International journal of clinical pharmacology and therapeutics (INT J CLIN PHARM TH)

Publisher: Dustri-Verlag

Journal description

The International Journal of Clinical Pharmacology and Therapeutics appears monthly and publishes manuscripts containing original material with emphasis on the following topics: Clinical trials, Pharmacoepidemiology - Pharmacovigilance, Pharmacodynamics, Drug disposition and Pharmacokinetics, Quality assurance, Pharmacogenetics, Biotechnological drugs such as cytokines and recombinant antibiotics. Case reports on adverse reactions are also of interest.

Current impact factor: 1.22

Impact Factor Rankings

2015 Impact Factor Available summer 2016
2014 Impact Factor 1.223
2013 Impact Factor 1.044
2012 Impact Factor 1.2
2011 Impact Factor 1.183
2010 Impact Factor 1.189
2009 Impact Factor 1.381
2008 Impact Factor 1.299
2007 Impact Factor 1.281
2006 Impact Factor 1.361
2005 Impact Factor 1.755
2004 Impact Factor 1.414
2003 Impact Factor 0.923
2002 Impact Factor 1.471
2001 Impact Factor 1.351
2000 Impact Factor 1.222
1999 Impact Factor 0.871
1998 Impact Factor 0.77
1997 Impact Factor 0.519
1996 Impact Factor 0.828
1995 Impact Factor 0.607
1994 Impact Factor 0.424
1993 Impact Factor 0.37
1992 Impact Factor 0.756

Impact factor over time

Impact factor

Additional details

5-year impact 1.17
Cited half-life 8.00
Immediacy index 0.24
Eigenfactor 0.00
Article influence 0.31
Website International Journal of Clinical Pharmacology & Therapeutics website
Other titles International journal of clinical pharmacology and therapeutics, Clinical pharmacology and therapeutics
ISSN 0946-1965
OCLC 29934177
Material type Periodical
Document type Journal / Magazine / Newspaper

Publisher details


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Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Purpose: To report a case of warfarin-response enhancement during administration of ifosfamide and etoposide chemotherapy. Case summary: A 15-yearold boy with rhabdomyosarcoma was treated with a regimen of alternating cycles of vincristine, doxorubicin, and cyclophosphamide (VDC) chemotherapy and ifosfamide and etoposide (IE) chemotherapy. During VDC chemotherapy, occlusion of the left middle cerebral artery occurred, and warfarin was started. On day 3 of IE chemotherapy, the patient's international normalized ratio (INR) transiently increased from baseline 2.61 to 5.45. The INR returned to normal within 3 days after warfarin discontinuation. An increase in INR was observed between days 1 and 3 of subsequent cycles of IE chemotherapy but not during VDC chemotherapy. This INR increase was also observed during concomitant use of aprepitant, an inducer of the CYP2C9. Discussion: There are no reports describing the interaction between warfarin and IE chemotherapy because coadministration of warfarin and IE chemotherapy is unusual. The Drug Interaction Probability Scale score of this interaction was 7, and it is probable that the enhancement of the warfarin response was caused by an interaction with IE chemotherapy. Moreover, in the present case, the enhancement of warfarin response was observed during concomitant use of aprepitant, which has been reported to weaken the warfarin response. Therefore, this interaction may be quite powerful and may increase the risk of warfarin toxicity. Conclusion: A patient who was administered both warfarin and IE chemotherapy experienced a rapid increase in INR, suggesting that INR should be closely monitored in patients receiving warfarin with IE chemotherapy.
    International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CP202426
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    ABSTRACT: Objective: This study investigated endogenous factors that may increase the elimination of vancomycin (VCM) in adult methicillin-resistant Staphylococcus aureus (MRSA) patients with pneumonia. Methods: 48 patients (32 men and 16 women) admitted to the National Hospital Organization Kumamoto Medical Center for pneumonia due to MRSA were evaluated. VCM (500 - 2,000 mg/dose) was administered intravenously for 60 - 120 min at 8- - 12-h intervals. The dose of VCM prescribed was determined based on the treatment guidelines of the Infectious Diseases Society of America and was dependent on a patient's creatinine clearance. Results: Univariate analysis identified that potassium value (K) (p = 0.081) and urinary pH (p = 0.026) were possibly associated with decreased VCM concentration. Multivariate analysis confirmed that urinary pH was an independent risk factor for VCM clearance (p = 0.029). VCM clearance in patients with a urine pH of 8 was significantly higher (p = 0.032) than in patients with a urinary pH of 5. As urinary pH increased in alkalinity, a greater decrease in VCM concentrations was observed. Conclusions: Elevation of urinary pH promotes the urinary excretion of VCM, likely by promoting the dissociation of the carboxyl group of VCM. Thus, in the clinical setting, urinary pH should be measured and considered when determining dosage, as it may affect the VCM blood concentration.
    International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CP202300

