Efficacy, Safety, and Biomarkers of Neoadjuvant Bevacizumab, Radiation Therapy, and Fluorouracil in Rectal Cancer: A Multidisciplinary Phase II Study
To assess the safety and efficacy of neoadjuvant bevacizumab with standard chemoradiotherapy in locally advanced rectal cancer and explore biomarkers for response. In a phase I/II study, 32 patients received four cycles of therapy consisting of: bevacizumab infusion (5 or 10 mg/kg) on day 1 of each...
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| Published in | Journal of clinical oncology Vol. 27; no. 18; pp. 3020 - 3026 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Alexandria, VA
American Society of Clinical Oncology
20.06.2009
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| Subjects | |
| Online Access | Get full text |
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| Abstract | To assess the safety and efficacy of neoadjuvant bevacizumab with standard chemoradiotherapy in locally advanced rectal cancer and explore biomarkers for response.
In a phase I/II study, 32 patients received four cycles of therapy consisting of: bevacizumab infusion (5 or 10 mg/kg) on day 1 of each cycle; fluorouracil infusion (225 mg/m(2)/24 hours) during cycles 2 to 4; external-beam irradiation (50.4 Gy in 28 fractions over 5.5 weeks); and surgery 7 to 10 weeks after completion of all therapies. We measured molecular, cellular, and physiologic biomarkers before treatment, during bevacizumab monotherapy, and during and after combination therapy.
Tumors regressed from a mass with mean size of 5 cm (range, 3 to 12 cm) to an ulcer/scar with mean size of 2.4 cm (range, 0.7 to 6.0 cm) in all 32 patients. 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-year local control and overall survival of 100%. Actuarial 5-year disease-free survival was 75% and five patients developed metastases postsurgery. Bevacizumab with chemoradiotherapy showed acceptable toxicity. Bevacizumab decreased tumor interstitial fluid pressure and blood flow. Baseline plasma soluble vascular endothelial growth factor receptor 1 (sVEGFR1), plasma vascular endothelial growth factor (VEGF), placental-derived growth factor (PlGF), and interleukin 6 (IL-6) during treatment, and circulating endothelial cells (CECs) after treatment showed significant correlations with outcome.
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. |
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| AbstractList | To assess the safety and efficacy of neoadjuvant bevacizumab with standard chemoradiotherapy in locally advanced rectal cancer and explore biomarkers for response.
In a phase I/II study, 32 patients received four cycles of therapy consisting of: bevacizumab infusion (5 or 10 mg/kg) on day 1 of each cycle; fluorouracil infusion (225 mg/m(2)/24 hours) during cycles 2 to 4; external-beam irradiation (50.4 Gy in 28 fractions over 5.5 weeks); and surgery 7 to 10 weeks after completion of all therapies. We measured molecular, cellular, and physiologic biomarkers before treatment, during bevacizumab monotherapy, and during and after combination therapy.
Tumors regressed from a mass with mean size of 5 cm (range, 3 to 12 cm) to an ulcer/scar with mean size of 2.4 cm (range, 0.7 to 6.0 cm) in all 32 patients. 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-year local control and overall survival of 100%. Actuarial 5-year disease-free survival was 75% and five patients developed metastases postsurgery. Bevacizumab with chemoradiotherapy showed acceptable toxicity. Bevacizumab decreased tumor interstitial fluid pressure and blood flow. Baseline plasma soluble vascular endothelial growth factor receptor 1 (sVEGFR1), plasma vascular endothelial growth factor (VEGF), placental-derived growth factor (PlGF), and interleukin 6 (IL-6) during treatment, and circulating endothelial cells (CECs) after treatment showed significant correlations with outcome.
