기관고유연구사업결과보고
작성요령
2001 ~ 2004 2005 ~ 2007 2008 ~ 2010 2001 ~ 2004 2005 ~ 2007 2008 ~ 2010 1 2/3 2 1 0 2 3 52 0 31 83 12 6 3 21 593 404 304 1,301 4 3 1 8 159 191 116 466 6 11 (`1: (1: 16 33 44 106 161 311 1) 1) 0 4 4 8 0 248 19 267 23 24 26 73 848 949 631 2,428
연구수행명 번호 승인일등재시작일등재완료일 제목 실제 목표환자수 명 비고
연구수행명 번호 승인일등재시작일등재완료일 등재중 제목 andomized phase II study of irinotecan/cisplatin versus gemcitabine/ cisplatin as the first-line therapy followed by two different sequences of pemetrexed or docetaxel as the second 실제 목표환자수 명 비고 등재진행중
연구수행명 번호 승인일등재시작일등재완료일 제목 실제 목표환자수 명 비고
연구수행명 번호 승인일등재시작일등재완료일 제목 실제 목표환자수 명 비고
First-SIGNAL: A Randomized Phase III Study of Gefitinib IRESSA TM ) versus Standard Chemotherapy (Gemcitabine plus Cisplatin) as a First-line Treatment for Never-smokers with Advanced or Metastatic Adenocarcinoma of the Lung (NCC-126) Background: Gefitinib has shown high response rate and extended survival in never smoker lung adenocarcinoma patients. A randomized phase III trial was conducted to compare the efficacy of gefitinib as a first-line treatment with standard chemotherapy in this patient population. (ClinicalTrials.gov, NCT00455936) Methods: From Oct 2005 to Nov 2007, a total of 313 never-smokers with chemonaïve stage IIIB/IV lung adenocarcinoma, ECOG PS 0-2 and adequate organ functions were randomly assigned to receive either gefitinib (250 mg/p.o. daily) or GP chemotherapy (G: Gemcitabine 1,250 mg/m 2 onday1&8; P: Cisplatin 80 mg/m 2 onday1every3weeks, up to 9 courses). Primary endpoint was overall survival (OS); secondary endpoints were objective response rate (ORR), progression-free survival (PFS), and toxicity. After initial disease progression, further treatment was at the discretion of the treating physicians. Results: Of 309 patients who received actual treatment, 88.7% were female, 90.0% had stage IV disease, and 9.1% had PS2, with no difference between the two arms. The median(range) was 57(19-74) years. The gefitinib arm had a numerically higher ORR than the GP arm (85/159 [53.5%] vs. 63/150 [42.0%], p=0.0811) and significantly better PFS (HR=0.737 [95% CI, 0.580-0.938], p=0.0063 by log-rank test) with the median of 5.9 vs. 5.8 months (mo) while the curve crosses over around the median time. This crossing-over of the PFS curve was in part due to the difference in PFS by the EGFR mutation status. In the gefitinib arm with known EGFR mutation status, the PFS was significantly shorter in the mutation-negative subgroup (N=26) than the mutation-positive subgroup (N=27) with median of 2.1 vs. 7.9 mo (HR=0.385 [95% CI, 0.208-0.711], p=0.0090) while there was no such difference in the GP arm (median 5.5 vs. 5.8 mo; HR=1.223 [95% CI, 0.650-2.305], p=0.2657) OS was similar between the two arms (HR=1.029 [95% CI, 0.756-1.401], p=0.4278 by log-rank test). The median and 1-year survival rate were 20.3 mo and 73.7% for the gefitinib arm, and 23.1 mo and 76.2% for the GP arm, respectively. Of note, 121 (80.7%) of the 150 GP arm patients received EGFR-TKI during their disease course. Grade 3/4 toxicity was less common in the gefitinib arm (28.3% vs. 67.3%, p<0.0001) while no unusual toxicity was noted in both
arms. Conclusion: While gefitinib did not improve OS over the standard GP chemotherapy, unprecedented survival outcome along with high ORR and better toxicity profile suggests that gefitinib might be a reasonable first-line therapy for this group of never smoker lung adenocarcinoma patients.
Cancer (4.632)