• 한국임상약학회지
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• 제25권3호
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• pp.151-158
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• 2015

Objective: This study was designed to compare pegfilgrastim and filgrastim in diffuse large B-cell lymphoma (DLBCL) patients treated with a rituximab with cyclophosphamide, hydroxydaunorubicin, oncovin, and prednisone (R-CHOP) regimen in terms of clinical efficacy and cost-effectiveness. Method: Clinical efficacy was measured by trough level of absolute neutrophil count (ANC), days of ANC under 50% of baseline value, days of ANC under 90% of baseline value, duration of ANC recovery to baseline value, days of ANC less than $0.5{\times}10^9cells/L$, and difference of peak and trough level of ANC during 1 cycle of R-CHOP regimen. To evaluate cost-effectiveness, total prices of used filgrastim and pegfilgrastim within 1 cycle of R-CHOP were analyzed. Results: In terms of clinical efficacy, trough level of ANC and days to ANC recovery showed statistical significance. The median trough levels of ANC with administration of filgrastim and pegfilgrastim were 0.18 and 1.94 (p = 0.021), respectively, and the median durations of ANC recovery to baseline value were 5.5 days and 2 days (p = 0.023), respectively. For the median days of ANC under 50% of baseline value, days of ANC under 90% of baseline value, days of ANC less than $0.5{\times}10^9cells/L$, and difference of peak and trough level of ANC during 1 cycle of R-CHOP, the pegfilgrastim group performed better than the filgrastim group. However the difference was not statistically significant. In terms of overall expense during 1 cycle of R-CHOP, pegfilgrastim is about 3.43 times more expensive than filgrastim. Conclusion: Pegfilgrastim is more efficient than filgrastim in terms of clinical efficacy. In terms of prices, pegfilgrastim is more expensive than filgrastim for patients, but it is more convenient in clinical use. Therefore, pegfilgrastim should be the preferred choice of G-CSF for neutropenic patients. Further comparative study of pegfilgrastim and filgrastim is needed.

• 한국임상약학회지
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• 제25권2호
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• pp.80-93
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• 2015

Objective: Pegfilgrastim is recently introduced that is long acting G-CSF for prophylaxis of febrile neutropenia. Treatment of non-Hodgikin's lymphoma (NHL) with R-CHOP is classified with relative high risk of febrile neutropenia. The study evaluated the prophylactic effect of pegfilgrastim to reduce the incidence of febrile neutropenia associated with R-CHOP of patient in NHL. And the risk factors associated with the incidence of FN and related events were evaluated. Methods: This retrospective study reviews the Electronic Medical Record of 68 NHL patients who received R-CHOP chemotherapy in single center between September 2013 and August 2014. These patients were classified who receive prophylaxis pegfilgrastim or no prophylaxis. Results: Sixty eight patients received R-CHOP with NHL. In 144 cycles of patients receiving pegfilgrastim, compared with no prophylaxis 178 cycles, had a lower incidence of febrile neutropenia (5.5% vs. 23.6%, p = 0.001), grade 3 or grade 4 neutropenia (14.4% vs. 89.8%, p < 0.001) and neutropenia related events (p < 0.05). The risk of febrile neutropenia after prophylaxis was significantly associated with age ${\geq}65$ (OR: 5.87, 95% CI 1.07-32.27, p = 0.042), $IPI{\geq}3$ (OR: 7.2, 95% CI 1.31-39.6, p = 0.023), S.alb < 3.5 g/dL (OR: 31.01, 95% CI 6.32-152.17, p < 0.0001). In multiple logistic regression analysis, lower baseline serum albumin (OR: 21.1, 95% CI 3.8-116.98, p = 0.001) was significantly associated with occurrence of febrile neutropenia. Conclusion: The study recommends prophylactic pegfilgrastim through risk assessment of febrile neutropenia in patients with non-Hodgikin's lymphoma receiving R-CHOP.

• 병원약사회지
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• 제35권4호
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• pp.409-417
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• 2018

Background : Febrile neutropenia (FN) is one of the side effects in the patients treated with chemotherapy, and the patients who have FN generally need immediate treatment with extended-spectrum antibiotics and hospitalization. Pegfilgrastim and pegteograstim, which are used for the prevention of FN as a granulocyte-colony stimulating factor (G-CSF), have been granted insurance coverage in the Republic of Korea for certain breast cancer patients using doxorubicin and cyclophosphamide (AC) from September 2016. Methods : The data of the patients with breast cancer using AC regimen and G-CSF were collected retrospectively. This study involves cost-utility analysis of pegfilgrastim and pegteograstim. In this study, we constructed a simple decision tree model for short-term observation and calculated quality-adjusted life year (QALY) and the direct medical costs from the medical provider's perspective. Results : From September 2016 to May 2017, 15 patients were treated with pegfilgrastim and 15 patients were treated with pegteograstim. As a result of dividing the average cost by QALY for each treatment group, it was observed that pegfilgrastim and pegteograstim were consumed 24,923,384 won and 22,808,336 won per 1QALY, respectively. Consequently, incremental cost effectiveness ratio (ICER) showed 2,115,048 won more per pegfilgrastim than pegteograstim per 1QALY, and the cost per 1QALY of both the drugs was lower than 30,500,000 won; the Koreans were willing to pay this amount. Conclusions : This study suggests that pegfilgrastim and pegteograstim can be used to improve the quality of life of breast cancer patients undergoing AC therapy. Among the two drugs, pegteograstim seems to be more cost-effective. However, since this study was conducted as a retrospective observation method on a small scale, it is associated with many limitations. Therefore, a long-term prospective cohort study is needed to supplement the present findings.

