Capecitabine and bevacizumab for non-resectable metastatic colorectal cancer patients: final results from phase II AIO KRK 0105 trial
By: Stein, Alexander, Kretzschmar, Albrecht, Behringer, Dirk, Wolff, Thomas, Zimber, Joachim, Hegewisch-Becker, Susanna, Kettner, Erika, Pflüger, Karl-Heinz, Kirsch, Andreas, Arnold, Dirk

BioMed Central Ltd
2013-10-04; doi: 10.1186/1471-2407-13-454
Abstract

Background

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.

Methods

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.

Results

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.







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