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Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer
Changhoon Yoo, Boram Han, Hyeong Su Kim, Kyu-pyo Kim, Deokhoon Kim, Jae Ho Jeong, Jae-Lyun Lee, Tae Won Kim, Jung Han Kim, Dae Ro Choi, Hong Il Ha, Jinwon Seo, Heung-Moon Chang, Baek-Yeol Ryoo, Dae Young Zang
Cancer Res Treat. 2018;50(4):1324-1330.   Published online January 8, 2018
DOI: https://doi.org/10.4143/crt.2017.526
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
Although gemcitabine plus cisplatin has been established as the standard first-line chemotherapy for patients with advanced biliary tract cancer (BTC), overall prognosis remains poor. We investigated the efficacy of a novel triplet combination of oxaliplatin, irinotecan, and S-1 (OIS) for advanced BTC.
Materials and Methods
Chemotherapy-naive patientswith histologically documented unresectable or metastatic BTC were eligible for this multicenter, single-arm phase II study. Patients received 65 mg/m2 oxaliplatin (day 1), 135 mg/m2 irinotecan (day 1), and 40 mg/m2 S-1 (twice a day, days 1-7) every 2 weeks. Primary endpoint was objective response rate. Targeted exome sequencing for biomarker analysis was performed using archival tissue.
Results
In total, 32 patients were enrolled between October 2015 and June 2016. Median age was 64 years (range, 40 to 76 years), with 24 (75%) male patients; 97% patients had metastatic or recurrent disease. Response rate was 50%, and median progression-free survival and overall survival (OS) were 6.8 months (95% confidence interval [CI], 4.8 to 8.8) and 12.5 months (95% CI, 7.0 to 18.0), respectively. The most common grade 3-4 adverse events were neutropenia (32%), diarrhea (6%), and peripheral neuropathy (6%). TP53 and KRAS mutations were the most frequent genomic alterations (42% and 32%, respectively), and KRAS mutations showed a marginal relationship with worse OS (p=0.07).
Conclusion
OIS combination chemotherapy was feasible and associated with favorable efficacy outcomes as a first-line treatment in patients with advanced BTC. Randomized studies are needed to compare OIS with gemcitabine plus cisplatin.

