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Neoadjuvant Gefitinib For Stage Ii-Iiia Nsclc With Activating Egfr Mutation (Nct01833572): An Open-Label, Single-Arm, Phase Ii Study.

JOURNAL OF CLINICAL ONCOLOGY(2016)

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摘要
e20026 Background: This a single arm open label trial is to explore the efficacy and safety of gefitinib as neoadjuvant treatment in stage II-IIIA NSCLC patients with activating EGFR mutation. Methods: Previously untreated patients with clinically or histologically confirmed stage II-IIIA NSCLC harboring activating EGFR mutation in exon 19 or 21 were recruited to receive gefitinib 250mg orally per day for 42 days during the neoadjuvant period. Tumour responses assessments were performed at day 0, day 21 and day 42. Patients receiving benefit (CR, PR or SD) from gefitinib and were evaluated to be resectable would receive surgery. The primary endpoint is objective response rate (ORR). The secondary endpoints included pathologic response rate, radical resection rate, disease free survival (DFS), overall survival (OS), safety and quality of life (QoL). Clinical trial identification: (NCT01833572) Results: From 12th Jul 2013 to 8th Dec 2015, 204 II-IIIA NSCLC patients were screened, 36 patients with EGFR mutation were enrolled (1 patient withdrawn and 4 patients were ineligible). Data of 31 patients was analyzed on 15th Jan, 2016 (Table 1). After gefitinib treatment, ORR was 51.6% (16/31), DCR was 100% (31/31). 29 patients underwent resection surgery and 2 patients didn’t receive surgery (1 patient refusal and 1 patient was not suitable for surgery) . Radical resection rate was 75.9% (22/29). DFS and OS data are immature. 19 patients had rash (grade I-II) and 11 patients had diarrhea (grade I) during gefitinib treatment. Conclusions: Gefitinib as neoadjuvant therapy is a efficacious treatment for EGFR mutant II-IIIA NSCLC patients alongside a tolerable safety profile.. Clinical trial information: NCT01833572.
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关键词
Neoadjuvant Chemotherapy,EGFR Mutations
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