☆ 4.7 Meeting Abstract

Safety, pharmacokinetics (PK), and cost-effectiveness of upfront genotyping of DPYD in fluoropyrimidine therapy

JOURNAL OF CLINICAL ONCOLOGY (2011)

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JOURNAL OF CLINICAL ONCOLOGY

卷 29, 期 15, 页码 -

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AMER SOC CLINICAL ONCOLOGY

DOI: 10.1200/jco.2011.29.15_suppl.3606

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Oncology

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Dihydropyrimidine Dehydrogenase Deficiency and Implementation of Upfront DPYD Genotyping

Cassandra White, Rodney J. Scott, Christine Paul, Andrew Ziolkowski, David Mossman, Stephen B. Fox, Michael Michael, Stephen Ackland

Summary: Upfront DPYD genotyping can identify high-risk patients for FP treatment and allow personalized dose adjustment, reducing toxicities and improving cost-effectiveness.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2022)

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Article Oncology

Upfront DPYD Genotyping and Toxicity Associated with Fluoropyrimidine-Based Concurrent Chemoradiotherapy for Oropharyngeal Carcinomas: A Work in Progress

Antoine Desilets, William McCarvill, Francine Aubin, Houda Bahig, Olivier Ballivy, Danielle Charpentier, Edith Filion, Rahima Jamal, Louise Lambert, Phuc Felix Nguyen-Tan, Charles Vadnais, Xiaoduan Weng, Denis Soulieres

Summary: The combination of carboplatin and 5-FU is effective in treating locoregionally advanced oropharyngeal carcinomas, but DPYD polymorphisms may increase the risk of severe toxicity. Upfront screening for DPYD genotypes can identify patients at risk for 5-FU-related toxicity.

CURRENT ONCOLOGY (2022)

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Article Biotechnology & Applied Microbiology

Implementation of upfront DPYD genotyping with a low-cost and high-throughput assay to guide fluoropyrimidine treatment in cancer patients

Manuela Pinheiro, Ana Peixoto, Patricia Rocha, Catarina Santos, Carla Escudeiro, Isabel Veiga, Miguel Porto, Joana Guerra, Ana Barbosa, Carla Pinto, Patricia Arinto, Adriana Resende, Manuel R. Teixeira

Summary: The study found that 7.4% of 457 patients carried heterozygous DPYD variants, with c.2846A>T being the most common. 15.7% of patients in the post-treatment group had DPYD variants, while only 2.5% of patients in the pretreatment group had a variant. The KASP genotyping assay designed in this study showed 100% genotype concordance with Sanger sequencing results, indicating its reliability for detecting DPYD variants.

PHARMACOGENETICS AND GENOMICS (2023)

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Article Pharmacology & Pharmacy

Implementing pharmacogenetic testing in fluoropyrimidine-treated cancer patients: DPYD genotyping to guide chemotherapy dosing in Greece

Georgia Ragia, Anthi Maslarinou, Natalia Atzemian, Eirini Biziota, Triantafyllia Koukaki, Charalampia Ioannou, Ioanna Balgkouranidou, George Kolios, Stylianos Kakolyris, Nikolaos Xenidis, Kyriakos Amarantidis, Vangelis G. Manolopoulos

Summary: This study aimed to analyze the prevalence of DPYD gene variants and assess their association with FP-induced toxicity in Greek cancer patients. The results showed a significant correlation between DPYD variants and FP-related toxicities.

FRONTIERS IN PHARMACOLOGY (2023)

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Article Oncology

Can upfront DPYD extended variant testing reduce toxicity and associated hospital costs of fluoropyrimidine chemotherapy? A propensity score matched analysis of 2022 UK patients

Apostolos Tsiachristas, Grant Vallance, Rositsa Koleva-Kolarova, Harriet Taylor, Luke Solomons, Giovanni Rizzo, Catherine Chaytor, Junel Miah, Sarah Wordsworth, A. Bassim Hassan

Summary: The study demonstrated the positive impact of mandatory testing using a DPYD variant panel on reducing toxicity, pain, and hospital costs in cancer patients receiving Capecitabine/5-FU treatment.

BMC CANCER (2022)

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Article Oncology

Cost-effectiveness of DPYD Genotyping Prior to Fluoropyrimidine-based Adjuvant Chemotherapy for Colon Cancer

Gabriel A. Brooks, Stephanie Tapp, Allan T. Daly, Jonathan A. Busam, Anna N. A. Tosteson

Summary: DPYD genotyping as a screening method for preventing rare but severe and sometimes fatal toxicities of fluoropyrimidine chemotherapy is a cost-effective strategy.

