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Efficacy and Safety of Low-Dose-Rate Endorectal Brachytherapy as a Boost to Neoadjuvant Chemoradiation in the Treatment of Locally Advanced Distal Rectal Cancer: A Phase-II Clinical Trial

대한대장항문학회지 2015년 31권 4호 p.123 ~ 130
 ( Omidvari Shapour ) - Shiraz University of Medical Sciences Namazi Hospital Department of Radiation Oncology

 ( Zohourinia Shadi ) - Shiraz University of Medical Sciences Department of Radiation Oncology
 ( Ansari Mansour ) - Shiraz University of Medical Sciences Namazi Hospital Department of Radiation Oncology
 ( Ghahramani Leila ) - Shiraz University of Medical Sciences Colorectal Research Center
 ( Zare-Bandamiri Mohammad ) - Kerman University of Medical Sciences Department of Epidemiology
 ( Mosalaei Ahmad ) - Shiraz University of Medical Sciences Shiraz Institute for Cancer Research
 ( Ahmadloo Niloofar ) - Shiraz University of Medical Sciences Namazi Hospital Department of Radiation Oncology
 ( Pourahmad Saeedeh ) - Shiraz University of Medical Sciences Department of Biostatistics
 ( Nasrolahi Hamid ) - Shiraz University of Medical Sciences Department of Radiation Oncology
 ( Hamedi Sayed-Hasan ) - Shiraz University of Medical Sciences Colorectal Research Center
 ( Mohammadianpanah Mohammad ) - Shiraz University of Medical Sciences Colorectal Research Center

Abstract


Purpose
Despite advances in rectal cancer treatment over the last decade, local control and risk of late side effects due to external beam radiation therapy (EBRT) remain as concerns. The present study aimed to investigate the efficacy and the safety of low-dose-rate endorectal brachytherapy (LDRBT) as a boost to neoadjuvant chemoradiation for use in treating locally advanced distal rectal adenocarcinomas.

Methods
This phase-II clinical trial included 34 patients (as the study arm) with newly diagnosed, locally advanced (clinical T3-T4 and/or N1/N2, M0) lower rectal cancer. For comparative analysis, 102 matched patients (as the historical control arm) with rectal cancer were also selected. All the patients were treated with LDRBT (15 Gy in 3 fractions) and concurrent chemoradiation (45-50.4 Gy). Concurrent chemotherapy consisted of oxaliplatin 130 mg/m2 intravenously on day 1 plus oral capecitabine 825 mg/m2 twice daily during LDRBT and EBRT.

Results
The study results revealed a significant differences between the study arm and the control arm in terms in the pathologic tumor size (2.1 cm vs. 3.6 cm, P = 0.001), the pathologic tumor stage (35% T3-4 vs. 65% T3-4, P = 0.003), and the pathologic complete response (29.4% vs. 11.7%, P < 0.028). Moreover, a significantly higher dose of EBRT (P = 0.041) was found in the control arm, and a longer time to surgery was observed in the study arm (P < 0.001). The higher rate of treatment-related toxicities, such as mild proctitis and anemia, in the study arm was tolerable and easily manageable.

Conclusion
A boost of LDRBT can optimize the pathologic complete response, with acceptable toxicities, in patients with distal rectal cancer.

키워드

Rectal neoplasms; Adenocarcinoma; Brachytherapy; Neoadjuvant treatment; Surgery
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