Cancer Research and Treatment

Original Articles

Hematologic malignancy

Assessing the Efficacy of Bortezomib and Dexamethasone for Induction and Maintenance Therapy in Relapsed/Refractory Cutaneous T-Cell Lymphoma: A Phase II CISL1701/BIC Study: Yoon Seok Choi, Joonho Shim, Ka-Won Kang, Sang Eun Yoon, Jun Sik Hong, Sung Nam Lim, Ho-Young Yhim, Jung Hye Kwon, Gyeong-Won Lee, Deok-Hwan Yang, Sung Yong Oh, Ho-Jin Shin, Hyeon-Seok Eom, Dok Hyun Yoon, Hong Ghi Lee, Seong Hyun Jeong, Won Seog Kim, Seok Jin Kim; Cancer Res Treat. 2025;57(1):267-279. Published online July 16, 2024; DOI: https://doi.org/10.4143/crt.2024.479

Abstract PDF Supplementary Material PubReader ePub: Purpose
This multicenter, open-label, phase II trial evaluated the efficacy and safety of bortezomib combined with dexamethasone for the treatment of relapsed/refractory cutaneous T-cell lymphoma (CTCL) in previously treated patients across 14 institutions in South Korea.
Materials and Methods
Between September 2017 and July 2020, 29 patients with histologically confirmed CTCL received treatment, consisting of eight 4-week cycles of induction therapy followed by maintenance therapy, contingent upon response, for up to one year. The primary endpoint was the proportion of patients achieving an objective global response.
Results
Thirteen of the 29 patients (44.8%) achieved an objective global response, including two complete responses. The median progression-free survival (PFS) was 5.8 months, with responders showing a median PFS of 14.0 months. Treatment-emergent adverse events were generally mild, with a low incidence of peripheral neuropathy and hematologic toxicities. Despite the trend toward shorter PFS in patients with higher mutation burdens, genomic profiling before and after treatment showed no significant emergence of new mutations indicative of disease progression.
Conclusion
This study supports the use of bortezomib and dexamethasone as a viable and safe treatment option for previously treated CTCL, demonstrating substantial efficacy and manageability in adverse effects. Further research with a larger cohort is suggested to validate these findings and explore the prognostic value of mutation profiles.

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A Pilot Study Evaluating Steroid-Induced Diabetes after Antiemetic Dexamethasone Therapy in Chemotherapy-Treated Cancer Patients: Yusook Jeong, Hye Sook Han, Hyo Duk Lee, Jiyoul Yang, Jiwon Jeong, Moon Ki Choi, Jihyun Kwon, Hyun-Jung Jeon, Tae-Keun Oh, Ki Hyeong Lee, Seung Taik Kim; Cancer Res Treat. 2016;48(4):1429-1437. Published online February 29, 2016; DOI: https://doi.org/10.4143/crt.2015.464

Abstract PDF PubReader ePub

Purpose
Dexamethasone is a mainstay antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting. The aim of this pilot study was to assess the incidence of and factors associated with steroid-induced diabetes in cancer patients receiving chemotherapy with dexamethasone as an antiemetic.
Materials and Methods
Non-diabetic patients with newly diagnosed gastrointestinal cancer who received at least three cycles of highly or moderately emetogenic chemotherapy with dexamethasone as an antiemetic were enrolled. Fasting plasma glucose levels, 2-hour postprandial glucose levels, and hemoglobin A1C tests for the diagnosis of diabetes were performed before chemotherapy and at 3 and 6 months after the start of chemotherapy. The homeostasis model assessment of insulin resistance (HOMA-IR) was used as an index for measurement of insulin resistance, defined as a HOMA-IR ≥ 2.5.
Results
Between January 2012 and November 2013, 101 patients with no history of diabetes underwent laboratory tests for assessment of eligibility; 77 of these patients were included in the analysis. Forty-five patients (58.4%) were insulin resistant and 17 (22.1%) developed steroid-induced diabetes at 3 or 6 months after the first chemotherapy, which included dexamethasone as an antiemetic. Multivariate analysis showed significant association of the incidence of steroid-induced diabetes with the cumulative dose of dexamethasone (p=0.049).
Conclusion
We suggest that development of steroid-induced diabetes after antiemetic dexamethasone therapy occurs in approximately 20% of non-diabetic cancer patients; this is particularly significant for patients receiving high doses of dexamethasone.

