Mantle cell lymphoma (MCL) is a distinct subtype of lymphoma which typically presents in elderly men and is characterized by high stage at diagnosis, frequent extranodal sites of involvement, and a poor prognosis. We conducted a phase II trial of 2-CDA for therapy of MCL at 5 mg/m2/d IV × 5 days q 28 days for 2-6 cycles depending on response. Cases were stratified according to previous therapy. We reported an overall response rate of 81% as initial therapy (ASH 1999). This report includes only data from previously treated patients. Central pathology review to confirm MCL was required. Twenty-five previously treated patients were enrolled into the study, but 1 was subsequently deemed ineligible. The remaining 24 included 20 males and 4 females, median age 68 years (range: 39-81). Ann Arbor Stage was IV in 18 cases, and I or II in 6. Two or more extranodal sites were involved in 12 patients. Pretreatment LDH was elevated in 5 patients. The International Prognostic Factor Index (IPFI) was 0 in 2 cases, 1 in 4 cases, 2 in 9 cases, 3 in 4 cases, 4 in 4 cases and 5 in 1 case. The median number of previous regimens was 1 (1-6). Previous treatments included: anthracycline-containing regimens (15), rituximab (5), platinum-based regimens (1) and autologous stem cell transplant (1). Of the 20 patients with available response data from the last previous therapy, 11 (55%) had responsive disease. Five patients received 1 cycle, 8 received 2 cycles, 2 received 3 cycles, 4 received 4 cycles, and 5 received 6 cycles of 2-CDA. By NCCTG criteria, the complete response (CR) rate was 13% with a partial response (PR) rate of 33% and a minor response rate of 8% (total response rate 54%). By the current Cheson et. al. criteria 2 PRs would become CR or CRu for a CR/CRu rate of 21% and a PR rate of 25%. Following 2-CDA, the median time to progression was 5.4 months. The IPFI was not a predictor for time to progression and showed only a trend for prediction of overall response rates (66% for 0-2, 33% for 3-5; p=.ll). Eleven patients have died to date, 8 from progressive MCL, 1 from infection, 1 from a transplant-related complication, and 1 from unknown causes. Treatment complications included 1 grade 4 thrombocytopenia, 5 grade 4 neutropenias and 2 grade 4 infections. 2-CDA has significant activity as a single agent for the treatment of relapsed mantle cell lymphoma, though responses are of short duration. Subsequent trials will incorporate this active agent in combination with other agents.
|Original language||English (US)|
|Issue number||11 PART I|
|State||Published - Dec 1 2000|
ASJC Scopus subject areas
- Cell Biology