Randomized phase II study of capecitabine plus cisplatin with or without sorafenib in patients with metastatic gastric cancer (STARGATE)open access
- Authors
- Ryu, Min-Hee; Lee, Kyung Hee; Shen, Lin; Yeh, Kun-Huei; Yoo, Changhoon; Hong, Young Seon; Park, Young Iee; Yang, Sung Hyun; Shin, Dong Bok; Zang, Dae Young; Kang, Won Ki; Chung, Ik-Joo; Kim, Yeul Hong; Ryoo, Baek-Yeol; Nam, Byung-Ho; Park, Young Soo; Kang, Yoon-Koo
- Issue Date
- Apr-2023
- Publisher
- John Wiley and Sons Ltd
- Keywords
- capecitabine; chemotherapy; cisplatin; gastric cancer; sorafenib; VEGF
- Citation
- Cancer Medicine, v.12, no.7, pp 7784 - 7794
- Pages
- 11
- Indexed
- SCIE
SCOPUS
- Journal Title
- Cancer Medicine
- Volume
- 12
- Number
- 7
- Start Page
- 7784
- End Page
- 7794
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/62017
- DOI
- 10.1002/cam4.5536
- ISSN
- 2045-7634
2045-7634
- Abstract
- Background
In this randomized phase II study, we evaluated the efficacy and safety of sorafenib in combination with capecitabine and cisplatin (XP) as first-line chemotherapy in advanced gastric cancer.
Patients and Methods
Patients with metastatic gastric or gastroesophageal junction adenocarcinoma were randomized (1:1) to receive either sorafenib plus XP (S + XP) or XP alone. In cases of disease progression in the XP arm, crossover to sorafenib alone was allowed. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), response rates, safety profiles, and biomarkers, and the response rates and PFS with secondline sorafenib alone after progression in the XP arm.
Results
Between Jan 2011 and Feb 2013, a total of 195 patients were accrued (97 in the S + XP arm and 98 in the XP alone arm). The overall response rate was 54% with S + XP, and 52% with XP alone (p = 0.83). With a median follow-up of 12.6 months (range, 0.1–29.2), the median PFS assessed by independent review was 5.6 months in the S + XP arm and 5.3 months in the XP arm (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.67–1.27, p = 0.61). Overall survival was not different between the two arms (median 11.7 vs. 10.8 months; HR 0.93, 95% CI 0.65–1.31, p = 0.66). Frequencies of grade 3/4 toxicities were similar between the S + XP and XP alone arms, except for neutropenia (21% vs. 37%), anorexia (0% vs. 5%), and hand-foot skin reaction (7% vs. 1%). Among 51 patients who crossed over to sorafenib alone after disease progression in the XP arm, there was no objective response and their median PFS was 1.3 months (95% CI, 1.2–1.7).
Conclusion
The addition of sorafenib to XP chemotherapy was safe but not more effective than XP alone for first-line treatment of metastatic gastric cancer.
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Collections - 2. Clinical Science > Department of Medical Oncology and Hematology > 1. Journal Articles
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