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    S0356: a phase II clinical and prospective molecular trial with oxaliplatin, fluorouracil, and external-beam radiation therapy before surgery for patients with esophageal adenocarcinoma

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    Authors
    Leichman, Lawrence P.
    Goldman, Bryan H.
    Bohanes, Pierre O.
    Lenz, Heinz J.
    Thomas, Charles R.
    Billingsley, Kevin G.
    Corless, Christopher L.
    Iqbal, Syma
    Gold, Philip J.
    Benedetti, Jacqueline K.
    Danenberg, Kathleen D.
    Blanke, Charles D.
    Show allShow less
    UMass Chan Affiliations
    Quality Assurance Review Center
    Document Type
    Journal Article
    Publication Date
    2011-12-01
    Keywords
    Health Services Administration
    Neoplasms
    Oncology
    Radiology
    
    Metadata
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    Link to Full Text
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3236655/
    Abstract
    PURPOSE: Pathologic complete response (pCR) after neoadjuvant therapy for locally advanced esophageal adenocarcinoma is associated with improved survival. The Southwest Oncology Group designed a trimodality, phase II, single-arm trial with objectives of achieving a pCR rate of 40% with prospective exploratory analyses of intratumoral molecular markers postulated to affect response and survival. PATIENTS AND METHODS: Patients with clinically staged II or III esophageal adenocarcinoma received oxaliplatin 85 mg/m(2) on days 1, 15, and 29; protracted-infusion fluorouracil (PI-FU) 180 mg/m(2)/d on days 8 through 43; and external-beam radiation therapy (EBRT) 5 days a week at 1.8 Gy/d for 25 fractions; surgery was performed 28 to 42 days after neoadjuvant therapy. Chemotherapy was planned after surgery. Tumors were analyzed for mRNA expression and polymorphisms in genes involved in drug metabolism and DNA repair. RESULTS: Ninety-three patients were evaluable. Two deaths (2.2%) were attributable to preoperative therapy, and two deaths (2.2%) were attributable to surgery. Grade 3 and 4 toxicities were recorded for 47.3% and 19.4% of patients, respectively. Seventy-nine patients (84.9%) underwent surgery; 67.7% of patients had R0 resections. Twenty-six patients (28.0%) had confirmed pCR (95% CI, 19.1% to 38.2%). At a median follow-up of 39.2 months, estimates of median and 3-year overall survival (OS) were 28.3 months and 45.1%, respectively. Intratumoral ERCC-1 gene expression was inversely related to progression-free survival and OS. CONCLUSION: Neoadjuvant oxaliplatin, PI-FU, and EBRT for esophageal adenocarcinoma is active and tolerable. Because the regimen failed to meet the primary end point, it does not define a new standard. However, future trials can be built on this platform to validate the role of ERCC-1 in determining the best systemic regimen for individual patients.
    Source
    J Clin Oncol. 2011 Dec 1;29(34):4555-60. doi: 10.1200/JCO.2011.36.7490. Epub 2011 Oct 24. Link to article on publisher's site
    DOI
    10.1200/JCO.2011.36.7490
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/46479
    PubMed ID
    22025151
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1200/JCO.2011.36.7490
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    Radiation Oncology Publications

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