615O - Randomized phase II study of capecitabine and cisplatin with or without sorafenib in patients with metastatic gastric cancer: STARGATE study

Date 28 September 2014
Event ESMO 2014
Session Gastrointestinal tumours, non-colorectal
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Min Hee Ryu
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors Y. Kang1, K.H. Lee2, L. Shen3, K. Yeh4, Y. Hong5, Y.I. Park6, S.H. Yang7, D.B. Shin8, D.Y. Zang9, W.K. Kang10, I.J. Chung11, Y.H. Kim12, B. Ryoo13, S.R. Park1, B. Nam14, M.H. Ryu1
  • 1Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 2Department Of Hemato-oncology, Yeungnam University Hospital, Daegu/KR
  • 3Department Of Gi Oncology, Peking University School of Oncology, 100036 - Beijing/CN
  • 4Oncology Dept., National Taiwan University Hospital, TW-100 - Taipei/TW
  • 5Division Of Oncology, Department Of Internal Medicine, Seoul St. Mary's Hospital, 137-701 - Seoul/KR
  • 6Center For Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang/KR
  • 7Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, 139-706 - Seoul/KR
  • 8Internal Medicine, Hematology And Oncology, Gachon University Gil Medical Center, 405-760 - Incheon/KR
  • 9Clinical Research Division, Hallym University Medical Center Hallym University College of Medicine, 431-070 - Anyang/KR
  • 10Department Of Medicine, Samsung Medical Center, Seoul/KR
  • 11Medical Oncology, Chonnam National University Hwasun Hospital, KR-519-763 - Jeollanamdo/KR
  • 12Division Of Hemato-oncology, College of Medicine, Korea University, Anam Hospital, Seoul/KR
  • 13Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 14Biometric Research Branch, National Cancer Center, Goyang/KR

Abstract

Aim

Capecitabine and cisplatin (XP) combination chemotherapy is one of the standard 1st line regimens for the treatment of metastatic gastric cancer (MGC). Sorafenib is a multi-kinase inhibitor with activity against angiogenesis and RAF-MEK-ERK pathway. In this study, we aimed to evaluate the efficacy of sorafenib (S) in combination with XP as the 1st line chemotherapy in MGC.

Methods

This study was a randomized (1:1), open-label, phase II study. The patients (pts) with metastatic gastric or gastroesophageal junction adenocarcinoma with measurable lesion(s) were eligible. The primary endpoint was progression-free survival (PFS). XP + S consisted of capecitaine 800 mg/m2 po bid on days 1-14, cisplatin 60 mg/m2 iv on day 1, and sorafenib 400 mg po bid on days 1-21, every 3 weeks. XP consisted of capecitabine 1000 mg/m2 on days 1-14, and cisplatin 80 mg/m2 iv on day 1, every 3 weeks. XP was continued up to 8 cycles until disease progression or intolerance. Pts in XP arm were allowed to cross over to sorafenib alone when their diseases progressed.

Results

Between Jan 2011 and Feb 2013, a total of 195 pts were randomized from 12 sites in Korea, China and Taiwan. Median age was 56 years. All pts had ECOG performance status 0-1. 19% of pts had prior gastrectomy. Overall response rate was 54% in XP + S arm, and 52% in XP arm (p = 0.826). With a median follow-up of 12.6 months (range, 0.1-29.2), median PFS assessed by independent review was 5.6 months in XP + S arm, and 5.3 months in XP arm (HR 0.92, 95% CI 0.67-1.27, p = 0.609). OS was not different between the two arms (median 11.7 vs. 10.8 months; HR 0.93, 95% CI 0.65-1.31, p = 0.661). Frequencies of grade 3/4 toxicities were similar between XP + S and XP arms, except neutropenia (21% vs 37%), febrile neutropenia (2% vs 6%), and palmar-plantar erythrodysesthesia syndrome (7% vs 1%). In 51 pts who crossed over to sorafenib alone in XP arm, there was no objective response and the median PFS was 1.3 months (95% CI, 1.2-1.7).

Conclusions

The addition of sorafenib to XP chemotherapy was safe but not more effective than XP chemotherapy alone for the 1st line treatment of MGC. Biomarker analyses are now ongoing to identify potential patients who can get benefit with XP + S.

Disclosure

Y. Kang: Honorarium, consultant for Bayer, Roche Research grant from Bayer, Roche. All other authors have declared no conflicts of interest.