18 results on '"Sriuranpong, V."'
Search Results
2. Everolimus for the treatment of advanced gastrointestinal or lung nonfunctional neuroendocrine tumors in East Asian patients: a subgroup analysis of the RADIANT-4 study
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Yao JC, Oh DY, Qian JM, Park YS, Herbst F, Ridolfi A, Izquierdo M, Ito T, Jia LQ, Komoto I, Sriuranpong V, and Shimada Y
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mTOR inhibitors ,East Asian population ,neuroendocrine tumors ,everolimus ,RADIANT-4 ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,lcsh:RC254-282 - Abstract
James C Yao,1 Do-Youn Oh,2 Jiaming Qian,3 Young Suk Park,4 Fabian Herbst,5 Antonia Ridolfi,6 Miguel Izquierdo,5 Tetsuhide Ito,7 Liqun Jia,8 Izumi Komoto,9 Virote Sriuranpong,10 Yasuhiro Shimada11 1Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA; 2Department of Medical Oncology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea; 3Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China; 4Department of Hematology and Oncology, Samsung Medical Center, Seoul, South Korea; 5Novartis Oncology, Novartis Pharma AG, Basel, Switzerland; 6Novartis Oncology, Novartis Pharma S.A.S, Rueil-Malmaison, Paris, France; 7Department of Gastroenterology, Kyushu University Hospital, Fukuoka, Japan; 8Department of Medical Oncology, China-Japan Friendship Hospital, Beijing, China; 9Department of Surgery, Kansai Electric Power Hospital, Osaka, Japan; 10Department of Medical Oncology, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand; 11Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tsukiji, Chuo-ku, Tokyo, Japan Background: In RADIANT-4, everolimus showed an improvement of 7.1 months in median progression-free survival (PFS) vs placebo among patients with advanced, well-differentiated, nonfunctional neuroendocrine tumors (NETs) of gastrointestinal (GI) or lung origin. The present analysis focuses on the effect of everolimus on the East Asian-subgroup population of the RADIANT-4 study. Methods: Patients were randomized to receive everolimus 10 mg/day or matching placebo. The primary end point was PFS (central review). Secondary end points were overall response rate, safety, and tolerability. Results: Among 302 patients enrolled in RADIANT-4, 46 were included in the East Asian subgroup (everolimus, n=28; placebo, n=18) analysis. Everolimus was associated with an 82% reduction in the relative risk of disease progression or death (HR 0.18, 95% CI 0.09–0.38). The median PFS (central review) in this subgroup was 11.2 months with everolimus vs 3.1 months with placebo. Adverse events (AEs) occurred in all 28 patients treated with everolimus and ten patients receiving placebo. The majority of these AEs were grade 1 or 2. Most commonly reported (≥30% of incidence) drug-related AEs of any grade included stomatitis (75%, n=21) and rash (43%, n=12) in the everolimus arm. Conclusion: Everolimus demonstrated a clinically meaningful PFS benefit in the East Asian population. The safety findings were consistent with the known safety profile of everolimus. These results support the use of everolimus in the East Asian population with advanced, nonfunctional NETs of GI or lung origin. Keywords: mTOR inhibitors, everolimus, RADIANT-4, neuroendocrine tumors, East Asian population
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- 2019
3. Clinical Benefits of First-Line (1L) Cemiplimab Monotherapy by PD-L1 Expression Levels in Patients With Advanced NSCLC
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Kilickap, S., Sezer, A., Gumus, M., Bondarenko, I., Ozguroglu, M., Gogishvili, M., Turk, H. M., Cicin, I., Bentsion, D., Gladkov, O., Clingan, P., Sriuranpong, V., Rizvi, N., Li, S., Lee, S., Makharadze, T., Paydas, S., Nechaeva, M., Seebach, F., Weinreich, D. M., Yancopoulos, G. D., Gullo, G., Lowy, I., Rietschel, P., and TÜRK, HACI MEHMET
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Kilickap S., Sezer A., Gumus M., Bondarenko I., Ozguroglu M., Gogishvili M., Turk H. M. , Cicin I., Bentsion D., Gladkov O., et al., -Clinical Benefits of First-Line (1L) Cemiplimab Monotherapy by PD-L1 Expression Levels in Patients With Advanced NSCLC-, JOURNAL OF THORACIC ONCOLOGY, cilt.16, sa.3, 2021 - Published
- 2021
4. EMPOWER-Lung 1: Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) >= 50%
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Sezer, A., Kilickap, S., Gumus, M., Bondarenko, I., ÖZGÜROĞLU, Mustafa, Gogishvili, M., TÜRK, HACI MEHMET, Cicin, I., Bentsion, D., Gladkov, O., Clingan, P., Sriuranpong, V., Rizvi, N., Li, S., Lee, S., Gullo, G., Lowy, I., Rietschel, P., and TÜRK, HACI MEHMET
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=+50%25-%2C+ESMO+Virtual+Congress%2C+ELECTR+NETWORK%2C+19+Eylül+-+18+Ekim+2020%2C+cilt%2E31+[Sezer+A%2E%2C+Kilickap+S%2E%2C+Gumus+M%2E%2C+Bondarenko+I%2E%2C+ÖZGÜROĞLU+M%2E%2C+Gogishvili+M%2E%2C+TÜRK+H%2E+M%2E+%2C+Cicin+I%2E%2C+Bentsion+D%2E%2C+Gladkov+O%2E%2C+et+al%2E%2C+-EMPOWER-Lung+1]%22">Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) >= 50%-, ESMO Virtual Congress, ELECTR NETWORK, 19 Eylül - 18 Ekim 2020, cilt.31 [Sezer A., Kilickap S., Gumus M., Bondarenko I., ÖZGÜROĞLU M., Gogishvili M., TÜRK H. M. , Cicin I., Bentsion D., Gladkov O., et al., -EMPOWER-Lung 1] - Published
- 2020
5. Randomized, open-label phase III study of pembrolizumab (pembro) vs docetaxel (doce) in patients (pts) with previously treated NSCLC with PD-L1 tumour proportion score (TPS) ≥1%: KEYNOTE-033
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Zhou, C., Feng, S., Ma, S., Chen, H., Ma, Z., Huang, C., Zhang, L., He, J., Wang, C., Zhou, J., Danchaivijtr, P., Huang, H-C., Vynnychenko, Ihor Oleksandrovych, Wang, K., Orlandi, F., Sriuranpong, V., Li, B., Ge, J., and Dang, T.
