Cancer Research and Treatment

Original Articles

Antiemetic Effect of Granisetron plus Dexamethasone for the Patients Refractory to Metoclopramide , Dexamethasone and Lorazepam ( MDL ): Se Hoon Lee, Dong Wan Kim, Kyun Hae Jung, Soo Mee Bang, Jae Ho Byun, Heung Moon Chang, Dae Seog Heo, Yung Jue Bang, Noe Kyeong Kim; J Korean Cancer Assoc. 1999;31(5):1027-1034.

Abstract PDF: PURPOSE
The combination of dexamethasone and granisetron provides effective prophylaxis in patients treated with high-dose cisplatin. We performed this study to evaluate the antiemetic effect of granisetron plus dexamethasone for the patients refractory to metoclo- pramide, dexamethasone, lorazepam (MDL) regimen.
MATERIALS AND METHODS
From 1996 to 1998, we administered the MDL regimen in patients who received high-dose cisplatin (more than 60 mg/m/day) for the first time. The granisetron plus dexamethasone were administered in the subsequent cycle for the patients refractory to the MDL regimen during the first or the second cycle of chemotherapy. Efficacies of treatment were assessed daily from days 1 to 5. Complete response was defined as the absence of vomiting episodes and major response as 1 or 2 episodes per day. Complete or major responses were considered effective.
RESULTS
Twenty patients received granisetron plus dexamethasone therapy. During the first 24 hours, complete and major responses were achieved in 75% and 15% respectively, thus it was effective in 90% of patients. For delayed vomiting (occurring during days 2 through 5), complete and major responses were achieved in 30% and 50% respectively, thus it was effective in 80%. Side effects included hiccups, headache, diarrhea, sedation, dizziness and insomnia, but discontinuation or dose adjustment was not needed.
CONCLUSION
The granisetron plus dexamethasone regimen was an effective antiemetic regimen for the patients refractory to the MDL regimen.

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Antiemetic Efficacy of 2-Hour Infusion of Granisetron in Patients Receiving High - Dose Cisplatin: Seung Taek Kim, Ji Hyun Lee, Kyung Soo Lee, Jung A Lee, Hye Young Kim, Kee Hyung Lee; J Korean Cancer Assoc. 1999;31(3):590-597.

Abstract PDF: PURPOSE
The physiologic mechanism of chemotherapy induced emesis is poorly understood, but recently it is thought to be mediated by serotonergic (5-hydroxytryptamine-3 or 5-HT3) receptars. 5-HT3 is released by enterochromaffin cells in the gastrointestinal tract, which peaks 2-6 hours after the start of chemotherapy. In this study, the granisetron, an antiemetic agent, was given over 2-hour from the start of cisplatin administration to synchronize the peak level of the drug with that of 5-HT3 release.
MATERIALS AND METHODS
Chemotherapy-naive patients undergoing their first cycle of cisplatin ( > 60 mg/m)-based chemotherapy were included. One milligram of granisetron was given intravenously 15 minutes before the start of cisplatin as a loading dose, then 2 mg was given over 2-hour starting with the cisplatin.
RESULTS
24 of 25 patients were evaluable for efficacy and safety. Fifteen (62.5%) of the 24 evaluable patients had advanced gastric carcinoma and 21 (87.5%) received FP (5-FU/ Cisplatin) combination chemotherapy. The complete response rate for acute and delayed vomiting/retching was 58.3% (10/24) and 33.3% (8/24), respectively. The median latency time to first vomiting or retching was 20.3 hours. Side effects were tolerable, but central nervous symptoms (dizziness, headache, or anxiety) and diarrhea were frequently noted.
CONCLUSION
Two-hour infusion of granisetron with the beginning of cisplatin showed no superior efficacy compared with historical controls that used bolus administration of granisetron, but somewhat more frequent central nervous system and gastrointestinal symptoms were observed.