CLINICAL COLORECTAL CANCER (2022)

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Review Pharmacology & Pharmacy

DPYD genotyping and dihydropyrimidine dehydrogenase (DPD) phenotyping in clinical oncology. A clinically focused minireview

Niels Herluf Paulsen, Fie Vojdeman, Stig Ejdrup Andersen, Troels K. Bergmann, Marianne Ewertz, Peter Plomgaard, Morten Rix Hansen, Peter Skov Esbech, Per Pfeiffer, Camilla Qvortrup, Per Damkier

Summary: The evidence supporting the use of DPD testing in routine oncological practice is insufficient, and further research is needed to guide clinicians in treatment decisions.

BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY (2022)

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Article Pharmacology & Pharmacy

Cost-effectiveness of extended DPYD testing before fluoropyrimidine chemotherapy in metastatic breast cancer in the UK

Rositsa Koleva-Kolarova, Heleen Vellekoop, Simone Huygens, Matthijs Versteegh, Maureen Rutten-van Moelken, Laszlo Szilberhorn, Tamas Zelei, Balazs Nagy, Sarah Wordsworth, Apostolos Tsiachristas

Summary: This study aimed to assess the cost-effectiveness of ToxNav (c), a multivariant genetic test, for screening DPYD and personalized chemotherapy dosing in metastatic breast cancer patients in the UK. Results showed that ToxNav (c) was dominant over standard of care, providing additional quality-adjusted life years and cost savings per patient. Sensitivity analysis further supported the effectiveness of the ToxNav (c) strategy.

PERSONALIZED MEDICINE (2023)

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Review Biochemistry & Molecular Biology

Bioanalytical Assay Strategies and Considerations for Measuring Cellular Kinetics

Amanda Hays, Jennifer Durham, Bryan Gullick, Nathan Rudemiller, Thomas Schneider

Summary: A significant revolution in drug modalities has occurred in recent decades, particularly in the field of cell and gene therapies. These novel modalities have shown remarkable efficacy in treating rare diseases and immune oncology. As a result, there is a substantial investment in the development of these therapies. Various bioanalytical techniques, such as quantitative PCR and multiparameter flow cytometry, play a crucial role in characterizing the pharmacokinetics of these therapies. This manuscript evaluates the advantages and disadvantages of both techniques and provides regulatory guidance on measuring cellular kinetics.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2023)

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Article Health Care Sciences & Services

Upfront DPYD Genotype-Guided Treatment for Fluoropyrimidine-Based Chemotherapy in Advanced and Metastatic Colorectal Cancer: A Cost-Effectiveness Analysis

Soroush Ahmadi Fariman, Zahra Jahangard Rafsanjani, Mandana Hasanzad, Kimia Niksalehi, Shekoufeh Nikfar

Summary: This study aimed to evaluate the cost-effectiveness of preemptive DPYD genotyping to guide fluoropyrimidine therapy in patients with advanced or metastatic colorectal cancer. The results showed that the genotype-guided treatment strategy was cost-saving compared to no screening. However, due to a possible reduction in patient survival with reduced-dose regimens, the genotype-guided treatment strategy was associated with fewer quality-adjusted life-years.

VALUE IN HEALTH REGIONAL ISSUES (2023)

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Review Oncology

Effectiveness, safety and pharmacokinetics of Polo-like kinase 1 inhibitors in tumor therapy: A systematic review and meta-analysis

Xiao Wei, Mingzhu Song, Chan Huang, Qiao Yu, Guirong Jiang, Guanghao Jin, Xibiao Jia, Zheng Shi

Summary: This study provided a systematic review of meta-analysis on the efficacy, safety, and pharmacokinetics of Plk1 inhibitors in tumor treatments. The results showed that Plk1 inhibitors improved overall survival and were well-tolerated and effective in reducing illness severity and improving quality of life. However, they did not prolong progression-free survival. Plk1 inhibitors should be avoided for tumors related to the blood circulatory system, digestive system, and nervous system.

FRONTIERS IN ONCOLOGY (2023)

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Article Chemistry, Medicinal

Safety, Pharmacokinetics and Pharmacodynamics of the Selective Glucocorticoid Receptor Modulator Velsecorat (AZD7594) Following Inhalation in Healthy Volunteers

Susanne Prothon, Magnus Aurivillius, Ulrika Tehler, Ulf G. Eriksson, Ajay Aggarwal, Yingxue Chen

Summary: The study provides initial clinical evaluation of inhaled Velsecorat (AZD7594) for the treatment of asthma. The drug was found to be well tolerated with proportional plasma exposure to the dose and dose-dependent effects on markers of glucocorticoid activity.

