Addition of amifostine to the CHOP regimen in elderly patients with aggressive non-Hodgkin lymphoma: a phase II trial showing reduction in toxicity without altering long-term survival

BACKGROUND AND OBJECTIVES: 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 AND METHODS: Patients were randomized to receive classical CHOP (cyclophosphamide 750 mg/ m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 [maximum 2 mg] on day 1 and prednisone 100 mg/day for 5 days) or CHOP plus amifostine (6 cycles of amifostine 910 mg/m2 on day 1). Efficacy (time to progression, TTP; disease-free survival, DFS; overall survival, OS) and toxicity endpoints were evaluated. RESULTS: 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). CONCLUSION: These results show that amifostine can be added to the standard CHOP treatment schedule with less acute toxicity and without influencing the outcome

Can Participatory Institutions Promote Pluralism? Mobilizing Low-Income Citizens in Brazil

Participatory decisionmaking institutions have proliferated across the developing world during the past decade as governments and civil society organizations sought to incorporate citizens directly into policymaking arenas. This article draws from a survey (n = 833) of elected delegates in Brazil\u27s Participatory Budgeting (PB) to explain what factors most strongly influence participants\u27 attitudes and behaviors. Do citizen-participants believe that they exercise authority within these new institutions? Have they modified their basic strategies to secure public goods? The purpose of this article is to account for the significant differences in the survey respondents\u27 attitudes and behaviors by developing individual- and municipal-level models that test the significance of civil society participation, institutions, social context, and partisan political identification. Ordinary least squared (OLS) and logistic regression are used to test these models. Group-oriented behavior, more commonly known as pluralism, is replacing clientelism and personalism in the most successful cases of PB due to the extension of authority to individual citizens. This article demonstrates that participatory institutions, in conjunction with participation in a civil society organization, can alter citizens\u27 attitudes and behavior