Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial

Purpose. TAS-102 is a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil. Efficacy and safety of TAS-102 in patients with metastatic colorectal cancer (mCRC) refractory or intolerant to standard therapies were evaluated in the phase 3 RECOURSE trial. Results of RECOURSE demonstrated significant improvement in overall survival (OS) and progression-free survival (PFS) with TAS-102 versus placebo [hazard ratio (HR) = 0.68 and 0.48 for OS and PFS, respectively; both P < 0.001]. The current analysis evaluates efficacy and safety of TAS-102 in the RECOURSE Spanish subgroup. Methods. Primary and key secondary endpoints were evaluated in a post hoc analysis of the RECOURSE Spanish subgroup, using univariate and multivariate analyses. Safety and tolerability were reported with descriptive statistics. Results. The RECOURSE Spanish subgroup included 112 patients (mean age 61 years, 62 % male). Median OS was 6.8 months in the TAS-102 group (n = 80) versus 4.6 months in the placebo group (n = 32) [HR = 0.47; 95 % confidence interval (CI): 0.28-0.78; P = 0.0032). Median PFS was 2.0 months in the TAS-102 group and 1.7 months in the placebo group (HR = 0.47; 95 % CI: 0.30-0.74; P = 0.001). Eighty (100 %) TAS-102 versus 31 (96.9 %) placebo patients had adverse events (AEs). The most common drug-related ≥Grade 3 AE was neutropenia (40 % TAS-102 versus 0 % placebo). There was 1 (1.3 %) case of febrile neutropenia in the TAS-102 group versus none in the placebo group. Conclusions. In the RECOURSE Spanish subgroup, TAS-102 was associated with significantly improved OS and PFS versus placebo, consistent with the overall RECOURSE population. No new safety signals were identified (AU)

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El máximo valor de captación estandarizado en la 18F-FDG PET es independiente de la expresión inmunohistoquímica del factor de crecimiento endotelial derivado de las plaquetas en pacientes con carcinoma de pulmón no microcítico / The maximum standardized uptake value 18F-FDGPET is independent of the immunohistochemical expression of platelet derived endothelia growth factor in patients with non-small cell lung cancer

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Onicolisis con exudado del hiponiquio secundaria a quimioterapia con paclitaxel y capecitabina / Onycholysis with hyponychium exudate secondary to chemotherapy with paclitaxel and capecitabine

Se presenta el caso de una paciente de 39 años que consultó por onicolisis, hiperqueratosis subungueal y presencia de exudado en el primer dedo del pie derecho. Las lesiones aparecieron durante el tratamiento oncológico de un cáncer mamario bilateral con metástasis linfáticas con paclitaxel cada tres semanas y capecitabina diaria. Las manifestaciones clínicas se deben a la afectación del lecho ungueal por la quimioterapia y deben conocerse y ser tenidas en cuenta debido al aumento del uso de este tipo de citotóxicos

A 39-year-old female patient who consulted due to onycholysis, subungual hyperkeratosis and presence of exudate in the big toe of the right foot. The lesions appeared during oncology treatment of bilateral breast cancer with lymphatic metastases with paclitaxel every three weeks and capecitabine daily. Clinical manifestations are due to the involvement of the nail bed caused by the chemotherapy. These should be known and taken into account due to the increased use of this type of cytotoxic agents