Barakat R R, Almadrones L, Venkatraman E S, Aghajanian C, Brown C, Shapiro F, Curtin J P, Spriggs D
Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Gynecol Oncol. 1998 Apr;69(1):17-22. doi: 10.1006/gyno.1998.4973.
To determine the efficacy of three courses of intraperitoneal (i.p.) cisplatin (CDDP) and etoposide (VP-16) as consolidation therapy following pathologically negative second-look surgical reassessment for Stage IIC-IV epithelial ovarian cancer (EOC).
Between September 1988 and April 1996, 40 patients were treated with three cycles of i.p. CDDP (100 mg/m2)/VP-16 (200 mg/m2) as consolidation therapy. Survival was compared to that of a group of 46 contemporaneous patients undergoing observation only.
Median age of the 36 eligible patients was 52 years (range 30-70 years). Stage distribution was II (3), III (31), and IV (2); histologic grade was 1 (2), 2 (7), 3 (25), and not recorded (2); and residual disease at completion of initial surgery was none/microscopic in 13/36 (36%) patients. Median age of the 46 patients who did not receive consolidation was 52 years (range, 27-80 years); stage distribution was II (18), III (26), and IV (2); histologic grade was 1 (5), 2 (12), 3 (28), and not recorded (1). With a median follow-up of 36 months in both groups, 14/36 (39%) of the protocol group have recurred compared with 25/46 (54%) of those undergoing observation alone. Median disease-free survival (DFS) for the observed patients is 28.5 months and has not been reached in the consolidation group. Disease-free survival distribution between the two groups was compared using the log-rank test and was found to be significant (P = 0.03). Multivariate analysis revealed that the only significant predictor of improved DFS was protocol treatment (P < 0.01).
Intraperitoneal consolidation with CDDP/VP-16 following negative second-look reassessment in patients with advanced EOC resulted in a significant increase in DFS compared to nonprotocol patients treated concurrently who underwent observation alone.
确定对于IIC-IV期上皮性卵巢癌（EOC）患者，在第二次手术探查病理结果为阴性后，采用三个疗程的腹腔内（i.p.）顺铂（CDDP）和依托泊苷（VP-16）进行巩固治疗的疗效。
1988年9月至1996年4月期间，40例患者接受了三个周期的腹腔内CDDP（100 mg/m²）/VP-16（200 mg/m²）巩固治疗。将其生存率与同期仅接受观察的46例患者的生存率进行比较。
36例符合条件的患者中位年龄为52岁（范围30 - 70岁）。分期分布为II期（3例）、III期（31例）和IV期（2例）；组织学分级为1级（2例）、2级（7例）、3级（25例），未记录（2例）；初始手术完成时残留病灶情况为13/36（36%）的患者无/微小残留。46例未接受巩固治疗患者的中位年龄为52岁（范围27 - 80岁）；分期分布为II期（18例）、III期（26例）和IV期（2例）；组织学分级为1级（5例）、2级（12例）、3级（28例），未记录（1例）。两组中位随访时间均为36个月，方案组14/36（39%）出现复发，而单纯观察组为25/46（54%）。观察组患者的无病生存期（DFS）中位数为28.5个月，巩固治疗组尚未达到。采用对数秩检验比较两组间的无病生存期分布，差异具有统计学意义（P = 0.03）。多因素分析显示，DFS改善的唯一显著预测因素是方案治疗（P < 0.01）。
对于晚期EOC患者，在第二次手术探查结果为阴性后采用CDDP/VP-16进行腹腔内巩固治疗，与同期单纯接受观察的非方案治疗患者相比，DFS显著延长。
