Activity of Sorafenib plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer
Mené sur 42 patients atteints d'un cancer colorectal de stade métastatique, cet essai de phase II évalue l'efficacité, du point de vue de la survie sans progression, et la toxicité d'un traitement combinant sorafénib et capécitabine après l'échec de plusieurs lignes thérapeutiques
Background : Capecitabine (Cape) is an oral prodrug of the antimetabolite 5‐fluorouracil (5‐FU). Sorafenib (Sor) inhibits multiple signaling pathways involved in angiogenesis and tumor proliferation. SorCape has been previously studied in metastatic breast cancer. Methods : This single‐arm, phase II study was designed to evaluate the activity of SorCape in refractory mCRC. Patients received Sor (200 mg PO BID max daily) and Cape (1,000 mg/m2 PO BID on days 1‐14) on a 21 day treatment cycle. Primary endpoint was progression free survival (PFS) with pre‐planned comparison to historical controls. Results : Forty‐two patients were treated for a median number of 3.5 cycles (range 1–39). Median PFS was 6.2 (95% CI: 4.3–7.9) months and overall survival (OS) was 8.8 (95% CI: 4.3–12.2) months. One patient (2.4%) had partial response (PR), and 22 patients (52.4%) had stable disease (SD) for a clinical benefit rate of 54.8% (95% CI: 38.7–70.2%). Hand‐foot syndrome was the most common adverse event seen in 36 patients (85.7%) and was grade ≥3 in 16 patients (38.1%). One patient (2.4%) had a grade 4 sepsis, and one patient (2.4%) died while on treatment. Conclusion : SorCape in this heavily pre‐treated population yielded a reasonable PFS with manageable, but notable toxicity. The combination should be investigated further.
The Oncologist 2021