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유방암 환자에서 TAC 항암치료에 의한 호중구감소증에 대한 트리페그필그라스팀의 예방효과 평가

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Author(s)
이미란
Issued Date
2017
Abstract
Neutropenia, an adverse event of cytotoxic chemotherapeutic agent, is one of the major concerns in breast cancer patients. As a therapeutic agent for the neutropenia, recombinant human granulocyte-colony stimulating factor (G-CSF, filgrastim) is developed. Recently, pegylated G-CSF (pegfilgrastim, tripegfilgrastim) used to prevent neutropenia induced by chemotherapeutic agent has been introduced for thepurpose of longer duration of action. Tripegfilgastim, a filgrastim with branched pegylation, is developed for the better bioavailability with less aggregation and depegylation than those of pegylated filgrastim.
In this study, breast cancer patients with TAC (docetaxel/doxorubicin/cyclophosphamide) regimen were collected. We analyzed prophylactic tripegfilgrastim (PT) group, prophylactic pegfilgrastim (PP) group and non-prophylactic G-CSF (non-PG) group with incidence of neutropenia, febrile neutropenia, events of absolute neutrophil count (ANC) below 50% of baseline, cycles of dose reduction of chemotherapeutic agent, hospitalization duration, risk factors associated with neutropenia and febrile neutropenia.
Among the total 97 breast cancer patients with TAC regimen, prophylactic G-CSFs were treated in 31 patients (tripegfilgrastim) and 33 patients (pegfilgrastim). Non-PG group was 33 patients. Incidence of neutropenia (PT 22.58%, PT 39.39% non-PG 81.82% p<0.001), febrile neutropenia (PT 6.45%, PP 15.15% non-PG 42.42% p=0.001), events of ANC below 50% of baseline (PT 19.35%, PP 48.48% non-PG 90.91% p<0.001) hospitalization duration (PT 7.35±2.09 days, PT 10.82±11.68 non-PG 13.27±8.77 p=0.002) of prophylactic group (PT, PP) are significantly lower than those of non-PG group. The risk factor associated with neutropenia was use of Tripegfilgrastim (HR 0.065 CI 0.02-0.22) and Pegfilgrastim (HR 0.144 CI 0.05-0.45)(p<0.001). And incidence of febrile neutropenia was lower in PT group (HR 0.094 CI 0.02-0.46) and PP group (HR 0.242 CI 0.07-0.78) than non-PG group (p=0.003).
In conclusion, use of prophylactic G-CSF is beneficial to the breast cancer patients treated with TAC regimen. The study showed better outcome in PT groups than PP groups.
호중구감소증은 항암치료를 받는 환자에게 있어 흔히 일어나는 세포화학독성 항암제의 주요 부작용으로써 항암요법을 지연시키거나, 변경하거나, 용량을 감소하게 하거나, 중단시킴으로써 환자의 치료에 부정적 영향을 줄 수 있다. 호중구감소증을 치료하기 위해서 재조합 메티오닐 인 과립구 콜로니자극인자(recombinant methionyl human granulocyte colony stimulating factor, r-metHuG-CSF)가 개발되었다. 최근에는 항암제로 인한 호중구감소증을 예방하는 목적으로 G-CSF를 pegylation하여 약효를 연장시킨 2세대 G-CSF (pegfilgrastim, tripegfilgrastim)가 개발되었다. 1세대 G-CSF인 Filgrastim에 branched PEG를 결합시킨 Tripegfilgrastim은 기존의 Pegylated filgrastim (Pegfilgrastim)보다 aggregation과 depegylation을 줄이기 위해 개발되었다.
본 연구에서는 호중구감소증 고위험 항암화학요법인 유방암의 adjuvant TAC 항암화학요법을 받은 환자를 대상으로 예방 목적으로 2세대 G-CSF를 사용한 군(tripegfilgrastim, pegfilgrastim), 그리고 예방적인 G-CSF를 사용하지 않은 군에서 호중구감소증, 열성 호중구감소증의 발생빈도를 비교하고 그에 영향을 끼치는 요인 및 발생위험요인 등을 분석하였다. 그리고 2세대 G-CSF 중 pegylation 형태가 다른 Tripegfilgrastim과 Pegfilgrastim에서 호중구감소증 및 열성 호중구감소증 발생률과 관련된 요인들을 비교 분석하였다. 이를 통하여 2세대 G-CSF의 호중구감소증 예방 효과와 2세대 G-CSF 중 Tripegfilgrastim과 Pegfilgrastim의 약효를 비교 분석하였다.