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Effect of Granisetron Plus Dexamethasone in the Prevention of Delayed Nausea and Vomiting: Jeong Woo Shim, Yong Seop Lee, Heung Up Kim, Geong Won Jung, Yeong Ho Park, Se Ho Chang, Jin Yong Whang, Jeong Soon Jang, Jong Seok Lee; J Korean Cancer Assoc. 1997;29(4):690-699.

Abstract PDF: BACKGROUND
Granisetron, a new 5-HT3 receptor antagonist, was reported as a highly effective antiemetics, especially in combination with dexamethasone, in the prevention of acute emesis induced by cisplatin. But there is lack of data about effectiveness in the prevention of delayed emesis. In this study, the efficacy of granisetron plus dexamethasone in the prevention of delayed emesis induced by cisplatin was evaluated.
MATERIALS AND METHODS
Sixty-four patients who were to receive high-dose cisplatin containing chemotherapy regimen were enrolled in this study. They were received 20 mg of dexamethasone and 3 mg of granisetron at 30 min and 10 minutes prior to cisplatin infusion, respectively. They were monitored for 5 days, first 24 hours for acute nausea/ vomiting and the subsequent 4 days for delayed nausea/vomiting. Antiemetic effect of granisetron was evaluated according to the criteria of Italian Group of Antiemetic Research.
RESULTS
Control of delayed nausea and vomiting was achieved in 58% and 84%, respectively. Eastern Cooperative Oncology Group performance status was a statistically significant prognostic factor for control of acute vomiting and delayed nausea/vomiting. There were no stastically significant differences between control of delayed nausea/ vomiting and other prognostic factors, including sex, age, and prior history of cisplatin therapy. The antiemetic effect was greater in the patients who had controled acute nausea/ vomiting than those who had not.
CONCLUSION
Granisetron plus dexamethasone is an excellent regimen in the control of not only acute emesis but also delayed emesis induced by high-dose cisplatin chemotherapy.

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Antiemetic Effect of Granisetron in Cisplatin - Induced Nausea and Vomiting: Seock Ah Im, Hee Jung Choi, Ki Youl Seo, Ki Youl Seo, Jin Hyuk Choi, Soon Nam Lee; J Korean Cancer Assoc. 1995;27(6):1040-1048.

Abstract PDF: Cisplatin is an highly effective agent against a variety of cancers but produces the most severe nausea and vomiting compared with other chemotherapeutic agents. Recently the role of 5-HT,(serotonin) in cisplatin induced nausea and vomiting was introduced and serotonin receptor antagonists seem to be as effective as corticosteroids in preventing cisplatin-induced emesis. From October 1994 to August 1995, we evaluate antiemetic effect of granisetron, a selective 5-HT, receptor antagonist, in 20 patients (M:F=11:9) who receiving their first course of combination chemotherapy containing high dose cisplatin(100 mg/§³). Granisetron 3 mg was given intravenous infusion before 100 mg/§³ of cisplatin infusion. In first 24 hours after chemotherapy, complete response achieved in 18 of 20 patients(90%). First episode of vomiting developed at 31.5¡¾20.3 hours after cisplatin infusion. For delayed emesis, on second day, complete response achieved in ll of 18 patients (61%), major response in 4 of 18 patients (22%), minor response in 3 patients (17%) and from third to seventh day, complete response achieved in 8 of 18 patients (44%), major response in 7 of 18 patients (39%), minor response in 3 patients (17%). Most commonly reported adverse effect of granisetron was headache. In conclusion, granisetron was an effective antiemetic agent in preventing cisplatin induced acute emesis but not so effective in delayed emesis. For better control of delayed emesis, new combination antiemetic therapy should be investigated.

