Chatani M, Matayoshi Y, Masaki N, Teshima T, Inoue T
Department of Radiation Therapy, Osaka University Medical School, Japan.
Strahlenther Onkol. 1994 Nov;170(11):636-42.
High-dose rate (HDR) remote afterloading intracavitary therapy has been recognized as an effective and safe treatment modality for carcinoma of the uterine cervix. Since 1983, a prospective randomized study was started in order to investigate the more advantageous treatment schedule with keeping the local control rate. This paper reports the final results in terms of survival, local control and complications.
Between January 1983 and February 1989, a total of 165 patients with carcinoma of the uterine cervix was entered in a prospective randomized study concerning the point A dose of HDR therapy (6 Gy/fraction vs 7.5 Gy/fraction) and external irradiation dose at Department of Radiation Therapy, The Center for Adult Diseases, Osaka. UICC [20] stage distribution of patients was as follows: stage IA = 4, stage IB = 33, stage IIA = 18, stage IIB = 38, stage III = 57, stage IV = 15.
Overall 5-year cause specific survivals were as follows: stage IA = 100%, stage IB = 96%, stage IIA = 92%, stage IIB = 79%, stage III = 57%, stage IV = 27%. In each stage, 5-year survival rates in groups A and B were 100%, 93% in stage I, 82% and 85% in stage II, 62% and 52% in stage II and 22% and 31% in stage IV, respectively. There were no statistically significant differences among these survival curves in each stage. Five-year local failure rates were 16% in group A and 16% in group B (p = 0.9096), and corresponding distant failure rates were 23% in group A and 19% in group B (p = 0.2955). Moderate-to-severe complications requiring treatment (Kottmeier's grade 2 or more) were noted in 6 patients (7%) in group A and 6 patients (7%) in group B. All of the bladder and rectal complications needed medical treatment (Kottmeier's grade 2). Severe complications receiving surgery were noted in 4 patients (A: 1; B: 3), i.e., small intestine 3 and sigmoid colon 1 patient. Another 1 patient (A) was dead of ileus.
There were no statistically significant differences between 2 treatment schedules in survival rates, failure patterns and complications rates. This fact suggests that small number of fractions (7.5 Gy/fraction) may be advantageous because of short duration and a low load of treatment.
高剂量率（HDR）后装腔内治疗已被公认为是子宫颈癌一种有效且安全的治疗方式。自1983年起，开展了一项前瞻性随机研究，以在保持局部控制率的前提下，探究更具优势的治疗方案。本文报告了关于生存、局部控制及并发症方面的最终结果。
1983年1月至1989年2月期间，大阪成人疾病中心放疗科对总共165例子宫颈癌患者进行了一项关于HDR治疗A点剂量（6Gy/分次与7.5Gy/分次）及外照射剂量的前瞻性随机研究。患者的国际妇产科联盟（UICC）[20]分期分布如下：IA期 = 4例，IB期 = 33例，IIA期 = 18例，IIB期 = 38例，III期 = 57例，IV期 = 15例。
总体5年病因特异性生存率如下：IA期 = 100%，IB期 = 96%，IIA期 = 92%，IIB期 = 79%，III期 = 57%，IV期 = 27%。在各期，A组和B组的5年生存率分别为：I期100%、93%，II期82%和85%，III期62%和52%，IV期22%和31%。各期这些生存曲线之间无统计学显著差异。A组5年局部失败率为16%，B组为16%（p = 0.9096），相应的远处失败率A组为23%，B组为19%（p = 0.2955）。A组有6例患者（7%）和B组有6例患者（7%）出现需要治疗的中重度并发症（Kottmeier 2级或更高）。所有膀胱和直肠并发症均需药物治疗（Kottmeier 2级）。有4例患者（A组：1例；B组：3例）出现需手术治疗的严重并发症，即小肠3例和乙状结肠1例。另有1例患者（A组）死于肠梗阻。
两种治疗方案在生存率、失败模式和并发症发生率方面无统计学显著差异。这一事实表明，较少的分次剂量（7.5Gy/分次）可能因治疗持续时间短和治疗负担低而具有优势。
