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Int J Radiat Oncol Biol Phys. 2014 Feb 1;88(2):301-5. doi: 10.1016/j.ijrobp.2013.10.034. Epub 2013 Dec 5.

Preoperative radiation therapy with concurrent capecitabine, bevacizumab, and erlotinib for rectal cancer: a phase 1 trial.

Author information

1
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address: PrajDas@mdanderson.org.
2
Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
3
Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
4
Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
5
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
6
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Abstract

PURPOSE:

The goal of this phase 1 trial was to determine the maximum tolerated dose (MTD) of concurrent capecitabine, bevacizumab, and erlotinib with preoperative radiation therapy for rectal cancer.

METHODS AND MATERIALS:

Patients with clinical stage II to III rectal adenocarcinoma, within 12 cm from the anal verge, were treated in 4 escalating dose levels, using the continual reassessment method. Patients received preoperative radiation therapy with concurrent bevacizumab (5 mg/kg intravenously every 2 weeks), erlotinib, and capecitabine. Capecitabine dose was increased from 650 mg/m(2) to 825 mg/m(2) orally twice daily on the days of radiation therapy; erlotinib dose was increased from 50 mg orally daily in weeks 1 to 3, to 50 mg daily in weeks 1 to 6, to 100 mg daily in weeks 1 to 6. Patients underwent surgery at least 9 weeks after the last dose of bevacizumab.

RESULTS:

A total of 19 patients were enrolled, and 18 patients were considered evaluable. No patient had grade 4 acute toxicity, and 1 patient had grade 3 acute toxicity (hypertension). The MTD was not reached. All 18 evaluable patients underwent surgery, with low anterior resection in 7 (39%), proctectomy with coloanal anastomosis in 4 patients (22%), posterior pelvic exenteration in 1 (6%), and abdominoperineal resection in 6 (33%). Of the 18 patients, 8 (44%) had pathologic complete response, and 1 had complete response of the primary tumor with positive nodes. Three patients (17%) had grade 3 postoperative complications (ileus, small bowel obstruction, and infection). With a median follow-up of 34 months, 1 patient developed distant metastasis, and no patient had local recurrence or died. The 3-year disease-free survival was 94%.

CONCLUSIONS:

The combination of preoperative radiation therapy with concurrent capecitabine, bevacizumab, and erlotinib was well tolerated. The pathologic complete response rate appears promising and may warrant further investigation.

PMID:
24315563
DOI:
10.1016/j.ijrobp.2013.10.034
[Indexed for MEDLINE]
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