A phase II study of catumaxomab administered intra- and postoperatively as part of a multimodal approach in primarily resectable gastric cancer.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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 %.

CONCLUSION:

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.

• Authors: Carsten Bokemeyer, Alexander Stein, Karsten Ridwelski, Djordje Atanackovic, Dirk Arnold, Ewald Wöll, Alexis Ulrich, Ramona Fischer, Colin Krüger, Christoph Schuhmacher
• Journal: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association (Gastric Cancer) Vol. 18 Issue 4 Pg. 833-42 (Oct 2015) ISSN: 1436-3305 [Electronic] Japan
• PMID: 25214034 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bispecific
• Antineoplastic Agents
• catumaxomab

Topics

• Adenocarcinoma (drug therapy, surgery)
• Adult
• Aged
• Antibodies, Bispecific (administration & dosage, adverse effects)
• Antineoplastic Agents (administration & dosage, adverse effects)
• Combined Modality Therapy
• Female
• Gastrectomy
• Humans
• Intraoperative Period
• Male
• Middle Aged
• Neoadjuvant Therapy
• Postoperative Period
• Stomach Neoplasms (drug therapy, surgery)