Hanlon A L, Schultheiss T E, Hunt M A, Movsas B, Peter R S, Hanks G E
Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
Int J Radiat Oncol Biol Phys. 1997 Apr 1;38(1):59-63. doi: 10.1016/s0360-3016(97)00234-4.
Serious late morbidity (Grade 3/4) from the conformal treatment of prostate cancer has been reported in <1% to 6% of patients based on existing late gastrointestinal (GI) morbidity scales. None of the existing morbidity scales include our most frequently observed late GI complication, which is chronic rectal bleeding requiring multiple fulgerations. This communication documents the frequency of rectal bleeding requiring multiple fulgerations and illustrates the variation in reported late serious GI complication rates by the selection of morbidity scale.
Between May 1989 and December 1993, 352 patients with T1-T3 nonmetastatic prostate cancers were treated with our four-field conformal technique without special rectal blocking. This technique includes a 1-cm margin from the clinical target volume (CTV) to the planning target volume (PTV) in all directions. The median follow-up for these patients was 36 months (range 2-76), and the median center of prostate dose was 74 Gy (range 63-81). Three morbidity scales are assessed: the Radiation Therapy Oncology Group (RTOG), the Late Effects Normal Tissue Task Force (LENT), and our modification of the LENT (FC-LENT). This modification registers chronic rectal bleeding requiring at least one blood transfusion and/or more than two coagulations as a Grade 3 event. Estimates for Grade 3/4 late GI complication rates were determined using Kaplan-Meier methodology. The duration of severe symptoms with chronic rectal bleeding is measured from the first to the last transrectal coagulation. Latency is measured from the end of radiotherapy to surgery, first blood transfusion, or third coagulation procedure.
Sixteen patients developed Grade 3/4 complications by one of the three morbidity scales. Two patients required surgery (colostomy or sigmoid resection), three required multiple blood transfusions, two required one or two blood transfusions, and nine required at least three coagulations. The median duration of bleeding for those patients requiring multiple procedures was 7 months (range 3-33) and the median latency was 22 months (range 9-40). The 5-year actuarial rate of Grade 3/4 complications by each scale are: RTOG 0.7%, LENT 2%, and FC-LENT 6%. The rate of chronic rectal bleeding increases with increasing dose and is low in patients treated with conventional techniques owing to lower doses.
Chronic rectal bleeding requiring any blood transfusion(s) or multiple coagulation procedures is our most frequently observed complication. This complication appears late in follow-up and is present for a long duration. We believe this justifies the inclusion of chronic rectal bleeding requiring multiple coagulation procedures as a Grade 3 event in future morbidity scales. Our data illustrate that published Grade 3/4 morbidity rates are highly dependent on the morbidity scale selected, as our data show 0.7% RTOG, 2% LENT, and 6% FC-LENT. Obviously, a uniform scale is required that includes the newly recognized serious late effects associated with the conformal treatment of prostate cancer.
根据现有的晚期胃肠道（GI）发病率量表，前列腺癌适形治疗导致的严重晚期发病率（3/4级）在<1%至6%的患者中被报道。现有的发病率量表均未纳入我们最常观察到的晚期GI并发症，即需要多次电灼的慢性直肠出血。本报告记录了需要多次电灼的直肠出血的发生率，并通过发病率量表的选择说明了所报道的晚期严重GI并发症发生率的差异。
1989年5月至1993年12月期间，352例T1 - T3期非转移性前列腺癌患者接受了我们的四野适形技术治疗，未进行特殊的直肠遮挡。该技术在各个方向上从临床靶区（CTV）到计划靶区（PTV）均有1 cm的边界。这些患者的中位随访时间为36个月（范围2 - 76个月），前列腺剂量的中位中心值为74 Gy（范围63 - 81 Gy）。评估了三种发病率量表：放射治疗肿瘤学组（RTOG）、正常组织晚期效应特别工作组（LENT）以及我们对LENT的修改版（FC - LENT）。这种修改将需要至少一次输血和/或超过两次凝血的慢性直肠出血记录为3级事件。使用Kaplan - Meier方法确定3/4级晚期GI并发症发生率的估计值。慢性直肠出血严重症状的持续时间从第一次到最后一次经直肠凝血进行测量。潜伏期从放疗结束到手术、首次输血或第三次凝血程序进行测量。
16例患者根据三种发病率量表之一出现了3/4级并发症。2例患者需要手术（结肠造口术或乙状结肠切除术），3例需要多次输血，2例需要一或两次输血，9例需要至少三次凝血。那些需要多次治疗的患者出血的中位持续时间为7个月（范围3 - 33个月），中位潜伏期为22个月（范围9 - 40个月）。每种量表的3/4级并发症的5年精算发生率分别为：RTOG为0.7%，LENT为2%，FC - LENT为6%。慢性直肠出血的发生率随剂量增加而增加，并且由于剂量较低，采用传统技术治疗的患者发生率较低。
需要任何输血或多次凝血程序的慢性直肠出血是我们最常观察到的并发症。这种并发症在随访后期出现且持续时间长。我们认为这证明了将需要多次凝血程序的慢性直肠出血作为3级事件纳入未来发病率量表是合理的。我们的数据表明，已发表的3/4级发病率高度依赖于所选择的发病率量表，因为我们的数据显示RTOG为0.7%，LENT为2%，FC - LENT为6%。显然，需要一个统一的量表，该量表应纳入与前列腺癌适形治疗相关的新认识到的严重晚期效应。
