EORTC Headquarters, Belgium.
Eur J Cancer. 2009 Nov;45(16):2825-34. doi: 10.1016/j.ejca.2009.07.009. Epub 2009 Aug 12.
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.
Centres selected the RT dose (70, 74 or 78Gy) and RT technique. Statistical significance is at 0.05.
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.
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.
本试验随机评估了短期辅助激素治疗联合放疗（RT）治疗中高危（1997 年 UICC cT2a 或 cT1b-c 期伴高 PSA 或高 Gleason 评分）局限性前列腺癌的效果。我们报告了在 RT 期间每周评估的急性毒性（CTCAE v2）与放射参数的关系。
各中心选择 RT 剂量（70、74 或 78Gy）和 RT 技术。统计学显著性为 0.05。
791 例患者中，652 例接受 3D-CRT（70Gy：195 例，74Gy：376 例，78Gy：81 例），139 例接受 IMRT（74Gy：28 例，78Gy：111 例）。在 RT 期间，分别有 7 例（0.8%）和 50 例（6.3%）患者报告了 3 级胃肠道（GI）和泌尿生殖系统（GU）毒性。无 4 级报告。随着直肠 D50%-（p=0.004）的增加，2 级 GI 毒性的风险显著增加，而只有膀胱 Dmax-（p=0.051）与 2 级 GU 毒性相关。3D-RT 技术、增加总剂量和 V95%＞400cc 增加了 D50%和 Dmax。RT 后 1 个月，仅有 14 例（1.8%）患者报告 3 级毒性。AST 似乎并不影响 GU 或 GI 急性毒性的风险。
78Gy 以下的 RT 是可以耐受的。Dmax-膀胱和 D50%-直肠分别影响 2 级 GU 毒性和 GI 毒性的风险。IMRT 时，这两种风险都较低，但 3D-RT 时，对于照射 RT 体积＞400cc 或剂量为 78Gy，仍处于较高水平。激素治疗不影响急性毒性。
