ABSTRACT
We report the 8-year follow-up of 34 patients aged >/= 69 years old with NHL included in a phase IIb open-label randomized parallel groups study to evaluate the effectiveness of amifostine in preventing the toxicity of cyclophosphamide, doxorubicin, vincristine and prednisone [CHOP regime]. Patients were randomized to receive classical CHOP [cyclophosphamide 750 mg/ m[2], doxorubicin 50 mg/m[2], vincristine 1.4 mg/m[2] [maximum 2 mg] on day 1 and prednisone 100 mg/day for 5 days] or CHOP plus amifostine [6 cycles of amifostine 910 mg/m[2] on day 1]. Efficacy [time to progression, TTP; disease-free survival, DFS; overall survival, OS] and toxicity endpoints were evaluated. Thirty-four patients were randomized to A-CHOP [n=18] or CHOP [n=16]. Patients with A-CHOP vs CHOP had significantly lower toxicity; neutropenia grade 4 ocurred in 13/92 [13%] vs 23/85 [27%, P=0.007] cycles, febrile neutropenia in 3/92 A-CHOP [3%] vs 8/85 [10%, P=.056] CHOP cycles, hospitalization for toxicity in 4/92 [4%] A-CHOP vs 11/85 [13%, P=.05] CHOP cycles. Median hospitalization stay for toxicity was 5 days with A-CHOP vs 8 days with CHOP [P=.05]. There were no significant differences at 8 years in TTP [A-CHOP, 48.9% vs CHOP, 36.3%; P=.65], DFS [A-CHOP, 72.9% vs CHOP 55.6%; P=.50] and OS [A-CHOP, 44.3% vs CHOP, 54.4%]. There was no long-term toxicity of clinical interest. The only prognostic factor identified to 8 years was the International Prognostic Index [IPI low/low intermediate risk vs high intermediate/high risk; HR=2.98; CI 95%:1.01-8.77; P=.048]. These results show that amifostine can be added to the standard CHOP treatment schedule with less acute toxicity and without influencing the outcome