Citations

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A Phase II Study to Evaluate the Efficacy of Ramosetron, Aprepitant, and Dexamethasone in Preventing Cisplatin-Induced Nausea and Vomiting in Chemotherapy-Naive Cancer Patients: Geundoo Jang, Hun Ho Song, Keon Uk Park, Hyeong Su Kim, Dae Ro Choi, Jung Hye Kwon, Ho Young Kim, Boram Han, Jung Han Kim, Joo Young Jung, Hyo Jung Kim, Dae Young Zang; Cancer Res Treat. 2013;45(3):172-177. Published online September 30, 2013; DOI: https://doi.org/10.4143/crt.2013.45.3.172

Abstract PDF PubReader ePub

PURPOSE
Combination therapy with aprepitant, serotonin receptor antagonist, and steroids improves the complete response rate of both acute and delayed chemotherapy-induced nausea and vomiting (CINV). However, it is not known whether ramosetron is suitable for administration in combination with aprepitant. Therefore, we conducted a multicenter, open-label, prospective, phase II study in order to assess the efficacy and tolerability of combination therapy with ramosetron, aprepitant, and dexamethasone (RAD) for prevention of cisplatin-based CINV in chemotherapy-naive patients with solid cancers.
MATERIALS AND METHODS
Forty-one patients with various solid cancers (31 male and 10 female; median age, 59 years) who received treatment with highly emetogenic chemotherapy (median cisplatin dose, 70 mg/m2; range 50 to 75 mg/m2) were enrolled in this study. Oral aprepitant (125 mg on day 1; 80 mg on days 2 and 3), intravenous ramosetron (0.6 mg on day 1), and oral dexamethasone (12 mg on day 1; 8 mg on days 2-4) were administered for prevention of CINV.
RESULTS
The complete response (no emesisand retching and no rescue medication) rate was 94.9% in the acute period (24 hours post-chemotherapy), 92.3% in the delayed period (24-120 hours post-chemotherapy), and 92.3% in the overall period (0-120 hours). The absolute complete response (complete response plus no nausea) rate was 74.4% in the acute period, 51.3% in the delayed period, and 46.2% in the overall period. There were no grade 3 or 4 toxicities related to these antiemetic combinations.
CONCLUSION
RAD regimen is a safe and effective antiemetic treatment for prevention of CINV in patients receiving highly emetogenic chemotherapy.

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Ramosetron Versus Ondansetron in Combination With Aprepitant and Dexamethasone for the Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Randomized Phase III Trial, KCSG PC10-21
Hyo Jung Kim, Sang Won Shin, Eun-Kee Song, Na-Ri Lee, Jun Suk Kim, Jin Seok Ahn, Hwan-Jung Yun, Yo-Han Cho, Keon Uk Park, Si-Young Kim, Joung Soon Jang, Sang-We Kim, Hyun Woo Lee, Se Ryeon Lee, Yang Soo Kim, Soon Nam Lee, Yoon Ho Ko, Hwa Jung Kim, Jin-Hyo
The Oncologist.2015; 20(12): 1440. CrossRef
Assessment of low-dose cisplatin as a model of nausea and emesis in beagle dogs, potential for repeated administration
Hannah Kenward, Ludovic Pelligand, Jonathan Elliott
Experimental Brain Research.2014; 232(8): 2685. CrossRef
Anticipatory nausea in animal models: a review of potential novel therapeutic treatments
Erin M. Rock, Cheryl L. Limebeer, Linda A. Parker
Experimental Brain Research.2014; 232(8): 2511. CrossRef

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Dexamethasone Inhibits TRAIL- and Anti-cancer Drugs-induced Cell Death in A549 Cells through Inducing NF-κB-independent cIAP2 Expression: Youn Seup Kim, Jae Seuk Park, Young Koo Jee, Kye Young Lee; Cancer Res Treat. 2004;36(5):330-337. Published online October 31, 2004; DOI: https://doi.org/10.4143/crt.2004.36.5.330

Abstract PDF PubReader ePub

Purpose

We have examined that dexamethasone inhibits apoptotic cell death of A549 lung epithelial cells through TRAIL and anti-cancer drugs. The purpose of the study is to determine the roles of GR, cIAP and NF-κB in this mechanism.

