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10 "Ji Yeon Baek"
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Gastrointestinal cancer
A Phase 1b/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer
Keun-Wook Lee, Sae-Won Han, Tae Won Kim, Joong Bae Ahn, Ji Yeon Baek, Sang Hee Cho, Howard Lee, Jin Won Kim, Ji-Won Kim, Tae-You Kim, Yong Sang Hong, Seung-Hoon Beom, Yongjun Cha, Yoonjung Choi, Seonhui Kim, Yung-Jue Bang
Cancer Res Treat. 2024;56(2):590-601.   Published online December 7, 2023
DOI: https://doi.org/10.4143/crt.2023.1117
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
GC1118 is a novel antibody targeting epidermal growth factor receptor (EGFR) with enhanced blocking activity against both low- and high-affinity EGFR ligands. A phase 1b/2a study was conducted to determine a recommended phase 2 dose (RP2D) of GC1118 in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) (phase 1b) and to assess the safety and efficacy of GC1118 plus FOLFIRI as a second-line therapy for recurrent/metastatic colorectal cancer (CRC) (phase 2a).
Materials and Methods
Phase 1b was designed as a standard 3+3 dose-escalation study with a starting dose of GC1118 (3 mg/kg/week) in combination with biweekly FOLFIRI (irinotecan 180 mg/m2; leucovorin 400 mg/m2; 5-fluorouracil 400 mg/m2 bolus and 2,400 mg/m2 infusion over 46 hours) in patients with solid tumors refractory to standard treatments. The subsequent phase 2a part was conducted with objective response rate (ORR) as a primary endpoint. Patients with KRAS/NRAS/BRAF wild-type, EGFR-positive, recurrent/metastatic CRC resistant to the first-line treatment were enrolled in the phase 2a study.
Results
RP2D of GC1118 was determined to be 3 mg/kg/wk in the phase 1b study (n=7). Common adverse drug reactions (ADRs) observed in the phase 2a study (n=24) were acneiform rash (95.8%), dry skin (66.7%), paronychia (58.3%), and stomatitis (50.0%). The most common ADR of ≥ grade 3 was neutropenia (33.3%). ORR was 42.5% (95% confidence interval [CI], 23.5 to 62.0), and median progression-free survival was 6.7 months (95% CI, 4.0-8.0).
Conclusion
GC1118 administered weekly at 3 mg/kg in combination with FOLFIRI appears as an effective and safe treatment option in recurrent/metastatic CRC.

Citations

Citations to this article as recorded by  
  • Drug combinations of camptothecin derivatives promote the antitumor properties
    Zhen Liu, Yajie Yuan, Ning Wang, Peng Yu, Yuou Teng
    European Journal of Medicinal Chemistry.2024; 279: 116872.     CrossRef
  • 3,365 View
  • 129 Download
  • 1 Web of Science
  • 1 Crossref
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A Phase II Study of Avelumab Monotherapy in Patients with Mismatch Repair–Deficient/Microsatellite Instability–High or POLE-Mutated Metastatic or Unresectable Colorectal Cancer
Jwa Hoon Kim, Sun Young Kim, Ji Yeon Baek, Yong Jun Cha, Joong Bae Ahn, Han Sang Kim, Keun-Wook Lee, Ji-Won Kim, Tae-You Kim, Won Jin Chang, Joon Oh Park, Jihun Kim, Jeong Eun Kim, Yong Sang Hong, Yeul Hong Kim, Tae Won Kim
Cancer Res Treat. 2020;52(4):1135-1144.   Published online April 24, 2020
DOI: https://doi.org/10.4143/crt.2020.218
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
We evaluated the efficacy and safety of avelumab, an anti-PD-L1 antibody, in patients with metastatic or unresectable colorectal cancer (mCRC) with mismatch repair deficiency (dMMR)/microsatellite instability-high (MSI-H) or POLE mutations.
Materials and Methods
In this prospective, open-label, multicenter phase II study, 33 patients with mCRC harboring dMMR/MSI-H or POLE mutations after failure of ≥1st-line chemotherapy received avelumab 10 mg/kg every 2 weeks. dMMR/MSI-H was confirmed with immunohistochemical staining (IHC) by loss of expression of MMR proteins or polymerase chain reaction (PCR) for microsatellite sequences. POLE mutation was confirmed by next-generation sequencing (NGS). The primary endpoint was the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors ver. 1.1.
Results
The median age was 60 years, and 78.8% were male. Thirty patients were dMMR/MSI-H and three had POLE mutations. The ORR was 24.2%, and all of the responders were dMMR/MSI-H. For 21 patients with MSI-H by PCR or NGS, the ORR was 28.6%. At a median follow-up duration of 16.3 months, median progression-free survival and overall survival were 3.9 and 13.2 months in all patients, and 8.1 months and not reached, respectively, in patients with MSI-H by PCR or NGS. Dose interruption and discontinuation due to treatment-related adverse events occurred in 4 and 2 patients, respectively, with no treatment-related deaths.
Conclusion
Avelumab displayed antitumor activity with manageable toxicity in patients with previously treated mCRC harboring dMMR/MSI-H. Diagnosis of dMMR/MSI-H with PCR or NGS could be complementary to IHC to select patients who would benefit from immunotherapy.

