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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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

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