Introduction The addition of imatinib to the therapeutic arsenal for chronic myeloid leukaemia (CML) has changed the natural course of the disease, in such a way that it is now considered a chronic pathology. However, to achieve therapeutic success, it is necessary to reach adequate plasma concentrations to ensure efficacy and safety. In this study, we aimed to evaluate the plasma concentration of imatinib, analysing its influence on effectiveness and safety in patients with CML. Methods We performed a descriptive, multicentre study in which imatinib plasma levels from patients diagnosed with CML between 2019–2020 were analysed. An optimal therapeutic range of 750–1500 ng/mL was established for the stratification of patients, according to their minimum plasma concentrations measured at steady state (Cssmin). Results A total of 28 patients were included, of whom only 39.3% (n = 11) showed Cssmin within the therapeutic range. 100% of patients with Cssmin >750 ng/mL achieved an optimal molecular response, while only 50% of patients with Cssmin <750 ng/mL achieved an optimal molecular response ( p = 0.0004). The toxicity rate was 36.4% for patients with Cssmin >1500 ng/mL and 5.9% for those with Cssmin <1500 ng/mL ( p = 0.039). Conclusions This study aimed to describe the correlation between the toxicity and effectiveness of imatinib according to its Cssmin in routine clinical practice conditions. Based on our findings, it would be certainly justified to monitor patient plasma concentrations of imatinib on a daily routine basis in our hospitals.

BackgroundAdalimumab and ustekinumab have demonstrated high effectiveness in the treatment of moderate-severe psoriasis in randomised controlled trials. There is, however, limited data available on the comparative effectiveness of ustekinumab and adalimumab in psoriasis patients unsuccessfully treated with a first biologic line with etanercept.PurposeTo evaluate the comparative effectiveness of adalimumab and ustekinumab in patients previously treated with etanercept using PASI 90 score.Material and methodsA single-centre, retrospective, observational, comparative study was carried out from 1 November 2011 to 31 November 2015. Participants were patients with moderate-severe psoriasis that, after unsuccessful etanercept therapy, were treated with adalimumab or ustekinumab. An unblinded revision of each patient’s clinical history was carried out to assess clinical data.The primary analysis compared the percentages of patients in each treatment group who achieved ≥90% improvement from baseline PASI score (PASI 90) at week 12. Secondary endpoints included percentages of patients with PASI 90 at week 96. Statistical analysis was performed with the SPSS 22.0 software.ResultsThirty-four psoriasis patients were included in the study: 15 (44.1%) patients received adalimumab and 19 (55.9%) received ustekinumab as a second-line therapy.The median age in adalimumab and ustekinumab group were 58 (SD 6.7) and 50 years (SD 17.3) (p=0.08).After 12 weeks of study treatment, 68.4% of ustekinumab-treated patients (13/19) achieved a PASI 90 response against 46.6% (7/15) in the adalimumab group (p=0.2). At week 96, more patients had a PASI 90 in the ustekinumab group compared with the adalimumab group, but the difference was not statistically significant (68.4% versus 46.6%; p=0,2).ConclusionPreviously studies have shown that adalimumab and ustekinumab are effective after anti-TNF inhibitors’ therapy.However, to our knowledge, the present study is the first to evaluate the comparative effectiveness measured as PASI 90 of ustekinumab and adalimumab in psoriasis patients that failed with etanercetp.Our results suggests that there is no significant difference in the efficacy of ustekinumab between ustekinumab and adalidumab in the percentage of patients achieving PASI90. Of course, these results need to be evaluated with randomised and prospective clinical trials.References and/or Acknowledgements1. J Dermatolog Treat2015;26(3):217–22.2. J Eur Acad Dermatol Venereol2011;25(9):1037–40.No conflict of interest

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Background and importance Regorafenib (REG) and trifluridine-tipiracil (TAS-102) are used in metastatic colorectal cancer (mCRC) after failure of conventional therapy based on fluorouracil (5-FU) schemes. Aim and objectives To evaluate the efficacy and safety of TAS-102 and regorafenib drugs in patients with mCRC. Material and methods A retrospective single centre study was conducted from January 2010 to August 2020, which included all patients diagnosed with CRBM treated with TAS-102/REG. Clinical and demographic variables were collected, corresponding to age, sex, time of disease follow-up, time of treatment with the drug, previous adjuvant/neoadjuvant, presence of RAS type mutation and number of previous metastatic lines.Efficacy was determined by calculating progression free survival (PFS) applying the Kaplan-Meyer statistic with SPSS V.15. Progression was analysed according to the radiological criteria response evaluation criteria in solid tumours (RECIST V.1.1). The occurrence of grade III/IV adverse effects (AEs) leading to early dose reduction/suspension of treatment was determined. AEs were classified according to the common terminology criteria for adverse effects (CTCAE V.6.0). Results 104 patients were included, 57.7% (n=60) treated with REG (66.3%, n=69); mean age was 63.9 years (41-83)). Mean follow-up time of the disease was 3.9 years (0.1-15.5). Mean duration of treatment was 3.9 months for TAS-102 and 4.2 for REG. 46% (n=48) of patients received adjuvant therapy and 16.3% (n=17) neoadjuvant. 48.1% presented RAS mutation (n=50). Mean of previous metastatic lines was 2.4 (1-7). 84% (n=37) of patients progressed with TAS-102 versus 72% (n=43) with REG. 11.5% (n=12) discontinued treatment due to toxicity. Median PFS was the same for both: 3.8 months (p=0.86). A reduction in drug doses due to the appearance of AEs was carried out in 25% of cases (n=11) with TAS-102 versus 61.7% with REG (n=37). The most common grade III/IV AEs with TAS-102 were haematological toxicity (20.5%, n=9), gastrointestinal (2.3%, n=1) and other (2.3%, n=1); for REG, gastrointestinal (16.7%, n=10), asthenia (13.3%, n=8), skin toxicity (11.7%, n=7), mucositis (6.7%, n=4), plaquetopenia (3.3%, n=2) and other (13.3%, n=8). Conclusion and relevanceThe study showed that there were no significant differences between PFS values between TAS-102 and REG. However, treatment with REG was tolerated worse, with AEs in more than 60% of cases compared with 25% with TAS-102.