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Efficacy and Safety Exposure-Response Analysis of Loncastuximab Tesirine in Patients with B cell non-Hodgkin Lymphoma

Brian Hess, William Townsend, Weiyun Ai, Anastasios Stathis, Melhem Solh, Juan Pablo Alderuccio, David Ungar, Sam Liao, Lori Liao, Lisa Khouri, Xiaoyan Zhang, Joseph Boni

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Dosimetry, Efficacy, Safety, and Cost-Effectiveness of Proton Therapy for Non-Small Cell Lung Cancer

Bin Qiu, Yu Men, Junjie Wang, Zhouguang Hui

Summary: Non-small cell lung cancer (NSCLC) is the most common malignancy requiring radiotherapy (RT) as an important part of its multimodality treatment. The emergence of proton therapy has potentially improved clinical outcomes of NSCLC, especially in terms of dose build-up and drop-off compared to photon therapy. Research on dosimetry, efficacy, safety, and cost-effectiveness of proton therapy for NSCLC is abundant, but comprehensive comparisons between therapies are still lacking.

CANCERS (2021)

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Article Pharmacology & Pharmacy

Evaluation of pharmacokinetics and safety of talazoparib in patients with advanced cancer and varying degrees of hepatic impairment

Cen Guo, Yanke Yu, Jayeta Chakrabarti, Sarina A. Piha-Paul, Rebecca Moroose, Anna Plotka, Haihong Shi, Chandrasekar Durairaj, Diane D. Wang, Zev A. Wainberg

Summary: This study investigated the pharmacokinetics and safety of talazoparib in patients with advanced solid tumors and varying degrees of hepatic function. The results showed that hepatic impairment had no impact on the pharmacokinetics of talazoparib. Therefore, dose modification is not recommended for patients with advanced solid tumors and different levels of hepatic impairment.

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2022)

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Systemic Pharmacokinetics of Oxaliplatin After Intraperitoneal Administration by Electrostatic Pressurized Intraperitoneal Aerosol Chemotherapy (ePIPAC) in Patients with Unresectable Colorectal Peritoneal Metastases in the CRC-PIPAC Trial

Robin J. Lurvink, Rudaba Tajzai, Koen P. Rovers, Emma C. E. Wassenaar, Dirk-Jan A. R. Moes, Giulia Pluimakers, Djamila Boerma, Jacobus W. A. Burger, Simon W. Nienhuijs, Ignace H. J. T. de Hingh, Maarten J. Deenen

Summary: This study investigated the pharmacokinetics of oxaliplatin after ePIPAC in 20 patients with unresectable colorectal peritoneal metastases, showing systemic exposure levels comparable to systemic chemotherapy, with urine concentrations gradually decreasing. Future research could focus on a direct comparison between oxaliplatin systemic exposure after ePIPAC and systemic chemotherapy.

ANNALS OF SURGICAL ONCOLOGY (2021)

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Article Oncology

Pressurized Intraperitoneal Aerosol Chemotherapy (Oxaliplatin) for Unresectable Colorectal Peritoneal Metastases: A Multicenter, Single-Arm, Phase II Trial (CRC-PIPAC)

Koen P. Rovers, Emma C. E. Wassenaar, Robin J. Lurvink, Geert-Jan M. Creemers, Jacobus W. A. Burger, Maartje Los, Clement J. R. Huysentruyt, Gesina van Lijnschoten, Joost Nederend, Max J. Lahaye, Maarten J. Deenen, Marinus J. Wiezer, Simon W. Nienhuijs, Djamila Boerma, Ignace H. J. T. de Hingh

Summary: This study aimed to evaluate the safety and antitumor activity of pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-OX) as a palliative monotherapy for patients with unresectable colorectal peritoneal metastases. The results showed that some major adverse events occurred and minor adverse events were common in these patients, with uncertain clinical relevance of observed biochemical, pathological, and ascites responses.

