Micha John P, Goldstein Bram H, Mattison Julie A, Bader Kathy, Graham Cheri, Rettenmaier Mark A, Brown John V, Markman Maurie
Gynecologic Oncology Associates, Hoag Cancer Center, 351 Hospital Road, Suite 507, Newport Beach, CA 92663, USA.
Gynecol Oncol. 2005 Jan;96(1):132-5. doi: 10.1016/j.ygyno.2004.10.001.
Twelve cycles of single-agent paclitaxel have been demonstrated to prolong progression-free survival in women with advanced ovarian cancer whom achieved a clinical complete response to a primary platinum/paclitaxel chemotherapy regimen. This trial was conducted to compare the toxicity and disease-free interval of 3 cycles vs. 12 cycles of paclitaxel consolidation in patients treated with an intensive three-drug front-line regimen of carboplatin, paclitaxel, and gemcitabine.
Following cytoreductive surgery, 26 ovarian cancer patients received primary chemotherapy with carboplatin (AUC = 5, day 1), paclitaxel (175 mg/m(2) over 1 h, day 1), and gemcitabine (800 mg/m(2), day 1 day 8), with treatment repeated every 21 days x 6 cycles. The first 13 patients (group A) received three additional cycles of paclitaxel (175 mg/m(2) over 1 h every 21 days). The second set of 13 patients (group B) also received three cycles of paclitaxel (175 mg/m(2) over 1 h every 21 days) and then received nine additional cycles of paclitaxel (135 mg/m(2) over 1 h every 21 days) consolidation therapy. The change from 3 cycles to 12 cycles of consolidation therapy for group B was made following the published results of GOG 178.
In group A, all 13 patients completed three courses of consolidation therapy. One patient experienced grade 3 neutropenia and two patients exhibited both grade 4 neutropenia and thrombocytopenia. Grade > or = 2 neuropathy developed in 3 patients (23%). In group B, 9 of the 13 patients whom were intended to receive 12 total cycles of paclitaxel consolidation were able to complete the program. There was no grade 3-4 neutropenia or anemia in this population, although 1 patient developed grade 3 thrombocytopenia. Grade > or = 2 neuropathy developed in 7 patients (54%). Although not a randomized experience, median progression-free interval was 76 weeks for group B, and 47 weeks for group A.
Single-agent paclitaxel consolidation therapy can be administered for 12 cycles following first-line carboplatin, paclitaxel, and gemcitabine induction therapy, but there is considerable risk for development of a moderately severe peripheral neuropathy.
已证实单药紫杉醇12个周期的治疗可延长晚期卵巢癌女性患者的无进展生存期，这些患者对铂类/紫杉醇一线化疗方案达到了临床完全缓解。本试验旨在比较接受卡铂、紫杉醇和吉西他滨强化三药一线方案治疗的患者中，3个周期与12个周期紫杉醇巩固治疗的毒性和无病间期。
26例卵巢癌患者在肿瘤细胞减灭术后接受卡铂（AUC = 5，第1天）、紫杉醇（175 mg/m²，静脉滴注1小时，第1天）和吉西他滨（800 mg/m²，第1天和第8天）的一线化疗，每21天重复治疗，共6个周期。前13例患者（A组）额外接受3个周期的紫杉醇治疗（175 mg/m²，静脉滴注1小时，每21天1次）。另外13例患者（B组）同样先接受3个周期的紫杉醇治疗（175 mg/m²，静脉滴注1小时，每21天1次），然后再接受9个周期的紫杉醇巩固治疗（135 mg/m²，静脉滴注1小时，每21天1次）。B组从3个周期巩固治疗改为12个周期是基于GOG 178公布的结果。
A组的13例患者均完成了3个疗程的巩固治疗。1例患者出现3级中性粒细胞减少，2例患者出现4级中性粒细胞减少和血小板减少。3例患者（23%）发生≥2级神经病变。B组中，计划接受12个周期紫杉醇巩固治疗的13例患者中有9例能够完成该方案。该组患者未出现3 - 4级中性粒细胞减少或贫血，尽管有1例患者出现3级血小板减少。7例患者（54%）发生≥2级神经病变。尽管并非随机试验，但B组的中位无进展间期为76周，A组为47周。
在一线卡铂、紫杉醇和吉西他滨诱导治疗后，单药紫杉醇巩固治疗可进行12个周期，但发生中度严重周围神经病变的风险较高。
