Kurbacher Christian Martin, Horn Olympia, Kurbacher Jutta Anna, Herz Susanne, Kurbacher Ann Tabea, Hildenbrand Ralf, Bollmann Reinhardt
Department of Gynecology and Obstetrics I (Gynecologic Oncology), Gynecologic Center Bonn-Friedensplatz, Bonn, Germany Faculty of Medicine, University of Cologne, Cologne, Germany
Department of Gynecology and Obstetrics I (Gynecologic Oncology), Gynecologic Center Bonn-Friedensplatz, Bonn, Germany.
Oncologist. 2015 Nov;20(11):1333-41. doi: 10.1634/theoncologist.2015-0076. Epub 2015 Sep 28.
Catumaxomab (CATU) is a trifunctional antibody approved for intraperitoneal (i.p.) treatment of malignant ascites (MA) related to carcinomas expressing the epithelial cell-adhesion molecule (EpCAM). CATU is mostly given to hospitalized patients, although outpatient treatment seems appropriate in selected individuals. This observational trial sought to obtain more detailed information regarding the feasibility of CATU in outpatients with MA related to various gynecologic tumors, including epithelial ovarian (EOC) and metastatic breast cancer (MBC).
A total of 30 patients were included, 17 with EOC, 7 with MBC, and 6 with other malignancies. The patients had failed a median of 5 (range 1-12) previous systemic treatments. CATU was administered via an indwelling i.p. catheter at four increasing doses (i.e., 10, 20, 50, and 150 µg) given at 4-day intervals over 2 weeks. Toxicities were scored according to the Common Terminology Criteria for Adverse Events, version 4.03. Puncture-free survival (PuFS) was calculated from the start of CATU until the next puncture for MA, death, or loss to follow-up. Overall survival (OS) was calculated from the start of CATU to death from any reason or loss to follow-up. We also investigated various clinical parameters to predict PuFS and OS. These included age, tumor type, performance status, intensity of pretreatment, presence of extraperitoneal metastases, relative lymphocyte count at baseline, patient adherence to therapy, and the patients' ability to undergo systemic treatment after CATU.
CATU was exclusively given on an outpatient basis, and 19 patients (63.3%) received all four planned i.p. instillations. Toxicity was the reason for discontinuation in only 2 patients. Toxicity was generally manageable, with abdominal pain, nausea/vomiting, fatigue, and fever the predominant adverse effects. Secondary hospitalization was necessary for 7 patients (23.3%), with a general deteriorated condition in 5 and fever/infection or abdominal pain in 1 patient each. Subsequent systemic treatment was possible in 11 patients (36.7%). Only 5 patients (16.7%) required a second puncture after i.p. CATU. The median PuFS was 56 days, and the median OS was 79.5 days. Positive predictors of both PuFS and OS were performance status, absence of extraperitoneal tumor, the capability to receive all four CATU infusions, and the ability to undergo subsequent systemic treatment.
Outpatient i.p. CATU therapy for MA related to various gynecologic carcinomas is safe and effective in producing good ascites control in most individuals, allowing for subsequent systemic therapy in a substantial proportion of patients.
Intraperitoneal treatment with the trifunctional antibody catumaxomab (CATU) was possible in a selected population of 30 outpatients with malignant ascites due to epithelial female genital tract or breast carcinoma. Toxicity was largely manageable. Patients in good condition at baseline, without extraperitoneal tumor and/or liver metastases, and with the ability to complete all four planned CATU instillations and the capability of undergoing subsequent systemic therapy benefited the most in terms of both puncture-free and overall survival. Outpatient i.p. CATU is safe and effective in a selected group of patients with malignant ascites due to various gynecologic malignancies and could be cost-saving compared with an inpatient approach.
卡妥索单抗（CATU）是一种三功能抗体，已被批准用于腹腔内（i.p.）治疗与表达上皮细胞粘附分子（EpCAM）的癌相关的恶性腹水（MA）。CATU大多给予住院患者，不过门诊治疗在特定个体中似乎也是合适的。这项观察性试验旨在获取更多关于CATU在患有与各种妇科肿瘤（包括上皮性卵巢癌（EOC）和转移性乳腺癌（MBC））相关的MA的门诊患者中的可行性的详细信息。
共纳入30例患者，其中17例为EOC，7例为MBC，6例为其他恶性肿瘤。患者之前的全身治疗中位数为5次（范围1 - 12次）。通过留置的腹腔导管以四种递增剂量（即10、20、50和150μg）给予CATU，在2周内每隔4天给药一次。根据不良事件通用术语标准4.03版对毒性进行评分。无穿刺生存期（PuFS）从CATU开始给药计算至下次因MA进行穿刺、死亡或失访。总生存期（OS）从CATU开始给药计算至因任何原因死亡或失访。我们还研究了各种临床参数以预测PuFS和OS。这些参数包括年龄、肿瘤类型、体能状态、预处理强度、腹膜外转移的存在情况、基线相对淋巴细胞计数、患者对治疗的依从性以及CATU治疗后患者接受全身治疗的能力。
CATU完全在门诊给予，19例患者（63.3%）接受了全部四次计划的腹腔内灌注。仅2例患者因毒性而停药。毒性一般可控，主要不良反应为腹痛、恶心/呕吐、疲劳和发热。7例患者（23.3%）需要再次住院，其中5例病情总体恶化，1例因发热/感染，1例因腹痛。11例患者（36.7%）随后可行全身治疗。腹腔内给予CATU后仅5例患者（16.7%）需要第二次穿刺。中位PuFS为56天，中位OS为79.5天。PuFS和OS的阳性预测因素为体能状态、无腹膜外肿瘤、能够接受全部四次CATU输注以及能够接受随后的全身治疗。
门诊腹腔内给予CATU治疗与各种妇科癌相关的MA是安全有效的，大多数个体的腹水得到良好控制，相当一部分患者随后可行全身治疗。
在30例因上皮性女性生殖道或乳腺癌导致恶性腹水的门诊患者中，使用三功能抗体卡妥索单抗（CATU）进行腹腔内治疗是可行的。毒性大多可控。基线状态良好、无腹膜外肿瘤和/或肝转移、能够完成全部四次计划的CATU灌注且能够接受随后全身治疗的患者在无穿刺生存期和总生存期方面获益最大。门诊腹腔内给予CATU对于因各种妇科恶性肿瘤导致恶性腹水的特定患者群体是安全有效的，与住院治疗相比可能节省费用。
