In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. 9003-9003
Kurzfassung:
9003 Background: Two continuous maintenance therapies, “Pem after Pem+Platinum” and “Bev after Bev+Plt-doublet”, demonstrated the prolongation of survival for advanced nSQ-NSCLC. We conducted a randomized trial of Bev versus Bev+Pem as continuation maintenance therapy after Car+Pem+Bev induction therapy. Methods: Patients were eligible if they had previously untreated advanced nSQ-NSCLC whose EGFR status was either wild-type, unknown, or other than Del19 or L858R. They received the induction treatment with Car (AUC6), Pem (500 mg/m 2 ), and Bev (15mg/kg) every 3 weeks for 4 cycles. Those who showed no progression during the induction therapy were randomized to receive maintenance therapy using Bev or Bev+Pem in a 1:1 ratio. The primary endpoint was overall survival (OS) from randomization. The planned sample size was 620 to provide a power of 85% at one-sided significance level of 5%. Violations found at a study site led us to conduct source document verification for 95.4% of patients to assure data quality. (Trial Identifier, UMIN000004194). Results: Between September 2010 and September 2015, 907 patients had the induction therapy. Of those, 621 patients were randomized; five did not receive study treatment and 22 did not meet the eligibility criteria. Among 594 patients for evaluable (299 in the Bev+Pem arm and 295 in the Bev arm), median age was 65 years; Male, 72%; PS 0/1, 60/40%; Stage IV, 83%; EGFR status, wild-type/others, 91/7%. Median OS was 23.3 vs 19.6 months (mo) with a hazard ratio (HR) of 0.87 (95%CI, 0.72-1.04) and one-sided logrank P= 0.069; in patients with wild-type EGFR tumor, HR for OS was 0.82 (0.68-0.99). Median progression-free survival was 5.7 vs 4.0 mo with a HR of 0.67 (0.57-0.79). 87.4% of patients received subsequent therapy. No new safety signals were observed. Conclusions: The primary analysis was not met. However, the incorporation of Pem significantly prolonged OS in patients with wild-type EGFR. Clinical trial information: UMIN000004194.
Materialart:
Online-Ressource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2019.37.15_suppl.9003
Sprache:
Englisch
Verlag:
American Society of Clinical Oncology (ASCO)
Publikationsdatum:
2019
ZDB Id:
2005181-5
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