  • International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CP202393
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    ABSTRACT: Objective: Amlodipine, a long-acting dihydropyridine calcium channel blocker, is frequently prescribed to pediatric patients. To date, no suitable pediatric formulation has been available. In this study, an amlodipine oral solution was developed and tested for bioequivalence to tablets in healthy adult volunteers. Methods: This study was designed as an open-label, single-dose, twosequence, two-period, crossover trial to assess the bioequivalence of a newly developed amlodipine besylate oral solution 0.5 mg/mL compared to Norvasc® 5 mg tablets. 13 adult subjects (mean [standard deviation] age of 23.2 [3.6] years, weight 71.5 [7.7] kg) were included and blood samples were collected for 72 hours. Amlodipine plasma levels were determined using a validated UPLC-MS/MS assay. Non-compartmental pharmacokinetic parameters were compared between the formulations according to European Medicines Agency (EMA) bioequivalence guidelines. Results: The 90% confidence intervals of the test/reference ratios of the geometric means for the primary pharmacokinetic parameters AUC0-72 (88.24 - 104.37%) and Cmax (99.00 - 121.40%) were within the acceptance range of 80.00 - 125.00% for bioequivalence. Mean (SD) AUC0-72 was 102.7 (26.8) μg×h/L for the solution and 108.2 (30.6) μg×h/L for the tablet. Mean (SD) Cmax of the solution was 3.11(1.06) μg/L with a median (IQR) tmax of 4.0 (2.6 - 7.5) hours. Mean (SD) Cmax of the tablet was 2.91 (0.84) μg/L with a median (IQR) tmax of 6.0 (4.0 - 14.0) hours. Intrasubject coefficients of variation were 10.2% (AUC0-72) and 12.4% (Cmax). Conclusions: The formulations are bioequivalent according to EMA guidelines. This warrants further study of our novel amlodipine oral solution in pediatric patients.
    International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CP202449

  • International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CPCES14EA11

  • International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CPXCES14EA08

  • International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CPXCES14EA02
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    ABSTRACT: A 40-year-old Korean man developed hemorrhagic fever in Xi'an, which is one of the main endemic areas for this illness in China. According to the local epidemiological situation, his condition could have been due to hantavirus infection, but this was not confirmed. He presented with the typical symptoms of hemorrhagic fever and rapidly progressed to a severe multisystem illness. The clinical situation deteriorated rapidly after admission, and he became coinfected with methicillin-resistant Staphylococcus aureus, Acinetobacter baumannii, aspergillus, and mucor. The patient was successfully treated with appropriate fluid infusion, hemodynamic support, continuous renal replacement therapy, liver protectants, and antibacterials. This case indicates that the choice of antimicrobials and the required dose are crucial issues, and that the vaccination campaign for hemorrhagic fever in Xi'an needs greater attention.
    International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CP202395