Materials and Methods

In the A549 lung epithelial cell line, TRAIL, taxol, doxorubicine & gemcitabine were used to investigate cell toxicity. Cells were pretreated 12 hours in advance with dexamethasone. RU486 was pretreated 30 minutes before dexamethasone. Crystal violet assay was used for cell toxicity tests. Apoptosis assay was performed by taking morphologic surveys with fluorescent microscopy after double staining with Hoechst 33342 & propium iodide. RT-PCR was used to investigate the gene expression of cIAP1 & cIAP2 by dexamethasone. Ad-IκB α-SR transduction study was used for the role of NF-κB.

Results

TRAIL and anti-cancer drug-induced apoptosis was partially suppressed in A549 cells pretreated with dexamethasone. The inhibitory effect on cell death disappeared in A549 cells pretreated with RU486. Using RT-PCR, changes of cIAP1 and cIAP2 genes manifestation in A549 cells subsequent to pretreatment with dexamethasone were examined. The results showed an increase in cIAP2 expression during a course of time which was suppressed by RU486 pretreatment. Induction of cIAP2 expression changes by dexamethasone was uniquely observed despite the blockade of NF-κB by Ad-IκBα-SR transduction.

Conclusions

These results suggest that dexamethasone inhibits TRAIL- and anti-cancer drug-induced apoptosis in A549 cells by inducing cIAP2 gene expression through a GR-mediated, NF-κB-independent pathway.

Citations

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NK1 receptor antagonists and dexamethasone as anticancer agents in vitro and in a model of brain tumours secondary to breast cancer
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Hematologic malignancy

Cyclophosphamide, Bortezomib, and Dexamethasone Consolidation in Patients with Multiple Myeloma after Stem Cell Transplantation: The KMM130 Study: Jongheon Jung, Kihyun Kim, Sung-Hoon Jung, Sung-Soo Yoon, Jae Hoon Lee, Jin Seok Kim, Ho-Jin Shin, Soo-Mee Bang, Sang Kyun Sohn, Cheolwon Suh, Dok Hyun Yoon, Sun-Young Kong, Chang-Ki Min, Hyeon-Seok Eom, The Korean Multiple Myeloma Working Party; Cancer Res Treat. 2023;55(2):693-703.; DOI: https://doi.org/10.4143/crt.2022.952

Abstract PDF Supplementary Material PubReader ePub

Purpose
A three-drug combination of cyclophosphamide, bortezomib, and dexamethasone (CVD) shows significant efficacy and manageable toxicity as induction therapy in patients with multiple myeloma.
Materials and Methods
In this phase II study, we enrolled 45 patients who achieved a very good partial response (VGPR) or partial response (PR) after autologous stem cell transplantation (ASCT) and evaluated the efficacy and toxicity of CVD consolidation. CVD consolidation comprised three cycles of cyclophosphamide 300 mg/m² orally on days 1, 8, and 15, and bortezomib 1.3 mg/m² subcutaneously on days 1, 8, 15, and 22, along with dexamethasone 20 mg orally or intravenously on days 1 and 2, 8 and 9, 15 and 16, and 22 and 23.
Results
At enrollment, 39 patients (86.7%) showed VGPR, and nine (13.3%) presented with PR. Nineteen patients (45.2%) achieved a complete response or better as their best response after the end of consolidation. Overall, 22 of 42 patients (52.4%) experienced an improved response status with CVD consolidation. Three-year overall survival and progression-free survival rates were 89.0% and 42.7%, respectively. The most common non-hematologic toxicities were peripheral neuropathy and infection (20.5%), with no grade ≥ 3 neuropathy observed.
Conclusion
These results showed that CVD consolidation therapy improved the response with reasonable toxicity in patients with residual disease after ASCT. This trial was registered with the Clinical Research Information Service, Republic of Korea (KCT0001327).

Citations

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Is There Still a Role for Stem Cell Transplantation in Multiple Myeloma?
Morie A. Gertz
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Li Lin, Dong Chen, Shuangyue Li, Tiantian Wang
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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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Results of CHOP-Bleo / CMED Alternating Chemotherapy for Aggressive Non - Hodgkin's Lymphoma: Suk Jin Kim, In Keun Choi, Sang Chul Oh, Jae Hong Seo, Byung Soo Kim, Sang Won Shin, Yeul Hong Kim, Jun Suk Kim; J Korean Cancer Assoc. 1998;30(2):350-356.