Citations

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  • A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study
    Hui-Jen Tsai, Shih-Hung Yang, Chin-Fu Hsiao, Hsiang-Fong Kao, Yung-Yeh Su, Yan-Shen Shan, Chia-Jui Yen, Jeng-Shiun Du, Chiun Hsu, I-Chen Wu, Li-Tzong Chen
    The Oncologist.2024; 29(10): e1396.     CrossRef
  • Liposomal irinotecan, oxaliplatin, and S-1 as first-line therapy for patients with locally advanced or metastatic pancreatic adenocarcinoma (NASOX): A multicenter phase I/IIa study
    Hyehyun Jeong, Bum Jun Kim, Choong-kun Lee, Inkeun Park, Dae Young Zang, Hye Jin Choi, Sang Soo Lee, Do Hyun Park, Tae Jun Song, Dongwook Oh, Sung-Hoon Moon, Kyu-pyo Kim, Zev Wainberg, Baek-Yeol Ryoo, Changhoon Yoo
    European Journal of Cancer.2024; 208: 114194.     CrossRef
  • Redox-responsive engineered hybrid nanomedicine for gallbladder cancer therapy via hyaluronic acid depletion
    Jinglin Zou, Cong Jiang, Xianglong Li, Tianyu Zhong, Shuqi Wang, Bo Wang, Dapeng Zhang, Ji-Na Hao, Yuanyuan Cao, Mengjia Guan, Peng Zhang, Bin Dai, Yongsheng Li
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    Cindy Neuzillet, Pascal Artru, Eric Assenat, Julien Edeline, Xavier Adhoute, Jean-Christophe Sabourin, Anthony Turpin, Romain Coriat, David Malka
    Targeted Oncology.2023; 18(1): 51.     CrossRef
  • Neoadjuvant Therapy for Extrahepatic Biliary Tract Cancer: A Propensity Score-Matched Survival Analysis
    Junya Toyoda, Kota Sahara, Tomoaki Takahashi, Kentaro Miyake, Yasuhiro Yabushita, Yu Sawada, Yuki Homma, Ryusei Matsuyama, Itaru Endo, Timothy Pawlik
    Journal of Clinical Medicine.2023; 12(7): 2654.     CrossRef
  • Modified FOLFIRINOX Versus CISGEM Chemotherapy for Patients With Advanced Biliary Tract Cancer (PRODIGE 38 AMEBICA): A Randomized Phase II Study
    Jean marc Phelip, Jérôme Desrame, Julien Edeline, Emilie Barbier, Eric Terrebonne, Pierre Michel, Hervé Perrier, Laetitia Dahan, Vincent Bourgeois, Faiza Khemissa Akouz, Emilie Soularue, Valérie Lebrun Ly, Yann Molin, Thierry Lecomte, François Ghiringhell
    Journal of Clinical Oncology.2022; 40(3): 262.     CrossRef
  • Early Recurrence in Resected Gallbladder Carcinoma: Clinical Impact and Its Preoperative Predictive Score
    Yuji Shimizu, Ryo Ashida, Teiichi Sugiura, Yukiyasu Okamura, Katsuhisa Ohgi, Mihoko Yamada, Shimpei Otsuka, Takeshi Aramaki, Akifumi Notsu, Katsuhiko Uesaka
    Annals of Surgical Oncology.2022; 29(9): 5447.     CrossRef
  • Efficacy and safety of modified FOLFIRINOX as salvage therapy for patients with refractory advanced biliary tract cancer: a retrospective study
    Liu-Fang Ye, Chao Ren, Long Bai, Jie-Ying Liang, Ming-Tao Hu, Hui Yang, Zhi-Qiang Wang, Feng-Hua Wang, Rui-Hua Xu, Yu-Hong Li, De-Shen Wang
    Investigational New Drugs.2021; 39(3): 836.     CrossRef
  • Current Status and Future Perspectives of Perioperative Therapy for Resectable Biliary Tract Cancer: A Multidisciplinary Review
    Changhoon Yoo, Sang Hyun Shin, Joon-Oh Park, Kyu-Pyo Kim, Jae Ho Jeong, Baek-Yeol Ryoo, Woohyung Lee, Ki-Byung Song, Dae-Wook Hwang, Jin-hong Park, Jae Hoon Lee
    Cancers.2021; 13(7): 1647.     CrossRef
  • Chemotherapy for advanced gallbladder cancer (GBC): A systematic review and meta-analysis
    Alexander A. Azizi, Angela Lamarca, Mairéad G. McNamara, Juan W. Valle
    Critical Reviews in Oncology/Hematology.2021; 163: 103328.     CrossRef
  • Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study
    Lu Zou, Xuechuan Li, Xiangsong Wu, Jiujie Cui, Xuya Cui, Xiaoling Song, Tai Ren, Xusheng Han, Yidi Zhu, Huaifeng Li, Wenguang Wu, Xu’an Wang, Wei Gong, Liwei Wang, Maolan Li, Wan Yee Lau, Yingbin Liu
    BMC Cancer.2021;[Epub]     CrossRef
  • A Novel Combination of Bevacizumab with Chemotherapy Improves Therapeutic Effects for Advanced Biliary Tract Cancer: A Retrospective, Observational Study
    Sung-Nan Pei, Chun-Kai Liao, Yaw-Sen Chen, Cheng-Hao Tseng, Chao-Ming Hung, Chong-Chi Chiu, Meng-Che Hsieh, Yu-Fen Tsai, Hsiu-Yun Liao, Wei-Ching Liu, Kun-Ming Rau
    Cancers.2021; 13(15): 3831.     CrossRef
  • Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study
    Changhoon Yoo, Kyu-pyo Kim, Jae Ho Jeong, Ilhwan Kim, Myoung Joo Kang, Jaekyung Cheon, Byung Woog Kang, Hyewon Ryu, Ji Sung Lee, Kyung Won Kim, Ghassan K Abou-Alfa, Baek-Yeol Ryoo
    The Lancet Oncology.2021; 22(11): 1560.     CrossRef
  • Efficacy and safety of FOLFIRINOX as salvage treatment in advanced biliary tract cancer: an open-label, single arm, phase 2 trial
