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Randomized Controlled Trial
. 2009 Nov;45(16):2825-34.
doi: 10.1016/j.ejca.2009.07.009. Epub 2009 Aug 12.

Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991

O Matzinger  1 , F Duclos, A van den Bergh, C Carrie, S Villà, P Kitsios, P Poortmans, S Sundar, E M van der Steen-Banasik, A Gulyban, L Collette, M Bolla; EORTC Radiation Oncology Group
Affiliations
Randomized Controlled Trial

Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991

O Matzinger et al. Eur J Cancer. 2009 Nov.

Abstract

Introduction: This trial randomly assessed short-term adjuvant hormonal therapy added to radiotherapy (RT) for intermediate- and high-risk (UICC 1997 cT2a or cT1b-c with high PSA or Gleason score) localised prostate cancer. We report acute toxicity (CTCAE v2) assessed weekly during RT in relation to radiation parameters.

Patients and methods: Centres selected the RT dose (70, 74 or 78Gy) and RT technique. Statistical significance is at 0.05.

Results: Of 791 patients, 652 received 3D-CRT (70Gy: 195, 74Gy: 376, 78Gy: 81) and 139 received IMRT (74Gy: 28, 78Gy: 111). During RT, grade 3 gastrointestinal (GI) and genitourinary (GU) toxicities were reported by 7 (0.8%) and 50 (6.3%) patients, respectively. No grade 4 was reported. The risk of grade 2 GI toxicity increased significantly with increasing D50%-rectum (p=0.004) and that of grade 2 GU toxicity correlated only to Dmax-bladder (p=0.051). 3D-RT technique, increasing total dose and V95% >400 cc increased D50% and Dmax. One month after RT, only 14 patients (1.8%) reported grade 3 toxicity. AST did not seem to influence the risk of GU or GI acute toxicity.

Conclusion: RT up to 78Gy was well tolerated. Dmax-bladder and D50%-rectum influenced the risk of grade 2 GU toxicity and GI toxicity, respectively. Both were lower with IMRT but remained high for an irradiated RT volume>400 cc for 3D-RT and for a dose of 78Gy. Hormonal treatment did not influence acute toxicity.

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