Mauriac L, Blanc-Vincent M P, Luporsi E, Cutuli B, Fourquet A, Garbay J R, Giard S, Spyratos F, Zafrani B, Dilhuydy J M
Institut Bergonié, Bordeaux.
Bull Cancer. 2000 Jun;87(6):469-90.
The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature systematic review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery.
To develop clinical practice guidelines according to the definitions of Standards, Options and Recommendations for endocrine therapy in patients with non metastatic breast cancer.
Data have been identified by literature search using Medline, Embase, Cancerlit and Cochrane databases - until july 1999 - and the personal reference lists of the expert group. Once the guidelines were defined, the document was submitted for review to 125 independent reviewers.
The main recommendations for the endocrine therapy of patients with non metastatic breast cancer are: 1) Endocrine therapy modalities depend on menopausal status or age of women: ovarian suppression for premenopausal women, antiestrogen drug therapy for postmenopausal women (standard). 2) Tamoxifen (20 mg/d - 5 years) is beneficial to women with positive estrogen receptor tumor (standard, level of evidence A). There is no indication of tamoxifen treatment for women with negative estrogen receptor tumor (standard, level of evidence A). 3) For postmenopausal women with positive estrogen receptor tumor, tamoxifen is the standard adjuvant treatment (level of evidence A). For postmenopausal women with negative estrogen receptor, adjuvant chemotherapy has to be considered (option, level of evidence A). No adjuvant treatment has to be considered for women with poor health condition (option). 4) For premenopausal women with estrogen receptor tumor, results of clinical trials of chemotherapy versus endocrine therapy, suggest a benefit for endocrine therapy. However, there is no sufficient evidence to consider endocrine therapy alone as a standard adjuvant treatment. 5) For premenopausal women, chemotherapy + ovarian suppression or chemotherapy + tamoxifen are not better than chemotherapy alone (level of evidence A). 6) For postmenopausal women, administration of chemotherapy plus adjuvant tamoxifen versus the same tamoxifen alone, is of additional benefit in reducing recurrences but not in prolonging overall survival (standard, level of evidence A). 7) Balance of known benefits (delay to recurrence and death) and risks (side-effects of therapy) for adjuvant chemoendocrine therapy has to be taken into consideration before decision making. Chemoendocrine therapy can be indicated for women at high risk of developing metastatic disease (recommendation, experts agreement).
“标准、选择与建议”（SOR）项目始于1993年，是法国癌症中心联合会（FNCLCC）、20家法国癌症中心以及法国公立大学、综合医院和私立诊所的专家之间的合作项目。主要目标是制定临床实践指南，以提高癌症患者的医疗质量和治疗效果。该方法基于多学科专家小组对文献的系统回顾和批判性评价，并参考癌症护理专家的反馈意见。
根据非转移性乳腺癌患者内分泌治疗的标准、选择和建议的定义制定临床实践指南。
通过使用Medline、Embase、Cancerlit和Cochrane数据库进行文献检索（截至1999年7月）以及专家组的个人参考文献列表来识别数据。一旦确定了指南，该文件将提交给125名独立评审员进行审查。
非转移性乳腺癌患者内分泌治疗的主要建议如下：1）内分泌治疗方式取决于女性的绝经状态或年龄：绝经前女性采用卵巢抑制，绝经后女性采用抗雌激素药物治疗（标准治疗）。2）他莫昔芬（20mg/天，共5年）对雌激素受体阳性肿瘤的女性有益（标准治疗，证据等级A）。雌激素受体阴性肿瘤的女性不建议使用他莫昔芬治疗（标准治疗，证据等级A）。3）对于雌激素受体阳性肿瘤的绝经后女性，他莫昔芬是标准辅助治疗（证据等级A）。对于雌激素受体阴性的绝经后女性，必须考虑辅助化疗（选择治疗，证据等级A）。健康状况较差的女性无需考虑辅助治疗（选择治疗）。4）对于雌激素受体阳性肿瘤的绝经前女性，化疗与内分泌治疗的临床试验结果表明内分泌治疗有益。然而，尚无足够证据将内分泌治疗单独作为标准辅助治疗。5）对于绝经前女性，化疗+卵巢抑制或化疗+他莫昔芬并不比单纯化疗更好（证据等级A）。6）对于绝经后女性，化疗加辅助他莫昔芬与单纯使用相同的他莫昔芬相比，在降低复发率方面有额外益处，但在延长总生存期方面并无差异（标准治疗，证据等级A）。7）在做出决策前，必须考虑辅助化疗内分泌治疗已知的益处（延迟复发和死亡）和风险（治疗副作用）。化疗内分泌治疗可用于有发生转移性疾病高风险的女性（推荐，专家共识）。
