Bertucci Alexandre, Bertucci François, Zemmour Christophe, Lerebours Florence, Pierga Jean-Yves, Levy Christelle, Dalenc Florence, Grenier Julien, Petit Thierry, Berline Marguerite, Gonçalves Anthony
Département d'Oncologie Médicale, Institut Paoli-Calmettes, Centre de Recherche en Cancérologie de Marseille (CRCM), INSERM UMR1068, CNRS UMR7258, Aix-Marseille Université, Marseille, France.
Laboratoire d'Oncologie Prédictive, CRCM, Institut Paoli-Calmettes, INSERM UMR1068, CNRS UMR7258, Aix-Marseille Université, Marseille, France.
Front Oncol. 2020 Nov 25;10:575978. doi: 10.3389/fonc.2020.575978. eCollection 2020.
Inflammatory breast cancer (IBC) is a highly aggressive entity with a poor outcome and relative resistance to treatment. Despite progresses achieved during the last decades, the survival remains significantly lower than non-IBC. Recent clinical trials assessing PD-1/PD-L1 inhibitors showed promising results in non-IBC. Pembrolizumab, an anti-PD-1 monoclonal antibody, revolutionized the treatment of different cancers. Several recent studies suggested a potential interest of targeting the immune system in IBC by revealing a more frequent PD-L1 expression and an enriched immune microenvironment when compared with non-IBC. Here, we describe the rationale and design of PELICAN-IPC 2015-016/Oncodistinct-003 trial, an open-label, randomized, non-comparative, phase II study assessing efficacy, and safety of pembrolizumab in combination with anthracycline-containing neoadjuvant chemotherapy in HER2-negative IBC. The trial is ongoing. The primary endpoint is the pCR rate (ypT0/Tis, ypN0) in overall population and the co-primary endpoint is safety profile during a run-in phase. Key secondary objectives include tolerability, invasive disease-free, event-free and overall survivals, as well as collection of tumor and blood samples for translational research.
https://clinicaltrials.gov/ (NCT03515798).
炎性乳腺癌（IBC）是一种侵袭性很强的疾病，预后较差且对治疗相对耐药。尽管在过去几十年中取得了进展，但其生存率仍显著低于非炎性乳腺癌。最近评估PD-1/PD-L1抑制剂的临床试验在非炎性乳腺癌中显示出了有前景的结果。派姆单抗，一种抗PD-1单克隆抗体，彻底改变了不同癌症的治疗方式。最近的几项研究表明，与非炎性乳腺癌相比，炎性乳腺癌中PD-L1表达更频繁且免疫微环境更丰富，因此靶向免疫系统在炎性乳腺癌中可能具有潜在意义。在此，我们描述了PELICAN-IPC 2015-016/Oncodistinct-003试验的基本原理和设计，这是一项开放标签、随机、非对照的II期研究，评估派姆单抗联合含蒽环类药物的新辅助化疗在HER2阴性炎性乳腺癌中的疗效和安全性。该试验正在进行中。主要终点是总体人群中的pCR率（ypT0/Tis，ypN0），共同主要终点是导入期的安全性。关键次要目标包括耐受性、无侵袭性疾病生存期、无事件生存期和总生存期，以及收集肿瘤和血液样本用于转化研究。
