惰性淋巴瘤治疗进展PPT.ppt

* * * 查 * There are 2 published studies looking at the role of Rituxan maintenance after R-monotherapy induction. These were performed by John Hainsworth and Michele Ghielmini. Hainsworth’s trial was in front-line indolent NHL patients. These patients included a group with SLL. Ghielmini’s trial included front-line and relapsed follicular NHL patients. After induction, there was a significant difference between the RR of the 57 chemotherapy-naive patients (RR 67% with 9% CR) and the 128 previously treated patients (RR 46% with 8% CR) (OR=2.34; P =.0097) The data above represents the best response data for patients treated in each of the trials. The median PFS is 52 months for FL pts in the Hainsworth trial. The Ghielmini showed a median PFS of 36 months for front-line and 15 months for relapsed pts given Rituxan maintenance therapy, compared with a median PFS of 19 months for front-line and 10 months for relapsed pts. Hainsworth study patients: Eligible patients were required to have biopsy-proven indolent B-cell NHL with one of the following histologies as defined by the revised European-American lymphoma classification: follicular small cleaved cell, follicular mixed small cleaved- and large-cell, follicular large-cell, plasmacytoid, and small lymphocytic lymphoma (SLL). Patients with stage II, III, or IV lymphoma at the time of diagnosis were eligible, as were patients with early-stage disease (stage I or II) who had relapsed or progressed after previous radiation therapy. No previous chemotherapy or monoclonal antibody therapy was permitted. Additional eligibility requirements included measurable or assessable disease, Eastern Cooperative Oncology Group performance status of 0, 1, or 2, age more than 18 years old, WBC count 3,000/L, platelet count 100,000/L, and adequate liver and kidney function. Patients who had severe lymphoma-related symptoms requiring a rapid response to therapy (eg, respiratory compromise because of large effusions or airway obstru