ANNALS OF SURGICAL ONCOLOGY (2021)

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Letter Oncology

RE: Phase I dose escalation study of oxaliplatin delivered via a laparoscopic approach using pressurized intraperitoneal aerosol chemotherapy (PIPAC) for advanced peritoneal metastases of gastrointestinal tract cancers PIPAC-oxaliplatin for peritoneal metastases of gastrointestinal cancers

Koen P. Rovers, Robin J. Lurvink, Maarten J. Deenen, Ignace H. J. T. de Hingh

EUROPEAN JOURNAL OF CANCER (2021)

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First-line palliative systemic therapy alternated with electrostatic pressurised intraperitoneal aerosol chemotherapy (oxaliplatin) for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, single-arm, phase II study (CRC-PIPAC-II)

Robin J. Lurvink, Paulien Rauwerdink, Koen P. Rovers, Emma C. E. Wassenaar, Maarten J. Deenen, Joost Nederend, Clement J. R. Huysentruyt, Iris van 't Erve, Remond J. A. Fijneman, Erik J. R. J. van der Hoeven, Cornelis A. Seldenrijk, Alexander Constantinides, Onno Kranenburg, Maartje Los, Karin H. Herbschleb, Anna M. J. Thijs, Geert-Jan M. Creemers, Jacobus W. A. Burger, Marinus J. Wiezer, Simon W. Nienhuijs, Djamila Boerma, Ignace H. J. T. de Hingh

Summary: This study aims to evaluate the safety, feasibility, antitumour activity, patient-reported outcomes, costs, and pharmacokinetics of first-line bidirectional therapy in patients with isolated unresectable colorectal peritoneal metastases. The primary outcome is the occurrence of grade >= 3 adverse events, and key secondary outcomes include treatment-related characteristics, tumour response, patient-reported outcomes, systemic pharmacokinetics, costs, progression-free survival, and overall survival.

BMJ OPEN (2021)

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Editorial Material Oncology

Standard-Dose Trifluridine/Tipiracil as Safe Treatment Alternative in Metastatic Colorectal Cancer Patients With DPD Deficiency

Jeroen F. Schouten, Jeroen Willems, Stefan J. W. J. Sanders, Geert-Jan Creemers, Maarten J. Deenen

Summary: Severe toxicity of fluoropyrimidine drugs is associated with DPD deficiency, screening and dose reduction are common strategies, but new treatment options are still needed. Trifluridine/tipiracil, an independent metabolism drug, may offer a new safe treatment paradigm for DPD-deficient metastatic colorectal cancer patients.

CLINICAL COLORECTAL CANCER (2021)

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Meeting Abstract Oncology

Safety and pharmacokinetic analysis of UGT1A1 genotype-guided dosing of irinotecan.

Emma C. Hulshof, Mirjam de With, Femke M. de Man, Geert-Jan Creemers, Birgit A. L. M. Deiman, Jesse J. Swen, Saskia Houterman, Stijn L. W. Koolen, Marjan Laven, Saskia Luelmo, Ron H. N. van Schaik, Henk-jan Guchelaar, Ron H. J. Mathijssen, Hans Gelderblom, Maarten J. Deenen

JOURNAL OF CLINICAL ONCOLOGY (2021)

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Toward predicting CYP2D6-mediated variable drug response from CYP2D6 gene sequencing data

Maaike van der Lee, William G. Allard, Rolf H. A. M. Vossen, Renee F. Baak-Pablo, Roberta Menafra, Birgit A. L. M. Deiman, Maarten J. Deenen, Patrick Neven, Inger Johansson, Stefano Gastaldello, Magnus Ingelman-Sundberg, Henk-Jan Guchelaar, Jesse J. Swen, Seyed Yahya Anvar

Summary: The study introduces a proof-of-concept approach using continuous-scale assignments to predict CYP2D6 enzyme activity, showing potential for more accurate prediction of individual drug response compared to conventional *-allele approach. This model, trained with complete CYP2D6 gene sequences and tamoxifen metabolism data, explained a higher percentage of interindividual variability in enzyme activity and demonstrated advantages in predicting known and novel allele combinations.

SCIENCE TRANSLATIONAL MEDICINE (2021)

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Article Oncology

UGT1A1 genotype-guided dosing of irinotecan: A prospective safety and cost analysis in poor metaboliser patients

Emma C. Hulshof, Mirjam de With, Femke M. de Man, Geert-Jan Creemers, Birgit A. L. M. Deiman, Jesse J. Swen, Saskia Houterman, Stijn L. W. Koolen, Sander Bins, Anna M. J. Thijs, Marjan M. J. Laven, Anke M. Hovels, Saskia A. C. Luelmo, Danny Houtsma, Katerina Shulman, Howard L. McLeod, Ron H. N. van Schaik, Henk-Jan Guchelaar, Ron H. J. Mathijssen, Hans Gelderblom, Maarten J. Deenen

Summary: This study aimed to determine the safety, feasibility, pharmacokinetics, and cost of UGT1A1 genotype-guided dosing of irinotecan. The results showed that UGT1A1 genotype-guided dosing significantly reduces the incidence of febrile neutropenia in UGT1A1 PM patients treated with irinotecan, results in a therapeutically effective systemic drug exposure, and is cost-saving.

