Activity of Sorafenib plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer
Lessons Learned
- Treatment for patients with metastatic colorectal cancer (mCRC) typically involves multiple lines of therapy with eventual development of treatment resistance.
- In this single arm, phase II study involving heavily pre‐treated patients, the combination of sorafenib and capecitabine (SorCape) yielded a clinically meaningful progression free survival of 6.2 months with an acceptable toxicity profile.
- This oral doublet therapy is worthy of continued investigation for clinical use in patients with mCRC.
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.
Published at Fri, 29 Jan 2021 12:56:15 +0000