Abstract
8080 Background: Individuals older than 60 years have a worse prognosis than younger patients with aggressive NHL. Vincristine is active in malignant lymphomas. Sphingosomal vincristine (SV) was well tolerated with 45% ORR in multiply relapsed aggressive NHL (ASH Abst. 412, 1999). Based on these data, a phase II study of CHOP with or without rituximab, and substituting SV for free vincristine, was undertaken in patients with previously untreated aggressive NHL. Methods: Patients were treated with standard dose CHOP that included SV 2.0 mg/m2 without dose capping ± rituximab 375 mg/m2, given every 21 days for 6 to 8 courses (ASH abst. 338, 2002). Results: Of 73 patients enrolled on study, 68 were evaluable for response. Median age was 63 (range 22–80), 37 pts (54%) were > 60. Overall, 24 pts (23 elderly) had an IPI score ≥ 3. Patients received a median of 6 study treatments (range 1–8). ORR was 92.6% (63/68 pts) with 55 pts achieving CR (80.1%), 7 CRu (10.3%), and 1 PR (1.5%). 3 pts had PD (4.4%) and 2 were not assessed for response (2.9%). ORR was similar in both elderly (>60) and younger pts (≤ 60): 91.9% and 93.5% respectively. The median PFS and OS have not been reached at a median follow up of 22 months. The probability of being progression free at 17 mos was 0.88 (5 relapses) for elderly pts and 0.86 (4 relapses) for pts ≤ 60. Overall survival probability was 0.98 (1 death) at 22 mos. Neuropathy was generally mild (Gr.1-2). Hematological toxicities were as follows: 56% Gr.3-4 neutropenia, 6% Gr.3 anemia, and 13% Gr.3-4 thrombocytopenia. Toxicites were comparable in both elderly and younger patients. Conclusions: CHOP plus rituximab regimen with sphingosomal vincristine substituted for free vincristine is a well tolerated therapy with only mild neurotoxicity. Remarkably, the activity in the elderly is comparable to that in younger patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration INEX
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