Citations

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Magnetic Resonance-Based Texture Analysis Differentiating KRAS Mutation Status in Rectal Cancer
Ji Eun Oh, Min Ju Kim, Joohyung Lee, Bo Yun Hur, Bun Kim, Dae Yong Kim, Ji Yeon Baek, Hee Jin Chang, Sung Chan Park, Jae Hwan Oh, Sun Ah Cho, Dae Kyung Sohn
Cancer Res Treat. 2020;52(1):51-59.   Published online May 7, 2019
DOI: https://doi.org/10.4143/crt.2019.050
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Mutation of the Kirsten Ras (KRAS) oncogene is present in 30%-40% of colorectal cancers and has prognostic significance in rectal cancer. In this study, we examined the ability of radiomics features extracted from T2-weighted magnetic resonance (MR) images to differentiate between tumors with mutant KRAS and wild-type KRAS.
Materials and Methods
Sixty patients with primary rectal cancer (25 with mutant KRAS, 35 with wild-type KRAS) were retrospectively enrolled. Texture analysis was performed in all regions of interest on MR images, which were manually segmented by two independent radiologists. We identified potentially useful imaging features using the two-tailed t test and used them to build a discriminant model with a decision tree to estimate whether KRAS mutation had occurred.
Results
Three radiomic features were significantly associated with KRASmutational status (p < 0.05). The mean (and standard deviation) skewness with gradient filter value was significantly higher in the mutant KRAS group than in the wild-type group (2.04±0.94 vs. 1.59±0.69). Higher standard deviations for medium texture (SSF3 and SSF4) were able to differentiate mutant KRAS (139.81±44.19 and 267.12±89.75, respectively) and wild-type KRAS (114.55±29.30 and 224.78±62.20). The final decision tree comprised three decision nodes and four terminal nodes, two of which designated KRAS mutation. The sensitivity, specificity, and accuracy of the decision tree was 84%, 80%, and 81.7%, respectively.
Conclusion
Using MR-based texture analysis, we identified three imaging features that could differentiate mutant from wild-type KRAS. T2-weighted images could be used to predict KRAS mutation status preoperatively in patients with rectal cancer.

