Annals of Coloproctology

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Colorectal cancer

Preventive efficacy of hydrocortisone enema for radiation proctitis in rectal cancer patients undergoing short-course radiotherapy: a phase II randomized placebo-controlled clinical trial: Mohammad Mohammadianpanah, Maryam Tazang, Nam Phong Nguyen, Niloofar Ahmadloo, Shapour Omidvari, Ahmad Mosalaei, Mansour Ansari, Hamid Nasrollahi, Behnam Kadkhodaei, Nezhat Khanjani, Seyed Vahid Hosseini; Ann Coloproctol. 2024;40(5):506-514. Published online October 22, 2024; DOI: https://doi.org/10.3393/ac.2024.00192.0027

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Purpose
This study aimed to investigate the efficacy of hydrocortisone enema in preventing radiation proctitis in patients with rectal cancer undergoing short-course radiotherapy (SCRT).
Methods
This phase II randomized controlled trial enrolled patients with newly diagnosed locally advanced rectal cancer (clinically staged T3–4 and/or N1–2M0). Participants received a median of 4 cycles of neoadjuvant chemotherapy (capecitabine plus oxaliplatin) followed by 3-dimensional conformal SCRT (25 Gy in 5 fractions). Patients were randomly assigned to receive either a hydrocortisone enema (n=50) or a placebo (n=51) once daily for 5 consecutive days during SCRT. The primary endpoint was the incidence and severity of acute proctitis.
Results
Of the 111 eligible patients, 101 were included in the study. Baseline characteristics, including sex, age, performance status, and tumor location, were comparable across the treatment arms. None of the patients experienced grade 4 acute gastrointestinal toxicity or had to discontinue treatment due to treatment-related adverse effects. Patients in the hydrocortisone arm experienced significantly less severe proctitis (P<0.001), diarrhea (P=0.023), and rectal pain (P<0.001) than those in the placebo arm. Additionally, the duration of acute gastrointestinal toxicity following SCRT was significantly shorter in patients receiving hydrocortisone (P<0.001).
Conclusion
Hydrocortisone enema was associated with a significant reduction in the severity of proctitis, diarrhea, and rectal pain compared to placebo. Additionally, patients treated with hydrocortisone experienced shorter durations of gastrointestinal toxicity following SCRT. This study highlights the potential benefits of hydrocortisone enema in managing radiation-induced toxicity in rectal cancer patients undergoing radiotherapy.

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Efficacy of Neoadjuvant Hypofractionated Chemoradiotherapy in Elderly Patients with Locally Advanced Rectal Cancer: A Single-Center Retrospective Analysis
Jae Seung Kim, Jaram Lee, Hyeung-min Park, Soo Young Lee, Chang Hyun Kim, Hyeong Rok Kim
Cancers.2024; 16(24): 4280. CrossRef

Efficacy and Feasibility of Adding Induction Chemotherapy to Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer: A Phase II Clinical Trial: Hamid Nasrolahi, Sepideh Mirzaei, Mohammad Mohammadianpanah, Ali Mohammad Bananzadeh, Maral Mokhtari, Mohammad Reza Sasani, Ahmad Mosalaei, Shapour Omidvari, Mansour Ansari, Niloofar Ahmadloo, Seyed Hasan Hamedi, Nezhat Khanjani; Ann Coloproctol. 2019;35(5):242-248. Published online October 31, 2019; DOI: https://doi.org/10.3393/ac.2018.09.06

