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Randomized Controlled Trial
. 2017 Mar 25;52(3):168-174.
doi: 10.3760/cma.j.issn.0529-567X.2017.03.006.

[A randomized study of intensity-modulated radiation therapy versus three dimensional conformal radiation therapy for pelvic radiation in patients of post-operative treatment with gynecologic malignant tumor]

[Article in Chinese]
Affiliations
Randomized Controlled Trial

[A randomized study of intensity-modulated radiation therapy versus three dimensional conformal radiation therapy for pelvic radiation in patients of post-operative treatment with gynecologic malignant tumor]

[Article in Chinese]
J Ni et al. Zhonghua Fu Chan Ke Za Zhi. .

Abstract

Objective: To study the difference between intensity-modulated radiation therapy (IMRT) and three dimensional conformal radiation therapy (3D-CRT) for pelvic radiation of post-operative treatment with gynecologic malignant tumor. Methods: A prospective investigation study was conducted on 183 patients of post-operative patients with whole pelvic radiation therapy of cervical cancer or endometrial cancer in Zhejiang Cancer Hospital [IMRT group (n=85) and 3D-CRT group (n=98)] from Oct. 2015 to Oct. 2016. The two groups received same dose (45 Gy in 25 fractions). Comparison of two groups with radiation dosimetry:the score according to the Radiation Therapy Oncology Group (RTOG) acute radiation injury grading standards before and after radiotherapy reaction, the score from functional assessment of cancer therapy scale-cervix (FACT-Cx) scale and expanded prostate cancer index composite for clinical practice (EPIC-CP) scale were also analyzed. Results: (1) There were no significant effect with age, culture level, family economic condition and ratio of radiochemotherapy between two groups (all P>0.05). (2) Dosimetric comparison for IMRT vs 3D-CRT: the average dose of planning target volume (PTV) decreased (46.1±0.4) vs (46.4±0.5) Gy, V(45) dose percentage increased (95.2±1.0) % vs (93.3±2.0) %, intestinal bag dose of V(4)0 decreased (24.4±6.8) % vs (36.5±15.9) %, rectal V(40) dose percentage decreased (73.9±12.3) % vs (85.4±8.4) %, and lower rectal V(45) dose percentage (32.8±13.4) % vs (71.5±13.7) %, bladder V(40) dose percentage decreased (55.5±13.0) % vs (84.4±13.0) %. Bone marrow V(20) lower: (67.9±5.4) % vs (79.5±6.6) %, V(1)0 lower: (82.1±6.0) % vs (86.3±6.6) %; there were significant differences (all P<0.05). There was no significant difference between the dose of V(45) in the intestinal pouch and bladder (P>0.05). (3) Acute radiation injury classification for IMRT vs 3D-CRT: big or small intestine: Ⅱ-Ⅲ reaction [13% (11/85) vs 24% (24/98); χ(2)=3.925, P=0.048], there was significant difference. Bladder: Ⅲ reaction [19% (16/85) vs 26% (25/98); χ(2)=1.171, P=0.279], there was no significant difference. Radiochemotherapy of bone marrow suppression: Ⅲ-Ⅳ reaction (14/20), the incidence rate [26% (14/54) vs 31% (20/65); χ(2)=0.339, P=0.562], the difference was not statistically significant. (4) Quality of life scale by FACT-Cx scale in IMRT vs 3D-CRT: there were no significant difference before radiotherapy (82±16 vs 85±16; t=1.279, P=0.203), while there was significant difference after radiotherapy (76±14 vs 71±18; t=-2.160, P=0.032). EPIC-CP scale score: before radiotherapy they were (16±7 vs 15±6; t=-0.174, P=0.862),but after radiotherapy (18±7 vs 22±7; t=3.158, P=0.002), there was significant difference between them. Before and after radiotherapy, the increased EPIC-CP scale of the IMRT group vs 3D-CRT group were 3±4 and 6±4, the 3D-CRT group was significantly higher, the difference was statistically significant (t=5.500, P=0.000). Conclusion: IMRT has shown that there are a significant benefit for the post-operative patients with cervical cancer and endometrial cancer compared to 3D-CRT.

