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TAMPA, Fla. -- Outpatient treatment of with a monoclonal antibody proved safe and feasible, and led to a survival benefit in gynecologic cancer patients who could receive chemotherapy, a small clinical study showed.

All 26 patients received at least three of four planned intraperitoneal (IP) instillations of , which led to a median interval of 15 days before a patient required an intraperitoneal puncture. Median overall survival was 92.5 days, but five patients remained alive and free of puncture for as long as 876 days.

The findings support previous randomized trials of catumaxomab for malignant ascites, all of which involved inpatient administration of the antibody, Christian M. Kurbacher, MD, reported here at the Society of Gynecologic Oncology meeting.

"The study represents a real-world population of patients treated for malignant ascites and is the largest series of outpatients treated with IP catumaxomab reported so far," said Kurbacher, of the Gynecologic Center Bonn-Friedensplatz in Bonn, Germany.

"IP catumaxomab can be administered in relatively frail outpatients, achieving good ascites control," he added. "A survival benefit was seen in fit patients who received complete IP catumaxomab treatment and were able to undergo subsequent systemic therapy."

Malignant ascites is a common complication of peritoneal carcinomatosis associated with epithelial malignancies, including ovarian, endometrial, and breast cancers. The ascites arises from tumors' expression of epithelial cell-adhesion molecule (EpCAM).

Catumaxomab targets both EpCAM and CD3 and is approved for treatment of malignant ascites in Europe, said Kurbacher. Until recently, administration of catumaxomab required a 2-week hospitalization except for carefully selected patients.

Outpatient administration would improve the convenience of the therapy, but the feasibility and safety of outpatient treatment for unselected patients remained unproven.

To examine the issue, Kurbacher and colleagues performed a retrospective review of their experience with catumaxomab in an outpatient setting. They identified 26 patients with malignant ascites related to various gynecologic cancers, all of whom received the monoclonal antibody as outpatients.

The study group consisted of 14 patients with epithelial ovarian cancer, six with metastatic breast cancer, three with endometrial cancer, and three with other cancers of epithelial origin. Most of the patients had an extensive treatment history associated with a median of four prior regimens and as many as 12. The patients had Karnofsky performance status ≥60% and life expectancy ≥12 weeks.

The patients received IP catumaxomab by a standard protocol, consisting of four IP instillations. The primary endpoints of the analysis were safety and feasibility. Secondary endpoints included ascites control, number of subsequent punctures, puncture-free interval, puncture-free survival, and overall survival.

Investigators defined puncture-free survival as the time from initiation of IP catumaxomab to the next puncture of the peritoneal cavity, death, or loss to follow-up. Overall survival was defined as the interval from the start of catumaxomab treatment to death from any cause or loss to follow-up.

Pre-medication and supportive treatment included metamizole, paracetamol, granisetron, nonsteroidal anti-inflammatory drugs, corticosteroids, and opioids by physician discretion. Each IP instillation lasted 3 to 6 hours.

The most frequent adverse events (all grades) were fatigue (seven patients), nausea/vomiting (six), abdominal pain (six), and fever (five). The most common grade 3/4 adverse event was fatigue (three).

Kurbacher reported that 17 (65.4%) of the patients had Karnofsky scores of 60% to 80%. Seven patients required secondary hospitalization: one because of fever/infection, one for abdominal pain/subileus, and five for general deterioration of patient condition.

All four catumaxomab infusions were completed by 17 patients, and the remaining nine completed three of the four planned infusions. Additionally, 11 of the 26 patients subsequently received one or more lines of systemic therapy.

Five patients required peritoneal punctures. The median puncture-free interval included a range of 8 to 169 days. The median puncture-free survival was 79.5 days and ranged from 9 to 876 days. The five patients still alive had a survival range of 276 to 876 days.

Kurbacher said the results warrant investigation in prospective clinical trials to confirm the feasibility, safety, and efficacy of outpatient administration of catumaxomab.

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