Abstract PDF: PURPOSE
To assess the efficacy and toxicity of a new protocol that consists of CHOP- Bleo alternated with a new regimen of Cyclophosphamide, methotrexate, etoposide, and dexamethasone(CMED) for aggressive Non-Hodgkin's Lymphoma(NHL). PATIENTS AND METHODS: Between January 1991 and December 1996, forty-six patients with Ann Arbor stages II-IV aggressive NHL were treated with alternating cycles of CHOP-Bleo and CMED for a total of 12 cycles. All eligible patients were evaluated for response, disease-free survival, and overall survival.
RESULTS
Twenty-two patients(47.8%) achieved a complete response and overall response rate was 83.9%. The range of survival duration was 1-68+months and the median survival time was 42 months. Overall 3-year survival rate was 54%. The range of disease-free survival time was 6-63+months and 3-year disease-free survival rate was 61%. The most common hematologic toxicity was leukopenia and the incidence of severe leukopenia(<1,000/mm3) was 11%. And alopecia(84.8%) was the most common non-hematologic toxicity.
CONCLUSION
The results of CHOP-Bleo/CMED alternating chemotherapy for patients with aggressive Non-Hodgkin's Lymphoma is not superior to other results of previous studies. Therefore further study will be warranted to determine clinical effectiveness of alternating chemotherapy.

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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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Anti - Emetic Effect of Ondansetron Combined with Dexamethasone in Cisplatin Induced Nausea and Vomiting: Wook Bum Pyun, Seong Nam Kim, Sung Ae Jung, Soon Nam Lee; J Korean Cancer Assoc. 1994;26(1):151-158.

Abstract PDF: Cisplatin, an agent highly effective against a variety of cancers, produces the most severe nausea and vomiting of any chemotherapeutic agents. Recently, the role of 5-HT,(serotonin) in cisplatin induced nausea and vomiting was introduced and ondansetron a selective 5-HT, receptor antagonist, was administered to prevent cisplatin induced nausea and vomiting. Remarkable effects on acute emesis was obtained but effects on delayed emesis was not controlled by ondansetron only. This study was done to investigate the effectiveness and side effects of ondsnsetron combined with dexamethasone in cisplatin induced nausea and vomitiog. To evaluate the effetiveness of ondansetron combined with dexamethasone in preventing cisplatin induced nause and vomiting, 16 cancer patients who were treated with intravenous cisplatin containing chemotherapy as the first anticancer therapy were administered 20 mg dexamethasone i.v. 20 minutes before and 8 mg ondansetron i.v. 15 minutes before, 4 hour and 8 hour after ciaplatin infusion respectively on day 1, and 8 mg ondansetron was administered orally three times a day on day 2-4. On the first day, the complete response and major response were noted in 75%(12/16 patients), and 19%(3/l6 patients) respectively, minor response in 6%(l/16 patients), and none showed failure. On the second day, the complete response and major response were noted in 44 %(7/16 patients) and 25%(4/16 Patients) respectively, minor response in 19%(3/16 patients), and 12%(2/16 patients) showed failure. On the third to fourth day, complete response was noted in 29%(4/14 patients), major response 29%(4/14 patients), and minor response and failure were noted in 21%(3/l4 patientsl respectively. Two patients complained headache, dizziness respectively and the other two patients complained abdominal pain and diarrhea, but the degree was mild and subsided by conservative management. With these results, the administration of ondansetron and dexamethasone to prevent the cisplatin induced nausea and vomiting was effective for acute emesis but not so effective in delayed emesis even with combination of dexamethasone. Further study would be necessary to overcome the low effectiveness on the control of delayed emesis.

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Effect of Steroid Hormone on the Expression of Cytokine Genes in the Peritoneal Macrophages of Mouse: Jong Suk Oh, Gi Young Im, Jin Jeong, Sun Sik Chung, Hyun Hul Lee; J Korean Cancer Assoc. 1994;26(4):607-618.

