Clinical Efficacy and Cost Benefit of Low-Dose Granulocyte Colony-Stimulating Factor after Standard Chemotherapy in Patients with Non-Hodgkin’s Lymphoma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4671-4671
Author(s):  
Satoshi Hashino ◽  
Masanobu Morioka ◽  
Tatsuro Irie ◽  
Noriyuki Shiroshita ◽  
Tsugumichi Kawamura ◽  
...  

Abstract High costs of molecule-targeted drugs such as rituximab, ibritumomab and tositumomab have given rise to an economical issue for treating patients with non-Hodgkin’s lymphoma (NHL). Granulocyte colony-stimulating factors (G-CSF), which are also expensive, are widely used for treating neutropenia after chemotherapy. In Japan, lenograstim at 2 μg/kg (almost 100 μg/body) or filgrastim at 50 μg/m2 (almost 75 μg/body) is commonly administered for patients with NHL after chemotherapy. Therefore, cost-effectiveness is an important issue in treatment for NHL. Patients with advanced-stage NHL who needed chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or a CHOP-like regimen with or without rituximab were enrolled in this randomized cross-over trial to investigate the efficacy and safety of low-dose G-CSF. Half of the patients were administered 75 μg filgrastim in the first course after neutropenia and 50 μg lenograstim in the second course, and the other half were crossed over. Forty-seven patients were enrolled in this cross-over trial, and twenty-four patients completed the trial. Frequencies of leukocytopenia and neutropenia of grade 4 were similar in patients who received filgrastim courses and those who received lenograstim courses (p=0.6366 in leukocytopenia and p=0.2207 in neutropenia, respectively). Durations of leukocytopenia and netropenia of grade 4 in each treatment course were not different statistically (p=0.3892 in leukocytopenia and p=0.1476 in neutropenia, respectively), and each period of G-CSF administration in both courses was not different statistically (p=0.0676). Frequency of fever higher than 37.5 degrees (p=0.6826) and duration of fever (p=0.7455) were also not statistically different in the two treatment courses. Documented infection containing FN after chemotherapy was not statistically different (p=0.1213). Although the administration dose of G-CSF was not determined on the basis of body weight or body surface area, eight febrile patients were not administered insufficient dose of G-CSF. Therefore, compared with the standard-dose G-CSF course (filgrastim at 75 μg), there was no statistically increased frequency of antibiotic usage in the low-dose G-CSF course (lenograstim at 50 μg) (p=0.2199). The total cost of G-CSF in the low-dose G-CSF (lenograstim at 50 μg) course was significantly lower than that in the standard-dose G-CSF (filgrastim at 75 μg) course (p<0.0001). In this clinical study, the total cost of treatment with G-CSF at a lower dose was 62% of the cost of treatment at the standard dose. This study also suggests that the half dose descalation of lenograstim is as effective as the standard dose of filgrastim.

1996 ◽  
Vol 14 (2) ◽  
pp. 565-571 ◽  
Author(s):  
L B Travis ◽  
J Weeks ◽  
R E Curtis ◽  
J T Chaffey ◽  
M Stovall ◽  
...  

PURPOSE Low-dose total body irradiation (TBI) is used to treat non-Hodgkin's lymphoma (NHL) and several other malignancies. Large volumes of bone marrow and other tissue receive considerable exposure, but few studies have quantified late carcinogenic sequelae. PATIENTS AND METHODS A cohort of 61 2-year survivors of NHL treated initially with low-dose TBI was monitored for second cancer occurrence. Data on primary and subsequent therapy were collected, and cumulative dose of radiation to active bone marrow (ABM) (median, 5.2 Gy) was reconstructed. RESULTS Thirteen second primary cancers occurred. Four patients developed acute nonlymphocytic leukemia (ANLL), which represents a relative risk (RR) of 117 (95% confidence interval [CI], 31.5 to 300) compared with population rates. A fifth patient was diagnosed with myelodysplastic syndrome (MDS). All five patients with secondary hematologic malignancies subsequently received salvage treatment, with either alkylating agents alone (n = 1) or combined modality therapy (CMT) (n = 4). Overall, eight solid tumors were observed (RR = 2.0; 95% CI, 0.9 to 4.0). The 15-year cumulative risks of all second cancers and secondary ANLL were 37% and 17%, respectively. CONCLUSIONS Despite the small number of subjects, a considerable risk of leukemia was observed among patients treated with low-dose TBI in combination with CMT including alkylating agents. Based on these results, approximately eight to nine excess ANLLs might be expected to occur among 100 NHL patients treated with low-dose TBI and salvage treatment and followed-up for 15 years.


1996 ◽  
Vol 14 (11) ◽  
pp. 3026-3035 ◽  
Author(s):  
J A Sparano ◽  
P H Wiernik ◽  
X Hu ◽  
C Sarta ◽  
E L Schwartz ◽  
...  

PURPOSE To determine the following: (1) the feasibility of combining the antiretroviral didanosine (ddl) with a 96-hour continuous intravenous (IV) infusion of cyclophosphamide (800 mg/m2), doxorubicin (50 mg/m2), and etoposide (240 mg/m2) (CDE) plus filgrastim in patients with non-Hodgkin's lymphoma (NHL) associated with human immunodeficiency virus (HIV) infection; (2) the effect of ddl on CDE-induced myelosuppression and CD4 lymphopenia; and (3) the effect of CDE on serum p24 antigen and quantitative HIV blood cultures. METHODS Twenty-five patients with HIV-related NHL received CDE every 28 or more days. Consecutive patients were assigned in an alternating fashion to group A (ddl given at a standard dose during cycles one, two, five, and six) or group B (ddl given during cycles three, four, five, and six). RESULTS ddl use was associated with less leukopenia (mean nadir, 3.33 v 1.49 x 10(3)/microL; p = .03), neutropenia (2.38 v 1.07 x 10(3)/microL; p = .03), and thrombocytopenia (76 v 48 x 10(3)/microL; p = .059), and fewer RBC (1.6 v 3.1 per cycle; p < .01) and platelet transfusions (0.7 v 1.5 per cycle; p < .01), but had no significant effect on CD4 lymphopenia. Furthermore, lymphomatous bone marrow involvement and low CD4 count were associated with significantly greater myelosuppression. Although there was no substantial change in serum p24 antigen, the HIV blood culture became quantitatively more positive or converted from negative to positive in seven patients (64%). Complete response (CR) occurred in 58% of patients (95% confidence interval, 38% to 78%), median CR duration exceeded 18 months, tumor-related mortality was 20%, and median survival was 18.4 months. CONCLUSION Our results suggest that the CDE and filgrastim regimen is tolerable and effective for patients with HIV-associated NHL, and that combination with ddl is feasible and may result in less myelosuppression.


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