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Validity and Reliability of Korean Version of Simplified Nutritional Appetite Questionnaire in Patients with Advanced Cancer: A Multicenter, Longitudinal Study
So Yeon Oh, Su-Jin Koh, Ji Yeon Baek, Kyung A Kwon, Hei-Cheul Jeung, Kyung Hee Lee, Young-Woong Won, Hyun Jung Lee
Cancer Res Treat. 2019;51(4):1612-1619.   Published online April 12, 2019
DOI: https://doi.org/10.4143/crt.2018.505
AbstractAbstract PDFPubReaderePub
Purpose
Malnutrition and a loss of muscle mass are frequent in cancer patients and have a negative effect on clinical outcome. Nutrition risk screening aims to increase awareness and allow early recognition and treatment of cancer cachexia. Therefore, screenings should be brief, inexpensive, highly sensitive, and have good specificity. Simplified Nutritional Appetite Questionnaire (SNAQ) is a simple screening tool including four questions, and validated to predict weight loss within 6 months in community-dwelling adults and nursing home residents. Our study aimed to translate the SNAQ into Korean, and to assess the validity and reliability of the translated screening tool in advanced cancer patients.
Materials and Methods
The SNAQ was translated into Korean according to linguistic validation. The internal consistency of the SNAQ was evaluated by Cronbach’s alpha coefficient. Test-retest reliability was evaluated using the intraclass correlation coefficient. Concurrent validity was evaluated by measuring the Pearson’s correlation coefficient between the SNAQ and Mini-Nutritional Assessment (MNA) and Patient-Generated Subjective Global Assessment (PG-SGA).
Results
In the 194 patients included in full analysis set, cancer stage was predominantly metastatic (98.5%), the mean age was 60 years (range, 23 to 81 years), and the mean body mass index was 24 kg/m2 (range, 15.6 to 39.6 kg/m2). According to MNA score ≤ 11, 57 patients (29.4%) were malnourished. The mean score (±standard deviation) of the Korean version of the SNAQ was 13.8±2.5 with a range of 6-19. Cronbach’s alpha coefficient was 0.737, and intraclass correlation coefficient was 0.869. The SNAQ was moderately correlated with MNA (r=0.404, p < 0.001) and PG-SGA (r=–0.530, p < 0.001). A significant weight loss of > 5% of the original bodyweightwithin 6 months occurred in 46 of the 186 patients (24.7%). SNAQ score ≤ 14 predicted > 5% weight loss with a sensitivity of 56.5% and a specificity of 44.3%.
Conclusion
The Korean version of the SNAQ had high validity and reliability. SNAQ is useful for the screening tool for advanced cancer patients. The SNAQ had a limitation to predict impending weight loss in advanced cancer patients.

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    Konstantina Vamvakari, Iliana Evangelou, Ioanna Panagiota Kalafati, Michail Kipouros, Rena I. Kosti, Arezina N. Kasti, Odysseas Androutsos
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    Binh Duong Thai, Jürgen M. Bauer, Annette Eidam, Jane Durga, Stefan Grund, Thomas Mross, Petra Benzinger
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    Annamária Pakai, Emese Havasi‐Sántha, Erzsébet Mák, Orsolya Máté, Dorina Pusztai, Noémi Fullér, Miklós Zrínyi, András Oláh
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    Mengqi Li, Si Zhao, Shuang Wu, Xiufen Yang, Hui Feng
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    Sue Youn Kim, Jae Moon Yun, Ji-Won Lee, Young Gyu Cho, Kyung-Hwan Cho, Yong Gyu Park, Belong Cho
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  • The Simplified Nutritional Appetite Questionnaire (SNAQ) as a Screening Tool for Risk of Malnutrition: Optimal Cutoff, Factor Structure, and Validation in Healthy Community-Dwelling Older Adults
    Sabrina Lau, Kalene Pek, Justin Chew, Jun Pei Lim, Noor Hafizah Ismail, Yew Yoong Ding, Matteo Cesari, Wee Shiong Lim
    Nutrients.2020; 12(9): 2885.     CrossRef
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Prospective Validation of The Korean Cancer Study Group Geriatric Score (KG)-7, a Novel Geriatric Screening Tool, in Older Patients with Advanced Cancer Undergoing First-line Palliative Chemotherapy
Jin Won Kim, Se Hyun Kim, Yun-Gyoo Lee, In Gyu Hwang, Jin Young Kim, Su-Jin Koh, Yoon Ho Ko, Seong Hoon Shin, In Sook Woo, Soojung Hong, Tae-Yong Kim, Ji Yeon Baek, Hyun Jung Kim, Hyo Jung Kim, Myung Ah Lee, Jung Hye Kwon, Yong Sang Hong, Hun-Mo Ryoo, Kyung Hee Lee, Jee Hyun Kim
Cancer Res Treat. 2019;51(3):1249-1256.   Published online January 2, 2019
DOI: https://doi.org/10.4143/crt.2018.451
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The purpose of this study was to prospectively validate the Korean Cancer Study Group Geriatric Score (KG)-7, a novel geriatric screening tool, in older patients with advanced cancer planned to undergo first-line palliative chemotherapy.
Materials and Methods
Participants answered the KG-7 questionnaire before undergoing geriatric assessment (GA) and first-line palliative chemotherapy. The performance of KG-7 was evaluated by calculating the sensitivity (SE), specificity (SP), positive and negative predictive value (PPV and NPV), balanced accuracy (BA), and area under the curve (AUC).
Results
The baseline GA and KG-7 results were collected from 301 patients. The median age was 75 years (range, 70 to 93 years). Abnormal GA was documented in 222 patients (73.8%). Based on the ≤ 5 cut-off value of KG-7 for abnormal GA, abnormal KG-7 score was shown in 200 patients (66.4%). KG-7 showed SE, SP, PPV, NPV, and BA of 75.7%, 59.7%, 84.4%, 46.0%, and 67.7%, respectively; AUC was 0.745 (95% confidence interval, 0.687 to 0.803). Furthermore, patients with higher KG-7 scores showed significantly longer survival (p=0.006).
Conclusion
KG-7 appears to be adequate in identifying patients with abnormal GA prospectively. Hence, KG-7 can be a useful screening tool for Asian countries with limited resources and high patient volume.

