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宫颈癌每周及每三周一次的顺铂同步放化疗:一项关于毒性和依从性的前瞻性随机研究

Weekly . tri-weekly cisplatin based chemoradiation in carcinoma cervix: a prospective randomized study of toxicity and compliance.

作者信息

Katke Aradhana, Nanda R, Thejaswini B, Pasha Tanveer, Giri G V, Babu Govind, Pawar Yashwant

机构信息

Department of Radiation Oncology, Kidwai Memorial Institute of Oncology, Bangalore, India.

出版信息

Rep Pract Oncol Radiother. 2021 Dec 30;26(6):948-954. doi: 10.5603/RPOR.a2021.0115. eCollection 2021.

Abstract

BACKGROUND

Addition of chemotherapy to radiation has improved 5-year survival by 6%. However, the optimal dose and schedule of concurrent cisplatin is not well defined, though widely accepted practice is the weekly schedule of 40 mg/m for 5 weeks. Repeated admissions for weekly cisplatin drain the limited resources in high volume centres. We intended to study the compliance and toxicity of two cisplatin schedules in our patients diagnosed with carcinoma cervix.

MATERIALS AND METHODS

Between 2007-2011, 212 patients, histologically proven squamous cell carcinoma with stages IIB to IIIB were randomized into two arms. All patients were planned for external beam radiotherapy 45 Gy/25 frs over 5 weeks followed by Intracavitary or Interstitial brachytherapy to a total BED dose of 75-85 Gy. Single agent cisplatin given concomitantly, was scheduled weekly (40 mg/m/cycle, 5 cycles) in an arm A and three weekly (100 mg/m/cycle, 2 cycles) in an arm B. Toxicity and compliance were evaluated weekly according to the RTOG guidelines. Analysis of the compiled data was done using SSPS version 20.

RESULTS

Of the evaluable 212, 109 patients received weekly cisplatin chemotherapy and 103 patients received three weekly cisplatin. The most common acute toxicity observed was grade I-II leucopoenia. The upper and lower gastrointestinal reactions were high in three weekly arms, which was statistically significant (57% and 42.7%, p < 0.05). Proctitis was observed in 10% of patients in both of the arms and only two patients had Gr1 Cystitis after 6 months of treatment.

CONCLUSIONS

Tri-weekly cisplatin based concurrent chemoradiation can be adopted in high volume centres with manageable haematological and gastrointestinal acute toxicities.

摘要

背景

放疗联合化疗可使5年生存率提高6%。然而,顺铂同步放化疗的最佳剂量和方案尚未明确,尽管目前广泛采用的方案是每周40mg/m²,共5周。每周重复住院接受顺铂治疗消耗了大型中心有限的资源。我们旨在研究两种顺铂方案在宫颈癌患者中的依从性和毒性。

材料与方法

2007年至2011年期间,212例经组织学证实为IIB至IIIB期鳞状细胞癌的患者被随机分为两组。所有患者计划在5周内接受45Gy/25次分割的体外照射放疗,随后进行腔内或组织间近距离放疗,使总生物等效剂量达到75 - 85Gy。A组患者同步给予单药顺铂,每周一次(40mg/m²/周期,共5个周期),B组患者每三周一次(100mg/m²/周期,共2个周期)。根据美国放射肿瘤学协作组(RTOG)指南每周评估毒性和依从性。使用SPSS 20版对汇总数据进行分析。

结果

在可评估的212例患者中,109例接受每周顺铂化疗,103例接受每三周顺铂化疗。观察到的最常见急性毒性为I - II级白细胞减少。每三周方案组的上消化道和下消化道反应发生率较高,具有统计学意义(分别为57%和42.7%,p < 0.05)。两组均有10%的患者出现直肠炎,治疗6个月后仅有2例患者出现1级膀胱炎。

结论

在大型中心,每三周一次顺铂同步放化疗方案可采用,其血液学和胃肠道急性毒性易于控制。

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