Rituximab immunotherapy for ocular adnexal lymphoma: clinicopathologic correlation with 5-year follow-up.

Two patients with primary ocular adnexal mucosa-associated lymphoid tumor lymphoma were treated with rituximab immunotherapy. One patient had refused radiotherapy. The other had bilateral ischemic retinopathy, a relative contraindication to radiotherapy. Biopsies were performed 6 months after treatment. One patient had complete resolution of local disease, and the other had a partial response, remaining stable without signs of progression. During the 5 years of clinical follow-up, there was no evidence of systemic disease in either patient. Rituximab immunotherapy is an alternative to regional radiotherapy for ocular adnexal mucosa-associated lymphoid tumor lymphoma.

Phase I clinical trial of irinotecan with oral capecitabine in patients with gastrointestinal and other solid malignancies.

The purpose of this study was to determine the safety of irinotecan and capecitabine in patients with advanced solid tumors. Thirty-four patients received 122 courses of irinotecan 200 to 300 mg/m(2) as an intravenous infusion during 30 minutes on day 1 and capecitabine 1,500 to 3,000 mg/d orally 12 hours apart starting on day 2 for 14 days, repeated every 21 days (one course). Three to seven patients were treated in six dose-escalation cohorts. Three of 7 (43%) patients treated with irinotecan 300 mg/m(2) and capecitabine 2,300 mg/d had course 1 dose-limiting toxicity (DLT) defining maximum tolerated dosage (MTD). Fatigue and diarrhea were the major DLTs, and other events included neutropenia, anorexia, and hand-foot syndrome. At one dose level below the MTD, none of 7 patients treated with irinotecan 275 mg/m(2), and capecitabine 2,300 mg/d (36 courses) had course 1 DLT. Grade III to IV toxicities beyond course 1 included neutropenia (11% of all courses), fatigue (3.4%) and hand-foot syndrome (3.4%). There were only two episodes of febrile grade II neutropenia. There were no toxic deaths. Transient antitumor response was noted in one patient with irinotecan and 5-fluorouracil-refractory colon cancer. The combination of irinotecan 275 mg/m(2) and capecitabine 2,300 mg/d represents a safe, favorable, and convenient outpatient regimen warranting further phase II evaluation.

A pilot study of edrecolomab (Panorex, 17-1A antibody) and capecitabine in patients with advanced or metastatic adenocarcinoma.

Edrecolomab (Panorex) is a monoclonal antibody directed against the 17-1A antigen located on the cell surfaces of carcinomas. Clinical activity has been seen in colon and breast cancer. This trial investigated the feasibility of combining edrecolomab with the oral fluoropyrimidine capecitabine (Xeloda). Patients received a loading dose of edrecolomab 500 mg intravenously (i.v.) on day--14, followed 2 weeks later by 100 mg i.v. every 28 days (day 1). Capecitabine was administered to single-patient cohorts at escalating doses of 1500, 2000, and 2500 mg/m2/day in two equally divided doses for 14 of 21 days, beginning on day 1. Additional patients were enrolled at the 2500 mg/m2/day dose level to better define the toxicities of combination therapy. Toxicity assessment was the primary endpoint. Twenty seven patients with advanced or metastatic adenocarcinoma were enrolled on this study: 20 were evaluable for toxicity and 18 for response. The most common toxicities were elevated liver enzymes, diarrhea, and hand-foot syndrome. In cycle 1, grade 3 hand-foot syndrome was seen in two patients, and grade 3 diarrhea in one patient. Grade 2 toxicities included diarrhea, hand-foot syndrome, anemia, leukopenia, and transaminitis. Cumulative hand-foot syndrome was observed in four patients treated beyond two cycles. Three patients had edrecolomab infusion reactions during the course of treatment. One complete response and two partial responses were seen. Nine patients had disease stabilization lasting a median of 17.5 weeks (range 14.5-28+). Edrecolomab and capecitabine may be safely given in combination to patients with advanced or metastatic adenocarcinoma. Clinical activity is seen in this heavily pretreated patient population.