Husain A, Sabbatini P, Spriggs D, Fennelly D, Aghajanian C, Barakat R, Curtin J, Venkatraman E, Hoskins W, Markman M
Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, USA.
Gynecol Oncol. 1999 Apr;73(1):96-101. doi: 10.1006/gyno.1998.5317.
The aim of this study was to determine the feasibility and efficacy of intraperitoneal cisplatin and mitoxantrone in patients with very small-volume residual disease at second-look surgery after completion of primary platinum-based intravenous chemotherapy.
Between February 1992 and February 1994, 42 patients were treated with up to five cycles of intraperitoneal cisplatin (100 mg/m2)/mitoxantrone (10 mg/m2). Patients were evaluated for surgically defined response rate and followed for progression-free (PFS) and overall survival (OS) using an intention-to-treat analysis, and grouped according to disease volume at initiation of treatment.
The mean age of all patients was 48.5 years. Thirty patients (71%) were Stage III at diagnosis; 18 patients (43%) had microscopic disease at the initiation of IP therapy, and 24 patients (57%) had macroscopic disease. Twenty-eight patients completed three or more cycles of protocol therapy, and 14 patients were changed to standard intravenous therapy after receiving fewer than three cycles of treatment secondary to catheter-related problems (12 patients), cisplatin ototoxicity (1 patient), or withdrawal from study (1 patient). Using an intention-to-treat analysis, the median PFS was 22.5 months, and the median OS of all patients (N = 42) was 47 months (6-72 months) with a median follow-up of 62.7 months. When grouped according to size of disease at initiation of treatment, the OS has not been reached at 62.7 months of follow-up in patients (N = 18) with microscopic disease.
(1) The combination of IP mitoxantrone and cisplatin has an unacceptable catheter failure rate due to mitoxantrone toxicity; (2) PFS and OS is longer in patients with microscopic rather than macroscopic residual disease; and (3) intraperitoneal platinum-based chemotherapy in patients with very small-volume residual disease may result in improved survival.
本研究旨在确定在以铂类为主的静脉化疗完成后进行二次探查手术时，腹腔内使用顺铂和米托蒽醌治疗微小残留病患者的可行性和疗效。
1992年2月至1994年2月期间，42例患者接受了多达五个周期的腹腔内顺铂（100mg/m²）/米托蒽醌（10mg/m²）治疗。评估患者手术确定的缓解率，并采用意向性分析对无进展生存期（PFS）和总生存期（OS）进行随访，并根据治疗开始时的疾病体积进行分组。
所有患者的平均年龄为48.5岁。30例患者（71%）诊断时为Ⅲ期；18例患者（43%）在腹腔内治疗开始时有微小疾病，24例患者（57%）有肉眼可见疾病。28例患者完成了三个或更多周期的方案治疗，14例患者因导管相关问题（12例）、顺铂耳毒性（1例）或退出研究（1例）在接受少于三个周期的治疗后改为标准静脉治疗。采用意向性分析，PFS的中位数为22.5个月，所有患者（N = 42）的OS中位数为47个月（6 - 72个月），中位随访时间为62.7个月。根据治疗开始时疾病的大小进行分组，随访62.7个月时，微小疾病患者（N = 18）的OS尚未达到。
（1）由于米托蒽醌毒性，腹腔内米托蒽醌和顺铂联合使用的导管失败率不可接受；（2）微小残留病患者的PFS和OS比肉眼可见残留病患者更长；（3）微小残留病患者进行腹腔内铂类化疗可能会提高生存率。