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A Comparative Study of Intravenous granistron Versus Intravenous / Oral Ondansetron in the Prevention of Nausea and Vomiting Associated with Moderately: Joon Oh Park, Hyun Cheol Chung, Yong Seok Yoon, Woong Chol Kang, Sang Hak Lee, Heui Cheul Chung, Jae Yong Cho, Sun Young Rha, Chong In Lee, Nae Choon Yoo, Joo Hang Kim, Jae Kyung Roh, Jin Sik Min, By; J Korean Cancer Assoc. 1995;27(6):1048-1061.

Abstract PDF: Nausea and vomiting are common and the most distressing side effects of cancer chemotherapy. As these symtoms can cause emotional instability and malnutrion from poor oral intake, which further lead to decrease the effect of chemotherapy, it is important to prevent emesis adequately and effectively. Ondansetron is a selective 5-HT, receptor antagonist and is reported to be effective in preventing cisplatin-induced emesis, Granisetron is a potent and the most selective 5-HT, receptor antagonist currently available. We conducted a prospective, randomized, open, single center, parallel group study to compare the antiemetic effect and safety of granisetron versus ondansetron in patients receiving moderately emetogenic chemotherapy. Form December l994 to May 1995, 65 consecutive patients who planned to receive moderately emetogenic chemotherapy(80 to 100 mg/§³ of cisplatin or 40 mg/§³of doxorubicin) were enrolled in this study. Granisetron was administered intravenously prior to chemotherapy at a dose of 3mg, and up to two doses of granisetron could be administered as rescue therapy within the first 24 hour period. Ondansetron 8 mg was given intravenously prior to chemotherapy followed by 2 more doses at 8 and 16 hours after chemotherapy. Finally, we evaluated 63 patients(32 receiving granisetron and 31 receiving ondansetron). In the first 24 hours after chemotherapy, complete and major response were achieved in 78.1 % of patients receiving granisetron and 74.2 % of patients receiving ondansetron(P=0.7163). There were also no differences in the control of delayed nausea and vomiting between two groups(56.3% vs 45.2%, P=0.3826). There were no differences in percentages of patients who received rescue therapy across the treatment groups: 3I.5% for granisetron vs. 45.2% for ondansetron during the study(P=0.3803). During the first 24 hours following chemotherapy, there were no differences in time to first episodes of nausea(granisetron 14 hours 20 minutes vs ondansetron 13 hours) and vomiting(granisetron 20 hours vs ondansetron 19 hours 20 minutes) between two groups. There were no significant adverse effects or toxicities with these antiemetics. We concluded that single dose granisetron was as effective in prophylaxis of emesis induced by moderatly emetogenic chemotherapy as triple doses of ondansetron and oral maintainence combination. For the non-responders to granisetron, combination of granisetron with other antiemetics of different action mechanism or maintainence granisetron trials are warranted.

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Effect of One - day ( G1 ) and Two - day ( G2 ) Schedule of Intravenous Granisetron on Prevention of nausea and Vomiting and Qualit Of Life during Cisplatin - Containin: Woo Sung Min, Han Lim Moon, Jin Hyoung Kang, Jong Youl Jin, Choon Choo Kim, Dong Jip Kim, Seong Ja Choo, Kyung Shim Kang, Jae Boon Ryu; J Korean Cancer Assoc. 1996;28(3):573-582.

