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Effect of hypofractionated, palliative radiotherapy on quality of life in late-stage oral cavity cancer: A prospective clinical trial

机译:超分割,姑息性放疗对晚期口腔癌生活质量的影响:一项前瞻性临床试验

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Context: The study was designed to evaluate the effect of a hypofractionated, palliative conformal radiotherapy regimen of 5250 cGy in 15 fractions in inoperable/incurable oral cavity carcinoma. Aims: The primary objective was to assess the change in the quality of life (QOL) with respect to pain and mouth opening pre- and post-radiotherapy using standardized questionnaires. The secondary objective was to assess overall QOL using the same questionnaires and also to assess response rates, survival, compliance, early and late toxicity. Settings and Design: This was a single-arm, prospective trial. Patients with incurable oral cavity cancer referred for palliative intent radiotherapy to the Department of Radiotherapy, RCC, JIPMER were recruited into the study. Subjects and Methods: Forty-eight patients were recruited and twenty-five patients were given conformal radiotherapy to a dose of 52.5 Gy in 15 fractions. QOL was assessed using the European Organization of Research and Treatment of Cancer (EORTC) questionnaires before and 2 months after the completion of radiotherapy. The response assessment was made using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 2 months after radiotherapy. The early and late toxicities were assessed at 2 months and 6 months after radiotherapy completion, respectively. Statistical Analysis Used: Sample size was calculated to be 53. The Wilcoxon signed-rank test was used to compare QOL scores pre- and post-radiotherapy. Median survival was assessed using the Kaplan–Meier method. Results: There was a significant improvement in the pain, mouth opening, speech, social contact, social eating, felt ill items of the EORTC QLQ-H and N35 questionnaire and role functioning, emotional functioning, social functioning, fatigue, pain, insomnia, appetite loss, financial difficulties, and Global QOL subscales of the QLQ-C30 questionnaire. 72% of the patients had grade 3 acute radiation oral mucositis and 36% had grade 3 acute radiation dermatitis. There were no significant treatment breaks due to toxicity. There were no grade 3 late toxicities observed. Overall median survival was 5.1 months. The overall response rate was 47%. The median time to treatment completion was 24 days. Conclusions: The improvement in QOL parameters suggests that the regimen of 52.5 Gy in 15 fractions is suitable for palliative intent radiotherapy in late-stage oral cavity cancer for effective palliation for short periods.
机译:背景:本研究旨在评估无法手术/无法治愈的口腔癌中15个部位的5250 cGy次分割姑息保形放射疗法的效果。目的:主要目的是使用标准调查表评估放疗前后疼痛和张口的生活质量(QOL)的变化。次要目标是使用相同的问卷评估总体QOL,还评估回应率,生存率,依从性,早期和晚期毒性。设置和设计:这是一项单臂前瞻性试验。该研究招募了患有顽固性口腔癌的患者,他们将姑息性放疗转诊至放射治疗,RCC,JIPMER部门。受试者与方法:招募了48位患者,对25位患者进行了15个分量的52.5 Gy剂量的适形放疗。在放疗完成前和放疗后两个月,使用欧洲癌症研究与治疗组织(EORTC)问卷对QOL进行了评估。放疗后2个月,使用实体瘤反应评估标准(RECIST)标准进行反应评估。放疗完成后2个月和6个月分别评估早期和晚期毒性。使用的统计分析:样本量经计算为53。Wilcoxon符号秩检验用于比较放疗前后的QOL得分。使用Kaplan-Meier方法评估中位生存期。结果:EORTC QLQ-H和N35问卷的疼痛,张口,言语,社交,社交饮食,感到不适的项目以及角色功能,情绪功能,社交功能,疲劳,疼痛,失眠,食欲不振,财务困难和QLQ-C30问卷的全球QOL量表。 72%的患者患有3级急性放射口腔粘膜炎,36%的患者具有3级急性放射性皮炎。没有由于毒性引起的重大治疗中断。没有观察到3级晚期毒性。总体中位生存期为5.1个月。总体回应率为47%。完成治疗的中位时间为24天。结论:QOL参数的改善表明,在15个分数中使用52.5 Gy的方案适用于晚期口腔癌的姑息性放疗,可在短期内有效缓解。

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