adjuvant TAC 치료를 받는 총 97명의 환자 중 예방적 목적으로 G-CSF를 사용한 환자는 Tripegfilgrastim군(PT군) 31명, Pegfilgrastim군(PP군) 33명, 예방적인 G-CSF를 사용하지 않은 환자(Non-PG군) 33명이었다. 호중구감소증 발생률(PT 22.58%, PT 39.39% non-PG 81.82% p<0.001), 열성 호중구감소증 발생률(PT 6.45%, PP 15.15% non-PG 42.42% p=0.001), 항암화학요법 후 측정한 ANC가 기저 ANC의 50% 이하로 감소한 환자수 (PT 19.35%, PP 48.48% non-PG 90.91% p<0.001), 평균재원일(PT 7.35±2.09 days, PT 10.82±11.68 non-PG 13.27±8.77 p=0.002)에서 유의한 차이를 보였다. 호중구감소증의 가장 큰 위험인자는 Tripegfilgrastim과(HR 0.065 CI 0.02-0.22) Pegfilgrastim의(HR 0.144 CI 0.05-0.45)(p<0.001) 사용 유무였다. 열성호중구 감소증 발생률은 PT군과(HR 0.094 CI 0.02-0.46) PP군(HR 0.242 CI 0.07-0.78)에서 Non-PG group군에 비해 낮게 나타났다(p=0.003).
예방적 2세대 G-CSF 사용군(PG군)은 호중구감소증 및 열성 호중구감소증의 예방뿐 아니라 재원일수의 감소 등 치료의 여러 측면에서 2세대 G-CSF를 사용하지 않은 군(Non-PG군)에 비해 통계적으로 양호한 결과를 보였다. 호중구감소증 및 열성 호중구감소증의 발생 유무가 전체 항암화학요법의 성패와도 연관 있는 것을 고려해보았을 때 약가와 효용성을 잘 고려하여 보다 적극적으로 예방적 G-CSF의 사용이 권장되어야 할 것이다.
Alternative Title
Analysis of preventive effect of tripegfilgrastim on the TAC chemotherapy induced neutropenia in breast cancer patients.
Alternative Author(s)
Miran Lee
Department
임상약학대학원 임상약학과
Advisor
신상미
Awarded Date
2017. 8
Table Of Contents
목 차
ABSTRACT
초 록
I. 서 론 ······························································ 1
A. 연구 배경···························································· 1
B. 연구 목적···························································· 3
Ⅱ. 연구 대상 및 방법··············································· 4
A. 연구 대상···························································· 4
B. 의학연구윤리심의위원회(IRB) 승인 ························· 4
C. 자료 수집······························································5
D. 결과 평가······························································5
E. 용어 정의······························································6
F. 통계 분석······························································7
Ⅲ. 연구 결과·······························································8
A. 연구 대상의 분포 및 특징·······································8
B. 세 군의 결과 비교················································11
1. 세 군의 ANC 비교·················································11
2. 전체 환자에서 호중구감소증 및 관계된 인자의 비교······12
3. 전체 주기에서 호중구감소증 및 관계된 인자의 비교······14
4. 호중구감소증 환자들의 분포 및 특징··························16
5. 기저 ANC 대비 50% 이하 감소 환자들의 분포 및 특징···18
6. 예방적 G-CSF 사용군의 호중구감소증 관련 인자 비교····20
7. 호중구감소증 및 열성 호중구감소증의 위험인자············22
8. 약가 및 기타사항 비교 ··········································24
Ⅳ. 고 찰····································································26
V. 결 론····························································30
VI. 참고문헌······························································31
Degree
Master
Publisher
조선대학교
Citation
이미란. (2017). 유방암 환자에서 TAC 항암치료에 의한 호중구감소증에 대한 트리페그필그라스팀의 예방효과 평가
Type
Dissertation
URI
https://oak.chosun.ac.kr/handle/2020.oak/2048
http://chosun.dcollection.net/common/orgView/200000266388
Appears in Collections:
Medicine & Parmacy > Theses(Master)(의학전문대학원/보건대학원/임상약학대학원)
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