Pinedo H M, Bramwell V H, Mouridsen H T, Somers R, Vendrik C P, Santoro A, Buesa J, Wagener T, van Oosterom A T, van Unnik J A
Cancer. 1984 May 1;53(9):1825-32. doi: 10.1002/1097-0142(19840501)53:9<1825::aid-cncr2820530904>3.0.co;2-z.
Two hundred forty-six adults with advanced progressive soft tissue sarcoma received combination chemotherapy with cyclophosphamide, vincristine, Adriamycin (doxorubicin), and DTIC. They were randomly allocated to receive the four drugs simultaneously every 4 weeks (S1: CYVADIC), or pairs of drugs (S2: ADIC-CYV) alternating at 4 weekly intervals. One hundred sixty-two patients completed 8 weeks of chemotherapy, and were considered to be evaluable for response. There were 18 complete remissions and 25 partial remissions, an overall response rate of 26%, with a highly significant difference between the two arms in favor of S1 (38% versus 14%, P = 0.001). There were no significant differences between S1 and S2 in terms of median duration of remissions (62 versus 39 weeks), and median survival of responders (85 versus 80 weeks) and of all evaluable patients (43 versus 45 weeks). Karnofsky index (KI) was the single most important prognostic factor. Patients with KI 90-100 showed a remission rate of 41% (56% on the S1 regimen) in contrast with 14% in those with KI 50-80. No patient with a KI of 50 responded to chemotherapy. The main toxicities were nausea, vomiting, anorexia, alopecia and myelosuppression, but did not differ significantly between the two regimens. Our findings suggest that stratification according to KI is essential for studies on chemotherapy for advanced soft tissue sarcomas in order to make a valuable comparison of treatment results.
246例晚期进展性软组织肉瘤成人患者接受了环磷酰胺、长春新碱、阿霉素（多柔比星）和达卡巴嗪的联合化疗。他们被随机分配，每4周同时接受这四种药物治疗（S1：CYVADIC方案），或每4周交替接受成对药物治疗（S2：ADIC-CYV方案）。162例患者完成了8周的化疗，被认为可对疗效进行评估。有18例完全缓解和25例部分缓解，总缓解率为26%，两组之间存在高度显著差异，S1方案更优（38%对14%，P = 0.001）。S1和S2在缓解期的中位数（62周对39周）、缓解者的中位生存期（85周对80周）以及所有可评估患者的中位生存期（43周对45周）方面无显著差异。卡诺夫斯基指数（KI）是唯一最重要的预后因素。KI为90 - 100的患者缓解率为41%（S1方案为56%），而KI为50 - 80的患者缓解率为14%。没有KI为50的患者对化疗有反应。主要毒性反应为恶心、呕吐、厌食、脱发和骨髓抑制，但两种方案之间无显著差异。我们的研究结果表明，对于晚期软组织肉瘤化疗研究，根据KI进行分层对于对治疗结果进行有价值的比较至关重要。