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docetaxel (doce) ,III study of pembrolizumab - Abstract
In KEYNOTE-010, pembro improved OS vs doce as 2L+ therapy for advanced NSCLC with PD-L1 TPS 1% and 50%. KEYNOTE-010 did not enroll any pts from mainland China, which has high NSCLC mortality. KEYNOTE-033 (NCT02864394) evaluates pembro vs doce in pts with previously treated advanced NSCLC with PD-L1 TPS 1%, with most pts enrolled in mainland China.
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- 2020
6. Effects of CYP2D6 and CYP3A5 polymorphisms on tamoxifen and its metabolites in Thai breast cancer patients
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Charoenchokthavee W, Areepium N, Panomvana D, and Sriuranpong V
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CYP3A5 ,Breast cancer ,tamoxifen ,CYP2D6 ,endoxifen ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,skin and connective tissue diseases ,Thai ,RC254-282 - Abstract
Wanaporn Charoenchokthavee,1 Nutthada Areepium,2 Duangchit Panomvana,2 Virote Sriuranpong2 1Department of Pharmacy Practice, Faculty of Pharmaceutical Science, Chulalongkorn University, 2Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Pathumwan, Bangkok, Thailand Purpose: This study aimed to determine the effects of CYP2D6 and CYP3A5 polymorphisms on the levels of tamoxifen (TAM) and its metabolites in the plasma of breast cancer patients. The protocol was designed to test the associations between CYP2D6, CYP3A5 genotypes and phenotypes (extensive metabolizer [EM], intermediate metabolizer [IM] and poor metabolizer [PM]) and TAM, N-desmethyl tamoxifen (NDMT), endoxifen (END) and 4-hydroxytamoxifen (4OHT) concentrations.Patients and methods: One hundred and thirty-four Thai breast cancer patients from the Thai Tamoxifen Project undergoing TAM treatment who met the inclusion/exclusion criteria were recruited. Plasma samples were assessed for the concentrations of TAM and its metabolites using high-performance liquid chromatography. The data are presented as actual values and metabolic ratios (MR). The hypotheses were tested using Kruskal–Wallis or Mann–Whitney U test, including the simple main effects analysis.Results: The patients had stage 0–IV breast cancer. The mean age and body mass index were 51.6±11.6 years and 24.0±4.3, respectively. Also, 53.0% of them were premenopausal, 10.4% were perimenopausal and 36.6% were postmenopausal, while 23.1% were CYP2D6-EM/CYP3A5-EM and 20.9% carried only CYP2D6 and CYP3A5 incomplete alleles. The median concentrations of TAM, NDMT, END and 4OHT were 374.7 (interquartile range [IQR] 230.2) ng/mL, 1,064.9 (IQR 599.6) ng/mL, 54.5 (IQR 52.5) ng/mL and 5.0 (IQR 3.1) ng/mL, respectively. MR (TAM-NDMT) and MR (NDMT-END) were statistically different (p=0.013 and p=0.014, respectively), while MR (4OHT-END) was not statistically different within the CYP2D6 phenotype (p=0.594). MR (TAM-4OHT) was not statistically different within the CYP2D6 phenotype (p=0.079), but it was potentially different from CYP3A5-PM (p=0.056). None of the MR was statistically different within the CYP3A5 phenotype.Conclusion: CYP2D6 polymorphisms appear to affect END concentration through an NDMT subpathway and potentially affect 4OHT concentrations through a 4OHT subpathway in CYP3A5-PM group. Keywords: endoxifen, cytochrome P450, single nucleotide polymorphisms, pharmacogenetics, pharmacogenomics, human
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- 2017
7. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study
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Burtness, B. Harrington, K.J. Greil, R. Soulières, D. Tahara, M. de Castro, G., Jr Psyrri, A. Basté, N. Neupane, P. Bratland, Å. Fuereder, T. Hughes, B.G.M. Mesía, R. Ngamphaiboon, N. Rordorf, T. Wan Ishak, W.Z. Hong, R.-L. González Mendoza, R. Roy, A. Zhang, Y. Gumuscu, B. Cheng, J.D. Jin, F. Rischin, D. Lerzo, G. Tatangelo, M. Varela, M. Zarba, J.J. Boyer, M. Gan, H. Gao, B. Hughes, B. Mallesara, G. Taylor, A. Burian, M. Barrios, C.H. de Castro Junior, D.O. Castro, G. Franke, F.A. Girotto, G. Lima, I.P.F. Nicolau, U.R. Pinto, G.D.J. Santos, L. Victorino, A.