J Cancer 2019; 10(25):6217-6224. doi:10.7150/jca.35510

Research Paper

The role of hypofractionated radiotherapy for the definitive treatment of localized prostate cancer: early results of a randomized trial

Petros Alexidis1, Dimitris Dragoumis10, Sotirios Karatzoglou10, Konstantinos Drevelegas11, Ioannis Tzitzikas2, Konstantinos Hatzimouratidis3, Ioannis Chrisogonidis4, Dimitris Giannakidis4, Charilaos Koulouris4, Athanasios Katsaounis4, Nikolaos Michalopoulos4, Haidong Huang5, Qiang Li5, Zoi Aidoini4, Varbara Fyntanidou6, Aikaterini Amaniti6, Wolfgang Hohenforst-Schmidt7, Elena Maragouli8, Savvas Petanidis9, Paul Zarogoulidis4✉, Konstantinos Sapalidis4, Christoforos Kosmidis4, Konstantinos Romanidis12, Panagoula Oinkonomou12, Anastasios Vagionas13, Iason Nikolaos-Katsios4, Aris Ioannidis4, Konstantina Boniou14, Isaak Kesisoglou4

1. Department of Radiation Oncology, Interbalkan European Medical Center; Thessaloniki, Greece.
2. Department of Radiation Oncology, AHEPA University Hospital of Thessaloniki, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Greece.
3. Department of Urology, Papageorgiou hospital of Thessaloniki, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki, Greece.
4. 3rd Department of Surgery, AHEPA University Hospital, Aristotle University of Thessaloniki, Medical School, Thessaloniki, Greece.
5. The Diagnostic and Therapeutic Center of Respiratory Diseases, Shanghai East Hospital, Tongji University, Shanghai, China.
6. Anesthisiology Department, AHEPA University Hospital, Aristotle University of Thessaloniki, Medical School; Thessaloniki, Greece.
7. Sana Clinic Group Franken, Department of Cardiology/Pulmonology/Intensive Care/Nephrology, "Hof" Clinics, University of Erlangen, Hof, Germany.
8. Oncology Department, University of Thessali, Larissa, Greece.
9. Department of Pulmonology, I.M. Sechenov First Moscow State Medical University; Moscow, 119992, Russian Federation.
10. Neurosurgical Department, ``G. Papanikolaou`` General Hospital, Thessaloniki, Greece
11. Radiology Department, Everlight Radiology, U.K
12. Second Department of Surgery, University Hospital of Alexandroupolis, Medical School, Democritus University of Thrace, 68100 Alexandroupolis, Greece
13. Oncology Department, General Hospital of Kavala, Greece
14. Radiology Department, ``Theageneio`` Cancer Hospital, Thessaloniki, Greece

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Citation:
Alexidis P, Dragoumis D, Karatzoglou S, Drevelegas K, Tzitzikas I, Hatzimouratidis K, Chrisogonidis I, Giannakidis D, Koulouris C, Katsaounis A, Michalopoulos N, Huang H, Li Q, Aidoini Z, Fyntanidou V, Amaniti A, Hohenforst-Schmidt W, Maragouli E, Petanidis S, Zarogoulidis P, Sapalidis K, Kosmidis C, Romanidis K, Oinkonomou P, Vagionas A, Nikolaos-Katsios I, Ioannidis A, Boniou K, Kesisoglou I. The role of hypofractionated radiotherapy for the definitive treatment of localized prostate cancer: early results of a randomized trial. J Cancer 2019; 10(25):6217-6224. doi:10.7150/jca.35510. Available from http://www.jcancer.org/v10p6217.htm

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Abstract

Background: Prostate cancer is considered to have a special biology which could affect the radiation therapy result based on the selected fractionation scheme. We present the preliminary results of a randomized trial comparing conventionally and hypofractionated radiation therapy for prostate cancer.

Methods: Patients included in the study had localized prostate cancer (cT1c-T3bN0M0) and were randomly assigned to mild hypofractionated (72 Gy in 32 fractions, arm1) or conventionally fractionated (74 Gy in 37 fractions, arm2) radiation therapy treatment with Volumetric Arc Therapy technique. The treatment was delivered only to the prostate with or without the seminal vesicles according to physician's discretion and hormone therapy was optional according to the disease stage and comorbidities. Here we present the preliminary results of acute toxicity from the gastrointestinal (GI) and genitourinary (GU) system.

Results: Between 2015 and 2016, 139 patients were enrolled. 67 patients were treated with conventional fractionation and 72 were treated with hypofractionation. Grade≥ 2 toxicity from GU and GI was observed in 23 and 21 patients (31,9% vs 31,3%, p=0,79) and 15 and 12 (20,8% vs 17,9%, p=0,6) for arm1 and arm2 respectively. No statistically significant differences were observed between arms in the incidence of early toxicity. There was no correlation observed between patient characteristics and toxicity from either GU or GI.

Conclusions: Hypofractionated radiotherapy appears to be equally tolerated compared to conventional fractionation in the early setting. Longer follow up is needed to assess the late toxicity profile of the patients and any potential differences between the control and experimental arm.

Keywords: hypofractionation, early toxicity, prostate cancer