Perez C A, Camel H M, Kao M S, Hederman M A
Gynecol Oncol. 1987 Jun;27(2):129-40. doi: 10.1016/0090-8258(87)90285-x.
A prospective randomized study in selected patients with Stage IB and IIA carcinoma of the uterine cervix was carried out at Washington University between January 1966 and December 1979. Patients were randomized to be treated with irradiation alone consisting of 1000 cGy whole pelvis, additional 4000 cGy to the parametria with a step wedge midline block, and two intracavitary insertions for 7500 mgh; or irradiation and surgery, consisting of 2000 cGy whole pelvis irradiation, one intracavitary insertion for 5000-6000 mgh followed 2 to 6 weeks later by a radical hysterectomy with pelvic lymphadenectomy. A total of 40 patients with Stage IB and 16 with Stage IIA were randomized to be treated with irradiation alone. A similar group of 48 patients with Stage IB and 14 with IIA were randomized to the preoperative radiation and surgery group. The 5-year, tumor-free actuarial survival for Stage IB patients treated with radiation was 89% and with preoperative radiation and surgery 80%. In Stage IIA, the tumor-free actuarial 5-year survival was 56% for the irradiation alone group and 79% for the patients treated with preoperative radiation and radical hysterectomy. In the patients with Stage IB treated by irradiation alone only one pelvic failure combined with distant metastasis occurred, and 3 patients developed distant metastasis. In the 48 patients treated with combined therapy, there were six pelvic failures (12.5%) all combined with distant metastases and two distant metastases alone. In the 16 patients with Stage IIA treated with radiotherapy alone, there were four pelvic failures (all parametrial), three of them combined with distant metastasis. In the 14 patients treated with irradiation and surgery, two developed a pelvic recurrence, and one distant metastasis. In the preoperative radiation group, the incidence of metastatic pelvic lymph nodes was 6.3% in Stage IB and 7.1% in Stage IIA. Major complications of therapy in the patients treated with radiation alone (10%) consisted of one rectovaginal fistula, two vesicovaginal fistulas, and one rectal stricture. In the preoperative radiation group, three ureteral strictures and two severe proctitis-rectal strictures were noted (8%). The present study shows no significant difference in therapeutic results or morbidity for invasive carcinoma of the uterine cervix Stage IB or IIA treated with irradiation alone or combined with a radical hysterectomy and lymphadenectomy.
1966年1月至1979年12月期间，华盛顿大学对部分IB期和IIA期子宫颈癌患者进行了一项前瞻性随机研究。患者被随机分为两组，一组仅接受放疗，包括全盆腔1000 cGy照射、用楔形中线挡铅对宫旁组织追加4000 cGy照射以及两次腔内照射共7500 mgh；另一组接受放疗加手术，即全盆腔2000 cGy照射、一次腔内照射5000 - 6000 mgh，2至6周后行根治性子宫切除术及盆腔淋巴结清扫术。共有40例IB期患者和16例IIA期患者被随机分配接受单纯放疗。另有48例IB期患者和14例IIA期患者被随机分配到术前放疗加手术组。接受放疗的IB期患者5年无瘤精算生存率为89%，接受术前放疗加手术的为80%。在IIA期，单纯放疗组5年无瘤精算生存率为56%，接受术前放疗及根治性子宫切除术的患者为79%。在仅接受放疗的IB期患者中，仅发生1例盆腔失败合并远处转移，3例出现远处转移。在接受联合治疗的48例患者中，有6例盆腔失败（12.5%）均合并远处转移，2例仅发生远处转移。在16例接受单纯放疗的IIA期患者中，有4例盆腔失败（均为宫旁组织），其中3例合并远处转移。在14例接受放疗加手术的患者中，2例发生盆腔复发，1例出现远处转移。在术前放疗组中，IB期患者盆腔淋巴结转移发生率为6.3%，IIA期为7.1%。单纯放疗患者的主要治疗并发症发生率为10%，包括1例直肠阴道瘘、2例膀胱阴道瘘和1例直肠狭窄。在术前放疗组中，发现3例输尿管狭窄和2例严重直肠炎 - 直肠狭窄（8%）。本研究表明，对于IB期或IIA期子宫颈浸润癌，单纯放疗或联合根治性子宫切除术及淋巴结清扫术在治疗效果或发病率方面无显著差异。
