Haie-Meder C, Kramar A, Lambin P, Lancar R, Scalliet P, Bouzy J, Gerbaulet A
Curietherapy Department, IGR, Villejuif, France.
Int J Radiat Oncol Biol Phys. 1994 Jul 30;29(5):953-60. doi: 10.1016/0360-3016(94)90388-3.
The analysis of complications in a prospective randomized trial comparing two preoperative brachytherapy low-dose rates in early stage cervical cancer is presented.
Between 1985 and 1988, 204 patients with Stage I and limited Stage II cervical cancer were randomized to receive one of two preoperative brachytherapy low-dose rates (0.4 and 0.8 Gy/hr). The objective of this trial was to determine the benefits, if any, of the higher-dose rate within the therapeutic arsenal for this patient population, in terms of survival, local control, and complications. The type and severity of all complications were evaluated according to a common glossary and a strict follow-up schedule was established given that the treatment of cervical cancer is multidisciplinary, involving gynecologists, surgeons, and radiotherapists.
Overall survival: 85% at 2 years and local control: 93% at 2 years, were similarly distributed between the two groups. Regardless of their nature and severity, 139 and 175 complications were observed among 63% and 75% of patients, in the 0.4 and 0.8 Gy/h dose rate groups respectively. Gynecologic and urinary complications were the most frequent (38% and 28% of all complications), followed by vascular (15%), digestive (10%), nervous (5%) and cutaneous (5%). A total of 14 and 17 severe complications (Grade 3) were observed in 7% and 13% of patients, respectively in the 0.4 and 0.8 Gy/h dose rate groups (p = 0.12). Nonparametric survival methods used to compare the time to the first complication did not show a significant difference between the two groups: 62% and 72% at 2 years (p = 0.27). When the first complication and its evolution were considered (early complications), the prevalence of complications was not significantly different between the two groups: 28% vs. 34% at 2 years (p = 0.31). In this prospective trial, patients were regularly followed-up and complications of varying nature and severity were observed in succession during follow-up. When successive complications and their evolution were taken into account, the prevalence of complications was significantly greater in the higher-dose rate group: 30% vs. 45% at 2 years (p = 0.03).
The results of this trial showed that long-term effects of treatment, when represented by prevalence of complications over time, were more frequent in the higher dose rate group. This underlines the importance of the regular follow-up of patients and of coding, not only the occurrence of all complications, but also their evolution over time.
对一项前瞻性随机试验中早期宫颈癌两种术前近距离放疗低剂量率的并发症进行分析。
1985年至1988年间，204例I期和局限II期宫颈癌患者被随机分配接受两种术前近距离放疗低剂量率（0.4和0.8Gy/小时）中的一种。本试验的目的是确定在该患者群体的治疗手段中，更高剂量率在生存、局部控制和并发症方面是否有任何益处。根据通用术语表评估所有并发症的类型和严重程度，并制定了严格的随访计划，因为宫颈癌的治疗是多学科的，涉及妇科医生、外科医生和放疗科医生。
总生存率：2年时为85%，局部控制率：2年时为93%，两组分布相似。无论性质和严重程度如何，在0.4和0.8Gy/小时剂量率组中，分别有63%和75%的患者出现了139例和175例并发症。妇科和泌尿系统并发症最为常见（分别占所有并发症的38%和28%），其次是血管性（15%）、消化系统（10%）、神经性（5%）和皮肤性（5%）。在0.4和0.8Gy/小时剂量率组中，分别有7%和13%的患者出现了14例和17例严重并发症（3级）（p = 0.12）。用于比较首次出现并发症时间的非参数生存方法显示两组之间无显著差异：2年时分别为62%和72%（p = 0.27）。当考虑首次出现的并发症及其演变（早期并发症）时，两组之间并发症的发生率无显著差异：2年时分别为28%和34%（p = 0.31）。在这项前瞻性试验中，对患者进行了定期随访，随访期间相继观察到性质和严重程度各异的并发症。当考虑相继出现的并发症及其演变时，高剂量率组并发症的发生率显著更高：2年时分别为30%和45%（p = 0.03）。
本试验结果表明，以并发症随时间的发生率来表示治疗的长期效果时，高剂量率组更为常见。这突出了对患者进行定期随访以及不仅对所有并发症的发生进行编码，而且对其随时间的演变进行编码的重要性。
