Bokemeyer Carsten, Stein Alexander, Ridwelski Karsten, Atanackovic Djordje, Arnold Dirk, Wöll Ewald, Ulrich Alexis, Fischer Ramona, Krüger Colin, Schuhmacher Christoph
Department of Internal Medicine II (Hematology, Oncology, Bone Marrow Transplantation), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Surgery, Städtisches Klinikum Magdeburg, Magdeburg, Germany.
Gastric Cancer. 2015 Oct;18(4):833-42. doi: 10.1007/s10120-014-0423-6. Epub 2014 Sep 12.
Postoperative relapse rate after gastrectomy and perioperative chemotherapy remain high in patients with advanced gastric cancer due to the spread of disseminated tumour cells in the peritoneal cavity. Perioperative administration of catumaxomab could potentially eliminate residual tumour cells after intended curative resection of the primary tumour.
This open-label, phase II study investigated the safety and efficacy of catumaxomab following neoadjuvant chemotherapy and subsequent surgery in patients with resectable (T2-4, N+, M0) gastric adenocarcinoma. Patients received catumaxomab intra- (single 10 μg dose) and postoperatively (10, 20, 50 and 150 μg on days 7, 10, 13 and 16, respectively). The primary endpoint was the postoperative complication rate (maximum rate defined as <62 %) within 30 days after surgery in patients who received at least the first catumaxomab dose.
Of 64 patients treated with neoadjuvant chemotherapy, 58 underwent surgery and 54 received at least the first catumaxomab dose. Postoperative complications were reported in 18 of 54 evaluable patients (complication rate 33 %; 95 % confidence interval: 21-48 %); thus, the primary endpoint was met. The most frequent complications were pulmonary infection (17 %) and anastomosis insufficiency requiring surgery (11 %). The most common catumaxomab-related adverse events were pyrexia (67 %), leucocytosis (19 %), abdominal pain (17 %) and chills (17 %). The 4-year disease-free and overall survival rates were 38 and 50 %.
Intra- and postoperative administration of catumaxomab as part of a multimodal treatment approach was feasible and tolerable in patients with advanced gastric cancer and should be further investigated in a randomised trial.
由于腹腔内播散性肿瘤细胞的扩散，晚期胃癌患者胃切除术后和围手术期化疗后的复发率仍然很高。围手术期给予卡妥索单抗可能会在原发性肿瘤进行预期根治性切除后消除残留的肿瘤细胞。
这项开放标签的II期研究调查了卡妥索单抗在可切除（T2-4，N+，M0）胃腺癌患者新辅助化疗及随后手术之后的安全性和疗效。患者在术中接受卡妥索单抗（单次10μg剂量），术后分别在第7、10、13和16天接受卡妥索单抗（剂量分别为10、20、50和150μg）。主要终点是接受至少第一剂卡妥索单抗的患者术后30天内的术后并发症发生率（最大发生率定义为<62%）。
在64例接受新辅助化疗的患者中，58例接受了手术，54例接受了至少第一剂卡妥索单抗。54例可评估患者中有18例报告了术后并发症（并发症发生率33%；95%置信区间：21-48%）；因此，达到了主要终点。最常见的并发症是肺部感染（17%）和需要手术的吻合口功能不全（11%）。最常见的与卡妥索单抗相关的不良事件是发热（67%）、白细胞增多（19%）、腹痛（17%）和寒战（17%）。4年无病生存率和总生存率分别为38%和50%。
作为多模式治疗方法的一部分，在晚期胃癌患者中术中及术后给予卡妥索单抗是可行且可耐受的，应在随机试验中进一步研究。