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Abstract PDF

Purpose
Currently, neoadjuvant chemoradiation (CRT) followed by total mesorectal resection is considered the standard of care for treating locally advanced rectal cancer. This study aimed to investigate the efficacy and feasibility of adding induction chemotherapy to neoadjuvant CRT in locally advanced rectal cancer.
Methods
This phase-II clinical trial included 54 patients with newly diagnosed, locally advanced (clinical T3–4 and/or N1–2, M0) rectal cancer. All patients were treated with 3 cycles of preoperative chemotherapy using the XELOX (capecitabine + oxaliplatin) regimen before and after a concurrent standard long course of CRT (45–50.4 Gy) followed by standard radical surgery. Pathologic complete response (PCR) rate and toxicity were the primary and secondary endpoints, respectively.
Results
The study participants included 37 males and 17 females, with a median age of 59 years (range, 20–80 years). Twenty-nine patients (54%) had clinical stage-II disease, and 25 patients (46%) had clinical stage-III disease. Larger tumor size (P = 0.006) and distal rectal location (P = 0.009) showed lower PCR compared to smaller tumor size and upper rectal location. Pathologic examinations showed significant tumor regression (6.1 ± 2.7 cm vs. 1.9 ± 1.8 cm, P < 0.001) with 10 PCRs (18.5%) compared to before the intervention. The surgical margin was free of cancer in 52 patients (96.3%). Treatment-related toxicities were easily tolerated, and all patients completed their planned treatment without interruption. Grade III and IV toxicities were infrequent.
Conclusion
The addition of induction chemotherapy to neoadjuvant CRT is an effective and well-tolerated treatment approach in patients with rectal cancer.

Citations

Citations to this article as recorded by

Nanomedicine integrating the lipidic derivative of 5-fluorouracil, miriplatin and PD-L1 siRNA for enhancing tumor therapy
An Lu, Yuhao Guo, Yi Yan, Lin Zhai, Xiangyu Wang, Weiran Cao, Zijie Li, Zhixia Zhao, Yujie Shi, Yuanjun Zhu, Xiaoyan Liu, Huining He, Zhiyu Wang, Jian-Cheng Wang
Chinese Chemical Letters.2024; 35(6): 108928. CrossRef
Watch and wait strategies for rectal cancer: A systematic review
In Ja Park
Precision and Future Medicine.2022; 6(2): 91. CrossRef
Intensified Total Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer: A Phase II Trial
F. De Felice, G. D'Ambrosio, F. Iafrate, A. Gelibter, F.M. Magliocca, D. Musio, S. Caponetto, G. Casella, I. Clementi, A. Picchetto, G. Sirgiovani, M. Parisi, C. Orciuoli, G. Torrese, G. De Toma, V. Tombolini, E. Cortesi
Clinical Oncology.2021; 33(12): 788. CrossRef
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
Alimohammad Bananzadeh, Ali Akbar Hafezi, NamPhong Nguyen, Shapour Omidvari, Ahmad Mosalaei, Niloofar Ahmadloo, Mansour Ansari, Mohammad Mohammadianpanah
Radiation Oncology Journal.2021; 39(4): 270. CrossRef
Induction Chemotherapy in Patients With Anal Canal Cancer: A Pilot Study
Francesca De Felice, Daniela Musio, Vincenzo Tombolini
Clinical Colorectal Cancer.2020; 19(3): e137. CrossRef

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: Shapour Omidvari, Shadi Zohourinia, Mansour Ansari, Leila Ghahramani, Mohammad Zare-Bandamiri, Ahmad Mosalaei, Niloofar Ahmadloo, Saeedeh Pourahmad, Hamid Nasrolahi, Sayed Hasan Hamedi, Mohammad Mohammadianpanah; Ann Coloproctol. 2015;31(4):123-130. Published online August 31, 2015; DOI: https://doi.org/10.3393/ac.2015.31.4.123

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11 Web of Science
14 Citations

Abstract PDF

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.