    Ali Belkouz, Judith de Vos-Geelen, Ron A. A. Mathôt, Ferry A. L. M. Eskens, Thomas M. van Gulik, Martijn G. H. van Oijen, Cornelis J. A. Punt, Johanna W. Wilmink, Heinz-Josef Klümpen
    British Journal of Cancer.2020; 122(5): 634.     CrossRef
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    Pin Lv, Yi‐Fan Luo, Wen‐Yi Zhou, Ben Liu, Zheng Zhou, Yong‐Zhong Shi, Ren Huang, Chuang Peng, Zi‐Li He, Jun Wang, Hong‐Hui Zhang, Sheng‐Dan Nie
    The Kaohsiung Journal of Medical Sciences.2020; 36(6): 429.     CrossRef
  • Advances in adjuvant therapy of biliary tract cancer: an overview of current clinical evidence based on phase II and III trials
    A. Belkouz, J.W. Wilmink, N. Haj Mohammad, J. Hagendoorn, J. de Vos-Geelen, C.H.C. Dejong, M.Y.V. Homs, B. Groot Koerkamp, T.M. van Gulik, M.G.H. van Oijen, C.J.A. Punt, H. Klümpen
    Critical Reviews in Oncology/Hematology.2020; 151: 102975.     CrossRef
  • A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer
    Ayhan Ulusakarya, Abdoulaye Karaboué, Oriana Ciacio, Gabriella Pittau, Mazen Haydar, Pamela Biondani, Yusuf Gumus, Amale Chebib, Wathek Almohamad, Pasquale F. Innominato
    BMC Cancer.2020;[Epub]     CrossRef
  • Overview of current targeted therapy in gallbladder cancer
    Xiaoling Song, Yunping Hu, Yongsheng Li, Rong Shao, Fatao Liu, Yingbin Liu
    Signal Transduction and Targeted Therapy.2020;[Epub]     CrossRef
  • Irinotecan combined with oxaliplatin and S-1 in patients with metastatic pancreatic adenocarcinoma: a single-arm, three-centre, prospective study
    Keke Nie, Ling Zhang, Yunhong You, Hongmei Li, Xiuhui Guo, Zhongfa Zhang, Chunling Zhang, Youxin Ji
    Therapeutic Advances in Medical Oncology.2020;[Epub]     CrossRef
  • The effect of adjuvant chemotherapy in resectable cholangiocarcinoma: A meta-analysis and systematic review
    Ming-Liang Wang, Zhang-Yan Ke, Shuai Yin, Chen-Hai Liu, Qiang Huang
    Hepatobiliary & Pancreatic Diseases International.2019; 18(2): 110.     CrossRef
  • Nal-IRI with 5-fluorouracil (5-FU) and leucovorin or gemcitabine plus cisplatin in advanced biliary tract cancer - the NIFE trial (AIO-YMO HEP-0315) an open label, non-comparative, randomized, multicenter phase II study
    L. Perkhofer, A. W. Berger, A. K. Beutel, E. Gallmeier, S. Angermeier, L. Fischer von Weikersthal, T. O. Goetze, R. Muche, T. Seufferlein, T. J. Ettrich
    BMC Cancer.2019;[Epub]     CrossRef
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The Clinical Utility of FDG PET-CT in Evaluation of Bone Marrow Involvement by Lymphoma
Ho Young Kim, Ju-Seok Kim, Dae Ro Choi, Hyeong Su Kim, Jung Hye Kwon, Geun-Doo Jang, Jung Han Kim, Joo Young Jung, Hun Ho Song, Young Kyung Lee, Soo Kee Min, Hee Sung Hwang, Hwa Jung Kim, Dae Young Zang, Hyo Jung Kim
Cancer Res Treat. 2015;47(3):458-464.   Published online November 24, 2014
DOI: https://doi.org/10.4143/crt.2014.091
AbstractAbstract PDFPubReaderePub
Purpose
Bone marrow biopsy is a standard method for the evaluation of bone marrow infiltration by lymphoma; however, it is an invasive and painful procedure. Fluorodeoxyglucose positron emission tomography–computed tomography (FDG PET-CT) is a noninvasive imaging technique with the potential to detect bone marrow involvement by lymphoma. Materials and Methods We retrospectively reviewed medical records of lymphoma patients. All patients were examined by FDG PET-CT and iliac crest bone marrow biopsy for initial staging work-up. Results The study population comprised 94 patients (median age, 60 years; 56 males) with Hodgkin’s lymphoma (n=8) or non-Hodgkin’s lymphoma (n=86). Maximum standardized uptake values on the iliac crest of patients with lymphoma infiltrated bone marrow were significantly higher than those of patients with intact bone marrow (2.2±1.2 g/mL vs. 1.3±0.4 g/mL; p=0.001). The calculated values for FDG PET-CT during evaluation of bone marrow involvement were as follows: sensitivity 50%, specificity 96%, positive predictive value 80%, negative predictive value 85%, and positive likelihood ratio (LR+) 11.7. The value of LR+ was 16.0 in patients with aggressive subtypes of non-Hodgkin’s lymphoma (NHL). Conclusion FDG PET-CT could not replace bone marrow biopsy due to the low sensitivity of FDG PET-CT for detection of bone marrow infiltration in lymphoma patients. Conversely, FDG PET-CT had high specificity and LR+; therefore, it could be a useful tool for image-guided biopsy for lymphoma staging, especially for aggressive subtypes of NHL. In addition, unilateral bone marrow biopsy could be substituted for bilateral bone marrow biopsy in lymphoma patients with increased FDG uptake on any iliac crest.

