Capecitabine and bevacizumab for non-resectable metastatic colorectal cancer patients: final results from phase II AIO KRK 0105 trial
- Equal contributors
1 University Medical Center, Hamburg-Eppendorf, Hamburg, Germany
2 Krankenhaus St Georg, Leipzig, Germany
3 Augusta-Kranken-Anstalt, Bochum, Germany
4 Praxis Lerchenfeld, Hamburg, Germany
5 Praxis, Nürnberg, Germany
6 Onkologische Schwerpunktpraxis Eppendorf, Hamburg, Germany
7 University of Magdeburg, Universitätsplatz 2, 39106 Magdeburg, Germany
8 Evangelisches Diakonie-Krankenhaus gGmbH, Bremen, Germany
9 Praxis Oskar Helene Heim, Berlin, Germany
10 Tumor Biology Center Freiburg, Breisacher Str. 117, 79106 Freiburg, Germany
BMC Cancer 2013, 13:454 doi:10.1186/1471-2407-13-454Published: 4 October 2013
Current guidelines recommend treatment with capecitabine and bevacizumab for patients (pts) with non-resectable metastatic colorectal cancer (mCRC), although clinical data in this particular patient group are lacking.
Previously untreated patients with non-resectable mCRC were to receive capecitabine (1,250 mg/sqm bid d1-14 oral) and bevacizumab (7.5 mg/kg i.v.) every 3 weeks. Progression-free survival (PFS) was the primary endpoint. Secondary endpoints include overall survival (OS), objective response rate (ORR) and toxicity.
82 pts were included: 40 female, median age 70 (range 50–86). ECOG PS 0/1/2 was 38/52/10%, respectively. Synchronous metastases were present in 58 pts. 16 pts had primary tumor in situ. Median treatment duration was 4.1 months (6 cycles). Toxicity was generally mild. ORR was 38%, with 5 complete and 23 partial responses. Median PFS was 7.0 months [95% CI (5.0-9.1)] and OS 17.9 months [95% CI (14.6-21.6)]. Second- and third-line systemic therapy was given to 57% and 33% of pts, respectively.
Besides the favourable tolerability, PFS and OS were shorter than reported by other trials. Careful patient selection for upfront capecitabine and bevacizumab is essential.