Regorafenib: Effectiveness and safety in the treatment of metastatic colorectal cancer

• Autores: Julia Sánchez Gundín, L. Martínez Valdivieso, Lidia Recuero Galve, Marta Llorente Serrano, Gema Marcos Pérez, Dolores Barreda Hernández
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 19, Nº. 1, 2017, págs. 7-15
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Introduction: To evaluate effectiveness, safety and cost of regorafenib in the treatment of metastatic colorectal cancer (mCRC).

    Method: Observational, descriptive, retrospective study (June 2013-June 2016) in patients with mCRC treated with regorafenib.

    Data recorded: sex, age, primary site of disease, KRAS mutational status, Performance Status (PS), stage at diagnosis and at regorafenib beginning, metastases number and localization at diagnosis and at regorafenib beginning, history of chemotherapies and administration doses.

    To evaluate:

    1) Effectiveness: Overall Survival (OS) and Progression-Free Survival (PFS), according to RECIST.

    2) Safety: severity of Adverse Events (AE), according to CTCAEv4.0.

    Results: 23 patients were reviewed (61% males), median age: 66 years (range: 50-90). The primary site of disease was colon (61%) and wild-type KRAS was reported in 30% of patients. PS was 0-2 in all cases with the exception of two patients (PS 3).

    All patients presented stage IV at regorafenib beginning (65% presented it at diagnosis).

    Median of metastases at diagnosis: 1 (range: 0-2), mainly hepatic (39%) and median of metastases at regorafenib beginning: 2 (range: 1-3) mainly pulmonary (83%). Two previous lines of treatment for mCRC were performed in 48% of patients, three in 22% and more than three in 30%. Principal prior chemotherapy for wild-type KRAS: FOLFIRI + bevacizumab (86%) and for mutated KRAS: FOLFOX + bevacizumab (35%).

    39% of patients suffered a reduced-dose administration of regorafenib in the initial cycle of the therapy because of a PS ≥2. Mean daily dose: 123 mg ±37 mg.

    Effectiveness: OS was six months (range: 1-29) and PFS three months (range: 1-17). At the time of data cut-off, one patient was still receiving regorafenib, 70% had died and 30% remained alive.

    Safety: 35% of patients required dose-modifications because of AE: hand-foot skin reaction (26%), diarrhea (9%), stomatitis (9%), thrombocytopenia and neutropenia (9%), asthenia (9%) and increase in transaminases (4%). 87% of patients experienced any AE: hand-foot skin reaction (52%), diarrhea (39%) and asthenia (35%).

    Discussion: Regorafenib seems to be a pharmacological alternative in patients with mCRC in whom standard treatments have failed. The AE reported in this study are consistent with the known safety profile of regorafenib in other clinical studies. Therefore, and because of its high cost, it would be necessary a patient selection in order to have benefit with the minimum AE.