-P. Chua, N. Couture, F. Gregg, R. Hansen, A. Hilton, J. McCarthy, J. Soulieres, D. Ascui, R. Gonzalez, P. Villanueva, L. Torregroza, M. Zambrano, A. Holeckova, P. Kral, Z. Melichar, B. Prausova, J. Vosmik, M. Andersen, M. Gyldenkerne, N. Jurgens, H. Putnik, K. Reinikainen, P. Gruenwald, V. Laban, S. Aravantinos, G. Boukovinas, I. Georgoulias, V. Kwong, D. Al-Farhat, Y. Csoszi, T. Erfan, J. Horvai, G. Landherr, L. Remenar, E. Ruzsa, A. Szota, J. Billan, S. Gluck, I. Gutfeld, O. Popovtzer, A. Benasso, M. Bui, S. Ferrari, V. Licitra, L. Nole, F. Fujii, T. Fujimoto, Y. Hanai, N. Hara, H. Matsumoto, K. Mitsugi, K. Monden, N. Nakayama, M. Okami, K. Oridate, N. Shiga, K. Shimizu, Y. Sugasawa, M. Takahashi, M. Takahashi, S. Tanaka, K. Ueda, T. Yamaguchi, H. Yamazaki, T. Yasumatsu, R. Yokota, T. Yoshizaki, T. Kudaba, I. Stara, Z. Cheah, S.K. Aguilar Ponce, J. Gonzalez Mendoza, R. Hernandez Hernandez, C. Medina Soto, F. Buter, J. Hoeben, A. Oosting, S. Suijkerbuijk, K. Bratland, A. Brydoey, M. Alvarez, R. Mas, L. Caguioa, P. Querol, J. Regala, E.E. Tamayo, M.B. Villegas, E.M. Kawecki, A. Karpenko, A. Klochikhin, A. Smolin, A. Zarubenkov, O. Goh, B.C. Cohen, G. du Toit, J. Jordaan, C. Landers, G. Ruff, P. Szpak, W. Tabane, N. Brana, I. Iglesias Docampo, L. Lavernia, J. Mesia, R. Abel, E. Muratidu, V. Nielsen, N. Cristina, V. Rothschild, S. Wang, H.-M. Yang, M.-H. Yeh, S.-P. Yen, C.-J. Soparattanapaisarn, N. Sriuranpong, V. Aksoy, S. Cicin, I. Ekenel, M. Harputluoglu, H. Ozyilkan, O. Agarwala, S. Ali, H. Alter, R. Anderson, D. Bruce, J. Campbell, N. Conde, M. Deeken, J. Edenfield, W. Feldman, L. Gaughan, E. Goueli, B. Halmos, B. Hegde, U. Hunis, B. Jotte, R. Karnad, A. Khan, S. Laudi, N. Laux, D. Martincic, D. McCune, S. McGaughey, D. Misiukiewicz, K. Mulford, D. Nadler, E. Nunnink, J. Ohr, J. O'Malley, M. Patson, B. Paul, D. Popa, E. Powell, S. Redman, R. Rella, V. Rocha Lima, C. Sivapiragasam, A. Su, Y. Sukari, A. Wong, S. Yilmaz, E. Yorio, J.
- Abstract
Background: Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response. Methods: KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment assignment. Investigators, participants, and representatives of the sponsor were masked to the PD-L1 combined positive score (CPS) results; PD-L1 positivity was not required for study entry. The primary endpoints were overall survival (time from randomisation to death from any cause) and progression-free survival (time from randomisation to radiographically confirmed disease progression or death from any cause, whichever came first) in the intention-to-treat population (all participants randomly allocated to a treatment group). There were 14 primary hypotheses: superiority of pembrolizumab alone and of pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival and progression-free survival in the PD-L1 CPS of 20 or more, CPS of 1 or more, and total populations and non-inferiority (non-inferiority margin: 1·2) of pembrolizumab alone and pembrolizumab with chemotherapy versus cetuximab with chemotherapy for overall survival in the total population. The definitive findings for each hypothesis were obtained when statistical testing was completed for that hypothesis; this occurred at the second interim analysis for 11 hypotheses and at final analysis for three hypotheses. Safety was assessed in the as-treated population (all participants who received at least one dose of allocated treatment). This study is registered at ClinicalTrials.gov, number NCT02358031. Findings: Between April 20, 2015, and Jan 17, 2017, 882 participants were allocated to receive pembrolizumab alone (n=301), pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy (n=300); of these, 754 (85%) had CPS of 1 or more and 381 (43%) had CPS of 20 or more. At the second interim analysis, pembrolizumab alone improved overall survival versus cetuximab with chemotherapy in the CPS of 20 or more population (median 14·9 months vs 10·7 months, hazard ratio [HR] 0·61 [95% CI 0·45–0·83], p=0·0007) and CPS of 1 or more population (12·3 vs 10·3, 0·78 [0·64–0·96], p=0·0086) and was non-inferior in the total population (11·6 vs 10·7, 0·85 [0·71–1·03]). Pembrolizumab with chemotherapy improved overall survival versus cetuximab with chemotherapy in the total population (13·0 months vs 10·7 months, HR 0·77 [95% CI 0·63–0·93], p=0·0034) at the second interim analysis and in the CPS of 20 or more population (14·7 vs 11·0, 0·60 [0·45–0·82], p=0·0004) and CPS of 1 or more population (13·6 vs 10·4, 0·65 [0·53–0·80], p
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- 2019
8. Prevalence of CYP2D6*2, CYP2D6*4, CYP2D6*10, and CYP3A5*3 in Thai breast cancer patients undergoing tamoxifen treatment
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Charoenchokthavee W, Panomvana D, Sriuranpong V, and Areepium N
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CYP3A5 ,breast cancer ,tamoxifen ,CYP2D6 ,prevalence ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,skin and connective tissue diseases ,Thai ,RC254-282 - Abstract
