Zagonel V, Babare R, Merola M C, Talamini R, Lazzarini R, Tirelli U, Carbone A, Monfardini S
Division of Medical Oncology, Centro di Riferimento Oncologico, INRCCS, Aviano, Italy.
Ann Oncol. 1994;5 Suppl 2:127-32. doi: 10.1093/annonc/5.suppl_2.s127.
Older patients with non-Hodgkin's lymphoma (NHL) display a poorer response to chemotherapy and a significantly higher treatment-associated toxicity than do younger individuals. We investigated the potential clinical benefits and the cost-effectiveness of accelerated granulocyte recovery induced by recombinant granulocyte colony-stimulating factor (G-CSF) in patients with aggressive NHLs, aged 60-70 years, during treatment with a second-generation combination chemotherapy.
12 consecutive patients (median age 66 years) treated with six to eight courses of CHVmP/VB plus subcutaneous G-CSF (5 micrograms/kg/day) were compared with 11 consecutive subjects (median age 65 years) who received the same chemotherapy regimen without growth factor support. The two groups of patients were fully comparable as to the clinicopathologic features. A comparative analysis of treatment costs (including hospitalization, antimicrobial prophylaxis and therapy, supportive and diagnostic procedures, and G-CSF) was also performed.
Both the overall response rate and the percentage of complete remissions were comparable in the two treatment groups. In the control group, 32.5% of chemotherapy courses were delayed, as opposed to 19% in the G-CSF group (p = 0.05). The mean duration of delay for patients receiving or not receiving G-CSF was 10.1 and 25.9 days, respectively (p = 0.02). Grade 3 and 4 granulocytopenia complicated 27.7% of chemotherapy courses in control patients and only 4.8% in subjects receiving G-CSF (p < 0.001). Similarly, severe infections and mucositis were significantly higher in patients receiving chemotherapy alone (15.6% and 3.6%, respectively) compared to the G-CSF group (4.8%, p = 0.01; p = 0.04, respectively). A mean of 1.1 days/course of hospitalization was required in the control group, as opposed to 0.2 days/course in patients receiving G-CSF (p = 0.05). Although overall treatment costs were higher in the control group, single cost of the recombinant growth factor exceeded by far all the other expenses in the G-CSF group, reaching a statistical relevance (p = 0.01).
The inclusion of prophylactic G-CSF in the treatment plan for aggressive NHL in older patients appears safe and cost-effective in view of the peculiar clinical features of aged subjects and the possibility of delivering effective doses of antineoplastic drugs on an outpatient setting.
与年轻患者相比,老年非霍奇金淋巴瘤(NHL)患者对化疗的反应较差,且治疗相关毒性显著更高。我们研究了重组粒细胞集落刺激因子(G-CSF)诱导的加速粒细胞恢复在60 - 70岁侵袭性NHL患者接受第二代联合化疗期间的潜在临床益处和成本效益。
将连续12例患者(中位年龄66岁)接受6至8个疗程的CHVmP/VB加皮下注射G-CSF(5微克/千克/天)与连续11例患者(中位年龄65岁)接受相同化疗方案但无生长因子支持进行比较。两组患者在临床病理特征方面完全可比。还对治疗成本(包括住院、抗菌预防和治疗、支持性和诊断性程序以及G-CSF)进行了比较分析。
两个治疗组的总缓解率和完全缓解百分比相当。在对照组中,32.5%的化疗疗程延迟,而G-CSF组为19%(p = 0.05)。接受或未接受G-CSF的患者的平均延迟持续时间分别为10.1天和25.9天(p = 0.02)。3级和4级粒细胞减少在对照组化疗疗程中占27.7%,而在接受G-CSF的患者中仅占4.8%(p < 0.001)。同样,单独接受化疗的患者中严重感染和粘膜炎显著更高(分别为15.6%和3.6%),而G-CSF组分别为4.8%(p = 0.01)和4.8%(p = 0.04)。对照组每个疗程平均需要住院1.1天,而接受G-CSF的患者为0.2天/疗程(p = 0.05)。虽然对照组的总体治疗成本更高,但重组生长因子的单项成本远远超过G-CSF组的所有其他费用,具有统计学意义(p = 0.01)。
鉴于老年患者的特殊临床特征以及在门诊环境中给予有效剂量抗肿瘤药物的可能性,在老年侵袭性NHL患者的治疗方案中加入预防性G-CSF似乎是安全且具有成本效益的。