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The Impact of Surgical Timing on Pathologic Tumor Response after Short Course and Long Course Preoperative Chemoradiation for Locally Advanced Rectal Adenocarcinoma
Sea-Won Lee, Jong Hoon Lee, In Kyu Lee, Seong Taek Oh, Dae Yong Kim, Tae Hyun Kim, Jae Hwan Oh, Ji Yeon Baek, Hee Jin Chang, Hee Chul Park, Hee Cheol Kim, Eui Kyu Chie, Taek-Keun Nam, Hong Seok Jang
Cancer Res Treat. 2018;50(3):1039-1050.   Published online November 21, 2017
DOI: https://doi.org/10.4143/crt.2017.252
AbstractAbstract PDFPubReaderePub
Purpose
A pooled analysis of multi-institutional trials was performed to analyze the effect of surgical timing on tumor response by comparing short course concurrent chemoradiotherapy (CCRT) with long course CCRT followed by delayed surgery in locally advanced rectal cancer.
Materials and Methods
Three hundred patients with cT3-4N0-2 rectal adenocarcinoma were included. Long course patients from KROG 14-12 (n=150) were matched 1:1 to 150 short course patients from KROG 10-01 (NCT01129700) and KROG 11-02 (NCT01431599) according to stage, age, and other risk factors. The primary endpoint was to determine the interval between surgery and the last day of neoadjuvant CCRT which yields the best tumor response after the short course and long course CCRT. Downstaging was defined as ypT0-2N0M0 and pathologic complete response (ypCR) was defined as ypT0N0M0, respectively.
Results
Both the long and short course groups achieved lowest downstaging rates at < 6 weeks (long 20% vs. short 8%) and highest downstaging rates at 6-7 weeks (long 44% vs. short 40%). The ypCR rates were lowest at < 6 weeks (both long and short 0%) and highest at 6-7 weeks (long 21% vs. short 11%) in both the short and long course arms. The downstaging and ypCR rates of long course group gradually declined after the peak at 6-7 weeks and those of the short course group trend to constantly increase afterwards.
Conclusion
It is optimal to perform surgery at least 6 weeks after both the short course and long course CCRT to obtain maximal tumor regression in locally advanced rectal adenocarcinoma.

