Background and objectives: Although intravenous (IV) FAMP in combination with Rituximab was reported to be effective against indolent B-NHL (
Results: Forty-one patients were enrolled and received oral FAMP with rituximab. Thirty-eight patients (93%) were follicular lymphoma, two with MALT lymphoma, and one with small lymphocytic lymphoma. Thirty-four patients (83%) received rituximab with or without chemotherapy prior to enrollment. Median treatment cycles were 6 cycles (range: 2 to 6, 66% of patients completed 6 cycles of treatment). Investigator-assessed overall response rate and complete response rate were 83% (34/41; CI: 68 to 93%) and 76% (31/41; CI: 60 to 83%), respectively. Central evaluation is pending. With median follow-up period of 9 months, median progression-free survival was not reached, and 28 patients (68%) were still alive without disease progression. Toxicity was primary hematologic, transient and manageable. Most common grade 4 hematologic toxicities included lymphopenia (98%), neutropenia (66%), and leukopenia (42%). Grade 3 or greater non-hematologic toxicities were observed in 29% of patients including one each of grade 4 stomatitis and hyperuricemia. Dose reduction of oral FAMP (from 40 to 30 mg/m2) was necessary in 44% of patients at some points of treatment courses. One patient died from Pneumocystis jiroveci pneumonia and other 2 from disease progression after the end of the study.
Conclusion: Oral FAMP combined with rituximab is highly effective with acceptable toxicities for patients with relapsed or refractory indolent B-NHL who have been mostly pretreated with rituximab, and more convenient than the combination with IV FAMP. Prolonged prophylactic therapy against Pneumocystis jiroveci pneumonia would be recommended.
Disclosure:Employment: Masaki Hayashi: Bayer