Wanaporn Charoenchokthavee,1 Duangchit Panomvana,1 Virote Sriuranpong,2 Nutthada Areepium1 1Department of Pharmacy Practice, Faculty of Pharmaceutical Science, 2Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand Background: Tamoxifen (TAM) is used in breast cancer treatment, but interindividual variabilities in TAM-metabolizing enzymes exist and have been linked to single nucleotide polymorphisms in the respective encoding genes. The different alleles and genotypes of these genes have been presented for Caucasians and Asians. This study aimed to explore the prevalence of the incomplete functional alleles and genotypes of the CYP2D6 and CYP3A5 genes in Thai breast cancer patients undergoing TAM treatment.Patients and methods: In total, 134 Thai breast cancer patients were randomly invited to join the Thai Tamoxifen Project. Their blood samples were collected and extracted for individual DNA. The alleles and genotypes were determined by real-time polymerase chain reaction with TaqMan® Drug Metabolism Genotyping Assays.Results: The patients were aged from 27.0 years to 82.0years with a body mass index range from 15.4 to 40.0, with the majority (103/134) in the early stage (stages 0–II) of breast cancer. The median duration of TAM administration was 17.2months (interquartile range 16.1months). Most (53%) of the patients were premenopausal with an estrogen receptor (ER) and progesterone receptor (PR) status of ER+/PR+ (71.7%), ER+/PR- (26.9%), ER-/PR+ (0.7%), and ER-/PR- (0.7%). The allele frequencies of CYP2D6*1, CYP2D6*2, CYP2D6*4, CYP2D6*10, CYP3A5*1, and CYP3A5*3 were 72.9%, 3.2%, 1.1%, 22.8%, 37.3%, and 62.7%, respectively, while the genotype frequencies of CYP2D6*1/*1, CYP2D6*1/*2, CYP2D6*2/*2, CYP2D6*4/*4, CYP2D6*1/*10, CYP2D6*2/*10, CYP2D6*4/*10, CYP2D6*10/*10, CYP3A5*1/*1, CYP3A5*1/*3, and CYP3A5*3/*3 were 9.7%, 2.2%, 3.7%, 1.5%, 15.7%, 9.7%, 3.7%, 53.7%, 13.4%, 47.8%, and 38.8%, respectively.Conclusion: The majority (97.8%) of Thai breast cancer patients undergoing TAM treatment carry at least one incomplete functional allele, including 20.9% of the patients who carry only incomplete functional alleles for both the CYP2D6 and CYP3A5 genes. This research indicates the high prevalence of these defective alleles that are involved in TAM-metabolic pathways that might further affect TAM treatment. Keywords: CYP450, SNPs, antihormone, oncology, pharmacogenetics, pharmacogenomics
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- 2016
9. EMPOWER-lung 1: A randomized, open-label, multi-national, phase III trial of cemiplimab, a human PD-1 monoclonal antibody, versus chemotherapy in first-line treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 >= 50%
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Sriuranpong, V., Altundag, O., Clingan, P., Rizvi, N., Frontera, O. Aren, Sezer, A., Paydas, S., and Çukurova Üniversitesi
- Abstract
ESMO Immuno-Oncology Congress -- DEC 13-16, 2018 -- Geneva, SWITZERLAND WOS: 000459294800115 … European Soc Med Oncol, Japanese Soc Med Oncol Regeneron Pharmaceutical Inc.; Sanofi Regeneron Pharmaceutical Inc. and Sanofi.
- Published
- 2018
10. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study
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Yao, James C, Fazio, Nicola, Singh, Simron, Buzzoni, Roberto, Carnaghi, Carlo, Wolin, Edward, Tomasek, Jiri, Raderer, Markus, Lahner, Harald, Voi, Maurizio, Pacaud, Lida Bubuteishvili, Rouyrre, Nicolas, Sachs, Carolin, Valle, Juan W, Delle Fave, Gianfranco, Van Cutsem, Eric, Tesselaar, Margot, Shimada, Yasuhiro, Oh, Do-Youn, Strosberg, Jonathan, Kulke, Matthew H, Pavel, Marianne E, Raderer, M, Pall, G, Van Cutsem, E, Borbath, I, Geboes, K, Peeters, M, Asmis, T, Kocha, W, Rayson, D, Ruether, J, Singh, S, Sideris, L, Kennecke, H, Wang, J, Shen, L, Xu, J, Qian, J, Jia, L, Maya, L F, Melichar, B, Sedlackova, E, Tomasek, J, Pavel, M, Bojunga, J, Malfertheiner, P, Vogel, A, Weber, M, Hörsch, D, Kaltsas, G, Papai, Z, Toth, M, Carnaghi, C, Luppi, G, Fazio, N, Tomassetti, P, Delle Fave, G, Cartenì, G, Buzzoni, R, Barone, C, Berruti, A, Giuffrida, D, Tortora, G, Di Costanzo, F, Tafuto, S, Ito, T, Okita, N, Komoto, I, Kattan, J, Shamseddine, A, Tesselaar, M, Jarzab, B, Ruchala, M, Vladimirova, L, Raef, H, Salek, T, Ruff, P, Kim, T W, Park, Y S, Oh, D-Y, Lee, M-A, Choi, H J, Capdevila, J, Salazar, R, Zoilo, J J R, Chen, J-S, Wu, C-C, Chen, Y-Y, Chao, Y, Yeh, K-H, Sriuranpong, V, Thongprasert, S, Turna, H, Sevinc, A, Valle, J, Sarker, D, Reed, N, Cave, J, Frilling, A, Corrie, P, Fanta, P, Yao, J, Strosberg, J, Verma, U, Libutti, S, Natale, R, Pommier, R, Lubner, S, Starodub, A, Kulke, M, Sigal, D, Polite, B, Lieu, C, Hande, K, Reidy-Lagunes, D, McCollum, A, and Forero, L
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0301 basic medicine ,Adult ,Male ,medicine.medical_specialty ,Lung Neoplasms ,Medizin ,Antineoplastic Agents ,Neuroendocrine tumors ,Placebo ,Gastroenterology ,Article ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Everolimus ,Aged ,Gastrointestinal Neoplasms ,Aged, 80 and over ,Performance status ,business.industry ,Sunitinib ,Medicine (all) ,Hazard ratio ,General Medicine ,Middle Aged ,medicine.disease ,Survival Analysis ,3. Good health ,Surgery ,Neuroendocrine Tumors ,030104 developmental biology ,Treatment Outcome ,Tolerability ,030220 oncology & carcinogenesis ,Female ,business ,medicine.drug - Abstract
