Department of Urology, Hacettepe University Medical School, Ankara, Turkey.
J Urol. 2010 Aug;184(2):519-24. doi: 10.1016/j.juro.2010.03.137. Epub 2010 Jun 17.
We investigated the efficacy of prophylactic radiotherapy for gynecomastia/breast pain induced by 150 mg bicalutamide in a prospective, randomized, multi-institutional trial.
After definitive treatment for localized prostate cancer 125 patients were randomized to 12 Gy radiotherapy before bicalutamide as prophylactic radiotherapy (53) or bicalutamide only for nonprophylactic radiotherapy (72). The incidence of gynecomastia, breast pain and tenderness, and discomfort perceived by the patients was assessed by physical examination and direct questioning at 3, 6 and 12 months of followup.
At the end of 12 months the gynecomastia rate was 15.8% in the prophylactic group and 50.8% in the nonprophylactic group (p <0.001). On patient evaluation the breast enlargement rate was 34.4%. The severity of breast pain and tenderness was not different between the groups. The breast pain rate was 36.4% and 49.2% by 12 months in the prophylactic and nonprophylactic groups, and the rate of patients who felt discomfort from gynecomastia was 11.4% and 29.5%, respectively.
In this prospective study the incidence of gynecomastia was not as high as previously believed. Although prophylactic breast irradiation seemed to decrease the gynecomastia rate in patients on 150 mg bicalutamide, our study proves that not all patients need prophylaxis since only 52% were significantly bothered by gynecomastia. Thus, individual assessment is needed to select patients who need prophylactic radiation while on 150 mg bicalutamide.
我们研究了预防性放疗对因应用 150mg 比卡鲁胺引起的男性乳房发育/乳房疼痛的疗效,该研究为前瞻性、随机、多中心试验。
在对局限性前列腺癌进行确定性治疗后,125 例患者被随机分为预防性放疗组(53 例)和非预防性放疗组(72 例)。预防性放疗组在应用比卡鲁胺前给予 12Gy 放疗,而非预防性放疗组仅应用比卡鲁胺。通过体格检查和直接询问,在随访的 3、6 和 12 个月评估患者的男性乳房发育、乳房疼痛和触痛以及患者自觉不适的发生率。
在 12 个月结束时,预防性放疗组的男性乳房发育发生率为 15.8%,而非预防性放疗组为 50.8%(p<0.001)。在患者评估中,乳房增大发生率为 34.4%。两组乳房疼痛和触痛的严重程度无差异。预防性放疗组和非预防性放疗组在 12 个月时的乳房疼痛发生率分别为 36.4%和 49.2%,感到乳房发育不适的患者比例分别为 11.4%和 29.5%。
在这项前瞻性研究中,男性乳房发育的发生率并不像以前认为的那么高。虽然预防性乳房照射似乎降低了应用 150mg 比卡鲁胺患者的男性乳房发育发生率,但我们的研究表明并非所有患者都需要预防,因为只有 52%的患者因男性乳房发育而显著不适。因此,需要进行个体评估以选择需要预防性放疗的应用 150mg 比卡鲁胺的患者。