Hughes Lorie L, Gray Robert J, Solin Lawrence J, Robert Nicholas J, Martino Silvana, Tripathy Debu, Ingle James N, Wood William C
Department of Radiation Oncology, WellStar Kennestone Hospital, Marietta, GA 30060, USA.
Cancer. 2004 Sep 1;101(5):969-72. doi: 10.1002/cncr.20481.
In 1994, the Eastern Cooperative Oncology Group (ECOG) initiated for the Breast Intergroup a randomized clinical trial (E3193) in premenopausal patients with early-stage breast carcinoma (lymph node-negative and receptor-positive, with tumors measuring < or = 3 cm) comparing tamoxifen as adjuvant systemic therapy with tamoxifen and ovarian ablation by one of three different methods. Ovarian ablation could be accomplished either via radiotherapy (RT) (20 Gray [Gy]/10 fractions to a modified pelvic volume), surgical oophorectomy, or goserelin/leuprolide injections as per patient/physician choice. In the current study, we report the efficacy of pelvic RT with this dose-fractionation scheme in the induction of ovarian ablation.
Twenty-two of 174 patients (13%) who were randomized to treatment with tamoxifen and ovarian ablation received RT for ovarian ablation. RT quality assurance was performed. Of the 22 patients, 19 were treated per protocol, 1 patient had a minor violation (20 elapsed days for 10 RT fractions), and 2 patients had major violations (1 patient who was treated with RT as per protocol but who was treated at a non-Intergroup center, and 1 patient who was treated at a dose of 15 Gy/5 fractions).
No acute Grade 3 or 4 (according to the Common Toxicity Criteria of the National Cancer Institute) toxicities were reported during RT. Of the 22 patients receiving RT, evaluable follow-up data were available for 20 patients. Based on postmenopausal levels of estradiol or follicle-stimulating hormone at varying intervals after the completion of RT, 15 of 20 patients (75%) achieved successful ovarian ablation with RT. At a median follow-up of 54 months (range, 21-66 months), no Grade 3 or 4 complications from RT were observed.
Ovarian ablation by RT as performed in the current trial (given at a dose of 20 Gy in 10 fractions to a modified pelvic treatment volume) was found to be effective for ovarian ablation in the majority of patients, but may take some months to be complete. Consequently, patients should be evaluated to ascertain that ablation has been accomplished.
1994年，东部肿瘤协作组（ECOG）启动了一项针对乳腺癌协作组的随机临床试验（E3193），该试验纳入绝经前早期乳腺癌患者（淋巴结阴性且受体阳性，肿瘤大小≤3 cm），比较他莫昔芬作为辅助全身治疗与他莫昔芬联合通过三种不同方法之一进行卵巢去势的疗效。卵巢去势可通过放射治疗（RT）（20格雷[Gy]/10次分割照射改良盆腔体积）、手术卵巢切除术或根据患者/医生选择使用戈舍瑞林/亮丙瑞林注射来完成。在本研究中，我们报告了采用这种剂量分割方案的盆腔RT诱导卵巢去势的疗效。
174例随机接受他莫昔芬和卵巢去势治疗的患者中有22例（13%）接受了RT进行卵巢去势。进行了RT质量保证。在这22例患者中，19例按方案治疗，1例有轻微违规（10次RT分割照射间隔20天），2例有严重违规（1例按方案接受RT治疗但在非协作组中心治疗，1例接受15 Gy/5次分割照射剂量治疗）。
RT期间未报告3级或4级（根据美国国立癌症研究所通用毒性标准）急性毒性反应。在接受RT的22例患者中，20例患者有可评估的随访数据。根据RT完成后不同时间间隔的绝经后雌二醇或促卵泡激素水平，20例患者中有15例（75%）通过RT成功实现卵巢去势。中位随访54个月（范围21 - 66个月），未观察到RT引起的3级或4级并发症。
本试验中采用的RT卵巢去势（以20 Gy分10次照射改良盆腔治疗体积）在大多数患者中被发现对卵巢去势有效，但可能需要数月才能完成。因此，应对患者进行评估以确定去势是否已完成。