Effective systemic therapies for patients with advanced, progressive neuroendocrine tumours of the lung or gastrointestinal tract are scarce. We aimed to assess the efficacy and safety of everolimus compared with placebo in this patient population.In the randomised, double-blind, placebo-controlled, phase 3 RADIANT-4 trial, adult patients (aged ≥18 years) with advanced, progressive, well-differentiated, non-functional neuroendocrine tumours of lung or gastrointestinal origin were enrolled from 97 centres in 25 countries worldwide. Eligible patients were randomly assigned in a 2:1 ratio by an interactive voice response system to receive everolimus 10 mg per day orally or identical placebo, both with supportive care. Patients were stratified by tumour origin, performance status, and previous somatostatin analogue treatment. Patients, investigators, and the study sponsor were masked to treatment assignment. The primary endpoint was progression-free survival assessed by central radiology review, analysed by intention to treat. Overall survival was a key secondary endpoint. This trial is registered with ClinicalTrials.gov, number NCT01524783.Between April 3, 2012, and Aug 23, 2013, a total of 302 patients were enrolled, of whom 205 were allocated to everolimus 10 mg per day and 97 to placebo. Median progression-free survival was 11·0 months (95% CI 9·2-13·3) in the everolimus group and 3·9 months (3·6-7·4) in the placebo group. Everolimus was associated with a 52% reduction in the estimated risk of progression or death (hazard ratio [HR] 0·48 [95% CI 0·35-0·67], p0·00001). Although not statistically significant, the results of the first pre-planned interim overall survival analysis indicated that everolimus might be associated with a reduction in the risk of death (HR 0·64 [95% CI 0·40-1·05], one-sided p=0·037, whereas the boundary for statistical significance was 0·0002). Grade 3 or 4 drug-related adverse events were infrequent and included stomatitis (in 18 [9%] of 202 patients in the everolimus group vs 0 of 98 in the placebo group), diarrhoea (15 [7%] vs 2 [2%]), infections (14 [7%] vs 0), anaemia (8 [4%] vs 1 [1%]), fatigue (7 [3%] vs 1 [1%]), and hyperglycaemia (7 [3%] vs 0).Treatment with everolimus was associated with significant improvement in progression-free survival in patients with progressive lung or gastrointestinal neuroendocrine tumours. The safety findings were consistent with the known side-effect profile of everolimus. Everolimus is the first targeted agent to show robust anti-tumour activity with acceptable tolerability across a broad range of neuroendocrine tumours, including those arising from the pancreas, lung, and gastrointestinal tract.Novartis Pharmaceuticals Corporation.
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- 2015
11. An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy
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Grünwald, V, Karakiewicz, P, Bavbek, S, Miller, K, Machiels, J, Lee, S, Larkin, J, Bono, P, Rha, S, Castellano, D, Blank, C, Knox, J, Hawkins, R, Anak, O, Rosamilia, M, Booth, J, Pirotta, N, Bodrogi, I, Romedi, M, Ferrandini, S, Rondinon, M, Pittman, K, Goldstein, D, Shapiro, J, Troon, S, Yip, D, Mainwaring, P, Zigeuner, R, Loidl, W, Greil, R, Schmidinger, M, De Grève, J, Rottey, S, Vermorken, J, Gil, T, Gennigens, C, Roumeguere, T, Barrios, C, Mathias, C, Assi, H, Hotte, S, Spadafora, S, Wood, L, Zalewski, P, Mackensie, M, Bjarnason, G, Lalancette, A, Chan, A, Higgins, B, North, S, Soulieres, D, Asselah, J, Sperlich, C, Miller, W, Yadav, S, El Maraghi, R, Godoy, J, Prausová, J, Katolicka, J, Petruzelka, L, Kiss, I, Lapela, M, Bergmann, L, Beck, J, Jäger, E, Kindler, M, Overkamp, F, Wirth, M, Hölzer, W, Gschwend, J, Stenzl, A, Gauler, T, Niederwieser, D, Marschner, N, Lück, A, Tessen, H, Eichelberg, C, Steiner, T, Goebell, P, Kettner, E, Bakhshandeh Bath, A, Wilhelm, M, Schmitz, S, Jacob, A, Bierer, S, Kube, U, Staehler, M, Engel, E, Frambach, M, Schellenberger, U, Albers, P, Simon, J, Gleissler, M, Klotz, T, Repp, R, Kröning, H, Westermann, J, Rebmann, U, Brehmer, B, Niederle, N, Grund, C, Verpoort, K, Fonara, P, Rassweiler, J, Bamias, A, Fountzilas, G, Razis, E, Mouratidou, D, Georgoulias, V, Samantas, E, Mangel, L, Szanto, J, Berger, R, Pe'Er, A, Sella, A, Ben Yosef, R, Nechushtan, H, Crinò, L, Bracarda, S, Ciuffreda, L, Graiff, C, Falcone, A, Roselli, M, Sternberg, C, Santoro, A, Ruggeri, E, Bearz, A, Venturini, M, Aglietta, M, Amadori, D, Di