Abstract PDF: Background
Nausea/vomiting is one of the most important item on deterioration of quality of life(QOL) in patients with cisplatin-containing chematherapy and may ultimately result in delay or refusal of the next chemotherapy. Although 5-hydroxy tryptamine 3(5-HT3) antagonist, ondansetron successfully controls cisplatin-induced nausea/vomiting during the first 24 hours, it fails to control nausea/vomiting on the following 24 hours in many patients. Authors performed this study to compare the effect of one-day and two-day schedule of intravenous granisetron on prevention of cisplatin-induced nausea and vomiting and QOL. Method: The antiemtic effect and QOL between one-day and two-day schedule of 3 mg/day of intravenous granisetron in cycle 1 and cycle 2 of cisplatin-based chemotherapy were compared. Frequency and severity of nausea/vomiting, QOL, oral intake and side effects were evaluated daily since day 0 to day 7 of chemotherapy. Results: Thirty eight patients were enrolled and 37 patients(31 male, 6 female, median age 60 with range of 42~74) were evaluable. The range of cisplatin were 50~l00mg/§³ and one or two of other chemotherapeutic agents such as 5FU, VP16, ifosfamide and mitomycin were combined. We evaluated the number of vomiting and QOL index with 10 items including nausea/vomiting and anorexia from day 0 to day 7 of chemotherapy. Twelve of 37 could not receive the G2 because of discontinuation of chemotherapy or patient's refusal of granisetron any more and eventually 25 had both Gl and G2. Time to first vomiting, control of vomiting and the amount of oral intake on day 1, day 2 and the worst day and side effects were not different between Gl and G2. QOL on day 2(G1; 56.2¡¾16.2 vs G2; 68.4¡¾20.3)(p<0.05) and change of QOL since day 1 to day 2 of cispltin(Gl; 16.3+2.1 vs G2 0.07+0.6)(p<0.01) were significantly different. Conclusion: Although the additiional intravenous granisetron on day 2 of cisplatin-based chemotherapy did not control nausea/vomiting more successfully, it improved QOL on the second day and the change of QOL from day 1 to day 2.

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A Comparison of the Acute Antiemetic Effect of Granisetron with Combination of Metoclopramide , Dexamethasone and Lorazepam in Patients Receiving High: Won Yong Shin, Seong Gyu Park, Jin Woo Jeon, Jong Ho Won, Seung Ho Baik, Dae Sik Hong, Dae Sik Hong, Hee Sook Park; J Korean Cancer Assoc. 1996;28(3):582-589.

Abstract PDF: Granisetron, a 5-hydroxytryptamine3(5-HT3) receptor antagonist, is effective antiemetic agent in the control of cisplatin-induced emesis. We compared the efficacy and safety of granisetron with those of intravenous high-dose metoclopramide(1.5 mg/kg, four times) plus dexamethasone(10 mg i.v.) and lorazepam(2 mg i.v.)(MDL therapy) to control the acute emesis induced by high-dose cisplatin(>60mg/§³) treatment. Granisetron was injected in dose of 3 mg intravenously as recommended schedule for the prophylaxis of acute cisplatin-induced emesis. Granisetron was effective as MDL therapy for controlling of acute emesis. Of 25 granisetron-treated patients, 18(72%) were complete or major responders compared with 19/25(76%) patients who recieved the MDL therapy on first day of chemotherapy(P> 0.05). Also, in controlling of nausea, granisetron results were similar to MDL therapy. Side effects attributable to MDL group were sedation(60%)(P<0.01) and dizziness(20%)(P<0.05). In contrast to, headache(20%) of the granisetron group was higher than that of MDL group(P<0.05). Granisetron was effective as MDL therapy for controlling of the acute em esis and nausea induced by cisplatin. But, granisetron was more feasible and safer than MDL therapy.

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A Randomized comparison of Granisetron Plus Dexamethasone and Ondansetron Plus Dexamethasone in the Prevention of High - dose Cisplatin - indu: Jung Ae Rhee, Young Suk Park, In Sook Woo, Young Iee Park, Duk Jhe Shun, Jeong A Kim, Sung Soo Yoon, Won Ki Kang, Keunchil Park, Chan Hyung Park; J Korean Cancer Assoc. 1996;28(4):739-748.