目的: 子宫颈癌及子宫内膜癌患者术后给予盆腔外调强放疗(IMRT)或三维适形放疗(3D-CRT),探讨这两种放疗方式的放疗剂量、患者生命质量及其治疗结局的差异。 方法: 采用前瞻性随机对照研究方法,对浙江省肿瘤医院妇瘤科2015年10月—2016年10月收治的183例子宫颈癌及子宫内膜癌术后患者,随机(随机数字表法)分为两组,即IMRT组(85例)和3D-CRT组(98例),两组患者的放疗总剂量均为45 Gy,分割为1.8 Gy/d,5次/周,共25次完成。比较两组患者的一般情况、放疗剂量、急性放射性损伤的发生率、生命质量评分以及临床疗效,其中,放疗剂量学指标包括计划靶区(PTV)剂量分布以及危及器官肠袋、直肠、膀胱的照射体积百分比;急性放射性损伤的评价采用美国肿瘤放疗协作组(RTOG)与欧洲癌症研究与治疗组织(EORTC)共同制定的急性放射性损伤的分级标准;生命质量评分采用癌症治疗功能评估量表(FACT-Cx量表)和前列腺癌临床生命质量量表(EPIC-CP量表)。 结果: (1)一般情况:183例患者中,Ⅰ~Ⅱa期子宫颈癌患者170例(包括IMRT组81例和3D-CRT组89例),Ⅰ~Ⅱ期子宫内膜癌患者13例(包括IMRT组4例和3D-CRT组9例),两组间子宫颈癌、子宫内膜癌患者所占比例分别比较,差异均无统计学意义(P>0.05);IMRT组、3D-CRT组患者行同步化疗的比例分别为64%(54/85)、66%(65/98),两组比较,差异无统计学意义(P>0.05);IMRT组、3D-CRT组患者的年龄、文化程度及家庭经济状况分别比较,差异均无统计学意义(P>0.05)。(2)放疗剂量:与3D-CRT组相比,IMRT组PTV平均照射剂量降低[分别为(46.4±0.5)、(46.1±0.4)Gy],45%处方剂量包绕的照射体积百分比(V(45))增高[分别为(93.3±2.0)%、(95.2±1.0)%];肠袋的V(40)降低[分别为(36.5±15.9)%、(24.4±6.8)%];直肠的V(40)[分别为(85.4±8.4)%、(73.9±12.3)%]、V(45)[分别为(71.5±13.7)%、(32.8±13.4)%]均降低;膀胱的V(40)降低[分别为(84.4±13.0)%、(55.5±13.0)%];骨髓的V(20)[分别为(79.5±6.6)%、(67.9±5.4)%]、V(10)[分别为(86.3±6.6)%、(82.1±6.0)%]均降低。两组间上述指标分别比较,差异均有统计学意义(P<0.05)。而IMRT组与3D-CRT组的肠袋V(45)、膀胱V(45)分别比较,差异均无统计学意义(P>0.05)。(3)急性放射性损伤:IMRT组、3D-CRT组患者Ⅱ~Ⅲ级急性放射性肠炎的发生率分别为13%(11/85)、24%(24/98),两组比较,差异有统计学意义(χ(2)=3.925,P=0.048);Ⅲ级急性放射性膀胱炎的发生率分别为19%(16/85)、26%(25/98),两组比较,差异无统计学意义(χ(2)=1.171,P=0.279);IMRT组、3D-CRT组患者中,未行同步化疗者Ⅲ度骨髓抑制的发生率分别为6%(2/31)、9% (3/33),行同步化疗者Ⅲ~Ⅳ度急性骨髓抑制的发生率分别为26%(14/54)、31%(20/65),两组分别比较,差异均无统计学意义(P>0.05)。(4)生命质量评分:放疗前,IMRT组、3D-CRT组的FACT-Cx量表评分分别为(82±16)、(85±16)分,EPIC-CP量表评分分别为(16±7)、(15±6)分,两组分别比较,差异均无统计学意义(P>0.05);放疗后,IMRT组、3D-CRT组的FACT-Cx量表评分分别为(76±14)、(71±18)分,EPIC-CP量表评分分别为(18±7)、(22±7)分,两组分别比较,差异均有统计学意义(P<0.05)。放疗前、后IMRT组、3D-CRT组患者的EPCI-CP量表评分升高幅度分别为(3±4)、(6±4)分,两组比较,差异有统计学意义(t=5.500,P=0.000)。(5)临床疗效:随访至2016年10月,IMRT组复发3例,复发率为4% (3/85),3D-CRT组复发2例,复发率为2%(2/98),两组比较,差异无统计学意义(χ(2)=0.026,P=0.538)。 结论: 子宫颈癌及子宫内膜癌患者术后IMRT相对于3D-CRT可以达到更好的靶区剂量分布,明显降低危及器官的照射体积百分比,并减少急性放射性损伤,获得更好的生命质量。.

Keywords: Endometrial neoplasms; Quality of life; Radiation injuries; Radiotherapy, conform; Radiotherapy, intensity-modulated; Uterine cervical neoplasms.

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