Liposomal Doxorubicin-containing Front-line Treatment in Elderly Patients With Classic Hodgkin Lymphoma: a Multicenter Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Study on the use of a polychemotherapy scheme based on liposomal doxorubicin, vinblastine and dacarbazine (MVD) as first line in the therapy of elderly patients affected by classic Hodgkin lymphoma
详细描述
Classic Hodgkin lymphoma (c-HL) is a neoplasm that originates from B lymphocytes and represents 10% of all lymphomas. The most affected age group is between 20 and 30 years of age, with a second peak in the epidemiological distribution involving patients over 60 years of age.
Elderly patients often present with already advanced disease stages and B symptoms. On the other hand, these patients often have multiple comorbidities and reduced fitness and this can limit the therapeutic possibilities with curative intent in terms of doses and adherence to the timing foreseen by the therapeutic protocol.
The optimal therapy for this category of patients is not yet well defined. In fact, the prognosis of these patients is typically poor.
The ABVD regimen (doxorubicin, i.e. Adriamycin, Bleomycin, Vinblastine, Dacarbazine) is a therapeutic option for elderly/unfit patients but is associated with considerable toxicity and mortality. In particular, mortality rates due to lung damage from Bleomycin are between 4-24% and mortality rates due to cardiac damage are reported in elderly patients suffering from c-HL and treated with regimens based on anthracyclines (of which doxorubicin belongs part) which fluctuate between 6 and 15%.
Non-pegylated liposomal anthracycline (NPLD) was initially used in patients with breast cancer and this particular formulation spares tissues characterized by tight capillary junctions (such as cardiac muscle tissue) from the direct cytotoxic effect of doxorubicin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously untreated, biopsy-proven c-HL
- •Ann Arbor stage III or IV
- •ECOG PS 0-3
- •LVEF≥50% at echocardiographic assessment
- •human immunodeficiency virus negativity.
- •any GLS value
排除标准
- •Ann Arbor stage I or II,
- •concomitant major illnesses
- •creatinine clearance <30 ml/min
- •serum transaminases more than three times the normal value
- •total bilirubin >3.4 mg/dl
- •absolute neutrophil count <500/mm 3
- •hemoglobin level <9 g/dL
- •platelet count <75 000/mm 3
- •Myocardial infarction represented an exclusion only if diagnosed within 3 months prior to MVD start.
结局指标
主要结局
Overall survival
时间窗: from 1 January 2013 to 1 January 2023
The primary endpoint was the activity of the liposomal doxorubicin-based front-line strategy in terms of OS.
次要结局
- End of Treatment response rate(from 1 January 2013 to 1 January 2023)
- Progression-free survival(from 1 January 2013 to 1 January 2023)
- Adverse events(from 1 January 2013 to 1 January 2023)
研究者
Marco Picardi
Professor
Federico II University