GOG 169:CISPLATIN VS CISPLATIN + PACLITAXEL IN SQUAMOUS CELL CARCINOM

GOG 169：鳞状细胞癌中顺铂与顺铂紫杉醇的比较

• 批准号: 6265791
• 负责人: PATRICIA S BRALY
• 金额: $ 1.12万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-07-19 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265791
• 关键词: antineoplastics; cervix neoplasms; cis platinum compound; clinical research; combination chemotherapy; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; paclitaxel; squamous cell carcinoma

For patients with advanced, persistent or recurrent squamous cell carcinoma of the cervix no longer amenable to surgical resection or radiation therapy, the prognosis is bleak. The need for effective chemotherapy in this clinical setting is well-organized, and optimal treatment has yet to be defined. For a number of years, cisplatin has been considered the most active drug against cervical cancer with initial response rates as high as 50%. The GOG conducted a study of cisplatin at three dose schedules to see if improved results could be achieved through increased dose intensity. Although the response rate increased from 21% to 31% with an increase in dose from 50 mg/m2 to 100 mg/m2 every three weeks, there was no associated improvement in the complete response rate, progression-free interval, or survival. The impact of single-agent cisplatin chemotherapy on overall survival is debatable. Paclitaxel is a diterpenoid compound extracted from the bark of the Pacific yew and its cytotoxicity is believed to be exerted via stabilization of tubulin polymer bundles, thus interfering with microtubular assembly and cell replication. It has demonstrated broad activity against a number of solid tumors, including cancers of the ovary, breast and endometrium. The GOG reported a 17% response rate for Paclitaxel against advanced squamous cell carcinoma of the cervix. The combination of cisplatin and Paclitaxel has been effectively used against a number of malignancies and is presently undergoing investigation against various squamous cell cancers, including cervical cancer. The present study will determine if the combination of cisplatin plus Paclitaxel improves the response rate, progression-free interval, and/or survival in advanced squamous cervical cancer compared to treatment with cisplatin alone. Furthermore, in a clinical setting where standard treatment may be viewed as palliative in nature, the study will assess differences in the two arms with respect to toxicity and/or quality of life.

对于晚期、持续性或复发性宫颈鳞状细胞癌患者，不再适合手术切除或放射治疗，预后黯淡。在这种临床环境中，需要有效的化疗是有组织的，最佳治疗尚未确定。多年来，顺铂一直被认为是治疗宫颈癌最有效的药物，其初始缓解率高达50%。GOG对三种剂量方案的顺铂进行了一项研究，以观察是否可以通过增加剂量强度来改善结果。虽然每三周将剂量从50mg /m2增加到100mg /m2，反应率从21%增加到31%，但完全缓解率、无进展时间间隔或生存期没有相关的改善。单药顺铂化疗对总生存期的影响尚存争议。紫杉醇是一种从太平洋红豆杉树皮中提取的二萜类化合物，其细胞毒性被认为是通过稳定微管蛋白聚合物束来发挥的，从而干扰微管组装和细胞复制。它已被证明对许多实体瘤有广泛的活性，包括卵巢癌、乳腺癌和子宫内膜癌。GOG报告紫杉醇治疗晚期宫颈鳞状细胞癌的有效率为17%。顺铂和紫杉醇联合使用已被有效地用于治疗多种恶性肿瘤，目前正在对包括宫颈癌在内的各种鳞状细胞癌进行研究。目前的研究将确定与单用顺铂治疗相比，顺铂联合紫杉醇是否能提高晚期鳞状宫颈癌的反应率、无进展时间间隔和/或生存率。此外，在临床环境中，标准治疗在本质上可能被视为姑息治疗，该研究将评估两组在毒性和/或生活质量方面的差异。