Costanzo, F, Bari, M, Gebbia, N, Conte, P, Bonetti, A, Bordonaro, R, Cascinu, S, Contu, A, Cruciani, G, Gasparro, D, Nardi, M, Lelli, G, Lo Re, G, Boccardo, F, Lorusso, V, Maiello, E, Manente, P, Passalacqua, R, Piantedosi, F, Porta, C, Sacco, C, Tondini, C, De Placido, S, Carteni, G, Dogliotto, L, Rosti, G, Milella, M, Roila, F, Amoroso, D, Farina, G, Al Khatib, H, Kim, T, Ahn, J, Lim, H, Chung, I, Kim, J, Chung, J, Ghosn, M, Shameseddine, A, Lugo, R, Cabrera, P, Osanto, S, Groenewegen, G, van den Eertwegh, F, van Herpen, C, Oosting, S, Soetekouw, P, Lilleby, W, Klepp, O, Guren, T, Alcedo, J, Karlov, P, Nosov, D, Roman, L, Rusakov, I, Bazarbashi, S, Toh, C, Mardiak, J, del Muro Solans, F, Ray, J, Mollins, J, Martinez, I, Gonzalez, B, Santasusana, M, Piqueras, M, Fuentes, J, Larriba, J, Caro, R, Garcia, A, Aparicio, L, Lopez, N, Aragon, V, Morales, C, Figueiras, M, Ibanez, J, Billalabeitia, G, Estrada, E, Arranz, J, Sorrosal, J, Lozano, A, de Villena, M, Espinosa, E, Lopez, R, Perez, J, Laurell, A, Stierner, U, Cwikiel, M, Borner, M, Dietrich, P, Rothermundt, C, Pu, Y, Chang, Y, Ou, Y, Chuang, C, Liao, Y, Srimuninnimit, V, Sriuranpong, V, Buyukberber, S, Yalcin, B, Goker, E, Yalcin, S, Geldart, T, Wagstaff, J, Nicholson, S, Chowdhury, S, Bahl, A, Jones, R, Azzabi, A, Chao, D, Fife, K, Mead, G, Nathan, P, Pandha, H, Hajdenberg, J, Gabrail, N, Nimeh, N, Logan, T, Flaig, T, Schraeder, R, Rini, B, O'Rourke, M, Alemany, C, Kessinger, A, Amin, A, Arriaga, M, Rodriguez, J, Gauler, Thomas (Beitragende*r), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, and Laboratory of Molecular and Medical Oncology
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Nephrology ,Oncology ,Male ,Cancer Research ,mTOR inhibitor ,Settore MED/06 - Oncologia Medica ,Medizin ,Advanced kidney cancer ,RAD001 ,REACT ,0302 clinical medicine ,Renal cell carcinoma ,Receptors ,80 and over ,Treatment Failure ,Neoplasm Metastasis ,Aged, 80 and over ,0303 health sciences ,Vascular Endothelial Growth Factor ,Sirolimus ,Young Adult ,Antineoplastic Agents ,Humans ,Aged ,Immunosuppressive Agents ,Protein Kinase Inhibitors ,Receptors, Vascular Endothelial Growth Factor ,Kidney Neoplasms ,Adult ,Carcinoma, Renal Cell ,Middle Aged ,Female ,3. Good health ,030220 oncology & carcinogenesis ,Safety ,medicine.drug ,medicine.medical_specialty ,SECOND LINE THERPAY ,Second-line therapy ,Everolimus ,03 medical and health sciences ,Internal medicine ,medicine ,Adverse effect ,030304 developmental biology ,business.industry ,Carcinoma ,Renal Cell ,medicine.disease ,Surgery ,Clinical trial ,Expanded access ,business ,Kidney cancer - Abstract
BACKGROUND AND OBJECTIVES: The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC. PATIENTS AND METHODS: REACT (Clinicaltrials.gov: NCT00655252) was a global, open-label, expanded-access programme in patients with mRCC who were intolerant of, or who had progressed on or after stopping treatment with, any available VEGFr-TKI therapy. Patients received everolimus 10mg once daily, with dose and schedule modifications allowed for toxicity. Patients were closely monitored for the development of serious and grades 3/4 adverse events (AEs). Response was assessed by RECIST every 3months for the first year and every 6months thereafter. RESULTS: A total of 1367 patients were enroled. Safety findings and tumour responses were consistent with those observed in RECORD-1, with no new safety issues identified. The most commonly reported serious AEs were dyspnoea (5.0%), pneumonia (4.7%) and anaemia (4.1%), and the most commonly reported grades 3/4 AEs were anaemia (13.4%), fatigue (6.7%) and dyspnoea (6.5%). Best overall response was stable disease in 51.6% and partial response in 1.7% of patients. Median everolimus treatment duration was 14weeks. CONCLUSION: Everolimus is well tolerated in patients with mRCC and demonstrates a favourable risk-benefit ratio.
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- 2012
12. QUALITY OF LIFE (QOL) AMONG PATIENTS (PTS) WITH LOCALLY RECURRENT (LR) OR METASTATIC BREAST CANCER (MBC): RESULTS FROM THE PHASE III AVADO STUDY OF FIRST-LINE BEVACIZUMAB (BV) PLUS DOCETAXEL (D) VERSUS D PLUS PLACEBO (PL)
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Greil, R., Im, Y. H., Pienkowski, T., Andrew Wardley, Awada, A., Ciruelos, E., Freitas-Junior, R., Fumoleau, P., Sriuranpong, V., and Miles, D. W.
13. Epidemiology, real world treatment and outcomes of 423 patients (pts) with angiosarcoma (AS) in Asia: A report from the Asian Sarcoma Consortium (ASC)
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Quek, R., Loong, H. H., Sriuranpong, V., Farid, M., Tan, S. H., Goh, W. L., Mingmalairak, S., Chen, T. W-W, Chang, C-C, Pang, A., Teo, S., Puhaindran, M. E., Maw, M. M., Ngan, R., Leung, A. K. C., Chan, J. C., Hirose, T., Makoto Endo, and Kawai, A.
