Bramwell V, Rouesse J, Steward W, Santoro A, Schraffordt-Koops H, Buesa J, Ruka W, Priario J, Wagener T, Burgers M
London Regional Cancer Centre, Canada.
J Clin Oncol. 1994 Jun;12(6):1137-49. doi: 10.1200/JCO.1994.12.6.1137.
To evaluate the benefit of adjuvant chemotherapy in adult patients with soft tissue sarcomas. The principal end points were freedom from local recurrence and/or metastases and overall survival.
Between January 1977 and June 1988, 468 patients entered this randomized study and 317 were considered eligible. Following complete surgical resection with or without radiotherapy, outcome in 145 eligible patients receiving cyclophosphamide 500 mg/m2 intravenously (IV) bolus on day 1, vincristine 1.4 mg/m2 IV bolus on day 1, doxorubicin (Adriamycin; Adria Laboratories, Columbus, OH) 50 mg/m2 IV bolus on day 1, and dacarbazine (DTIC) 400 mg/m2 by 1-hour infusion on days 1 to 3 (CYVADIC) cycles repeated every 28 days for eight courses was compared with that in 172 control patients.
With a median follow-up duration of 80 months (range, 39 to 165), actuarial percentage survival figures at 7 years were compared. Relapse-free survival rates were higher for CYVADIC, 56% versus 43% (P = .007), and local recurrence was significantly reduced in the CYVADIC arm at 17% versus 31% (P = .004). In contrast, distant metastases occurred with similar frequency in both arms, 32% for CYVADIC versus 36% for control patients (P = .42), and overall survival rates were not significantly different at 63% versus 56% (P = .64). A reduction in local recurrence was only apparent in the group of head, neck, and trunk sarcomas (P = .002), but not in limb tumors (P = .31).
Adjuvant chemotherapy with CYVADIC cannot be recommended outside the context of a clinical trial. Experience from this study has been used to plan a trial of neoadjuvant chemotherapy with doxorubicin/ifosfamide, which is currently in progress.
评估辅助化疗对成人软组织肉瘤患者的益处。主要终点是无局部复发和/或转移以及总生存期。
1977年1月至1988年6月期间，468例患者进入这项随机研究，其中317例被认为符合条件。在接受或未接受放疗的完整手术切除后，比较了145例符合条件的患者的预后情况，这些患者在第1天静脉推注环磷酰胺500mg/m²、第1天静脉推注长春新碱1.4mg/m²、第1天静脉推注阿霉素（阿霉素；阿德里亚实验室，俄亥俄州哥伦布市）50mg/m²，以及在第1至3天通过1小时输注给予达卡巴嗪（DTIC）400mg/m²（CYVADIC方案），每28天重复一个周期，共八个疗程，与172例对照患者的预后情况。
中位随访时间为80个月（范围39至165个月），比较了7年时的精算生存率。CYVADIC方案组的无复发生存率更高，分别为56%和43%（P = 0.007），CYVADIC方案组的局部复发率显著降低，分别为17%和31%（P = 0.004）。相比之下，两组远处转移的发生率相似，CYVADIC方案组为32%，对照组为36%（P = 0.42），总生存率无显著差异，分别为63%和56%（P = 0.64）。局部复发率的降低仅在头颈部和躯干肉瘤组中明显（P = 0.002），而在肢体肿瘤组中不明显（P = 0.31）。
在临床试验背景之外，不推荐使用CYVADIC方案进行辅助化疗。这项研究的经验已被用于计划一项关于阿霉素/异环磷酰胺新辅助化疗的试验，该试验目前正在进行中。