• 핵의학기술
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• 제13권3호
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• pp.17-23
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• 2009

많은 암 환자들 중 특히 미만성 거대 B 세포 림프종 환자의 추적 검사에서 PET/CT 검사는 기타 다른 검사들과 견주어 볼 때 매우 중요하다는 것은 이미 알려져 있다. 이들 환자의 치료는 대부분 환자의 장기 한 곳에 국한된 경우가 없으므로, 방사선 치료나 항암 화학 요법 치료로 시행한다. 이러한 항암 화학 요법 치료는 골수의 활동을 억제하는 치료이기 때문에 환자에게서 호중구감소증과 같은 백혈구의 감소가 나타날 수 있다. 이러한 증상을 개선하기 위하여 과립구 자극요소(Granulocyte colony-stimulating factor)인 Filgrastim 성분의 골수촉진제를 사용하는 경우가 일반적이며, 이 약제가 투여된 환자에게서 단기간에 PET/CT 검사를 진행하게 되면, 검사에 사용되는 $^{18}F$-FDG의 섭취가 조혈 세포가 모여 있는 골수의 활성화로 그 곳에 섭취가 가중되어 정확한 영상의 정보를 얻는데 한계가 있다. 이 연구의 목적은 Filgrastim의 약제 투여 1일 후의 영상과 어느 정도 시간이 지난 후 영상의 SUV를 각각 비교하여 수치화하고, 대략 어느 정도 시간이 지난후에 정확한 영상의 정보를 줄 수 있는 $^{18}F$-FDG의 섭취가 일어나는지를 유추해 보고자 한다. 환자대상은 2007년 1월~2009년 1월까지 미만성 거대 B 세포 림프종을 진단받고 추적 검사 중인 환자 10명을 대상으로 하였다. 남자 4명, 여자 6명이고, 평균나이는 53.8세 평균 체중은 57.3 kg이다. PET/CT (Discovery STe; GE Healthcare, Milwaukee, WI, USA) 검사를 위해 환자에게 $^{18}F$-FDG 정맥주사 후 1시간 가량 안정시키고, PET/CT 영상을 획득하였다. 영상 분석은 ROI ($12\;mm^2$)를 $C_6$ (6 번 경추), $L_4$ (4 번 요추), 간, 비장, 폐에 각각 그린 후 표준화 섭취 계수(SUV)를 측정하였다. 같은 환자를 골수촉진제 주사 1일 후 영상과 5~7일 후 영상을 각각 분석하였으며, 통계 프로그램으로는 SPSS version 12. Wilcoxon signed rank test를 사용하여 두 집단 간의 유의성을 확인하였다. 검사를 시행한 10명의 환자의 SUV를 분석한 결과, 골수촉진제를 투여하고 1일 후의 SUV가 5~7일 후에 비해 $C_6$ (6 번경추), L4 (4 번 요추), 비장에서 현저하게 높게 나타났고, 간과 폐에서는 비슷하게 나타났다. SUV의 차이와 더불어, 5~7일 후의 영상에서는 뼈의 섭취가 거의 없어진 정상 섭취 영상을 얻을 수 있었다. 위의 연구에서도 보여진 것과 같이 과립구 자극요소 약제투여 후 1일째 환자의 영상과 5~7일 후의 영상에서 SUV의 현저한 차이가 있었으며, 약제를 투여한 환자의 영상에 뼈의 $^{18}F$-FDG 섭취가 집중되었으며, 평균 5~7일 후에 검사에서는 뼈의 섭취가 현저하게 줄어든 정상적이 영상을 얻을 수 있었다. 본 연구를 통하여 SUV를 측정하고, 통계분석 함으로서 기존의 사실을 수치화 하였으며, 정상 섭취가 가능한 기간을 유추 할 수 있었다. 추후에 과립구 자극요소인 Filgrastim 이 외에 Pegfilgrastim, Lenograstim등 기타약제와의 유사성과 차이점에 대한 유사 연구에도 기여할 수 있으리라 사료된다.