Citations

Citations to this article as recorded by  
  • FDG PET/CT versus Bone Marrow Biopsy for Diagnosis of Bone Marrow Involvement in Non-Hodgkin Lymphoma: A Systematic Review
    Jawaher Almaimani, Charalampos Tsoumpas, Richard Feltbower, Irene Polycarpou
    Applied Sciences.2022; 12(2): 540.     CrossRef
  • Comparison of the RECIST and EORTC PET criteria in the tumor response assessment: a pooled analysis and review
    Jung Han Kim, Bum Jun Kim, Hyun Joo Jang, Hyeong Su Kim
    Cancer Chemotherapy and Pharmacology.2017; 80(4): 729.     CrossRef
  • Comparison of the RECIST and PERCIST criteria in solid tumors: a pooled analysis and review
    Seon Jeong Min, Hyun Joo Jang, Jung Han Kim
    Oncotarget.2016; 7(19): 27848.     CrossRef
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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
AbstractAbstract PDFPubReaderePub
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.

Citations

Citations to this article as recorded by  
  • 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
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    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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Case Report
F-18 FDG PET-positive Fibrous Dysplasia in a Patient with Intestinal Non-Hodgkin's Lymphoma
Mi Kim, Hyeong Su Kim, Jung Han Kim, Joo Hyun Jang, Kook Jin Chung, Mi Kyung Shin, Hee Sung Hwang, Byung Chun Kim, So Young Jung
Cancer Res Treat. 2009;41(3):171-174.   Published online September 28, 2009
DOI: https://doi.org/10.4143/crt.2009.41.3.171
AbstractAbstract PDFPubReaderePub

Fibrous dysplasia (FD) is a common benign bone disorder of an unclear etiology. It is known that FD can appear without an increased FDG uptake on F-18 fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT). However, there are also several reports that FD showed increased FDG uptake and this mimicked malignant bone involvement on FDG-PET. Herein we describe a case of biopsy-proven FDG-PET positive FD in a patient with intestinal non-Hodgkin's lymphoma (NHL). A 45-year-old woman was diagnosed with intestinal NHL, which was removed by right hemicolectomy. After the operation, the FDG-PET/CT scan showed hypermetabolic activity in the right transverse process of the T10 vertebra. The patient then received a total of 6 cycles of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone) chemotherapy every 3 weeks. After completion of the planned chemotherapy, the 2nd FDG-PET/CT showed increased FDG uptake (SUVmax=6.0 g/mL) of the previous bone lesion. The MR images revealed a T1-hypointense lesion with sharp borders in the same region, and this showed homogenous contrast enhancement on the fat-suppressed T1-weighted images. After the radiologic studies were carefully reviewed, the bone lesion was assumed to be benign such as FD. We performed bone biopsy and the histological examination confirmed the diagnosis of FD. In conclusion, bone lesions with FDG uptake need to be carefully interpreted when evaluating patients with known malignancy.

Citations

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  • Polyostotic Fibrous Dysplasia Mimicking Bone Involvement in Hodgkin Lymphoma: A Pediatric Case and Literature Review
    Gianfranco Lapietra, Maria Luisa Moleti, Fiorina Giona, Arianna Turchetti, Mauro Celli, Alessandro Corsi, Anna Zambrano, Miriam D'Avanzo, Luca Celli, Anna Maria Testi
    Acta Haematologica.2021; 144(2): 212.     CrossRef
  • PET/CT and PET/MRI in ophthalmic oncology (Review)
    Maria Kalemaki, Apostolos Karantanas, Dimitris Exarchos, Efstathios Detorakis, Odysseas Zoras, Kostas Marias, Corina Millo, Ulas Bagci, Ioannis Pallikaris, Andreas Stratis, Ioannis Karatzanis, Kostas Perisinakis, Pavlos Koutentakis, Georgios Kontadakis, D
    International Journal of Oncology.2020;[Epub]     CrossRef
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    William Makis, Stephan Probst
    BJR|case reports.2016; 2(3): 20150440.     CrossRef
  • FDG Uptake in Liposclerosing Myxofibrous Tumor Causes Upstaging of Hodgkin Lymphoma
    Jongho Kim, Wengen Chen, Charles Resnik, Vasken Dilsizian, Qing Chen, Amy S. Kimball
    Clinical Nuclear Medicine.2015; 40(4): 325.     CrossRef
  • Fibrous dysplasia mimicking vertebral bone metastasis on 18F-FDG PET/computed tomography in a patient with tongue cancer
    Ibrahim Guler, Alaaddin Nayman, Gonca Kara Gedik, Mustafa Koplay, Oktay Sari
    The Spine Journal.2015; 15(6): 1501.     CrossRef
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    Sudhir Suman KC, Punit Sharma, Harmandeep Singh, Chandrasekhar Bal, Rakesh Kumar
    Nuclear Medicine and Molecular Imaging.2012; 46(4): 318.     CrossRef
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