J Cancer 2020; 11(5):1008-1016. doi:10.7150/jca.37825 This issue

Research Paper

Late results of a randomized trial on the role of mild hypofractionated radiotherapy for the treatment of localized prostate cancer

Petros Alexidis1, Sotirios Karatzoglou2, Dimitris Dragoumis2, Konstantinos Drevelegas3, Ioannis Tzitzikas4, Konstantinos Hatzimouratidis5, Ioannis Chrisogonidis6, Aris Ioannidis7, Iason Nikolaos Katsios7, Paul Zarogoulidis7✉, Konstantinos Sapalidis7, Charilaos Koulouris7, Nikolaos Michalopoulos7, Dimitrios Giannakidis7, Zoi Aidoni8, Varbara Fyntanidou9, Aikaterini Amaniti9, Konstantina Boniou10, Isaak Kesisoglou7, Anastasios Vagionas11, Konstantinos Romanidis12, Panagoula Oikonomou12, Alexandru Marian Goganau13, Savas Petanidis14, Elena Maragouli15, Christoforos Kosmidis7

1. Department of Radiation Oncology, “ Interbalkan European Medical Center” Thessaloniki, Greece.
2. Neurosurgical Department, “G. Papanikolaou” General Hospital, Thessaloniki, Greece.
3. Radiology Department, Everlight Radiology, U.K.
4. Department of Radiation Oncology, AHEPA University Hospital of Thessaloniki, Faculty of Medicine, School of Health Sciences, Aristoteleion University of Thessaloniki, Greece.
5. Department of Urology, Papageorgiou hospital of Thessaloniki, Faculty of Medicine, School of Health Sciences, Aristoteleion University of Thessaloniki, Greece.
6. Department of Radiology, AHEPA University Hospital of Thessaloniki, Faculty of Medicine, School of Health Sciences, Aristoteleion University of Thessaloniki, Greece.
7. 3rd Department of Surgery, “AHEPA” University Hospital, Aristotle University of Thessaloniki, Medical School, Thessaloniki, Greece.
8. Ιntensive Care Unit (ICU), “AHEPA” University Hospital of Thessaloniki, Faculty of Medicine, School of Health Sciences, Aristoteleion University of Thessaloniki, Greece.
9. Anesthesiology Department, “AHEPA” University Hospital, Aristotle University of Thessaloniki, Medical School, Thessaloniki, Greece.
10. Radiotherapy Department, “Theageneio” Anti-Cancer Hospital, Thessaloniki, Greece.
11. Oncology Department, General Hospital of Kavala, Kavala, Greece.
12. Second Department of Surgery, University Hospital of Alexandroupolis, Medical School, Democritus University of Thrace, 68100 Alexandroupolis, Greece.
13. General Surgery Clinic 1, University of Medicine and Pharmacy of Craiova, Craiova County Emergency Hospital, Craiova, Romania
14. Department of Pulmonology, I.M. Sechenov First Moscow State Medical University; Moscow, 119992, Russian Federation.
15. Oncology Department, University of Thessali, Larissa, Greece.

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Citation:
Alexidis P, Karatzoglou S, Dragoumis D, Drevelegas K, Tzitzikas I, Hatzimouratidis K, Chrisogonidis I, Ioannidis A, Katsios IN, Zarogoulidis P, Sapalidis K, Koulouris C, Michalopoulos N, Giannakidis D, Aidoni Z, Fyntanidou V, Amaniti A, Boniou K, Kesisoglou I, Vagionas A, Romanidis K, Oikonomou P, Goganau AM, Petanidis S, Maragouli E, Kosmidis C. Late results of a randomized trial on the role of mild hypofractionated radiotherapy for the treatment of localized prostate cancer. J Cancer 2020; 11(5):1008-1016. doi:10.7150/jca.37825. Available from https://www.jcancer.org/v11p1008.htm

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Abstract

Background: Prostate cancer is considered to be highly sensitive to changes in radiation therapy dose per fraction, specifically to hypofractionation. An increase in the fractionation dose could cause a higher increase to the prostate than to the normal tissues leading to better disease control with less toxicity. Here we present the results of a randomized trial comparing mild hypofractionation to conventional fractionation after a median of 3,6 years follow up. Patients and Methods: 139 patients were randomized to receive either hypofractionated radiotherapy with 2,25 Gy/fr to a total of 72 Gy (arm 1) or conventionally fractionated treatment with 2Gy/fr to a total of 74 Gy (arm 2). 72 patients were assigned to arm 1 and 67 to arm 2. Results: After a median follow up of 3,6 years, 23 patients (31,9%) from arm 1 developed grade≥ 2 acute genitourinary toxicity and 21 (31,3%) from arm 2 (p=0,79). The corresponding values from gastrointestinal were 15 (20,8%) and 12 (17,9%) (p=0,6). For late toxicity from GU, 8 patients (11,1%) developed grade≥ 2 symptoms in arm 1 and 7 (10,4%) in arm 2 (p=0,92). late GI toxicity grade≥ 2 was observed in 8 (11,1%) patients in arm 1 and 8 (11,9%) in arm 2 (p=0,88). In multivariate analysis, hormone therapy was significantly associated with late GI events, while acute toxicity from both GU and GI was a prognostic factor of late adverse reaction. Conclusion: No difference in the toxicity profile could be identified between hypofractionation and conventional fractionation. Our schedule of 2,25Gy/fr seems safe and tolerable by the patients with acceptable rates of acute and late toxicity.

Keywords: hypofractionation, early, late toxicity, prostate cancer.