Abstract PDF: Macrophages have been known to produce monokines and to involve to the cytotoxic activity against microorganisms or tumor cells. Using murine peritoneal macrophages the effect of interferon-r(rIFN), lipopolysaccharide (LPS), 1,25 dihydroxy-vitamin D,(DHVD,) or dexamethasone alone or in combination was as- sessed on the expression of interleukin-1 and tumor necrosis factor, the production of nitric oxide (NO) and the tumoricidal activity against lymphocytic leukemic cell L1210. The results were as follows; 1) The activity of interleukin-1 was increased in the murine peritoneal macrophages treated with combination of rIFN and LPS, compared with control cells and the cells treated with each agent alone, and decreased by adding DHVD or dexamethasone. 2) The activity of tumor necrosis factor in the combined rIFN and LPS-treated cells was increased in comparison with the cells treated with each agent alone. It was not affected in the combined rIFN and LPS-treated cells by adding DHVD, while being considerably decreased by adding dexamethasone. 3) The expression of tumor necrosis factor mRNA was significantly increased in the combined rIFN and LPS-treated cells. By the addition of DHVD, the expression was a little decreased, while being considerably decreased by adding dexamethasone. 4) The production of NO was significantly increased in the cells treated with combination of rIFN and LPS, compared with the cells treated with each agent alone. By the addition of DHVD the production amount of NO in the combined rIFN and LPS-treated cells wasnt changed, however by the addition of dexamethasone the production was suppressed. 5) The tumoricidal activity of cells was significantly increased in the rlFN and LPS-treated cells, compared with the single agent-treated cells. This increased activity wasnt changed by the addition of DHVDhowever, suppressed by the addition of dexamethasone. These results indicate that DHVD slightly affects the expression of cytokine genes and the tumoricidal activity against murine lymphocytic leukemic cell LI210 in murine peritoneal macrophages, while dexamethasone considerably suppresses them.

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A Prospective Randomized Study Comparing the Efficacy of Tropisetron Versus Metoclopramide / Dexamethasone / Diazepam (: Ki Bok Park, Dong Hoon Jeong, Jong Hoon Kim, Byoung Kee Kim, Sang Yoong Park, Eui Don Lee, Kyung Hee Lee; J Korean Cancer Assoc. 1996;28(3):562-573.

Abstract PDF: Background
Chemotherapy-induced emesis is one of the most disturbing side effects in the cancer chemotherapy. Despite a number of significant advances over the past decade, prevention and treatment of chemotherapy induced emesis remain formidable problems, particularly with cisplatin based regimens. In the prior reports, tropisetron(Navoban, Sandoz Pharma. Ltd., Basel, Switzerland), a 5-HT3-receptor antagonist, was effective in the control of cisplatin induced emesis. In this study, we compared effectiveness of tropisetron (TRP) with metoclopramide/dexamethasone /diazepam(MDD) in the prevention of emetic episodes in patients receiving cisplatin-based combination chemotherapy. Methods: Sixty-three patients with cervical carcinoma receiving 60 mg/§³ of cisplatin (day 1) and 1000mg/§³ of 5-FU(day 1~5) were randomized to two arms(arm I: tropisetron; n=32, arm II: MDD; n=31). In TRP group, tropisetron(5 mg) was given intravenously(i.v.) l5 min before cisplatin on day 1, and per orally(p.o.). 30 min before breakfast from day 2 to 6. In MDD group, metoclopramide(l mg/kg/time, 2 times/day), dexamethasone(20mg) and diazepam(5 mg) were given intravenously before cisplatin infusion on day 1, and from day 2 to 6, metoclopramide(l0 mg) was given p.o, every 6 hours, and dexamethasone was given p.o . every 12 hours at a dose of 8mg on day 2~3 and at a dose of 4mg on day 4~6. Sixty patients were evaluable and 3 patients(arm I, 2 patients; arm II, 1 patient) were excluded from the analysis due to their refusal during study due to emesis. Results: In TRP group, during first 24 hours(acute emesis), 83.3%(25/30) of patients had fewer than three emetic episodes and 63.3%(19/30) had no emetic episodes. These results were similar to those of MDD group; 90.0%(27/30) and 63.3%(l9/30), respectively. But from that time to day 6, in TRP group, anly 53.3%(16/30) of patients had less than three emetic episodes and 20.0%(6/30) had no emetic episode. These were significantly less than those of MDD group; 86.7%(26/30) and 50.0%(15/30)(p<0.001). The mean nausea ratings per visual analogue scale between two groups on day 1 were similar; 49.0¡¾7.5(mean¡¾S.E.M) for TRP group and 43.3¡¾7.1 for MDD group. But from day 2 to day 5, the mean nausea ratings for MDD group were significantly less than those for TRP group(p<0.05). We could observe various side effects such as gastrointestinal symptoms and sedation in MDD group but no side effects except mild headache(10.0%) were observed in TRP group. Extrapyramidal symptom was not observed in both groups. Conclusion: These results suggest that TRP was as effective as MDD in controlling the acute emesis but less effective in controlling the delayed emesis induced by cisplatin-based chemotherapy. Although antiemetic effect of tropisetron was not more excellent than that of MDD regimens, it seems to be a clinically efficacious drug due to simplicity of administration and less side effects.

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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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