (95% confidence intervals [CI]: 5.7; 13.2), DCR was 57.5% (95% CI: 51.1; 63.7), median PFS and OS were 3.3 (95% CI: 2.8; 4.0) and 8.5 (95% CI: 7.6; 10.3) months, respectively.
Conclusions
This pooled analysis showed that weekly oral VNR dosing was a valid option in this population of patients with advanced or metastatic NSCLC, confirming the results from previous studies. Safety analysis will be presented at the meeting.
Clinical trial identification
Two of the studies used in this analysis do not have official designation CT (old studies). TEMPO LUNG, with European trial protocol number EudraCT 2014-003859-61. And the last trial used had European trial protocol number EudraCT 2012-003361-18.
Editorial acknowledgement
An editorial assistance in the writing of the abstract was provided by Keyrus Life Science and funded by Pierre Fabre.
Legal entity responsible for the study
Pierre Fabre Médicament.
Funding
Pierre Fabre Médicament.
Disclosure
C. Chouaid: Financial Interests, Personal and Institutional, Training: AstraZeneca, Boehringer Ingelheim, Clovis, GlaxoSmithKline, Hoffmann La Roche, GSK, Eli Lilly, Pfizer, BMS, MSD, Novartis, Accord Healthcare, Sandoz, Janssen, Takeda, Sanofi, Pierre Fabre and Amgen; Financial Interests, Personal and Institutional, Expert Testimony: AstraZeneca, Boehringer Ingelheim, Clovis, GlaxoSmithKline, Hoffmann La Roche, GSK, Eli Lilly, Pfizer, BMS, MSD, Novartis, Accord Healthcare, Sandoz, Janssen, Takeda, Sanofi, Pierre Fabre and Amgen; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Clovis, GlaxoSmithKline, Hoffmann La Roche, GSK, Eli Lilly, Pfizer, BMS, MSD, Novartis, Accord Healthcare, Sandoz, Janssen, Takeda, Sanofi, Pierre Fabre and Amgen; Financial Interests, Personal and Institutional, Advisory Role: AstraZeneca, Boehringer Ingelheim, Clovis, GlaxoSmithKline, Hoffmann La Roche, GSK, Eli Lilly, Pfizer, BMS, MSD, Novartis, Accord Healthcare, Sandoz, Janssen, Takeda, Sanofi, Pierre Fabre and Amgen; Financial Interests, Personal and Institutional, Other, Clinical research: AstraZeneca, Boehringer Ingelheim, Clovis, GlaxoSmithKline, Hoffmann La Roche, GSK, Eli Lilly, Pfizer, BMS, MSD, Novartis, Accord Healthcare, Sandoz, Janssen, Takeda, Sanofi, Pierre Fabre and Amgen. F. Grossi: Financial Interests, Personal and Institutional, Advisory Board: Eli Lilly, Roche, Boehringer Ingelheim, AstraZeneca, Pierre Fabre, BMS, MSD, Novartis, Merck, Otsuka, Novartis, Takeda, Bayer. C. Ta Thanh Minh: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre. R. Raymond: Financial Interests, Personal, Full or part-time Employment: Pierre Fabre. J. Bosch-Barrera: Financial Interests, Personal and Institutional, Research Grant: Pfizer; Financial Interests, Personal, Other, Outside the submitted work: Pfizer, MSD, BMS, AstraZeneca Boehringer Ingelheim, Vifor, Sanofi.