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V. Garcia Montes
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-032 - Multicenter Trial of Nintedanib in Combination with Docetaxel in Metastatic Lung Adenocarcinoma: Expertise in the Real-Life Setting (ID 6022)
14:30 - 14:30 | Author(s): V. Garcia Montes
- Abstract
Background:
In Mexico, 8,600 new cases of lung cancer are annually diagnosed, with 22 daily deaths.[1] Nintedanib is a multikinase inhibitor, acts as a potent oral anti-angiogenic blocking the vascular endothelial growth factor (VEGFR 1-3), the fibroblast growth factor receptor (FGFR 1-3) and the platelet-derived growth factor receptor (PGFR α y β). The LUME-Lung 1 trial showed an improvement with docetaxel + nintedanib in overall survival of patients with lung adenocarcinoma accomplished disease control in 60.2%.[4 ]
Methods:
We present a descriptive trial, with a clinical data collection of patients with advanced lung adenocarcinoma who progressed to a platinum-based, first-line treatment (+ bevacizumab), included in the compassionate-use program of nintedanib, carried out between March 2014 and September 2015 in 38 medical centers in Mexico. Treatment consisted in IV dose of docetaxel 75 mg/m[2 ]every 21 days, combined with oral nintedanib 200 mg/BID, administered from 2-21 days until maximum toxicity or disease progression. Primary Objective: Describe patients and tumors characteristics, including previous therapies. Secondary Objectives: Estimate the time under nintedanib treatment, response rate (measured by RECISTv1.1 criteria) and evaluate safety in daily clinical practice (by means of CTACAEv4 criteria). The SPSSv statistics software was used.
Results:
Ninety-nine patients were included. The median of age was 59 years old, 53% were male, 51.5% were smokers, 50% had ECOG 1, 96% stage IIIB and IV, 16% had controlled brain metastases, and 85% had access to a EGFR mutational test (11% out of them positive). First-line, platinum-based chemotherapy was given to 99% of the patients, 7% were administered first-line bevacizumab, 40% receive maintenance treatment, 50% had had partial response as the best response to first-line treatment. The objective response rate was 53%, stable disease 26.5%, disease progression 16.3%, non-evaluable 4% and disease control rate of 79.6%. The combination had an adequate tolerance, mostly toxicities grades 1-2. Toxicities grade 3-4 were mainly fatigue (14%), diarrhea (13%), hiporexia (7%), neutropenia (7%), nausea (6%), vomiting (1%). Nintedanib dose was reduced in 27 patients (27%). The median duration of the treatment with nintedanib was 6.7 months.
Conclusion:
Overestimated responses may be related to the retrospective desing of the study and due to that were valued by investigator wich could influence the results. The Safety of nintedanib in real-life patients was demostrated and not very different from the results in the LUME-Lung 1 trial. Gastrointestinal toxicity were the most frequent side effects, mostly toxicities grades 1-2.