EUROPEAN JOURNAL OF CANCER (2022)

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Letter Oncology

Response to letter entitled re: UGT1A1 genotype-guided dosing of irinotecan: A prospective safety and cost analysis in poor metaboliser patients Is it time for everyone treated with irinotecan to be tested for UGT1A1 gene polymorphism?

Emma C. Hulshof, Mirjam de With, Geert-Jan Creemers, Henk-Jan Guchelaar, Ron HJ. Mathijssen, Hans Gelderblom, Maarten J. Deenen

EUROPEAN JOURNAL OF CANCER (2022)

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Article Chemistry, Analytical

Quantification of uracil, dihydrouracil, thymine and dihydrothymine for reliable dihydropyrimidine dehydrogenase (DPD) phenotyping critically depend on blood and plasma storage conditions

Sebastian A. H. van den Wildenberg, Alexander S. Streng, Renske van den Broek, Maarten A. C. Broeren, Maarten J. Deenen, Joost L. J. van Dongen, Maarten A. Hanrath, Chyara Lapre, Luc Brunsveld, Volkher Scharnhorst, Daan van de Kerkhof

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Review Biochemistry & Molecular Biology

Dutch pharmacogenetics working group (DPWG) guideline for the gene-drug interaction between UGT1A1 and irinotecan

Emma C. Hulshof, Maarten J. Deenen, Marga Nijenhuis, Bianca Soree, Nienke J. De Boer-Veger, Anne-Marie Buunk, Elisa J. F. Houwink, Arne Risselada, Gerard A. P. J. M. Rongen, Ron H. N. van Schaik, Daan J. Touw, Jan van der Weide, Roos van Westrhenen, Vera H. M. Deneer, Henk-Jan Guchelaar, Jesse J. Swen

Summary: The Dutch Pharmacogenetics Working Group has developed evidence-based guidelines for the optimal starting dose of the anti-cancer drug irinotecan, based on UGT1A1 gene variants. UGT1A1 genotyping is considered essential prior to initiating irinotecan treatment to decrease the risk of severe toxicity.

EUROPEAN JOURNAL OF HUMAN GENETICS (2023)

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Correction Biochemistry & Molecular Biology

Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene-drug interaction between UGT1A1 and irinotecan (Nov, 10.1038/s41431-022-01243-2, 2022)

Emma C. Hulshof, Maarten J. Deenen, Marga Nijenhuis, Bianca Soree, Nienke J. de Boer-Veger, Anne-Marie Buunk, Elisa J. F. Houwink, Arne Risselada, Gerard A. P. J. M. Rongen, Ron H. N. van Schaik, Daan J. Touw, Jan van der Weide, Roos van Westrhenen, Vera H. M. Deneer, Henk-Jan Guchelaar, Jesse J. Swen

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The Effect of Genotyping on the Number of Pharmacotherapeutic Gene-Drug Interventions in Chronic Kidney Disease Patients

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Summary: Patients with CKD stage 3-5 are commonly on multiple medications. This study investigated the benefits of pharmacogenetic testing in evaluating medication therapy for these patients. Pharmacogenetic profiles were determined for adult CKD patients, and medication surveillance was performed to identify gene-drug interactions. Relevance and necessity of pharmacotherapeutic interventions were assessed, resulting in improved pharmacotherapy for 20 patients.

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Editorial Material Pharmacology & Pharmacy

UGT1A1 genotype-guided dosing of irinotecan: time to prioritize patient safety

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Article Economics

Trends in Drug Costs and Overall Survival in Patients with Metastatic Non-small Cell Lung Cancer in The Netherlands Diagnosed from 2008 Through 2014

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PHARMACOECONOMICS-OPEN (2021)

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Safety, pharmacokinetics (PK), and cost-effectiveness of upfront genotyping of DPYD in fluoropyrimidine therapy

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出版社

AMER SOC CLINICAL ONCOLOGY

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