  • International journal of clinical pharmacology and therapeutics 11/2015; DOI:10.5414/CPCES14EA10
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    ABSTRACT: Objective: Mepolizumab is a humanized IgG1 monoclonal antibody that blocks human IL-5 from binding to the IL-5 receptor, which is mainly expressed on eosinophils. Eosinophils are key cells in the inflammatory cascade of various diseases, including asthma. This study investigated the pharmacokinetic (PK)/pharmacodynamic (PD) relationship between exposure of mepolizumab subcutaneous (SC) administration and blood eosinophil reduction compared with intravenous (IV) administration in adult subjects with asthma. Methods: In this multi-center, randomized, open-label, parallel-group, repeat-dose study, 70 adult subjects received one of four possible treatment regimens: mepolizumab 12.5, 125, or 250 mg SC or 75 mg IV. In addition to analyzing the dose and PK/PD relationship, absolute bioavailability, safety, tolerability, and incidence of anti-mepolizumab antibodies were evaluated. Results: Blood eosinophil levels decreased in a dose-dependent manner with the lowest (12.5 mg) dose clearly differentiating from the other doses. A non-linear inhibition Imax model based on blood eosinophi levels at week 12 identified that the SC doses providing 50% and 90% of maximal blood eosinophil inhibition were 11 mg (95% confidence interval (CI): 5.19 - 16.85) and 99 mg (95% CI: 47 - 152), respectively. The route of administration did not affect the exposure-response relationship. The estimated mepolizumab SC absolute bioavailability (arm) was 74% (90% CI: 54 - 102%). The safety profile of mepolizumab was favorable. Conclusions: A dose-dependent reduction in blood eosinophils across all mepolizumab doses investigated was observed. The subcutaneous absolute bioavailability was 74%. The route of administration did not affect the mepolizumab exposure eosinophil response relationship.
    International journal of clinical pharmacology and therapeutics 10/2015; DOI:10.5414/CP202446
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    ABSTRACT: Objective: This randomized, double-blind, active- and placebo-controlled, crossover, thorough QT study assessed the effect of two inhaled loxapine doses on cardiac repolarization as measured by corrected QT (QTc) interval in healthy subjects ( NCT01854710). Methods: Subjects received two doses of inhaled loxapine (10 mg) 2 hours apart + oral placebo, two doses of inhaled placebo + oral placebo, or two doses of inhaled placebo + oral moxifloxacin (400 mg; positive control), with ≥ 3 days washout between treatments. Two-sided 90% confidence intervals (CIs) were calculated around least-squares mean predose placebo-subtracted individually corrected QT durations (ΔΔQTcIs) at 12 time points throughout 24 hours after dosing. A ΔΔQTcI 95% upper CI exceeding 10 msec was the threshold indicating QTc prolongation (primary endpoint). Secondary endpoints included Fridericia- and Bazettcorrected QT duration and QTcI outliers Pharmacokinetics and adverse events (AEs) were also assessed. Results: Of 60 subjects enrolled (mean age, 33.8 years; 52% male), 44 completed the study. Post loxapine dosing, no ΔΔQTcI 95% upper CI exceeded 10 msec; the largest was 6.31 msec 5 minutes post dose 2. Methodology was validated by ΔΔQTcI 95% lower CIs exceeding 5 msec at 9 of 12 time points after moxifloxacin dosing. Loxapine plasma concentrations increased rapidly (mean Cmax, 177 ng/mL; median tmax 2 minutes after dose 2, 2.03 hours after dose 1). There were no deaths, serious AEs, or AEs leading to discontinuation, and one severe AE. Conclusions: Primary and secondary endpoints indicated two therapeutic doses of inhaled loxapine did not cause threshold QTc prolongation in this study.
    International journal of clinical pharmacology and therapeutics 10/2015; 53(11). DOI:10.5414/CP202457
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    ABSTRACT: Objective: The objective was to determine the impact of VKORC1 polymorphisms on warfarin anticoagulant therapy (stable warfarin maintenance dose, time required to reach therapeutic dose and time spent in therapeutic range) and its adverse events (overanticoagulation and bleeding events, time to first overanticoagulation or bleeding event, and therapy for bleeding events) in Croatian patients. Materials: Blood samples were collected from 186 patients on stable warfarin therapy. Methods: VKORC1 1173C>T and VKORC1 -1639G>A gene polymorphisms were analyzed using real-time PCR. Prothrombin time international normalized ratio (INR) values were determined and overanticoagulation as well as bleeding events were