Sutton G P, Blessing J A, McGuire W P, Patton T, Look K Y
Section of Gynecologic Oncology, Indiana University School of Medicine, Indianapolis.
Am J Obstet Gynecol. 1993 Mar;168(3 Pt 1):805-7. doi: 10.1016/s0002-9378(12)90824-8.
Our objective was to determine the activity of ifosfamide and mesna in women with advanced or recurrent squamous carcinoma of the cervix who had never received chemotherapy.
This is a phase II drug study in which the starting dose of ifosfamide was 1.5 gm/m2 daily intravenously for 5 days. The starting dose of ifosfamide was reduced to 1.2 gm/m2 daily in patients who had received prior radiotherapy. The uroprotector mesna was given intravenously with, and at 4 and 8 hours after, the administration of ifosfamide. Each dose of mesna was 20% of the total daily dose of ifosfamide.
Fifty-six patients were placed in the study; 52 were evaluable for toxicity and 51 for response. Twenty-eight (54.9%) patients had previously undergone surgery and 46 (90.2%) had received radiotherapy before this trial. Gynecologic Oncology Group grade 3 or 4 granulocytopenia occurred in 7 (13.5%) patients, and 2 (3.9%) had grade 3 thrombocytopenia. Six (11.5%) patients had grade 3 or 4 neurotoxicity. Complete response was observed in 2 (3.9%) patients and partial responses in 6 (11.5%) patients, for a total response rate of 15.7% (95% confidence interval 7.02% to 28.59%).
This response rate is higher than that reported by the Gynecologic Oncology Group in patients with previously treated squamous carcinoma of the cervix. Our findings fail to confirm that ifosfamide is a highly active agent in patients with squamous carcinoma of the cervix as reported by others; nonetheless, the observed activity of this drug deserves further study in combination therapy of squamous carcinoma of the cervix.
我们的目的是确定异环磷酰胺和美司钠对从未接受过化疗的晚期或复发性宫颈鳞癌女性患者的疗效。
这是一项II期药物研究，异环磷酰胺的起始剂量为每日1.5克/平方米，静脉注射，共5天。对于曾接受过放疗的患者，异环磷酰胺的起始剂量减至每日1.2克/平方米。尿路保护剂美司钠在给予异环磷酰胺时、给药后4小时和8小时静脉注射。美司钠的每次剂量为异环磷酰胺每日总剂量的20%。
56例患者纳入本研究；52例可评估毒性，51例可评估疗效。28例（54.9%）患者此前接受过手术，46例（90.2%）患者在本试验前接受过放疗。7例（13.5%）患者出现妇科肿瘤学组3级或4级粒细胞减少，2例（3.9%）出现3级血小板减少。6例（11.5%）患者出现3级或4级神经毒性。2例（3.9%）患者观察到完全缓解，6例（11.5%）患者出现部分缓解，总缓解率为15.7%（95%置信区间7.02%至28.59%）。
该缓解率高于妇科肿瘤学组报告的既往治疗过的宫颈鳞癌患者的缓解率。我们的研究结果未能证实异环磷酰胺如其他人所报告的那样是宫颈鳞癌患者的高效活性药物；尽管如此，该药物观察到的活性值得在宫颈鳞癌联合治疗中进一步研究。
