随机 II 期试验：在 I-III 期三阴性乳腺癌（NeoSTOP）中使用不含蒽环类药物和含蒽环类药物的新辅助卡铂化疗方案。
Randomized Phase II Trial of Anthracycline-free and Anthracycline-containing Neoadjuvant Carboplatin Chemotherapy Regimens in Stage I-III Triple-negative Breast Cancer (NeoSTOP).
机构信息
Department of Internal Medicine, University of Kansas Medical Center, Westwood, Kansas.
Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas.
出版信息
Clin Cancer Res. 2021 Feb 15;27(4):975-982. doi: 10.1158/1078-0432.CCR-20-3646. Epub 2020 Nov 18.
PURPOSE
Addition of carboplatin (Cb) to anthracycline chemotherapy improves pathologic complete response (pCR), and carboplatin plus taxane regimens also yield encouraging pCR rates in triple-negative breast cancer (TNBC). Aim of the NeoSTOP multisite randomized phase II trial was to assess efficacy of anthracycline-free and anthracycline-containing neoadjuvant carboplatin regimens.
PATIENTS AND METHODS
Patients aged ≥18 years with stage I-III TNBC were randomized (1:1) to receive either paclitaxel (P) weekly × 12 plus carboplatin AUC6 every 21 days × 4 followed by doxorubicin/cyclophosphamide (AC) every 14 days × 4 (CbP → AC, arm A), or carboplatin AUC6 + docetaxel (D) every 21 days × 6 (CbD, arm B). Stromal tumor-infiltrating lymphocytes (sTIL) were assessed. Primary endpoint was pCR in breast and axilla. Other endpoints included residual cancer burden (RCB), toxicity, cost, and event-free (EFS) and overall survival (OS).
RESULTS
One hundred patients were randomized; arm A ( = 48) or arm B ( = 52). pCR was 54% [95% confidence interval (CI), 40%-69%] in arm A and 54% (95% CI, 40%-68%) in arm B. RCB 0+I rate was 67% in both arms. Median sTIL density was numerically higher in those with pCR compared with those with residual disease (20% vs. 5%; = 0.25). At median follow-up of 38 months, EFS and OS were similar in the two arms. Grade 3/4 adverse events were more common in arm A compared with arm B, with the most notable differences in neutropenia (60% vs. 8%; < 0.001) and febrile neutropenia (19% vs. 0%; < 0.001). There was one treatment-related death (arm A) due to acute leukemia. Mean treatment cost was lower for arm B compared with arm A ( = 0.02).
CONCLUSIONS
The two-drug CbD regimen yielded pCR, RCB 0+I, and survival rates similar to the four-drug regimen of CbP → AC, but with a more favorable toxicity profile and lower treatment-associated cost.
目的
添加卡铂（Cb）到蒽环类化疗可提高病理完全缓解（pCR），并且卡铂加紫杉烷方案在三阴性乳腺癌（TNBC）中也产生令人鼓舞的 pCR 率。NeoSTOP 多中心随机 2 期试验的目的是评估无蒽环类和含蒽环类新辅助卡铂方案的疗效。
患者和方法
年龄≥18 岁的 I-III 期 TNBC 患者按 1:1 随机分为接受每周紫杉醇（P）× 12 联合每 21 天卡铂 AUC6×4 加每 14 天多柔比星/环磷酰胺（AC）×4（CbP→AC，A 组）或每 21 天卡铂 AUC6+多西他赛（D）×6（CbD，B 组）治疗。评估间质肿瘤浸润淋巴细胞（sTIL）。主要终点是乳房和腋窝的 pCR。其他终点包括残留肿瘤负荷（RCB）、毒性、成本和无事件（EFS）及总生存（OS）。
结果
共随机分配了 100 例患者；A 组（=48）或 B 组（=52）。A 组的 pCR 为 54%（95%CI，40%-69%），B 组为 54%（95%CI，40%-68%）。两组的 RCB 0+I 率均为 67%。与残留疾病患者相比，pCR 患者的中位 sTIL 密度更高（20%比 5%；=0.25）。在中位随访 38 个月时，两组的 EFS 和 OS 相似。与 B 组相比，A 组的 3/4 级不良事件更为常见，其中最显著的差异是中性粒细胞减少（60%比 8%；<0.001）和发热性中性粒细胞减少（19%比 0%；<0.001）。A 组有 1 例治疗相关死亡（急性白血病）。与 A 组相比，B 组的平均治疗费用更低（=0.02）。
结论
两药 CbD 方案的 pCR、RCB 0+I 和生存率与四药 CbP→AC 方案相似，但毒性谱更有利，与治疗相关的成本更低。
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