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  • 1
    Online Resource
    Online Resource
    Prospective Trial of Synchronous Bevacizumab, Erlotinib, and Concurrent Chemoradiation in Locally Advanced Head and Neck Cancer
    American Association for Cancer Research (AACR) ; 2012
    In:  Clinical Cancer Research Vol. 18, No. 5 ( 2012-03-01), p. 1404-1414
    Details
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 18, No. 5 ( 2012-03-01), p. 1404-1414
    Abstract: Purpose: We assessed the safety and efficacy of synchronous VEGF and epidermal growth factor receptor (EGFR) blockade with concurrent chemoradiation (CRT) in locally advanced head and neck cancer (HNC). Experimental Design: Newly diagnosed patients with stage III/IV HNC received a 2-week lead-in of bevacizumab and/or erlotinib, followed by both agents with concurrent cisplatin and twice daily radiotherapy. Safety was assessed using Common Toxicity Criteria version 3.0. The primary efficacy endpoint was clinical complete response (CR) rate after CRT. Results: Twenty-nine patients enrolled on study, with 27 completing therapy. Common grade III toxicities were mucositis (n = 14), dysphagia (n = 8), dehydration (n = 7), osteoradionecrosis (n = 3), and soft tissue necrosis (n = 2). Feeding tube placement was required in 79% but no patient remained dependent at 12-month posttreatment. Clinical CR after CRT was 96% [95% confidence interval (CI), 82%–100%]. Median follow-up was 46 months in survivors, with 3-year locoregional control and distant metastasis-free survival rates of 85% and 93%. Three-year estimated progression-free survival, disease-specific survival, and overall survival rates were 82%, 89%, and 86%, respectively. Dynamic contrast enhanced MRI (DCE-MRI) analysis showed that patients who had failed had lower baseline pretreatment median Ktrans values, with subsequent increases after lead-in therapy and 1 week of CRT. Patients who did not fail had higher median Ktrans values that decreased during therapy. Conclusions: Dual VEGF/EGFR inhibition can be integrated with CRT in locally advanced HNC, with efficacy that compares favorably with historical controls albeit with an increased risk of osteoradionecrosis. Pretreatment and early DCE-MRI may prospectively identify patients at high risk of failure. Clin Cancer Res; 18(5); 1404–14. ©2012 AACR.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
    URL: Article
    DOI: 10.1158/1078-0432.CCR-11-1982
    RVK:
    XA 36791
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2012
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    detail.hit.zdb_id: 2036787-9
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  • 2
    Online Resource
    Online Resource
    Utility of Intraoperative Frozen Sections during Thyroid Surgery
    Hindawi Limited ; 2013
    In:  International Journal of Otolaryngology Vol. 2013 ( 2013), p. 1-4
    Details
    In: International Journal of Otolaryngology, Hindawi Limited, Vol. 2013 ( 2013), p. 1-4
    Abstract: Objective . To describe the usefulness of intraoperative frozen section in the diagnosis and treatment of thyroid nodules where fine needle aspirate biopsies have evidence of follicular neoplasm. Study Design . Retrospective case series. Methods . All patients have a fine needle aspirate biopsy, an intraoperative frozen section, and final pathology performed on a thyroid nodule after initiation of the Bethesda System for Reporting Thyroid Cytopathology in 2009 at a single tertiary referral center. Sensitivity, specificity, positive predictive value, and negative predictive value are calculated in order to determine added benefit of frozen section to original fine needle aspirate data. Results . The sensitivity and specificity of the frozen section were 76.9% and 67.9%, respectively, while for the fine needle aspirate were 53.8% and 74.1%, respectively. The positive and negative predictive values for the fine needle aspirates were 25% and 90.9%, respectively, while for the frozen sections were 27.8% and 94.8%, respectively. There were no changes in the operative course as a consequence of the frozen sections. Conclusion . Our data does not support the clinical usefulness of intraoperative frozen section when the fine needle aspirate yields a Bethesda Criteria diagnosis of follicular neoplasm, suspicious for follicular neoplasm, or suspicious for malignancy at our institution.
    Type of Medium: Online Resource
    ISSN: 1687-9201 , 1687-921X
    URL: Article
    DOI: 10.1155/2013/496138
    Language: English
    Publisher: Hindawi Limited
    Publication Date: 2013
    detail.hit.zdb_id: 2503281-1
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  • 3
    Online Resource
    Online Resource
    Evaluation of Safety of Endoscopic Harmonic Diverticulostomy
    Wiley ; 2011
    In:  Otolaryngology–Head and Neck Surgery Vol. 145, No. S2 ( 2011-08)
    Details
    In: Otolaryngology–Head and Neck Surgery, Wiley, Vol. 145, No. S2 ( 2011-08)
    Abstract: Review a series of patients with Zenker diverticulum who were treated with endoscopic diverticulostomy using Harmonic Ultrasonic Surgical Instrumentation (Ethicon Endosurgery, Cincinnati, Ohio) in order to evaluate the safety and optimal application of this technology to the treatment of patients with this disorder. Method Retrospective chart review of patients undergoing endoscopic surgical correction of Zenker diverticulum with Harmonic Ace curved shears between July 1, 2009 and November 1, 2010. Presenting symptoms, size of diverticulum, operative times, length of hospital stay, outcomes, and complications were reviewed. Results A total of 60 endoscopic diverticulostomies were performed, and 24 were Harmonic‐assisted. Eight required hospital stays, with their average stay being 2.13 days (0.7 days for all Harmonic patients). There were 6 complications with Harmonic treatments (25%). Two patients had chest pain with negative work‐ups. Two patients had subcutaneous air. One had a documented salivary leak. One patient had diverticulum recurrence. No patients had hemorrhage, mediastinitis, or death. The average diverticulum size was 3.24 cm, and there were no complications with diverticula less than 2 cm. There were two complications with the staple technique (6.45%). Conclusion Endoscopic staple diverticulostomy is a proven safe treatment for Zenker diverticulum with few limitations. Harmonic instrumentation may be effective with diverticula less than 2 cm. However, based on observed complication rates, additional evaluations are warranted before endoscopic Harmonic diverticulostomy can be recommended as treatment for the majority of cases.
