A Phase 1 Safety Study of Avelumab Plus Stereotactic Body Radiation Therapy in Malignant Pleural Mesothelioma.
A Phase 1 Safety Study of Avelumab Plus Stereotactic Body Radiation Therapy in Malignant Pleural Mesothelioma.
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DOI：
10.1016/j.jtocrr.2022.100440
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发表时间：
2023-01
影响因子：
--
通讯作者：
Zauderer, Marjorie G.
中科院分区：
文献类型：
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作者：
Rimner, Andreas;Adusumilli, Prasad S.;Solomon, Stephen B.;Ziv, Etay;Hayes, Sara A.;Ginsberg, Michelle S.;Sauter, Jennifer L.;Gelblum, Daphna Y.;Shepherd, Annemarie F.;Guttmann, David M.;Eichholz, Jordan E.;Zhang, Zhigang;Ritter, Erika;Wong, Phillip;Iqbal, Afsheen N.;Daly, Robert M.;Namakydoust, Azadeh;Li, Henry;Mccune, Megan;Gelb, Emily H.;Taunk, Neil K.;von Reibnitz, Donata;Tyagi, Neelam;Yorke, Ellen D.;Rusch, Valerie W.;Zauderer, Marjorie G.
针对程序性死亡配体1（PD-L1）的单药单克隆抗体治疗恶性胸膜间皮瘤的疗效中等。放射治疗可以增强免疫治疗的抗肿瘤效果。然而，抗PD-L1治疗与立体定向体部放射治疗（SBRT）联合使用的安全性尚不清楚。我们介绍了一项评价抗PD-L1抗体avelumab联合SBRT治疗恶性胸膜间皮瘤患者的安全性的I期试验结果。这是一项在既往化疗后进展的患者中进行的单组、化疗药物启动的试验。Avelumab每隔一周给药一次，SBRT分3 - 5次（最少30戈伊）给药至一个病灶，随后继续avelumab治疗长达24个月或直至疾病进展。研究的主要终点是安全性，基于SBRT 3个月内3+级非血液学不良事件（AE）。13例可评估患者接受了中位7个周期（范围：2-26个周期）的avelumab治疗。有27例1级、17例2级、4例3级Avelumab相关AE，无4级或5级Avelumab相关AE。最常见的是输注相关过敏反应（n = 6）、厌食或体重减轻（n = 6）、疲乏（n = 6）、甲状腺疾病（n = 5）、腹泻（n = 3）和肌痛或关节痛（n = 3）。有10例1级、4例2级、1例3级，无4级或5级SBRT相关AE。最常见的是腹泻（n = 3）、胸痛/肌痛（n = 2）、疲乏（n = 2）、咳嗽（n = 2）、呼吸困难（n = 2）和恶心/呕吐（n = 2）。根据Simon两阶段设计I期研究第一阶段预先规定的毒性终点，avelumab + SBRT联合治疗似乎是可耐受的。
Single-agent monoclonal antibody therapy against programmed death-ligand 1 (PD-L1) has modest effects in malignant pleural mesothelioma. Radiation therapy can enhance the antitumor effects of immunotherapy. Nevertheless, the safety of combining anti-PD-L1 therapy with stereotactic body radiation therapy (SBRT) is unknown. We present the results of a phase 1 trial to evaluate the safety of the anti-PD-L1 antibody avelumab plus SBRT in patients with malignant pleural mesothelioma. This was a single-arm, investigator-initiated trial in patients who progressed on prior chemotherapy. Avelumab was delivered every other week, and SBRT was delivered to one lesion in three to five fractions (minimum of 30 Gy) followed by continuation of avelumab up to 24 months or until disease progression. The primary end point of the study was safety on the basis of grade 3+ nonhematologic adverse events (AEs) within 3 months of SBRT. Thirteen assessable patients received a median of seven cycles (range: 2–26 cycles) of avelumab. There were 27 grade 1, 17 grade 2, four grade 3, and no grade 4 or 5 avelumab-related AEs. The most common were infusion-related allergic reactions (n = 6), anorexia or weight loss (n = 6), fatigue (n = 6), thyroid disorders (n = 5), diarrhea (n = 3), and myalgia or arthralgias (n = 3). There were 10 grade 1, four grade 2, one grade 3, and no grade 4 or 5 SBRT-related AEs. The most common were diarrhea (n = 3), chest pain/myalgia (n = 2), fatigue (n = 2), cough (n = 2), dyspnea (n = 2), and nausea/vomiting (n = 2). Combination avelumab plus SBRT seems tolerable on the basis of the prespecified toxicity end points of the first stage of this Simon two-stage design phase 1 study.
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影响因子：
28.4
作者：
Jabbour SK;Lee KH;Frost N;Breder V;Kowalski DM;Pollock T;Levchenko E;Reguart N;Martinez-Marti A;Houghton B;Paoli JB;Safina S;Park K;Komiya T;Sanford A;Boolell V;Liu H;Samkari A;Keller SM;Reck M
通讯作者：
Reck M
影响因子：
20.4
作者：
MacLeod, Nicholas;Chalmers, Anthony;Laird, Barry J.
通讯作者：
Laird, Barry J.
影响因子：
64.8
作者：
Twyman-Saint Victor, Christina;Rech, Andrew J.;Maity, Amit;Rengan, Ramesh;Pauken, Kristen E.;Stelekati, Erietta;Benci, Joseph L.;Xu, Bihui;Dada, Hannah;Odorizzi, Pamela M.;Herati, Ramin S.;Mansfield, Kathleen D.;Patsch, Dana;Amaravadi, Ravi K.;Schuchter, Lynn M.;Ishwaran, Hemant;Mick, Rosemarie;Pryma, Daniel A.;Xu, Xiaowei;Feldman, Michael D.;Gangadhar, Tara C.;Hahn, Stephen M.;Wherry, E. John;Vonderheide, Robert H.;Minn, Andy J.
通讯作者：
Minn, Andy J.
与I期非小细胞肺癌（NSCLC）相比，立体定向的身体放射治疗（SBRT）可改善局部控制和总体存活率。
DOI：
10.1080/0284186x.2018.1481292
发表时间：
2018-11
期刊：
Acta oncologica (Stockholm, Sweden)
影响因子：
--
作者：
von Reibnitz D;Shaikh F;Wu AJ;Treharne GC;Dick-Godfrey R;Foster A;Woo KM;Shi W;Zhang Z;Din SU;Gelblum DY;Yorke ED;Rosenzweig KE;Rimner A
通讯作者：
Rimner A
太平洋试验的五年生存结果：在III期非小细胞肺癌中进行化学放录后的杜瓦卢马布。
DOI：
10.1200/jco.21.01308
发表时间：
2022-04-20
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Spigel DR;Faivre-Finn C;Gray JE;Vicente D;Planchard D;Paz-Ares L;Vansteenkiste JF;Garassino MC;Hui R;Quantin X;Rimner A;Wu YL;Özgüroğlu M;Lee KH;Kato T;de Wit M;Kurata T;Reck M;Cho BC;Senan S;Naidoo J;Mann H;Newton M;Thiyagarajah P;Antonia SJ
通讯作者：
Antonia SJ