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S. Campos-Gomez
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-070 - Experience with Docetaxel plus Nintedanib with Previously Treated NSCLC Patients: Compassionate Use Program Single Institution in Mexico (ID 2604)
09:30 - 09:30 | Author(s): S. Campos-Gomez
- Abstract
Background:
Nintedanib is an oral, potent, tyrosine kinase inhibitor that simultaneously targets vascular endothelial growth factor receptors 1-3, platelet-derived growth factor receptors α and β, and fibroblast growth factor receptors 1-3, as well as FLT3 and Src. Currently, the molecule has proved benefit for second-line in non-small cell lung cancer patients. We report the results of a cohort of NSCLC patients receiving nintedanib within a compassionate-use program (CUP) in México.
Methods:
Patients with advanced NSCLC progressing after one line of chemotherapy were enrolled. Eligible patients received docetaxel 75 mg/m(2) (day 1) plus nintedanib 200 mg twice daily; days 2-21) in 21-day cycles. Data collection was monitored. Treatment continued until disease progression or unacceptable drug-related AEs. The intention of this CUP was to provide controlled access to nintedanib
Results:
From February 2014 to April 2015, 17 patients (63% male; median age: 61 years [range: 29-83 years]) were enrolled. Patients received nintedanib 200 mg BID (n=16). The primary analysis was done after a median follow-up of 7 months; the median overall survival was 42 months (33-52 weeks). Grade 3 or worse febrile neutropenia developed in eight patients (31 %) and neutropenia in four patients (15 %). The most frequent drug-related adverse events (all grades) were diarrhea (30%), asthenia (61.9%), nausea (23%), hand-foot syndrome (15%), and vomiting (7.6%). Drug-related adverse events all grades included neutropenia (12.5%), fatigue (18.7%), decreased appetite (18.7%), and elevations in alanine aminotransferase (37.5%) and aspartate aminotransferase (31.2%). Dose-limiting toxicities (all grade 3 hepatic enzyme elevations) occurred only in 2/16 patients (12.5%). All hepatic enzyme elevations were reversible and manageable with dose reduction. Among 16 evaluable patients, 13 (81.25%) had a partial response and 3 (18.75%) had stable disease by Response Evaluation Criteria In Solid Tumours criteria. Three of all patients died of events unrelated to disease progression; the most common of these events were sepsis and pneumonia.
Conclusion:
Based on cohort result, treatment with second-line nintedanib combined with docetaxel was well tolerated and showed efficacy in Mexican patients with advanced non-small-cell lung cancer.