recorded. Results: Both tested VKORC1 gene polymorphisms (VKORC1 1173C>T and VKORC1 -1639G>A) were in perfect linkage disequilibrium. Genotype analysis showed that 33.9% of patients were homozygous for wild-type, 46.8% were heterozygous and 19.4% were homozygous for the variant allele. We have found a statistically significant difference between variantallele carriers and wild-type patients in stable warfarin maintenance dose (p < 0.001) and incidence of bleeding events (p = 0.040). Patients homozygous for variant-allele were more likely to experience an overanticoagulation event in the first 30 days of therapy (p = 0.040). Conclusions: Our study showed that VKORC1 1173C>T and VKORC1 -1639G>A gene polymorphisms are associated with stable warfarin maintenance dose and adverse events of warfarin therapy.
    International journal of clinical pharmacology and therapeutics 10/2015; DOI:10.5414/CP202424
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    ABSTRACT: Objective: In January 2011, a biological therapies commission was created in our hospital to fully address the management of biological drugs. A biological therapy prioritization protocol was developed for ankylosing spondylitis (AS) patients. Here, we describe it and report on its economic impact to illustrate how we are optimizing the use of these expensive new drugs. Methods: The biological therapies commission established several procedures for the rational use of biological drugs such as cost-efficiency therapeutic protocols, pharmacovigilance, and therapeutic drug monitoring programs. The AS protocol was based on clinical and economic aspects. We estimated the economic impact of the protocol by comparing the cost of treating AS patients with biological drugs in the pre-commission (2009 - 2010) vs. post-commission period (2011 - 2013). AS patients treated with adalimumab (ADA), etanercept (ETN) or infliximab (IFX) for at least 6 months in the 2009 - 2013 period were included. Results: 107 patients were included. In the pre-commission period, total expenses increased by +30,944 € (+4%). After protocol implementation, total expenses decreased by 11,441 € (-1%) during 2011, and by an additional 36,781 € (-4%) and 53,872 € (-8%) in 2012 and 2013, respectively. In the 2010 - 2013 period the cost of biological therapy per patient-year decreased by 869 €, suggesting the positive effects of the biological therapy prioritization protocol instauration. Conclusion: We describe the establishment of a multidisciplinary biological therapy commission to optimize the use of biological therapies. We illustrate its work in developing a protocol for the management of AS patients with such therapies. We show that after 3-years of implementation, the biological therapy prioritization protocol allowed us to steadily decrease the direct cost of biological drug therapies per patient, up to 869 €.
    International journal of clinical pharmacology and therapeutics 09/2015; DOI:10.5414/CP202410
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    ABSTRACT: Objective: Acute community-acquired pneumonia in Côte d'Ivoire, mainly in the pneumology units, is the second most common cause of hospitalization after tuberculosis. This study aimed to evaluate the compliance of antibiotic therapy during bacterial acute community-acquired pneumonia with international guidelines serving as frame of reference at the University Hospital of Cocody. Materials and methods: We carried out a descriptive retrospective and analytic study on 62 hospitalized patients from December 1, 2008 to November 30, 2010 in the Pneumophtisiology department at the University Hospital of Cocody (Abidjan). The prescription of antibiotics was compared with the recommendations of the 15th consensus conference on anti-infectious therapy by the Société de Pathologie Infectieuse de Langue Française (SPILF) (French Speaking Society of Infectious Pathology) held in 2006. Results: The main antibiotics prescribed were amoxicillin-clavulanic acid (42.27%), netilmicin (34.5%) and ciprofloxacin (6%). The antibiotic therapy diagrams were dominated by an antibiotic bitherapy; the association of amoxicillin-clavulanic acid + netilmicin was observed in 80.64% of the prescriptions. An antibiotic monotherapy was reported in 14.52% of the prescriptions. Apyrexia at 72 hours was obtained with 64% of the patients with nonstop antibiotic treatment, 24% of them presented a lack of apyrexia, and 12% of them died. The lack of apyrexia at 72 hours treatment correlated with concomitant administration of cotrimoxazole with prophylactic doses among HIV positive patients. The level of the compliance with the SPILF recommendations is low (3.6%). Conclusion: Thus, our results convey the necessity to draw up national recommendations because of the specific realities of countries with limited incomes.