Citations

Citations to this article as recorded by

Intraoperative low-dose rate brachytherapy as an adjunct to surgery for marginally resectable rectal and recurrent anorectal carcinomas
Mustafa M. Al Balushi, Teresia M. Perkins, Kee-Young Shin, Ivan M. Buzurovic, Simon G. Talbot, Joel E. Goldberg, Desmond A. O’Farrell, Martin T. King, Harvey J. Mamon, Philip M. Devlin
Brachytherapy.2025; 24(6): 931. CrossRef
Neoadjuvant Therapy for Organ Preservation in Locally Advanced Rectal Cancer: A Review
Liangting Qiu, Jianjun Li
Therapeutics and Clinical Risk Management.2025; Volume 21: 1289. CrossRef
Examining external control arms in oncology: A scoping review of applications to date
Eliya Farah, Matthew Kenney, Matthew T. Warkentin, Winson Y. Cheung, Darren R. Brenner
Cancer Medicine.2024;[Epub] CrossRef
Brachytherapy of rectal cancer: comparative characteristics of techniques (review)
Roman V. Novikov, Sergey N. Novikov
Koloproktologia.2023; 22(3): 158. CrossRef
Neoadjuvant Radiotherapy Dose Escalation in Locally Advanced Rectal Cancer: a Systematic Review and Meta-analysis of Modern Treatment Approaches and Outcomes
N. Hearn, D. Atwell, K. Cahill, J. Elks, D. Vignarajah, J. Lagopoulos, M. Min
Clinical Oncology.2021; 33(1): e1. CrossRef
Recommendations on Management of Locally Advanced Rectal Cancer During the COVID-19 Pandemic: an Iranian Consensus
Zahra Siavashpour, Farzad Taghizadeh-Hesary, Afshin Rakhsha
Journal of Gastrointestinal Cancer.2020; 51(3): 800. CrossRef
Recent advances in (chemo-)radiation therapy for rectal cancer: a comprehensive review
F. Roeder, E. Meldolesi, S. Gerum, V. Valentini, C. Rödel
Radiation Oncology.2020;[Epub] CrossRef
Predictive Significance of Mucinous Histology on Pathologic Complete Response Rate Following Capecitabine-Based Neoadjuvant Chemoradiation in Rectal Cancer: a Comparative Study
Sare Hosseini, NamPhong Nguyen, Mohammad Mohammadianpanah, Sepideh Mirzaei, Ali Mohammad Bananzadeh
Journal of Gastrointestinal Cancer.2019; 50(4): 716. CrossRef
A systematic review comparing radiation toxicity after various endorectal techniques
An-Sofie Verrijssen, Thirza Opbroek, Murillo Bellezzo, Gabriel P. Fonseca, Frank Verhaegen, Jean-Pierre Gerard, Arthur Sun Myint, Evert J. Van Limbergen, Maaike Berbee
Brachytherapy.2019; 18(1): 71. CrossRef
Is the Pathologic Response of T3 Rectal Cancer to High-Dose-Rate Endorectal Brachytherapy Comparable to External Beam Radiotherapy?
Richard Garfinkle, Sebastian Lachance, Te Vuong, Alexandre Mikhail, Vincent Pelsser, Adrian Gologan, Nancy A. Morin, Carol-Ann Vasilevsky, Marylise Boutros
Diseases of the Colon & Rectum.2019; 62(3): 294. CrossRef
Phase 2 Neoadjuvant Treatment Intensification Trials in Rectal Cancer: A Systematic Review
Mark T.W. Teo, Lucy McParland, Ane L. Appelt, David Sebag-Montefiore
International Journal of Radiation Oncology*Biology*Physics.2018; 100(1): 146. CrossRef
Colorectal Cancer Staging Using Three Clustering Methods Based on Preoperative Clinical Findings
Saeedeh Pourahmad, Soudabeh Pourhashemi, Mohammad Mohammadianpanah
Asian Pacific Journal of Cancer Prevention.2016; 17(2): 823. CrossRef
Lentivirus‐mediated shRNA interference of ghrelin receptor blocks proliferation in the colorectal cancer cells
An Liu, Chenggang Huang, Jia Xu, Xuehong Cai
Cancer Medicine.2016; 5(9): 2417. CrossRef
Is Low-Dose-Rate Endorectal Brachytherapy a New Treatment Method for Locally Advanced Distal Rectal Cancer?
Seung Hyuk Baik
Annals of Coloproctology.2015; 31(4): 115. CrossRef

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