美国临床肿瘤学会于2021年首次发表《激素受体阴性或内分泌治疗后HER2阴性晚期乳腺癌化疗和靶向治疗指南》并于2022年8月更新，纳入了DESTINY-Breast04研究结果。2022年10月10日正式发表的TROPiCS-02研究结果又向指南更新发出另一个信号。TROPiCS-02 (NCT03901339): Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens 2023年1月10日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表哈佛大学麻省总医院、美国临床肿瘤学会、北卡罗来纳大学莱恩伯格综合癌症中心的美国临床肿瘤学会《激素受体阴性或内分泌治疗后HER2阴性晚期乳腺癌化疗和靶向治疗指南》推荐意见快速更新。 美国临床肿瘤学会首先有针对性进行文献检索，以确定该患者人群治疗方案的任何其他随机对照三期临床研究，但是并未发现，于是重新召集原指南专家组对来自TROPiCS-02研究的新证据进行审核，并审核并批准修订后的推荐意见。 TROPiCS-02为国际多中心随机对照三期临床研究，将激素受体阳性HER2阴性乳腺癌内分泌治疗耐药且局部复发不可手术或远处转移后接受过2～4种化疗方案的543例患者随机分为两组，其中272例给予戈沙妥珠单抗，其余271例由医师选择给予艾立布林、长春瑞滨、卡培他滨、吉西他滨其中之一进行单药化疗。主要终点为盲法独立集中审核评定的无进展生存。 第一次计划中期分析的无进展生存主要终点已公布于2022年美国临床肿瘤年会，并在线发表于2022年8月26日美国临床肿瘤学会《临床肿瘤学杂志》。中位随访10.2个月到达主要终点，戈沙妥珠单抗与医师选择化疗相比：- 中位无进展生存：5.5个月比4.0个月（95%置信区间：4.2～7.0、3.1～4.4）
- 进展或死亡风险：减少34%（风险比：0.66，95%置信区间：0.53～0.83，P=0.0003）
- 半年无进展生存率：46%比30%（95%置信区间：39～53、24～37）
- 一年无进展生存率：21%比7%（95%置信区间：15～28、3～14）
当时，总生存尚未达到中位（风险比：0.84，P=0.14）。 戈沙妥珠单抗≥3级治疗相关不良事件为腹泻（5%）和中性粒细胞减少并发症，包括发热性中性粒细胞减少（4%）和中性粒细胞减少性结肠炎（2%）。 第二次计划中期分析时，中位随访12.5个月，戈沙妥珠单抗与医师选择化疗相比：- 总死亡风险：减少21%（风险比：0.79，95%置信区间：0.65～0.96，P=0.020）
根据美国临床肿瘤学会方法，用推荐意见分级评定系统GRADE5对该研究报告进行评估，发现证据确定性为中等。 因此，本次推荐意见更新为：对于激素受体阳性HER2阴性晚期乳腺癌内分泌治疗失败且转移后接受过至少两线化疗的患者，可以给予戈沙妥珠单抗（证据类型：循证，利大于弊；证据质量：中等；推荐意见强度：强）。J Clin Oncol. 2023 Jan 10. IF: 50.717Chemotherapy and Targeted Therapy for Endocrine-Pretreated or Hormone Receptor-Negative Metastatic Breast Cancer: ASCO Guideline Rapid Recommendation Update.Moy B, Rumble RB, Carey LA; Chemotherapy and Targeted Therapy for Endocrine-Pretreated or Hormone Receptor-Negative Metastatic Breast Cancer Expert Panel.Massachusetts General Hospital, Boston, MA; American Society of Clinical Oncology, Alexandria, VA; UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC.ASCO Rapid Recommendations Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the ASCO Guideline Methodology Manual. The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options.BACKGROUND: In 2021, ASCO published a guideline on chemotherapy and targeted therapy for patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer that is either endocrine-pretreated or hormone receptor-negative. That guideline was updated in August 2022 to incorporate the results of the DESTINY-Breast04 trial. The results of the TROPiCS-02 trial, published on October 10, 2022, provided another signal to update.METHODS: A targeted electronic literature search was conducted to identify any additional phase III randomized controlled trials of treatment options in this patient population. No additional randomized controlled trials were identified. The original guideline Expert Panel was reconvened to review new evidence from TROPiCS-02 and to review and approve the revised recommendation.EVIDENCE REVIEW: TROPiCS-02 was an international, randomized, phase III trial that compared sacituzumab govitecan (SG) (n = 272) against four other chemotherapy options (single-agent eribulin, vinorelbine, capecitabine, or gemcitabine), which comprised treatment of physician's choice (TPC) (n = 271) in 543 patients with endocrine-resistant hormone receptor-positive and HER2-negative locally recurrent inoperable or metastatic breast cancer who had received 2-4 prior chemotherapy regimens for metastatic disease. The primary end point for TROPiCS-02 was progression-free survival (PFS) as assessed by blinded independent central review.The PFS primary end point at the first planned interim analysis was presented at ASCO 2022 and recently published in the Journal of Clinical Oncology. After a median follow-up of 10.2 months, the primary end point was met with a 34% reduction in risk of progression or death (hazard ratio [HR], 0.66; 95% CI, 0.53 to 0.83; P = .0003). The median PFS was 5.5 months (95% CI, 4.2 to 7.0) with SG and 4.0 months (95% CI, 3.1 to 4.4) with TPC. At 6 months, the PFS was 46% (95% CI, 39 to 53) versus 30% (95% CI, 24 to 37), and at 12 months, it was 21% (95% CI, 15 to 28) versus 7% (95% CI, 3 to 14). At that time, median overall survival was not yet mature (HR, 0.84; P = .14). Key grade ≥ 3 treatment-related adverse events with SG were diarrhea (5%) and neutropenic complications including febrile neutropenia (4%) and neutropenic colitis (2%).At the planned second interim analysis after a median follow-up of 12.5 months, SG had a statistically significant improvement in overall survival compared with TPC (HR, 0.79; 95% CI, 0.65 to 0.96; P = .020). The median overall survival was 14.4 versus 11.2 months in patients treated with SG and TPC, respectively. Appraisal of the trial report using the GRADE5 instrument was performed as per ASCO's methodology and found a moderate certainty of the evidence.UPDATED RECOMMENDATION: Patients with hormone receptor-positive HER2-negative metastatic breast cancer who are refractory to endocrine therapy and have received at least two prior lines of chemotherapy for metastatic disease may be offered SG. (Type: Evidence-based, benefits outweigh harms; Evidence quality: Moderate; Strength of recommendation: Strong.)DOI: 10.1200/JCO.22.02807
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美国晚期乳腺癌靶向治疗指南更新
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