A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer: An Asian Gynecologic Oncology Group study

作者：Wang Chun Chieh; Chou Hung Hsueh; Yang Lan Yan; Lin Hao; Liou Wen Shiung; Tseng Chih Wen; Liu Feng Yuan; Liou Jui Der; Huang Kuan Gen; Huang Huei Jean; Huang Eng Yen; Chen Chien Hsun; Chang Ting Chang; Chang Chee Jen; Hong Ji Hong^*; Lai Chyong Huey

来源：Gynecologic Oncology, 2015, 137(3): 462-467.

DOI：10.1016/j.ygyno.2015.03.046

• Cervical cancer
• Squamous cell carcinoma
• Chemoradiotherapy
• Cisplatin
• Gemcitabine

Objective. A recent randomized trial demonstrated that concurrent chemoradiotherapy (CCRT) with weekly cisplatin and gemcitabine, followed by two adjuvant cycles of cisplatin and gemcitabine improved survival for advanced cervical cancer patients. An Asian Gynecologic Oncology Group (AGOG) study was designed to determine whether only adding gemcitabine in the chemoradiation phase without adjuvant chemotherapy could improve survival.
Methods. Between March 2009 and March 2013, 74 eligible patients with International Federation of Obstetrics and Gynecology stage III/IVA cervical cancer or stage I/II with positive pelvic/para-aortic nodal metastasis were enrolled. Thirty-seven patients were randomized to arm C (weekly cisplatin 40 mg/m(2)) and 37 patients were randomized to arm CG (weekly cisplatin 40 mg/m(2) and gemcitabine 125 mg/m(2)), for six cycles. Six eligible patients were excluded before the beginning of treatment.
Results. An interim analysis showed superimposable progression-free (PFS) and overall survival (OS), a decision of closing accrual was made. A 3-year PFS was similar in both arms (arm C 65.1% vs. arm CG 71.0%, p = 0.71), and a 3-year OS was 74.1% in arm C vs. 85.9% in arm CG (p = 0.89), but crossed over at 5 years. Grade 2-4 hematological toxicities, including neutropenia (p = 0.028) and thrombocytopenia (p = 0.001), were more frequent in arm CG than arm C.
Conclusions. Despite limitation in power, it suggests that only adding gemcitabine at the CCRT phase does not provide substantially superior results, but treatment toxicities could increase. Further studies are required to determine the role of post-CCRT adjuvant chemotherapy in advanced cervical cancer.

• 出版日期2015-6
• 单位长春大学