    International journal of clinical pharmacology and therapeutics 09/2015; DOI:10.5414/CP202349
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    ABSTRACT: Objective: This study was designed to investigate patient responses to a medication counseling intervention program piloted by the National Health Insurance Service (NHIS), the national health insurer in Korea, to improve medication management in patients with hypertension, hyperlipidemia, or diabetes. Methods and materials: Interventions were conducted from July to September 2013 through direct mailing followed by two telephone-initiated counseling sessions for the medication discontinuation group (< 80% medication possession ratio (MPR) and ≥ 2 months of discontinuation) and the medication over-possession group (≥ 150% MPR). The telephone intervention was applied through two models: model 1 (counseling by NHIS staff only) and model 2 (counseling by NHIS staff with contract-based working pharmacists in community pharmacies). Multivariate logistic regression analysis was performed to identify factors affecting favorable responses of patients to the telephone-initiated intervention. Patient responses to the telephone-initiated intervention were evaluated by a counselor. Results: In all, 891 patients were counseled via telephone. Patient responses to the telephone-initiated intervention were favorable in 57.6%, neutral in 17.4% and not favorable in 24.9% overall. Counseling by NHIS staff together with pharmacists (model 2) produced more favorable responses from patients than counseling by NHIS staff alone (model 1) (OR 2.73, 95% CI 1.97 - 3.77). Conclusion: Our findings of favorable responses to interventions support a personalized approach by the NHIS to improve patient behavior for medication adherence.
    International journal of clinical pharmacology and therapeutics 09/2015; DOI:10.5414/CP202409
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    ABSTRACT: Objective: The application of dexmedetomidine in patient sedation is generally accepted, though its clinical application is limited because of the lack of information detailing the specific properties among diverse populations of patients. The aim of this study was to compare the pharmacokinetic and pharmacodynamic characteristics of dexmedetomidine between elderly and young patients during spinal anesthesia. Methods: 34 subjects (elderly group: n = 15; young group: n = 19) with spinal anesthesia were enrolled in the present study following the inclusion/exclusion criteria detailed below. All subjects received intravenous infusion of dexmedetomidine with a loading dose of 0.5 µg×kg-1 for 10 minutes and a maintenance dose of 0.5 µg×kg-1×h-1 for 50 minutes. Plasma concentrations of dexmedetomidine were detected by the HPLC-MS/MS method and pharmacokinetic parameters were calculated using WinNolin software. Results: There was no significant difference between the elderly and young subjects in major pharmacokinetic parameters. There was a marked gender difference in the Cmax (peak plasma concentration) and tmax (time to reach Cmax) between genders in elderly subjects, though in this cohort the other pharmacokinetic parameters were not significantly different. In the young subjects there were no noteworthy variations between genders in pharmacokinetic parameters. There was no significant difference between the two groups in BISAUC0-t (the area under the bispectral index-time curve from time 0 to t hours), BISmin (the minimum value of the bispectral index after drug delivery), and or tmin-BIS (bispectral index for the minimum value of time). SBP (systolic blood pressure), DBP (diastolic blood pressure), HR (heart rate), and SpO2 (pulse oxygen saturation) developed substantive differences in a time-dependent manner, but there were no statistically significant differences in these four indicators in the time*group at three time points (1 hour, 2 hours, and 3 hours after drug administration); while SBP was significantly different between the groups, this differential declined in a time-dependent manner, and there were no significant attendant differences in the D-value. The observed values and D-values of DBP and HR were similar in the groups, but the observed value and D-value of SpO2 did differ. There were 14 drug-related adverse events in the young group, and 26 drug-related adverse events in the elderly group, a 46% differential. The percentage of patients who requiring intervention during surgery was 68.75% (11/16) in the elderly group and 