Clinical Outcomes for Patients With Metastatic Breast Cancer Treated With Immunotherapy Agents in Phase I Clinical Trials.
Clinical Outcomes for Patients With Metastatic Breast Cancer Treated With Immunotherapy Agents in Phase I Clinical Trials.
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DOI：
10.3389/fonc.2021.640690
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发表时间：
2021
影响因子：
4.7
通讯作者：
Diamond JR
中科院分区：
文献类型：
--
作者：
Schreiber AR;Kagihara JA;Weiss JA;Nicklawsky A;Gao D;Borges VF;Kabos P;Diamond JR
免疫肿瘤学（IO）药物已经证明了对许多肿瘤类型的疗效，并导致了护理标准的改变。在乳腺癌方面，atezolizumab和pembrolizumab最近被fda批准与化疗联合用于pd - l1阳性转移性三阴性乳腺癌（TNBC）患者。然而，单药PD-1/PD-L1抑制剂在乳腺癌中仅显示出适度的单药疗效。本研究的目的是研究新型IO药物在科罗拉多大学I期临床试验中治疗转移性乳腺癌（MBC） （TNBC以外）患者的疗效。我们对2012年1月1日至2018年7月1日在科罗拉多大学医院I/Ib期临床试验中接受IO药物治疗的MBC患者的数据库进行了回顾性分析。获得患者统计资料、治疗方法和临床结果。我们确定了43例使用IO药物治疗的患者，无论是单一药物还是联合药物。平均年龄为53岁；激素受体阳性/ her2阴性乳腺癌占55.8%，TNBC占39.5%，her2阳性占4.7%。在转移性肿瘤中，患者平均接受2次化疗（范围0-7）。大多数患者（72.1%）单独接受IO， 27.9%的患者接受IO加化疗。中位无进展生存期（PFS）为2.3个月，中位总生存期（OS）为12.1个月。与PFS < 6个月的患者相比，持续研究≥6个月的患者（20.9%）更有可能接受化疗加IO治疗（77.8% vs 14.7%）。PFS≥6个月和< 6个月的患者在转移部位数量、既往化疗线、乳腺癌亚型、绝对淋巴细胞计数或LDH方面没有差异。我们的I期经验表明，IO治疗不仅局限于TNBC患者，而且证实了IO药物与化疗联合治疗的疗效。在I期临床试验中，一部分接受IO药物治疗的MBC患者获得了长期的临床获益。乳腺癌免疫治疗反应的预测因素尚未确定，需要进一步的研究来确定这些因素。
Immuno-oncology (IO) agents have demonstrated efficacy across many tumor types and have led to change in standard of care. In breast cancer, atezolizumab and pembrolizumab were recently FDA-approved in combination with chemotherapy specifically for patients with PD-L1-positive metastatic triple-negative breast cancer (TNBC). However, the single agent PD-1/PD-L1 inhibitors demonstrate only modest single agent efficacy in breast cancer. The purpose of this study was to investigate the efficacy of novel IO agents in patients with metastatic breast cancer (MBC), beyond TNBC, treated in phase I clinical trials at the University of Colorado. We performed a retrospective analysis using a database of patients with MBC who received treatment with IO agents in phase I/Ib clinical trials at the University of Colorado Hospital from January 1, 2012 to July 1, 2018. Patient demographics, treatments and clinical outcomes were obtained. We identified 43 patients treated with an IO agent either as a single agent or in combination. The average age was 53 years; 55.8% had hormone receptor-positive/HER2-negative breast cancer, 39.5% TNBC and 4.7% HER2-positive. Patients received an average of 2 prior lines of chemotherapy (range 0-7) in the metastatic setting. Most patients (72.1%) received IO alone and 27.9% received IO plus chemotherapy. Median progression-free survival (PFS) was 2.3 months and median overall survival (OS) was 12.1 months. Patients remaining on study ≥ 6 months (20.9%) were more likely to be treated with chemotherapy plus IO compared to patients with a PFS < 6 months (77.8% v. 14.7%). No differences in number of metastatic sites, prior lines of chemotherapy, breast cancer subtype, absolute lymphocyte count, or LDH were identified between patients with a PFS ≥ 6 months vs. < 6 months. Our phase I experience demonstrates benefit from IO therapy that was not limited to patients with TNBC and confirms improved efficacy from IO agents in combination with chemotherapy. A subset of patients with MBC treated in phase I clinical trials with an IO agent derived prolonged clinical benefit. Predictors of response to immunotherapy in breast cancer remain uncharacterized and further research is needed to identify these factors.
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影响因子：
--
作者：
Sabatier R;Finetti P;Mamessier E;Adelaide J;Chaffanet M;Ali HR;Viens P;Caldas C;Birnbaum D;Bertucci F
通讯作者：
Bertucci F
影响因子：
4.6
作者：
Kurozumi, Sasagu;Inoue, Kenichi;Shirabe, Ken
通讯作者：
Shirabe, Ken
影响因子：
45.3
作者：
Nanda, Rita;Chow, Laura Q. M.;Buisseret, Laurence
通讯作者：
Buisseret, Laurence
影响因子：
28.4
作者：
Adams S;Gatti-Mays ME;Kalinsky K;Korde LA;Sharon E;Amiri-Kordestani L;Bear H;McArthur HL;Frank E;Perlmutter J;Page DB;Vincent B;Hayes JF;Gulley JL;Litton JK;Hortobagyi GN;Chia S;Krop I;White J;Sparano J;Disis ML;Mittendorf EA
通讯作者：
Mittendorf EA
影响因子：
158.5
作者：
Schmid, P.;Adams, S.;Emens, L. A.
通讯作者：
Emens, L. A.