Abstract PDF: We report the prospective, randomized clinical study comparing granisetron and ondansetron as antiemetics in cancer chemotherapy. This study compares the efficacy and safety of a single dose of granisetron plus dexamethasone(GD) with three doses of ondansetron plus dexamethasone(OD) in the prevention of acute emesis induced by chemotherapy. One hundred one chemotherapy-native patients who received high dose ciaplatin(¡Al00mg /§³)-based combination chemotherapy were stratified by chemotherapeutic regimen. Patients were randomized to receive either 3 mg of granisetron intravenously(i.v.) or 8 mg of ondansetron for three doses i.v. in combination with dexamethasone to prevent emesis in the first 24 hours. In the GD group, a complete response(CR)(i.e., no emetic episode) was achived in 57% cases and a major response(MR)(i.e. ¡A2 emetic episodes) in 24%. In the OD group, a CR was seen in 71% of patients and an MR in 25%. Failure was recored in 7% and 2% of cases in the GD and OD, respectively. No statistically significant difference in any response category was seen between the two groups. Both GD and OD were well tolerated with no severe or unexpected side effects. In summary, these data suggest that single daily dose of granisetron(3mg/day) appeared similarly effective and well tolerated to three daily doses of ondansetron(8mg three times daily) in prevention of acute emesis induced by high dose cisplatin-based combination chemotherapy.

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Effect of Granisetron in the Prevention of Nausea and Vomiting Associated with Cisplatin Containing Chemotherapy: Yeul Hong Kim, Byung Soo Kim, Suk Jin Kim, Sang Chul Oh, Sang Won Shin, Jun Suk Kim; J Korean Cancer Assoc. 1996;28(4):748-761.

Abstract PDF: Background
Granisetron is a new, highly selective 5-TH antagonist with a long half life which has been shown to be highly effective at one dose per day in the prevention of nausea and vomiting induced by cisplatin containing chemotherapy. We evaluated the efficacy and safety of granisetron to prevent nausea and vomiting induced by multiple low dose cisplatin containing regimen or single high dose cisplatin containing regimen. Methods: From December 1994 to December 1995, 44 consecutive chemotherapy-naive patients who were to receive cisplatin containing reaimen, were enrolled in this study. Twenty four patients, who were treated with multiple low dose cisplatin were classified as group I and 20 patients, who were treated with single high dose cisplatin were classified as group II. On the first day of chemotherapy, the patients had received granisetron(3 mg/ 3 ml) at 5 minutes prior to cisplatin injection. And then, the patients checked the degree of nausea and the number of vomiting, at every 24 hours for 6 days by themselves. According to the criteria of Italian Group of Antiemetic Research (IGAR), we regarded the none and mild nausea as the surcessful control of nausea and the complete and major response of vomiting as the successful control of vomiting. Also, complete and major response by the criteria of Soukop and Smith was regarded as the successful control. Results: 1) At first 24 hours, nausea control was achieved in 84%(20 cases) and vomiting control was achieved in 88%(21 cases) of the group I patients by the criteria of IGAR and 88%(21 cases) of the group I patients had successful control by the criteria of Soukop and Smith. At second and third day, when cisplatin administration was continued, nausea control rate was 59%(14 cases), 33%(8 cases), respectively and vomiting control rate was 67% (16 cases) at both days by the criteria of IGAR. According to the criteria of Soukop and Smith, control rate was 63%(15 cases) and 58%(14 cases) at second and third day in group I patients, respectively. 2) At first 24 hours, nausea control was aehieved in 85%(l7 cases) and vomiting control was achieved in 95%(19 cases) of the group II patients by the criteria of IGAR and 75%(15 cases) of the group II patients had successful control by the criteria of Soukop and Smith. After cisplatin administration, symptoms were aggravated temporally during day 2 and recovered gradually. After day 1, nausea control rate was 55~90% and vomiting control rate was 75~100% in group II patients. 3) Rescue therapy was attempted in 3 cases of group I patients and 6 cases of group II patients. Six out of those nine patients got improved and additional granisetron administration as a rescue therapy was quite effective. 4) The observed side effects of granisetron were dizziness(2 cases), headache(l case), and diarrhea(1 case), which were improved without any therapy. Conelusion: These results suggested that granisetron was well tolerable and effective for the control of nausea and vomiting induced by cisplatin containing chemotherapy with the convenience of single injection.

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