36.84% (7/19) in the young group, with no significant difference between the two groups once age was factored in (p = 0.06). None of the pharmacodynamic indices, however, correlated with the key pharmacokinetic parameters (Cmax, AUC(0→t), AUC(0→∞)) of dexmedetomidine. Conclusions: The clearance of dexmedetomidine in elderly patients showed a declining trend compared to young patients. Interventions in the elderly group were more frequent than in the young group, and the elderly group showed significant adverse effects. It is suggested that elderly patients who use dexmedetomidine may benefit from a different dose. However, further research with a larger population size is required to confirm these findings.
    International journal of clinical pharmacology and therapeutics 09/2015; DOI:10.5414/CP202443
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    ABSTRACT: Background: Acetyl-L-carnitine (ALC) has demonstrated neuroprotective effects in several experiments and is widely prescribed to reduce cognitive impairment in Alzheimer's disease patients or manage neuropathic symptoms in diabetic patients. Objectives: This study was designed to assess the pharmacokinetic (PK) bioequivalence between a new generic (test) formulation of ALC hydrochloride 590 mg and a branded (reference) formulation of ALC hydrochloride 590 mg in healthy Korean male volunteers. Methods: This was a randomizedsequence, single-dose, two-way crossover study. All subjects randomly received one formulation of the test or reference tablet and the other formulation with a 7-day washout period. Blood samples (7 mL) were collected immediately before dosing, and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours postdose. The plasma concentrations of ALC were analyzed using liquid chromatography tandem mass spectrometry. Tolerability was assessed throughout the study. Results: The PK profiles of both formulations showed similar rends. The mean (± SD) baseline (predose) concentration of ALC was 1.23 ± 0.31 μg/mL and 1.09 ± 0.30 μg/mL for the test and the reference formulations, respectively. The mean Cmax for the test and reference formulations were 1.74 ± 0.43 μg/mL and 1.68 ± 0.48 μg/mL, respectively. The mean AUClast of ALC was 12.96 ± 1.89 μg×h/mL and 12.49 ± 2.44 μg×h/mL for the test and reference formulations, respectively. The geometric mean ratios of test/reference (90% CI) were 1.050 (0.960 - 1.149) for Cmax and 1.048 (1.000 - 1.099) for AUClast. Both formulations were well tolerated in all treatment groups. Conclusion: The test and the reference formulations of ALC were bioequivalent with regard to the PK parameters.
    International journal of clinical pharmacology and therapeutics 09/2015; DOI:10.5414/CP202381
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    ABSTRACT: Background: The shifts to second-line chemotherapy for metastatic breast cancer (MBC) were widely required based on pharmaceutical molecular profiles to reach out precision medicine. The emerging precise treatment of cancer requires the implementation of clarified pharmacogenetic profiles which are capable of elucidating the predictive responses to cancer chemotherapy. Therefore we were interested in the analysis of the roles of single nucleotide polymorphism (SNP) of GSTP1 (glutathione S-transferase pi 1 gene) alleles to identify pharmacological links with predictors of clinical responses and toxicities. Methods: 93 MBC patients receiving thiotepa plus docetaxel chemotherapy were enrolled in this study. Optimized CYP3A5, CYP2B6, and GSTP1 were predominantly selected as candidate genes and their three SNPs (CYP2B6 G516T, CYP3A5 A6986G, and GSTP1 A313G) were genotyped by matrix-assisted laser desorption ionization/time of flight (MALDI-TOF) mass spectrometry. Progression-free survival (PFS), disease control rate, and chemo-related toxicities were recorded. Results: GSTP1 A313G (rs1695) was identified to be related with disease progression. In particular, patients harboring AG/GG genotype demonstrated a statistically longer PFS than those with AA. Multivariate analysis confirmed that AG/GG genotype was associated with both clinical responses and liver-localized metastatic lesions. No correlation was found between these three SNPs and chemotherapy-induced toxicity. Conclusions: These results suggest that the GSTP1 polymorphism is a novel prognostic marker for clinical response to thiotepa-containing chemotherapy regimens. Such evidence could provide insight into the role of pharmacogenetics to deprive of biases in shifting regimens solely by empirical choices.
    International journal of clinical pharmacology and therapeutics 09/2015; DOI:10.5414/CP202391