14. Optimal first line systemic therapy in patients (pts) with metastatic angiosarcoma: A report from the Asian Sarcoma Consortium
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Chen, T. W-W, Pang, A., Puhaindran, M. E., Maw, M. M., Herbert Loong, Sriuranpong, V., Chang, C-C, Teo, S., Mingmalairak, S., Hirose, T., Endo, M., Kawai, A., Farid, M., Tan, S. H., Goh, W. L., Quek, R., Chan, J. C., Leung, A. K. C., and Ngan, R.
15. Epidermal growth factor receptor-independent constitutive activation of STAT3 in head and neck squamous cell carcinoma is mediated by the autocrine/paracrine stimulation of the interleukin 6/gp130 cytokine system
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Sriuranpong, V., Park, J. I., Amornphimoltham, P., Patel, V., Nelkin, B. D., and J Silvio Gutkind
16. Alectinib (ALC) vs crizotinib (CRZ) in treatment-naive ALK plus non-small-cell lung cancer (NSCLC): Asian vs non-Asian subgroup analysis of the ALEX study
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Tony Mok, Peters, S., Camidge, D. R., Ou, S. H. I., Ahn, J. S., Tan, E. H., Li, Z., Lee, J. S., Cho, B. C., Geater, S. L., Sriuranpong, V., Ho, J., Chan, O. S. H., Zeaiter, A., Balas, B., Nueesch, E., Mitry, E., Morcos, P. N., and Kim, D. W.
17. Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer
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Rafael Rosell, Alice T. Shaw, Ali Zeaiter, Shirish M. Gadgeel, Emmanuel Mitry, Bogdana Balas, Jin S. Ahn, Maurice Perol, Johannes Noe, Sai-Hong Ignatius Ou, Peter N. Morcos, D. Ross Camidge, Solange Peters, Tony Mok, Dong Wan Kim, Rafal Dziadziuszko, Sophie Golding, ALEX Trial Investigators, Nordman, I., Pittman, K., Dear, R., Lwin, Z., Briggs, P., Pavlakis, N., Ceric, T., Mehic, B., Stanetic, M., Franke, F.A., Castro, G., Santo Borges, G., Pereira, J., Brust, L., Santos, L., Cruz, M., Ribeiro, R., De Azevedo, S., Neron, Y.V., Sangha, R., Cohen, V., Burkes, R., Abdelsalam, M., Yadav, S., Cheema, P., Yanez, E., Aren, O., Zhou, C., Zhang, L., Liu, X., Corrales Rodriguez, L., Meldgaard, P., Soerensen, J.B., McCulloch, T., Rodriguez, N., Gaafar, R., Abdel Azeem, H., Coudert, B., Moro-Sibilot, D., Lena, H., Bennouna, J., Cortot, A., Veillon, R., Cadranel, J., Barlesi, F., Reck, M., Mezger, J., von Pawel, J., Fischer, J.R., Dickgreber, N.K., Zarogoulidis, K., Syrigos, K., Georgoulias, V., Agelaki, S., Castro-Salguero, H., Ho, J., Chan, S.H., Cheng, C.K., Ng, A., Stemmer, S., Wollner, M., Gottfried, M., Dudnik, J., Cyjon, A., Heching, N., Novello, S., Tiseo, M., Platania, M., Misino, A., Gridelli, C., Ciardiello, F., Favaretto, A., De Marinis, F., Longo, F., Bordonaro, R., Dazzi, C., Chiari, R., Mercuri, E., Macedo, E., Rodriguez Cid, J.R., McKeage, M., Vera, L., Morón Escobar, H.D., Rodriguez, M., Mas, L., Ramlau, R., Kowalski, D., Szczesna, A., Kazarnowicz, A., Milanowski, J., Luboch-Kowal, J., Oliveira, J., Barata, F., Almodovar, T., Lee, J.S., Cho, B.C., Kim, S.W., Han, J.Y., Karaseva, N., Stroyakovskii, D., Kuzmin, A., Smolin, A., Laktionov, K., Ragulin, Y., Filippov, A., Levchenko, E., Jovanovic, D., Perin, B., Andric, Z., Soo, R., Tan, E.H., De Castro Carpeno, J., Provencio Pulla, M., Garrido Lopez, P., Felip Font, E., Morano Bueno, T., Sanchez, A., Isla Casado, D., Ponce Aix, S., Reguart Aransay, N., Viteri Ramirez, S., Rodriguez Abreu, D., Sanchez Torres, J.M., Massuti Sureda, B., Ramos Vazquez, M., Tabernero, J.M., Curioni, A., Rothschild, S., Scherz, A., Chiu, C.H., Su, W.C., Yang, CHJ, Chang, G.C., Hsia, T.C., Yang, C.T., Tharavichitkul, E., Pongthai, P., Arpornwirat, W., Geater, S., Srimuninnimit, V., Sriuranpong, V., Demirkazik, A., Goker, E., Harputluoglu, H., Cicin, I., Kose, F., Erman, M., Bondarenko, I., Vinnyk, Y., Shparyk, Y., Golovko, Y., Lal, R., Forster, M., Califano, R., Skailes, G., Thompson, J., Mekhail, T., Polikoff, J., Spigel, D., Waqar, S., Hermann, R., Deo, E., Simon, G., Rybkin, I., Kaywin, P.R., Uyeki, J., Gubens, M., Limaye, S., Gerber, D.E., Leal, T., Spira, A.I., Bazhenova, L., Cetnar, J., Socinski, M., Jahanzeb, M., Kabbinavar, F., Lawler, W.E., Hancock, M.R., Raez, L.E., DiCarlo, B.A., Lowe, T.E., Fidler, M., Ross, H., Davidson, S.J., Sanchez, J.D., Hamm, J., Kerr, S., Belman, N., Baker, S., Naraev, B., Jung, G., Edelman, M., Feldman, L., Belani, C., and Pakkala, S.
