Ann Coloproctol.
2015 Aug;31(4):123-130. 10.3393/ac.2015.31.4.123.
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
- Affiliations
-
- 1Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
- 2Department of Radiation Oncology, Shiraz University of Medical Sciences, Shiraz, Iran.
- 3Colorectal Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. mohpanah@sums.ac.ir
- 4Department of Epidemiology, Kerman University of Medical Sciences, Kerman, Iran.
- 5Shiraz Institute for Cancer Research, Shiraz University of Medical Sciences, Shiraz, Iran.
- 6Department of Biostatistics, Shiraz University of Medical Sciences, Shiraz, Iran.
- KMID: 2169715
- DOI: http://doi.org/10.3393/ac.2015.31.4.123
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.
- Full Text Links
-
- Actions
-
Cited
- CITED
-
- Close
- Share
-
- Similar articles
-
- Is Low-Dose-Rate Endorectal Brachytherapy a New Treatment Method for Locally Advanced Distal Rectal Cancer?
- Efficacy and safety of sequential neoadjuvant chemotherapy and short-course radiation therapy followed by delayed surgery in locally advanced rectal cancer: a single-arm phase II clinical trial with subgroup analysis between the older and young patients
- Efficacy and Feasibility of Adding Induction Chemotherapy to Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer: A Phase II Clinical Trial
- Prospective Phase II Study of Preoperative Chemoradiation with Capecitabine in Locally Advanced Rectal Cancer
- Recent Progress in Diagnosis and Treatment of Rectal Cancer
