Recommendations regarding transversal topics applicable to bladder cancer patients independent of tumor grade and stage were established by members of the Spanish Oncology Genitourinary Multidisciplinary Working Group (SOGUG). Liquid biopsy in urine and blood samples is useful in the surveillance of non-muscle-invasive and muscle-invasive bladder cancer, respectively. Multiparametric MRI is an accurate, faster and non-invasive staging method overcoming the understaging risk of other procedures. The combination of FDG-PET/MRI could improve diagnostic reliability, but definite criteria for imaging interpretation are still unclear. Hospital oncology pharmacists as members of tumor committees improve the safety of drug use. Additionally, safety recommendations during BCG preparation should be strictly followed. The initial evaluation of patients with bladder cancer should include a multidimensional geriatric assessment. Orthotopic neobladder reconstruction should be offered to motivated patients with full information of self-care requirements. Bladder-sparing protocols, including chemoradiation therapy and immune checkpoints inhibitors (ICIs), should be implemented in centers with well-coordinated multidisciplinary teams and offered to selected patients. The optimal strategy of treatment with ICIs should be defined from the initial diagnostic phase with indications based on scientific evidence. Centralized protocols combined with the experience of professional groups are needed for the integral care of bladder cancer patients.
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 relevance The 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.
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