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Adult ,Male ,0301 basic medicine ,Oncology ,Alectinib ,medicine.medical_specialty ,Pathology ,Lung Neoplasms ,Brigatinib ,Pyridines ,medicine.drug_class ,Carbazoles ,Antineoplastic Agents ,Kaplan-Meier Estimate ,Aged, 80 and over ,Animals ,Antineoplastic Agents/adverse effects ,Antineoplastic Agents/therapeutic use ,Carbazoles/adverse effects ,Carbazoles/therapeutic use ,Carcinoma, Non-Small-Cell Lung/drug therapy ,Carcinoma, Non-Small-Cell Lung/mortality ,Central Nervous System Neoplasms/drug therapy ,Central Nervous System Neoplasms/secondary ,Disease-Free Survival ,Female ,Follow-Up Studies ,Humans ,Intention to Treat Analysis ,Lung Neoplasms/drug therapy ,Lung Neoplasms/mortality ,Middle Aged ,Piperidines/adverse effects ,Piperidines/therapeutic use ,Protein Kinase Inhibitors/adverse effects ,Protein Kinase Inhibitors/therapeutic use ,Pyrazoles/adverse effects ,Pyrazoles/therapeutic use ,Pyridines/adverse effects ,Pyridines/therapeutic use ,Receptor Protein-Tyrosine Kinases/analysis ,Receptor Protein-Tyrosine Kinases/antagonists & inhibitors ,Young Adult ,Central Nervous System Neoplasms ,03 medical and health sciences ,0302 clinical medicine ,Piperidines ,Carcinoma, Non-Small-Cell Lung ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Anaplastic lymphoma kinase ,Lung cancer ,Protein Kinase Inhibitors ,Crizotinib ,Ceritinib ,business.industry ,Receptor Protein-Tyrosine Kinases ,General Medicine ,medicine.disease ,Lorlatinib ,ALK inhibitor ,030104 developmental biology ,030220 oncology & carcinogenesis ,Pyrazoles ,business ,medicine.drug - Abstract
Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P
- Published
- 2017
18. Adaptation of international guidelines for metastatic colorectal cancer: an asian consensus
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Maximino Bello, Joong B. Ahn, Hwai L. Kong, Su Z. Zhang, Michael Shaw, Fortunato Ciardiello, Jin Li, Virote Sriuranpong, Li-Tzong Chen, Ka O. Lam, Ann-Lii Cheng, Aru W Sudoyo, Young Suk Park, Jaw-Yuan Wang, Gwo F. Ho, Brigette B.Y. Ma, Ashok K. Vaid, Clause Henning Köhne, Jun Zhang, Tian S. Liu, Catherine Teh, Tae Won Kim, Chaiyut Charoentum, Gilberto Lopes, Cheng, Al, Li, J, Vaid, Ak, Ma, Bb, Teh, C, Ahn, Jb, Bello, M, Charoentum, C, Chen, Lt, de Lima Lopes G., Jr, Ho, Gf, Kong, Hl, Lam, Ko, Liu, T, Park, Y, Sriuranpong, V, Sudoyo, Aw, Wang, Jy, Zhang, J, Zhang, Sz, Ciardiello, Fortunato, Köhne, Ch, Shaw, M, and Kim, Tw
- Subjects
Oncology ,Lung Neoplasms ,Organoplatinum Compounds ,Oxaloacetates ,Colorectal cancer ,Leucovorin ,Cetuximab ,medicine.disease_cause ,Deoxycytidine ,FOLFOX ,Antineoplastic Combined Chemotherapy Protocols ,Panitumumab ,Liver Neoplasms ,Gastroenterology ,Antibodies, Monoclonal ,Combined Modality Therapy ,Magnetic Resonance Imaging ,Bevacizumab ,ErbB Receptors ,Drug Combinations ,Colonic Neoplasms ,Practice Guidelines as Topic ,KRAS ,Fluorouracil ,Guideline Adherence ,medicine.drug ,medicine.medical_specialty ,Asia ,Antibodies, Monoclonal, Humanized ,Capecitabine ,Proto-Oncogene Proteins p21(ras) ,Internal medicine ,Proto-Oncogene Proteins ,medicine ,Humans ,Neoplasm Staging ,Tegafur ,business.industry ,Rectal Neoplasms ,Metastasectomy ,medicine.disease ,digestive system diseases ,Surgery ,Oxaliplatin ,Oxonic Acid ,ras Proteins ,Camptothecin ,business ,Tomography, X-Ray Computed - Abstract
Colorectal cancer (CRC) is among the most common cancers worldwide, but marked epidemiological differences exist between Asian and non-Asian populations. Hence, a consensus meeting was held in Hong Kong in December 2012 to develop Asia-specific guidelines for the management of metastatic CRC (mCRC). A multidisciplinary expert panel, consisting of 23 participants from 10 Asian and 2 European countries, discussed current guidelines for colon or rectal cancer and developed recommendations for adapting these guidelines to Asian clinical practice. Participants agreed that mCRC management in Asia largely follows international guidelines, but they proposed a number of recommendations based on regional 'real-world' experience. In general, participants agreed that 5-fluorouracil (5-FU) infusion regimens in doublets can be substituted with UFT (capecitabine, tegafur-uracil) and S1 (tegafur, 5-chloro-2,4-dihydroxypyridine and oxonic acid), and that the monoclonal antibodies cetuximab and panitumumab are recommended for KRAS wild type tumors. For KRAS mutant tumors, bevacizumab is the preferred biological therapy. FOLFOX (folinic acid, 5-FU, and oxaliplatin) is preferred for initial therapy in Asian patients. The management of mCRC is evolving, and it must be emphasized that the recommendations presented here reflect current treatment practices and thus might change as more data become available.
- Published
- 2014
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