‘ADVANCE’ (a pilot trial) ADjuVANt chemotherapy in the elderly: Developing and evaluating lower-toxicity chemotherapy options for older patients with breast cancer,Journal of Geriatric Oncology

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‘ADVANCE’ (a pilot trial) ADjuVANt chemotherapy in the elderly: Developing and evaluating lower-toxicity chemotherapy options for older patients with breast cancer
Journal of Geriatric Oncology ( IF 3 ) Pub Date : 2022-09-23 , DOI: 10.1016/j.jgo.2022.09.006
Rachel A Freedman ₁ , Tianyu Li ₂ , Mina S Sedrak ₃ , Judith O Hopkins ₄ , Nabihah Tayob ₅ , Meredith G Faggen ₆ , Natalie F Sinclair ₇ , Wendy Y Chen ₁ , Heather A Parsons ₁ , Erica L Mayer ₁ , Paulina B Lange ₈ , Ameer S Basta ₈ , Adriana Perilla-Glen ₈ , Ruth I Lederman ₈ , Andrew Wong ₃ , Abhay Tiwari ₃ , Sandra S McAllister ₉ , Elizabeth A Mittendorf ₁₀ , Peter G Miller ₁₁ , Christopher J Gibson ₁₂ , Harold J Burstein ₁

Affiliation

Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.
Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, CA, USA.
Novant Health Cancer Institute / SCOR NCORP, Winston Salem, NC, USA.
Harvard Medical School, Boston, MA, USA; Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.
Dana-Farber Brigham Cancer Center at South Shore Hospital, South Weymouth, MA, USA.
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center, Milford, MA, USA.
Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA; Hematology Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Harvard Stem Cell Institute, Cambridge, MA, USA; Broad Institute of the Massachusetts Institute of Technology and Harvard University, Cambridge, MA, USA.
Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA; Broad Institute of the Massachusetts Institute of Technology and Harvard University, Cambridge, MA, USA; Center for Cancer Research, Massachusetts General Hospital, Boston, MA, USA.
Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.

Introduction

Older adults with breast cancer receiving neo/adjuvant chemotherapy are at high risk for poor outcomes and are underrepresented in clinical trials. The ADVANCE (ADjuVANt Chemotherapy in the Elderly) 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.

Materials and Methods

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/m² for twelve weeks; cohort 2 received weekly paclitaxel 80 mg/m² plus every-three-weekly cyclophosphamide 600 mg/m² 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.

Results

Forty women (n = 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.

Discussion

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.

ClinicalTrials.gov Identifier: NCT03858322.

中文翻译：

“ADVANCE”（一项试验性试验）ADjuVANt 老年化疗：为老年乳腺癌患者开发和评估低毒性化疗方案

介绍

接受新化疗/辅助化疗的老年乳腺癌患者预后不良的风险很高，并且在临床试验中的代表性不足。ADVANCE（AD ju VAN t C hemotherapy in the Elderly）试验评估了两种新/辅助化疗方案在人类表皮生长因子受体 2 阴性乳腺癌老年患者平行入组队列中的可行性：队列 1-三重-消极的; 队列 2-激素受体阳性。

材料和方法

入组年龄≥ 70 岁且患有 I-III 期乳腺癌且需要新/辅助化疗的成年人。第 1 组每周接受卡铂（曲线下面积 2）和每周一次紫杉醇 80 mg/m ²，持续十二周；队列 2 在12 周内每周接受 80 mg/m ²的紫杉醇以及每三周一次的环磷酰胺 600 mg/m ^{2 。}主要研究终点是可行性，定义为≥80% 的患者接受了≥80% 的预期周数/治疗剂量。根据临床医生的判断应用所有剂量修改。

结果

从 2019 年 3 月 25 日到 2020 年 8 月 3 日，从三个中心招募了40 名女性（每组n = 20 名）；队列 1 和队列 2 中分别有 45% 和 35% 的患者年龄 > 75 岁。两个队列都没有达到可行性的目标阈值。在队列 1 中，8 位 (40.0%) 符合可行性（95% 置信区间 [CI] = 19.1–63.9%），而队列 2 中有 10 位 (50.0%) 符合可行性（95% CI = 27.2–72.8）。中性粒细胞减少是最常见的 3-4 级毒性（队列 1-65%，队列 2-55%）。在队列 1 中，分别有 80% 和 85% 的患者需要 ≥ 1 剂卡铂和/或紫杉醇。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。