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World J Gastrointest Oncol. Jan 15, 2018; 10(1): 40-47
Published online Jan 15, 2018. doi: 10.4251/wjgo.v10.i1.40
Neoadjuvant hyperfractionated accelerated radiotherapy plus concomitant 5-fluorouracil infusion in locally advanced rectal cancer: A phase II study
Zeynep Gural, Serap Yucel, Department of Radiation Oncology, Acibadem University Medical Faculty, Istanbul 34303, Turkey
Sezer Saglam, Cetin Ordu, Department of Medical Oncology, Istanbul Bilim University, Istanbul 34349, Turkey
Esra Kaytan-Saglam, Ahmet Kizir, Ethem N Oral, Department of Radiation Oncology, Istanbul Medical Faculty, Istanbul University, Istanbul 34093, Turkey
Oktar Asoglu, Department of General Surgery, Academia of Clinical Science of Bogazici, Istanbul 34357, Turkey
Hediye Acun, Department of Medical Biophysics, Harran University Medical Faculty, Şanlıurfa 60300, Turkey
Rasul Sharifov, Department of Radiology, Bezm-i Alem University, Istanbul 34093, Turkey
Semen Onder, Department of Pathology, Istanbul Medical Faculty, Istanbul University, Istanbul 34093, Turkey
Author contributions: All the authors contributed to this study; Gural Z and Saglam S contributed equally to the study.
Institutional review board statement: The study was reviewed and approved by the Istanbul Medical Faculty Institutional Review Board.
Informed consent statement: All information was obtained with the appropriate institutional review board waivers, and the data were collected without revealing any personal information.
Conflict-of-interest statement: The authors have no conflicts of interest, financial or otherwise.
Data sharing statement: Dataset is available from the corresponding author by e-mail at: firstname.lastname@example.org.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Zeynep Gural, MD, Attending Doctor, Department of Radiation Oncology, Acibadem University Medical Faculty, Halkalı Merkez Mahallesi, Turgut Özal Blv No:16, Istanbul 34303, Turkey. email@example.com
Telephone: +90-533-2696742 Fax: +90-212-4044445
Received: September 4, 2017
Peer-review started: September 7, 2017
First decision: October 9, 2017
Revised: November 26, 2017
Accepted: December 4, 2017
Article in press: December 4, 2017
Published online: January 15, 2018
To evaluate the efficacy and tolerability of neoadjuvant hyperfractionated accelerated radiotherapy (HART) and concurrent chemotherapy in patients with locally advanced infraperitoneal rectal cancer.
A total of 30 patients with histopathologically confirmed T2-3/N0+ infraperitoneal adenocarcinoma of rectum cancer patients received preoperative 42 Gy/1.5 Gy/18 days/bid radiotherapy and continuous infusion of 5-fluorouracil (325 mg/m2). All patients were operated 4-8 wk after neoadjuvant concomitant therapy.
In the early phase of treatment, 6 patients had grade III-IV gastrointestinal toxicity, 2 patients had grade III-IV hematologic toxicity, and 1 patient had grade V toxicity due to postoperative sepsis during chemotherapy. Only 1 patient had radiotherapy-related late side effects, i.e., grade IV tenesmus. Complete pathological response was achieved in 6 patients (21%), while near-complete pathological response was obtained in 9 (31%). After a median follow-up period of 60 mo, the local tumor control rate was 96.6%. In 13 patients, distant metastasis occurred. Disease-free survival rates at 2 and 5 years were 63.3% and 53%, and corresponding overall survival rates were 70% and 53.1%, respectively.
Although it has excellent local control and complete pathological response rates, neoadjuvant HART concurrent chemotherapy appears to not be a feasible treatment regimen in locally advanced rectal cancer, having high perioperative complication and intolerable side effects. Effects of reduced 5-fluorouracil dose or omission of chemotherapy with the aim of reducing toxicity may be examined in further studies.
Core tip: This study includes a first phase II study evaluating neoadjuvant hyperfractionated accelerated radiotherapy plus concomitant infusional 5-fluorouracil (5-FU) chemotherapy in locally advanced rectal cancer (not resectable cancer). This regimen may allow clinicians to design other neoadjuvant hyperfractionated accelerated radiotherapies. This study showed excellent local control but high rate of perioperative complications. Decreasing or modifying the 5-FU dose could provide better local control.