Sutton G, Blessing J A, Malfetano J H
Section of Gynecologic Oncology, Indiana University Medical School, Indianapolis 46202, USA.
Gynecol Oncol. 1996 Aug;62(2):226-9. doi: 10.1006/gyno.1996.0220.
This is a Phase II groupwide study of the Gynecologic Oncology Group (GOG) to determine the toxicity and efficacy of a combination of ifosfamide and doxorubicin in patients with advanced or metastatic leiomyosarcomas of the uterus who had not received other chemotherapy. Thirty-five women were entered into this study; 1 patient was ineligible (primary not documented), leaving 34 patients treated with ifosfamide, 5.0 g/m2/24 hr, and mesna, 6.0 g/m2/36 hr, by continuous IV infusion preceded by doxorubicin, 50 mg/m2 iv over 15 min. Each course of therapy was repeated every 3 weeks if counts allowed. One patient was inevaluable for response, leaving 34 evaluable for toxicity and 33 evaluable for response of chemotherapy. GOG grade 3 or 4 granulocytopenia occurred in 17 patients (48.6%), 2 patients developed granulocytopenic fever (5.7%), and 1 died of sepsis. Two patients developed grade 3 thrombocytopenia, and 1 died of cardiotoxicity. There were nine partial and one complete responses for an overall response rate of 30.3%; the response duration averaged 4 months. The combination of ifosfamide and doxorubicin is toxic but has moderate activity in patients with advanced or metastatic leiomyosarcoma of the uterus.
这是妇科肿瘤学组（GOG）进行的一项全组范围的II期研究，旨在确定异环磷酰胺与阿霉素联合用药对未接受过其他化疗的晚期或转移性子宫平滑肌肉瘤患者的毒性和疗效。35名女性进入该研究；1名患者不符合条件（原发灶未记录），剩余34名患者接受了异环磷酰胺（5.0 g/m²/24小时）和美司钠（6.0 g/m²/36小时）持续静脉输注治疗，输注前先静脉注射阿霉素50 mg/m²，持续15分钟。如果血细胞计数允许，每3周重复一个疗程的治疗。1名患者无法评估疗效，剩余34名可评估毒性，33名可评估化疗反应。17名患者（48.6%）出现GOG 3级或4级粒细胞减少，2名患者发生粒细胞减少性发热（5.7%），1名患者死于败血症。2名患者出现3级血小板减少，1名患者死于心脏毒性。有9例部分缓解和1例完全缓解，总缓解率为30.3%；缓解持续时间平均为4个月。异环磷酰胺与阿霉素联合用药有毒性，但对晚期或转移性子宫平滑肌肉瘤患者有中度活性。
