Morrow C P, Bundy B N, Homesley H D, Creasman W T, Hornback N B, Kurman R, Thigpen J T
Division of Gynecologic Oncology, University of Southern California Medical School, Los Angeles.
Gynecol Oncol. 1990 Feb;36(2):166-71. doi: 10.1016/0090-8258(90)90166-i.
The Gynecologic Oncology Group studied the use of adjuvant doxorubicin after surgery and radiation therapy for endometrial carcinoma in a randomized, prospective manner. The study population consisted of patients clinically stage I or II (occult) who, after surgical-pathologic evaluation, had one or more risk factors for recurrence: greater than 50% myometrial invasion, pelvic or aortic node metastasis, cervical involvement, or adnexal metastases. All patients without aortic node metastasis received 5000 rads to the whole pelvis at 160-180 rads per day. If aortic node metastasis was documented, aortic field radiation to the top of T12 was offered. The aortic target dose was 4500 rads at 150 rads per day. After completion of radiation therapy, the patients were randomized to receive doxorubicin bolus therapy (60 mg/m2 starting dose) to a maximum cumulative dose of 500 mg/m2. Between November 1977 and July 1986, 92 patients were entered into the doxorubicin (DOX) treatment arm, and 89 patients entered the no-DOX arm. There was no statistically significant difference in survival or progression-free interval of the two arms. The 5-year survival rates for patients with deep myometrial invasion, cervical involvement, and pelvic node metastases were similar (63-70%), whereas the rate for patients with aortic node metastases was 26%. There was no significant difference in the recurrence pattern between the two treatment arms. There were no cases of grade 3 or 4 cardiac toxicity. Twelve patients (6.9%) developed small bowel obstruction after radiation therapy. There were three treatment-related deaths in the DOX arm and two in the radiation therapy-only arm. We conclude that, because of protocol violations, small sample size, and the number of patients lost to follow-up, this study was unable to determine what effect use of doxorubicin as adjuvant therapy had on recurrence, progression, and survival of the endometrial cancer study population. The combination of surgical staging and postoperative radiation as used in this study appears to increase the risk of bowel complications.
妇科肿瘤学组以随机、前瞻性的方式研究了子宫内膜癌手术及放疗后辅助使用阿霉素的情况。研究人群包括临床分期为I期或II期（隐匿性）的患者，这些患者在手术病理评估后有一个或多个复发风险因素：肌层浸润超过50%、盆腔或主动脉旁淋巴结转移、宫颈受累或附件转移。所有无主动脉旁淋巴结转移的患者每天以160 - 180拉德的剂量接受全盆腔5000拉德的放疗。如果记录到主动脉旁淋巴结转移，则对T12水平以上的主动脉区域进行放疗。主动脉区域的目标剂量为每天150拉德，共4500拉德。放疗结束后，患者被随机分为接受阿霉素大剂量冲击疗法（起始剂量60mg/m²），最大累积剂量为500mg/m²。1977年11月至1986年7月，92例患者进入阿霉素（DOX）治疗组，89例患者进入非DOX组。两组在生存率或无进展生存期方面无统计学显著差异。肌层深部浸润、宫颈受累和盆腔淋巴结转移患者的5年生存率相似（63 - 70%），而主动脉旁淋巴结转移患者的5年生存率为26%。两个治疗组之间的复发模式无显著差异。未出现3级或4级心脏毒性病例。12例患者（6.9%）放疗后发生小肠梗阻。DOX组有3例与治疗相关的死亡，单纯放疗组有2例。我们得出结论，由于方案违规、样本量小以及失访患者数量，本研究无法确定使用阿霉素作为辅助治疗对子宫内膜癌研究人群的复发、进展和生存有何影响。本研究中使用的手术分期和术后放疗联合应用似乎增加了肠道并发症的风险。