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    Ting‐Yu Chiang, Yu‐Jen Hsu, Yih‐Jong Chern, Chun‐Kai Liao, Wen‐Sy Tsai, Pao‐Shiu Hsieh, Hung‐Chih Hsu, Yu‐Fen Lin, Hsiu‐Lan Lee, Jeng‐Fu You
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    AmirHossein Latif, Mohammad Shirkhoda, Mohammad Reza Rouhollahi, Saeed Nemati, Seyed Hossein Yahyazadeh, Kazem Zendehdel, Ahmad Reza Soroush, Aidin Yaghoobi Notash
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Redefining the Positive Circumferential Resection Margin by Incorporating Preoperative Chemoradiotherapy Treatment Response in Locally Advanced Rectal Cancer: A Multicenter Validation Study
Joo Ho Lee, Eui Kyu Chie, Seung-Yong Jeong, Tae-You Kim, Dae Yong Kim, Tae Hyun Kim, Sun Young Kim, Ji Yeon Baek, Hee Jin Chang, Min Ju Kim, Sung Chan Park, Jae Hwan Oh, Sung Hwan Kim, Jong Hoon Lee, Doo Ho Choi, Hee Chul Park, Sung-Bum Kang, Jae-Sung Kim
Cancer Res Treat. 2018;50(2):506-517.   Published online May 24, 2017
DOI: https://doi.org/10.4143/crt.2016.607
AbstractAbstract PDFPubReaderePub
Purpose
This study was conducted to validate the prognostic influence of treatment response among patients with positive circumferential resection margin for locally advanced rectal cancer.
Materials and Methods
Clinical data of 197 patientswith positive circumferentialresection margin defined as ≤ 2 mm after preoperative chemoradiotherapy followed by total mesorectal excision between 2004 and 2009were collected forthis multicenter validation study. All patients underwent median 50.4Gy radiationwith concurrentfluoropyrimidine based chemotherapy. Treatmentresponse was dichotomized to good response, including treatmentresponse of grade 2 or 3, and poor response, including grade 0 or 1.
Results
After 52 months median follow-up, 5-year overall survival (OS) for good responders and poor responders was 79.1% and 48.4%, respectively (p < 0.001). In multivariate analysis, circumferential resection margin involvement and treatment response were a prognosticator for OS and locoregional recurrence-free survival. In subgroup analysis, good responders with close margin showed significantly better survival outcomes for survival. Good responders with involved margin and poor responders with close margin shared similar results, whereas poorresponderswith involved margin hadworst survival (5-year OS, 81.2%, 57.0%, 50.0%, and 32.4%, respectively; p < 0.001).
Conclusion
Among patients with positive circumferential resection margin after preoperative chemoradiotherapy, survival of the good responders was significantly better than poor responders. Subgroup analysis revealed that definition of positive circumferential resection margin may be individualized as involvement for good responders, whereas ≤ 2 mm for poor responders.

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  • Tailored Strategy for Locally Advanced Rectal Carcinoma (GRECCAR 4): Long-term Results From a Multicenter, Randomized, Open-Label, Phase II Trial
    Philippe Rouanet, Eric Rullier, Bernard Lelong, Philippe Maingon, Jean-Jacques Tuech, Denis Pezet, Florence Castan, Stephanie Nougaret
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What Is the Ideal Tumor Regression Grading System in Rectal Cancer Patients after Preoperative Chemoradiotherapy?
Soo Hee Kim, Hee Jin Chang, Dae Yong Kim, Ji Won Park, Ji Yeon Baek, Sun Young Kim, Sung Chan Park, Jae Hwan Oh, Ami Yu, Byung-Ho Nam
Cancer Res Treat. 2016;48(3):998-1009.   Published online October 22, 2015
DOI: https://doi.org/10.4143/crt.2015.254
AbstractAbstract PDFPubReaderePub
Purpose
Tumor regression grade (TRG) is predictive of therapeutic response in rectal cancer patients after chemoradiotherapy (CRT) followed by curative resection. However, various TRG systems have been suggested, with subjective categorization, resulting in interobserver variability. This study compared the prognostic validity of four different TRG systems in order to identify the most ideal TRG system. Materials and Methods This study included 933 patients who underwent preoperative CRT and curative resection. Primary tumors alone were graded according to the American Joint Committee on Cancer (AJCC), Dworak, and Ryan TRG systems, and both primary tumors and regional lymph nodes were graded according to a modified Dworak TRG system. The ability of each TRG system to predict recurrence-free survival (RFS) and overall survival (OS) was analyzed using chisquare and C statistics.
Results
All four TRG systems were significantly predictive of both RFS and OS (p < 0.001 each), however none was a better predictor of prognosis than ypStage. Among the four TRGs, the mDworak TRG system was a better predictor of RFS and OS than the AJCC, Dworak, and Ryan TRG systems, and both the chi-square and C statistics were higher for the former, although the differences were not statistically significant. The combination of ypStage and the modified Dworak TRG better predicted RFS and OS than ypStage alone. Conclusion The modified Dworak TRG system for evaluation of entire tumors including regional lymph nodes is a better predictor of survival than current TRG systems for evaluation of the primary tumor alone.