    Type of Medium: Online Resource
    ISSN: 0194-5998 , 1097-6817
    URL: Article
    DOI: 10.1177/0194599811416318a124
    Language: English
    Publisher: Wiley
    Publication Date: 2011
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  • 4
    Online Resource
    Online Resource
    First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-Positive Metastatic Breast Cancer
    American Association for Cancer Research (AACR) ; 2013
    In:  Clinical Cancer Research Vol. 19, No. 18 ( 2013-09-15), p. 4911-4916
    Details
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 19, No. 18 ( 2013-09-15), p. 4911-4916
    Abstract: On June 8, 2012, the U.S. Food and Drug Administration (FDA) approved pertuzumab (Perjeta, Genentech) for use in combination with trastuzumab (Herceptin, Genentech) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Approval was based on the results of a randomized, double-blind, placebo-controlled trial conducted in 808 patients with HER2-positive MBC. Patients were randomized (1:1) to receive pertuzumab (n = 402) or placebo (n = 406) in combination with trastuzumab and docetaxel. The primary endpoint was progression-free survival (PFS) and a key secondary endpoint was overall survival (OS). A statistically significant improvement in PFS (difference in medians of 6.1 months) was observed in patients receiving pertuzumab [HR, 0.62; 95% confidence interval (CI), 0.51–0.75; P & lt; 0.0001]. A planned interim analysis suggested an improvement in OS (HR, 0.64; 95% CI, 0.47–0.88; P = 0.0053) but the HR and P value did not cross the stopping boundary. Common adverse reactions ( & gt;30%) observed in patients on the pertuzumab arm included diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. No additive cardiac toxicity was observed. Significant manufacturing issues were identified during the review. On the basis of substantial evidence of efficacy for pertuzumab in MBC and the compelling public health need, FDA did not delay availability to patients pending final resolution of all manufacturing concerns. Therefore, FDA approved pertuzumab but limited its approval to lots not affected by manufacturing problems. The applicant agreed to multiple manufacturing and testing postmarketing commitments under third-party oversight to resolve manufacturing issues. Clin Cancer Res; 19(18); 4911–6. ©2013 AACR.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
    URL: Article
    DOI: 10.1158/1078-0432.CCR-13-1212
    RVK:
    XA 36791
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2013
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    detail.hit.zdb_id: 2036787-9
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  • 5
    Online Resource
    Online Resource
    A Cenozoic record of the equatorial Pacific carbonate compensation depth
    Springer Science and Business Media LLC ; 2012
    In:  Nature Vol. 488, No. 7413 ( 2012-8), p. 609-614
    Details
    In: Nature, Springer Science and Business Media LLC, Vol. 488, No. 7413 ( 2012-8), p. 609-614
    Type of Medium: Online Resource
    ISSN: 0028-0836 , 1476-4687
    URL: Article
    DOI: 10.1038/nature11360
    RVK:
    TA 1000
    RVK:
    UA 1000
    RVK:
    WA 15000
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2012
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    detail.hit.zdb_id: 1413423-8
    SSG: 11
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  • 6
    Online Resource
    Online Resource
    ARN-509: A Novel Antiandrogen for Prostate Cancer Treatment
    American Association for Cancer Research (AACR) ; 2012
    In:  Cancer Research Vol. 72, No. 6 ( 2012-03-15), p. 1494-1503
    Details
    In: Cancer Research, American Association for Cancer Research (AACR), Vol. 72, No. 6 ( 2012-03-15), p. 1494-1503
    Abstract: Continued reliance on the androgen receptor (AR) is now understood as a core mechanism in castration-resistant prostate cancer (CRPC), the most advanced form of this disease. While established and novel AR pathway–targeting agents display clinical efficacy in metastatic CRPC, dose-limiting side effects remain problematic for all current agents. In this study, we report the discovery and development of ARN-509, a competitive AR inhibitor that is fully antagonistic to AR overexpression, a common and important feature of CRPC. ARN-509 was optimized for inhibition of AR transcriptional activity and prostate cancer cell proliferation, pharmacokinetics, and in vivo efficacy. In contrast to bicalutamide, ARN-509 lacked significant agonist activity in preclinical models of CRPC. Moreover, ARN-509 lacked inducing activity for AR nuclear localization or DNA binding. In a clinically valid murine xenograft model of human CRPC, ARN-509 showed greater efficacy than MDV3100. Maximal therapeutic response in this model was achieved at 30 mg/kg/d of ARN-509, whereas the same response required 100 mg/kg/d of MDV3100 and higher steady-state plasma concentrations. Thus, ARN-509 exhibits characteristics predicting a higher therapeutic index with a greater potential to reach maximally efficacious doses in man than current AR antagonists. Our findings offer preclinical proof of principle for ARN-509 as a promising therapeutic in both castration-sensitive and castration-resistant forms of prostate cancer. Cancer Res; 72(6); 1494–503. ©2012 AACR.
    Type of Medium: Online Resource
    ISSN: 0008-5472 , 1538-7445
    URL: Article
    DOI: 10.1158/0008-5472.CAN-11-3948
    RVK:
    XA 36000
    RVK:
    XA 10000
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2012
    detail.hit.zdb_id: 2036785-5
    detail.hit.zdb_id: 1432-1
    detail.hit.zdb_id: 410466-3
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