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. To assess the safety and efficacy of neoadjuvant bevacizumab with standard chemoradiotherapy in locally advanced rectal cancer and explore biomarkers for response.PURPOSETo assess the safety and efficacy of neoadjuvant bevacizumab with standard chemoradiotherapy in locally advanced rectal cancer and explore biomarkers for response.In a phase I/II study, 32 patients received four cycles of therapy consisting of: bevacizumab infusion (5 or 10 mg/kg) on day 1 of each cycle; fluorouracil infusion (225 mg/m(2)/24 hours) during cycles 2 to 4; external-beam irradiation (50.4 Gy in 28 fractions over 5.5 weeks); and surgery 7 to 10 weeks after completion of all therapies. We measured molecular, cellular, and physiologic biomarkers before treatment, during bevacizumab monotherapy, and during and after combination therapy.PATIENTS AND METHODSIn a phase I/II study, 32 patients received four cycles of therapy consisting of: bevacizumab infusion (5 or 10 mg/kg) on day 1 of each cycle; fluorouracil infusion (225 mg/m(2)/24 hours) during cycles 2 to 4; external-beam irradiation (50.4 Gy in 28 fractions over 5.5 weeks); and surgery 7 to 10 weeks after completion of all therapies. We measured molecular, cellular, and physiologic biomarkers before treatment, during bevacizumab monotherapy, and during and after combination therapy.Tumors regressed from a mass with mean size of 5 cm (range, 3 to 12 cm) to an ulcer/scar with mean size of 2.4 cm (range, 0.7 to 6.0 cm) in all 32 patients. 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-year local control and overall survival of 100%. Actuarial 5-year disease-free survival was 75% and five patients developed metastases postsurgery. Bevacizumab with chemoradiotherapy showed acceptable toxicity. Bevacizumab decreased tumor interstitial fluid pressure and blood flow. Baseline plasma soluble vascular endothelial growth factor receptor 1 (sVEGFR1), plasma vascular endothelial growth factor (VEGF), placental-derived growth factor (PlGF), and interleukin 6 (IL-6) during treatment, and circulating endothelial cells (CECs) after treatment showed significant correlations with outcome.RESULTSTumors regressed from a mass with mean size of 5 cm (range, 3 to 12 cm) to an ulcer/scar with mean size of 2.4 cm (range, 0.7 to 6.0 cm) in all 32 patients. 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-year local control and overall survival of 100%. Actuarial 5-year disease-free survival was 75% and five patients developed metastases postsurgery. Bevacizumab with chemoradiotherapy showed acceptable toxicity. Bevacizumab decreased tumor interstitial fluid pressure and blood flow. Baseline plasma soluble vascular endothelial growth factor receptor 1 (sVEGFR1), plasma vascular endothelial growth factor (VEGF), placental-derived growth factor (PlGF), and interleukin 6 (IL-6) during treatment, and circulating endothelial cells (CECs) after treatment showed significant correlations with outcome.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.CONCLUSIONBevacizumab 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. |
| Author | Johanna Lahdenranta Rakesh K. Jain Dan G. Duda Helen X. Chen Yves Boucher Erik Paulson Zeljko Vujaskovic Marek Ancukiewicz Dushyant V. Sahani Brian G. Czito Christopher G. Willett Rex Bentley Terence Z. Wong Paul Shellito Emmanuelle di Tomaso Martin Poleski Jeffrey W. Clark Gregory Y. Lauwers Alan J. Fischman Daniel C. Chung |
| Author_xml | – sequence: 1 givenname: Christopher G. surname: Willett fullname: Willett, Christopher G. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 2 givenname: Dan G. surname: Duda fullname: Duda, Dan G. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 3 givenname: Emmanuelle surname: di Tomaso fullname: di Tomaso, Emmanuelle organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 4 givenname: Yves surname: Boucher fullname: Boucher, Yves organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 5 givenname: Marek surname: Ancukiewicz fullname: Ancukiewicz, Marek organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 6 givenname: Dushyant V. surname: Sahani fullname: Sahani, Dushyant V. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 7 givenname: Johanna surname: Lahdenranta fullname: Lahdenranta, Johanna organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 8 givenname: Daniel C. surname: Chung fullname: Chung, Daniel C. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 9 givenname: Alan J. surname: Fischman fullname: Fischman, Alan J. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 10 givenname: Gregory Y. surname: Lauwers fullname: Lauwers, Gregory Y. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 11 givenname: Paul surname: Shellito fullname: Shellito, Paul organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 12 givenname: Brian G. surname: Czito fullname: Czito, Brian G. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 13 givenname: Terence Z. surname: Wong fullname: Wong, Terence Z. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 14 givenname: Erik surname: Paulson fullname: Paulson, Erik organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 15 givenname: Martin surname: Poleski fullname: Poleski, Martin organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 16 givenname: Zeljko surname: Vujaskovic fullname: Vujaskovic, Zeljko organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 17 givenname: Rex surname: Bentley fullname: Bentley, Rex organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 18 givenname: Helen X. surname: Chen fullname: Chen, Helen X. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 19 givenname: Jeffrey W. surname: Clark fullname: Clark, Jeffrey W. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD – sequence: 20 givenname: Rakesh K. surname: Jain fullname: Jain, Rakesh K. organization: From the Departments of Radiation Oncology, Radiology, Surgery, Medicine, and Pathology, Duke University Medical Center, Durham, NC; Departments of Radiation Oncology, Radiology, Nuclear Medicine, Pathology, Hematology/Oncology, Surgery, and the Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston, MA; and the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=21667926$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/19470921$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1038/nm988 10.1093/annonc/mdi118 10.1200/JCO.2005.02.5635 10.1038/ncponc0403 10.1200/JCO.2005.01.5388 10.1200/jco.2008.26.15_suppl.4091 10.1200/JCO.2005.02.2574 10.1016/j.ccr.2006.11.021 10.1126/science.1104819 10.1056/NEJMoa040694 10.1158/0008-5472.CAN-07-3217 10.1038/nprot.2007.111 10.1002/1097-0142(19940601)73:11<2680::AID-CNCR2820731105>3.0.CO;2-C 10.1158/1078-0432.CCR-07-1154 10.1158/1078-0432.CCR-04-0157 10.1200/JCO.2007.14.5375 10.1056/NEJMoa032691 10.1200/JCO.2008.20.9908 |
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