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Endoscopic Criteria for Evaluating Tumor Stage after Preoperative Chemoradiation Therapy in Locally Advanced Rectal Cancer
Kyung Su Han, Dae Kyung Sohn, Dae Yong Kim, Byung Chang Kim, Chang Won Hong, Hee Jin Chang, Sun Young Kim, Ji Yeon Baek, Sung Chan Park, Min Ju Kim, Jae Hwan Oh
Cancer Res Treat. 2016;48(2):567-573.   Published online September 22, 2015
DOI: https://doi.org/10.4143/crt.2015.195
AbstractAbstract PDFPubReaderePub
Purpose
Local excision may be an another option for selected patients with markedly down-staged rectal cancer after preoperative chemoradiation therapy (CRT), and proper evaluation of post-CRT tumor stage (ypT) is essential prior to local excision of these tumors. This study was designed to determine the correlations between endoscopic findings and ypT of rectal cancer.
Materials and Methods
In this study, 481 patients with locally advanced rectal cancer who underwent preoperative CRT followed by surgical resection between 2004 and 2013 at a single institution were evaluated retrospectively. Pathological good response (p-GR) was defined as ypT ≤ 1, and pathological minimal or no response (p-MR) as ypT ≥ 2. The patients were randomly classified according to two groups, a testing (n=193) and a validation (n=288) group. Endoscopic criteria were determined from endoscopic findings and ypT in the testing group and used in classifying patients in the validation group as achieving or not achieving p-GR.
Results
Based on findings in the testing group, the endoscopic criteria for p-GR included scarring, telangiectasia, and erythema, whereas criteria for p-MR included nodules, ulcers, strictures, and remnant tumors. In the validation group, the kappa statistic was 0.965 (p < 0.001), and the sensitivity, specificity, positive predictive value, and negative predictive value were 0.362, 0.963, 0.654, and 0.885, respectively.
Conclusion
The endoscopic criteria presented are easily applicable for evaluation of ypT after preoperative CRT for rectal cancer. These criteria may be used for selection of patients for local excision of down-staged rectal tumors, because patients with p-MR could be easily ruled out.

