Cisplatin 병용 항암화학요법시 Granisetron의 오심 및 구토에 대한 효과 (제 2상 연구) -Granisetron 단일요법과 Ondansetron/Dexamethasone/Lorazepam(ODL) 병용요법의 개별 교차 비교 연구-
Granisetron in the Prevention of Nausea and Vomiting in Patients Receiving Platinum-Containing Chemotherapy
대한암학회지 1998년 30권 6호 p.1249 ~ 1258
소속 상세정보
김우식/Woo Shik Kim
김시영/조경삼/김정희/윤휘중/Si Young Kim/Kyung Sam Cho/Jung Hee Kim/Hwi Joong Yoon
KMID : 0360319980300061249
Abstract
서론
항암화학요법으로 널리 사용되는 cisplatin은 심한 오심(nausea)과 구토(vomiting)를 유발
하며, 이것은 항암화학요법을 시행받는 환자들이 겪는 부작용 중 가장 고통스러운 부작용의
하나로 알려져 있다. 이러한 부작용을 적절히 해결해 주지 못한 경우, 오심과 구토로 인한
식이 섭취의 감퇴로 영양 상태가 불량해질 뿐만 아니라, 심리적으로 불안한 상태를 유발할
수 있으며, 항암화학요법으로 증세의 완화나 완쾌를 기대할 수 있는 환자들이 치료를 거부
하는 경우도 있다. 그러므로 항암제에 의해 야기되는 오심과 구토를 적절히 예방 또는 조절
하는 것은 항암화학요법의 효과를 향상시키는 데 중요한 인자가 된다. Cisplatin 사용시 발
생하는 오심이나 구토를 예방하기 위하여 고전적으로 metoclopramide, dexamethasone과
lorazepam의 병합요법을 사용하여 왔다. 최근에는
5-hydroxytryptamine(5-HT3) 수용체에 작용하는 ondansetron, granisetron
등이 개발되어, cisplatin 항암화학요법을 받는 환자에서 추체외로증상 등의 부작용 없이 탁
월한 항진토효과를 갖는다고 알려져 있다.
저자 등은 cisplatin 항암화학요법시 유발되는 구토와 오심에 대해 granisetron을 투여하여
진토효과 및 부작용에 대하여 관찰하였으며, 상대적으로 granisetron 효과를 비교하기위하
여, 다음 항암화학요법시에는 표준복합항구토제인 ondansetron/dexamethasone/lorazepam(이
하 ODL로 약함)을 투여하여 효과를 비교하였다.
Purpose : The management of nausea and vomiting caused by cancer chemotherapy
has greatly improved since the introduction of potent, selective 5-HT3
agonist, such as ondansetron or granisetron. The present study evaluated the antiemetic
efficacy and safety of a single intravenous dose of granisetron for control of nausea and
vomiting in cisplatin-treated patients. Then the antiemetic effect of granisetron was
compared with ODL(ondansetrou/dexamethasone/ lorazepam).
Materials & Methods : Patients with advanced cancer who were being treated with
cisplatin were entered into two trials. In the first trial patients were randomly assigned
to receive granisetron, and in the second trial they received ODL regimen. The efficacy
of antiemetic treatments was graded as follows; complete response (CR, no vomiting
episodes), major response (MR, 1∼2 vomiting episodes), mild response (mR, 3∼5
vomiting episodes), and treatment failure (F, more than 6 vomiting episodes). The
complete or major response was considered to indicate successful treatment. The
intensity of nausea was evaluated by patients according to the degree of interference
with normal daily life as followings; (a) none; (b) present but no interference with
normal daily life (mild); (c) interference with normal daily life (moderate); and (d)
bedridden because of nausea(severe). None or mild state was considered to indicate
successful treatment. Chemotherapy-induced nausea or vomiting is classifiud as acute,
subacute, and delayed phase.
Results : A total of 33 patients were enrolled. Of these, 31 were assessable for
efficacy. In the granisetron group, total antiemetic control (CR plus MR) was noted in
58.1%, 48%, and 55.6% of patients during acute, subacute, and delayed phase,
respectively; total nausea control(none plus mild) was noted in 58.1%, 56%, and 51.9% of
patients, respectively. No severe side reaction was seen in patients receiving granisetron,
while transient elevation in aspartate or alanine aminotransferase level were observed in
8 patients. Patients who received ODL had a higher antiemetic response rate (85.7% vs
61.9%, P=.01) and less nausea (85.7% vs 61.9%, p=.02) than those who received
granisetron during acute phase. But, no statistical significant difference was observed
between the granisetron arm and the ODL arm during subacute and delayed phase.
Conclusion : Patients who received granisetron alone had less protection from acute
vomiting and nausea than those who received ODL. Although ODL are effective drugs
for the control of acute emesis and nausea, their efficacy against subacute and delayed
emesis is not entirely satisfactory.
키워드
Cisplatin; Antiemetics; Granisetron; Ondansetron/Dexamethasone/Lorazepart;
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