Oncology Medical News about rectal cancer;neoadjuvant Bevacizumab;radiation therapy;Fluorouracil

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Efficacy, safety, and biomarkers of neoadjuvant bevacizumab, radiation therapy, and fluorouracil in rectal cancer: A multidisciplinary phase II study
Journal of Clinical Oncology, 06/22/09

Willett CG et al. – Phase I/II study reports that bevacizumab with chemoradiotherapy appears safe and active and yields promising survival results in locally advanced rectal cancer. Plasma VEGF, PlGF, sVEGFR1, and IL-6 and CECs should be further evaluated as candidate biomarkers of response for this regimen.

Methods

Aim was to assess in locally advanced rectal cancer:
- Safety and efficacy of neoadjuvant bevacizumab with standard chemoradiotherapy and
- Explore biomarkers for response
32 pts received 4 cycles of therapy consisting of:
1. Bevacizumab infusion (5 or 10 mg/kg) on day 1 of each cycle
2. Fluorouracil infusion (225 mg/m2/24 hours) during cycles 2 to 4
3. External-beam irradiation (50.4 Gy in 28 fractions over 5.5 weeks); and
4. Surgery 7 to 10 weeks after completion of all therapies
Molecular, cellular, and physiologic biomarkers were measured before treatment, during bevacizumab monotherapy, and during and after combination therapy

Results

Tumors regressed from a mass with mean size of 5 cm to an ulcer/scar with mean size of 2.4 cm in all 32 pts
Histologic examination revealed either no cancer or varying numbers of scattered cancer cells in a bed of fibrosis at the primary site
This treatment resulted in an actuarial 5-yr local control and overall survival of 100%
Actuarial 5-yr DFS was 75% and 5 pts developed metastases postsurgery
Bevacizumab with chemoradiotherapy showed acceptable toxicity
Bevacizumab decreased tumor interstitial fluid pressure and blood flow
Baseline plasma sVEGFR1, VEGF, PlGF, and IL-6 during treatment, and circulating endothelial cells (CECs) after treatment showed correlations with outcome

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