Citations

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    Bin Liu, Chuan Sun, Xinyu Zhao, Lingyu Liu, Shuang Liu, Haichuan Ma
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  • Feasibility of endoscopic techniques in assessing the radicality of chemoradiotherapy in patients with rectal cancer
    A. A. Salimova, M. V. Makarova, M. Yu. Kurdanova, Yu. P. Kuvshinov, I. A. Karasev, T. S. Davydkina
    Surgery and Oncology.2024; 14(2): 48.     CrossRef
  • Clinical predictors of pathological good response in locally advanced rectal cancer
    Kongfeng Shao, Rong Zheng, Anchuan Li, Xiaobo Li, Benhua Xu
    Radiation Oncology.2021;[Epub]     CrossRef
  • A prospective clinical study assessing the presence of exfoliated cancer cells and rectal washout including tumors in patients who receive neoadjuvant chemoradiotherapy for rectal cancer
    Kazutake Okada, Sotaro Sadahiro, Yutaro Kamei, Lin Fung Chan, Takashi Ogimi, Hiroshi Miyakita, Gota Saito, Akira Tanaka, Toshiyuki Suzuki
    Surgery Today.2020; 50(4): 352.     CrossRef
  • Oncologic Risk of Rectal Preservation Against Medical Advice After Chemoradiotherapy for Rectal Cancer: A Multicenter Comparative Cross‐Sectional Study with Rectal Preservation as Supported by Surgeon
    Kwang‐Seop Song, Sung Chan Park, Dae Kyung Sohn, Jae Hwan Oh, Min Jung Kim, Ji Won Park, Seung‐Bum Ryoo, Seung‐Yong Jeong, Kyu Joo Park, Heung‐Kwon Oh, Duck‐Woo Kim, Sung‐Bum Kang
    World Journal of Surgery.2019; 43(12): 3216.     CrossRef
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    Dae Kyung Sohn, Kyung Su Han, Byung Chang Kim, Chang Won Hong, Hee Jin Chang, Ji Yeon Baek, Min Ju Kim, Sung Chan Park, Jae Hwan Oh, Dae Yong Kim
    Surgical Oncology.2017; 26(4): 453.     CrossRef
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    Rutger CH. Stijns, Mike-Stephen R. Tromp, Niek Hugen, Johannes HW de Wilt
    European Journal of Surgical Oncology.2017;[Epub]     CrossRef
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Open-label, Randomized Comparison of the Efficacy of Intravenous Dolasetron Mesylate and Ondansetron in the Prevention of Acute and Delayed Cisplatin-induced Emesis in Cancer Patients
Jin-Soo Kim, Ji Yeon Baek, Sook Ryun Park, In Sil Choi, Sang-Il Kim, Dong-Wan Kim, Seock-Ah Im, Tae-You Kim, Dae Seog Heo, Yung-Jue Bang, Noe Kyeong Kim
Cancer Res Treat. 2004;36(6):372-376.   Published online December 31, 2004
DOI: https://doi.org/10.4143/crt.2004.36.6.372
AbstractAbstract PDFPubReaderePub
Purpose

The aim of this study is to compare the antiemetic efficacy and tolerability of intravenous dolasetron mesylate and ondansetron in the prevention of acute and delayed emesis.

Material and Methods

From April 2002 through October 2002, a total of 112 patients receiving cisplatin- based combination chemotherapy were randomized to receive a single i.v. dose of dolasetron 100 mg or ondansetron 8 mg, 30 minutes before the initiation of chemotherapy. In the ondansetron group, two additional doses of ondansetron 8 mg were given at intervals of 2 to 4 hours. To prevent delayed emesis, dolasetron 200 mg p.o. daily or ondansetron 8 mg p.o. bid was administered from the 2nd days to a maximum of 5 days. The primary end point was the proportion of patients that experienced no emetic episodes and required no rescue medication (complete response, CR) during the 24 hours (acute period) and during Day 2 to Day 5±2 days (delayed period), after chemotherapy. The secondary end points included the incidence and severity of emesis.

Results

105 patients were evaluable for efficacy. CR rates during the acute period were 36.0% for a single dose of dolasetron 100 mg, and 43.6% for three doses of ondansetron 8 mg. CR rates during the delayed period were 8.0% and 10.9%, respectively. There was no significant difference in the efficacy between the two groups. Adverse effects were mostly mild to moderate and not related to study medication.

Conclusions

A single i.v. dose of dolasetron 100 mg is as effective as three i.v. doses of ondansetron 8 mg in preventing acute and delayed emesis after cisplatin-based chemotherapy, with a comparable safety profile.

Citations

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  • Efficacy, safety and effectiveness of ondansetron compared to other serotonin-3 receptor antagonists (5-HT3RAs) used to control chemotherapy-induced nausea and vomiting: systematic review and meta-analysis
    Giovana Paula Rezende Simino, Lays Pires Marra, Eli Iola Gurgel de Andrade, Francisco de Assis Acúrcio, Ilka Afonso Reis, Vânia Eloisa De Araújo, Mariângela Leal Cherchiglia
    Expert Review of Clinical Pharmacology.2016; 9(9): 1183.     CrossRef
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    Andrea C Tricco, Charlene Soobiah, Wing Hui, Jesmin Antony, Vladi Struchkov, Brian Hutton, Brenda Hemmelgarn, David Moher, Sharon E Straus
    BMC Pharmacology and Toxicology.2015;[Epub]     CrossRef
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