Older adults with breast cancer receiving neo/adjuvant chemotherapy are at high risk for poor outcomes and are underrepresented in clinical trials. The ADVANCE (jut hemotherapy in the lderly) trial evaluated the feasibility of two neo/adjuvant chemotherapy regimens in parallel-enrolling cohorts of older patients with human epidermal growth factor receptor 2-negative breast cancer: cohort 1—triple-negative; cohort 2—hormone receptor-positive. Adults age ≥ 70 years with stage I-III breast cancer warranting neo/adjuvant chemotherapy were enrolled. Cohort 1 received weekly carboplatin (area under the curve 2) and weekly paclitaxel 80 mg/m for twelve weeks; cohort 2 received weekly paclitaxel 80 mg/m plus every-three-weekly cyclophosphamide 600 mg/m over twelve weeks. The primary study endpoint was feasibility, defined as ≥80% of patients receiving ≥80% of intended weeks/doses of therapy. All dose modifications were applied per clinician discretion. Forty women ( = 20 per cohort) were enrolled from March 25, 2019 through August 3, 2020 from three centers; 45% and 35% of patients in cohorts 1 and 2 were age > 75, respectively. Neither cohort achieved targeted thresholds for feasibility. In cohort 1, eight (40.0%) met feasibility (95% confidence interval [CI] = 19.1–63.9%), while ten (50.0%) met feasibility in cohort 2 (95% CI = 27.2–72.8). Neutropenia was the most common grade 3–4 toxicity (cohort 1—65%, cohort 2—55%). In cohort 1, 80% and 85% required ≥1 dose holds of carboplatin and/or paclitaxel, respectively. In cohort 2, 10% required dose hold(s) for cyclophosphamide and/or 65% for paclitaxel. In this pragmatic pilot examining chemotherapy regimens in older adults with breast cancer, neither regimen met target goals for feasibility. Developing efficacious and tolerable regimens for older patients with breast cancer who need chemotherapy remains an important goal.

中文翻译：

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“ADVANCE”（一项试点试验）老年人辅助化疗：为老年乳腺癌患者开发和评估低毒性化疗方案


接受新/辅助化疗的老年乳腺癌患者预后不良的风险很高，并且在临床试验中代表性不足。 ADVANCE（老年人 Jut 血疗法）试验在平行入组的人类表皮生长因子受体 2 阴性乳腺癌老年患者队列中评估了两种新/辅助化疗方案的可行性：队列 1 — 三阴性；队列 1 — 三阴性；第 2 组——激素受体阳性。年龄≥ 70 岁、患有 I-III 期乳腺癌且需要新/辅助化疗的成人纳入研究。第 1 组每周接受卡铂治疗（曲线 2 下面积），每周接受 80 mg/m2 紫杉醇治疗，持续 12 周；第 2 组每周接受 80 mg/m2 紫杉醇治疗，加每三周一次 600 mg/m2 环磷酰胺治疗，持续 12 周。主要研究终点是可行性，定义为≥80%的患者接受≥80%的预期治疗周数/剂量。所有剂量修改均根据临床医生的判断进行。 2019 年 3 月 25 日至 2020 年 8 月 3 日期间，来自三个中心的 40 名女性（每组 20 名）入组；队列 1 和队列 2 中分别有 45% 和 35% 的患者年龄为 > 75。两组都没有达到可行性目标阈值。在队列 1 中，八个 (40.0%) 满足可行性（95% 置信区间 [CI] = 19.1–63.9%），而队列 2 中十个 (50.0%) 满足可行性 (95% CI = 27.2–72.8)。中性粒细胞减少症是最常见的 3-4 级毒性（队列 1-65%，队列 2-55%）。在队列 1 中，80% 和 85% 分别需要 ≥1 次卡铂和/或紫杉醇剂量保持。在队列 2 中，环磷酰胺需要 10% 的剂量保持和/或紫杉醇需要 65% 的剂量保持。在这项检查老年乳腺癌化疗方案的务实试点中，两种方案均未达到可行性目标。 为需要化疗的老年乳腺癌患者开发有效且可耐受的治疗方案仍然是一个重要目标。