Patients with indolent conjunctival
lymphomas exhibit good prognosis, with exceptional cases of dissemination, and are suitable candidates for intralesional
therapies. We report the first prospective phase 2 trial using intralesional
rituximab supplemented with autologous serum in adults with relapsed/refractory indolent CD20+
lymphoma of the conjunctiva (NCT01514344). Patients received 4 weekly
intralesional injections of
rituximab, followed by 6 monthly
injections; 500 μL of autologous serum was added to
rituximab in patients with
lymphoma unresponsive to weekly doses. Safety, activity, and antitumor effect of autologous serum were investigated. Twenty patients with mucosa-associated lymphoid tissue (MALT)-type
lymphoma were enrolled. Tolerability was excellent, with only 3 mild local reactions. After weekly
injections, 11 patients achieved
tumor regression, 8 had stable disease, and 1 experienced progressive disease; 9 patients received autologous serum, with response improvement in 4 cases (3 complete responses, 1 partial response). At the end of treatment, 12 patients achieved a complete remission, and 1 achieved a partial response, with an overall response rate of 65% (95% confidence interval, 45-85). At a median follow-up of 42 months (range, 10-78), 12 patients remain relapse free, with 5-year progression-free survival and time-to-next-treatment rates of 59% ± 11% and 69% ± 11%, respectively. Three patients with local relapse were retreated with intralesional
rituximab and serum; 2 achieved a complete response that lasted 25+ and 38+ months. Thus, intralesional
rituximab is a safe and active
therapy in patients with relapsed conjunctival
MALT lymphoma. The addition of autologous serum improves response in some cases.
Retreatment of local relapses can result in a second durable remission.