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First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study.
- Source :
-
Annals of Oncology . Oct2017, Vol. 28 Issue 10, p2443-2450. 8p. 1 Diagram, 2 Charts, 2 Graphs. - Publication Year :
- 2017
-
Abstract
- Background: Icotinib has been previously shown to be non-inferior to gefitinib in non-selected advanced non-small-cell lung cancer patients when given as second-or further-line treatment. In this open-label, randomized, phase 3 CONVINCE trial, we assessed the efficacy and safety of first-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutation. Patients and methods: Eligible participants were adults with stage IIIB/IV lung adenocarcinoma and exon 19/21 EGFR mutations. Participants were randomly allocated (1 : 1) to receive oral icotinib or 3-week cycle of cisplatin plus pemetrexed for up to four cycles; non-progressive patients after four cycles were maintained with pemetrexed until disease progression or intolerable toxicity. The primary end point was progression-free survival (PFS) assessed by independent response evaluation committee. Other end points included overall survival (OS) and safety. Results: Between January 2013 and August 2014, 296 patients were randomized and 285 patients were treated (148 to icotinib, 137 to chemotherapy). Independent response evaluation committee-assessed PFS was significantly longer in the icotinib group (11.2 versus 7.9months; hazard ratio, 0.61, 95% confidence interval 0.43-0.87; P=0.006). No significant difference for OS was observed between treatments in the overall population or in EGFR-mutated subgroups (exon 19 Del/21 L858R). The most common grade 3 or 4 adverse events (AEs) in the icotinib group were rash (14.8%) and diarrhea (7.4%), compared with nausea (45.9%), vomiting (29.2%) and neutropenia (10.9%) in the chemotherapy group. AEs (79.1% versus 94.2%; P<0.001) and treatment-related AEs (54.1% versus 90.5%; P<0.001) were significantly fewer in the icotinib group than in the chemotherapy group. Conclusions: First-line icotinib significantly improves PFS of advanced lung adenocarcinoma patients with EGFR mutation with a tolerable and manageable safety profile. Icotinib should be considered as a first-line treatment for this patient population. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 09237534
- Volume :
- 28
- Issue :
- 10
- Database :
- Academic Search Index
- Journal :
- Annals of Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 125448400
- Full Text :
- https://doi.org/10.1093/annonc/mdx359