Published in:
01-05-2014 | Clinical Trial Report
Neoadjuvant capecitabine and oxaliplatin (XELOX) combined with bevacizumab for high-risk localized rectal cancer
Authors:
Junichi Hasegawa, Junichi Nishimura, Tsunekazu Mizushima, Yasuhiro Miyake, Ho Min Kim, Hiroyoshi Takemoto, Hroshi Tamagawa, Shingo Noura, Makoto Fujii, Yujiro Fujie, Takeshi Kato, Hideaki Miwa, Ichiro Takemasa, Masataka Ikeda, Hirofumi Yamamoto, Mistugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori
Published in:
Cancer Chemotherapy and Pharmacology
|
Issue 5/2014
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Abstract
Purpose
Chemoradiotherapy followed by total mesorectal excision (TME) is the standard treatment for locally advanced rectal cancer. Although this approach decreases the risk of local recurrence, pelvic radiation is associated with long-term morbidity and delays systemic treatment. We conducted this study to evaluate the feasibility of neoadjuvant capecitabine and oxaliplatin (XELOX) plus bevacizumab as a treatment for high-risk localized rectal cancer.
Methods
Patients with T4 or lymph node-positive rectal cancer were treated with three cycles of XELOX plus bevacizumab and one additional cycle of XELOX. This was followed by TME performed 3–8 weeks after the last chemotherapy session.
Results
Twenty-five patients were recruited between December 2009 and November 2011. In seven of the patients (28.0 %), grade 3–4 adverse events occurred. After preoperative chemotherapy, the frequency of tumor (T) downstaging was 69.6 %, and that of lymph node (N) downstaging was 78.9 %. Seven patients discontinued the treatment after 2–3 cycles of XELOX plus bevacizumab. The frequency of subsequent surgery was 92 %, and all patients underwent R0 resections. Postoperative complications occurred in six patients (26.1 %). One patient achieved a pathological complete response (pCR) for the primary tumor and lymph nodes, whereas an additional four patients achieved near-pCR. After a median follow-up of 31 months, five patients displayed metastatic progression, including one who suffered local recurrence.
Conclusions
XELOX plus bevacizumab followed by TME is feasible for high-risk localized rectal cancer, as it achieves good tumor regression and causes manageable toxicity.