دورية أكاديمية
Cetuximab Plus Chemoradiotherapy for HIV-Associated Anal Carcinoma: A Phase II AIDS Malignancy Consortium Trial.
| العنوان: | Cetuximab Plus Chemoradiotherapy for HIV-Associated Anal Carcinoma: A Phase II AIDS Malignancy Consortium Trial. |
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| المؤلفون: | Sparano JA; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Lee JY; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Palefsky J; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Henry DH; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Wachsman W; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Rajdev L; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Aboulafia D; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Ratner L; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Fitzgerald TJ; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Kachnic L; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA., Mitsuyasu R; Joseph A. Sparano and Lakshmi Rajdev, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Jeannette Y. Lee, University of Arkansas for Medical Sciences, Little Rock, AR; Joel Palefsky, University of California San Francisco, San Francisco; William Wachsman, University of California San Diego, San Diego; Ronald Mitsuyasu, University of California Los Angeles, Los Angeles, CA; David H. Henry, University of Pennsylvania, Philadelphia, PA; David Aboulafia, Virginia Mason Medical Center, Seattle, WA; Lee Ratner, Washington University, St Louis, MO; Thomas J. Fitzgerald, Quality Assurance Review Center, Providence, RI; and Lisa Kachnic, Boston University Medical Center, Boston, MA. |
| المصدر: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2017 Mar; Vol. 35 (7), pp. 727-733. Date of Electronic Publication: 2016 Dec 12. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology Original Publication: New York, N.Y. : Grune & Stratton, c1983- |
| مواضيع طبية MeSH: | Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Anus Neoplasms/*therapy , Anus Neoplasms/*virology , Carcinoma, Squamous Cell/*therapy , Carcinoma, Squamous Cell/*virology , HIV Infections/*pathology, Adult ; Aged ; Anus Neoplasms/pathology ; Carcinoma, Squamous Cell/pathology ; Cetuximab/administration & dosage ; Chemoradiotherapy ; Cisplatin/administration & dosage ; Disease-Free Survival ; Female ; Fluorouracil/administration & dosage ; Humans ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome |
| مستخلص: | Purpose Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after definitive chemoradiation (CRT), associated with anogenital human papilloma virus, and often appears in HIV infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus-associated oropharyngeal SCC, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC. Methods Forty-five patients with stage I to III SCCAC and HIV infection received CRT: 45 to 54 Gy radiation therapy to the primary tumor and regional lymph nodes plus eight once-weekly doses of concurrent cetuximab and two cycles of cisplatin and fluorouracil. The study was designed to detect at least a 50% reduction in 3-year LRF rate (one-sided α, 0.10; power, 90%), assuming a 35% LRF rate from historical data. Results The 3-year LRF rate was 42% (95% CI, 28% to 56%; one-sided P = .9) by binomial proportional estimate using the prespecified end point (LRF or alive without LRF and followed < 3 years), and 20% (95% CI, 10% to 37%) by Kaplan-Meier estimate in post hoc analysis using definitions and methods consistent with historical data. Three-year rates by Kaplan-Meier estimate were 72% (95% CI, 56% to 84%) for progression-free survival and 79% (95% CI, 63% to 89%) for overall survival. Grade 4 toxicity occurred in 26%, and 4% had treatment-associated deaths. Conclusion HIV-associated SCCAC is potentially curable with definitive CRT. Although addition of cetuximab may result in less LRF, the 20% recurrence and 26% grade 4 toxicity rates indicate the continued need for more-effective and less-toxic therapies. |
| References: | J Natl Cancer Inst. 2000 Feb 2;92 (3):205-16. (PMID: 10655437) Lancet. 1996 Oct 19;348(9034):1049-54. (PMID: 8874455) JAMA. 2008 Apr 23;299(16):1914-21. (PMID: 18430910) Dis Colon Rectum. 1994 Sep;37(9):861-5. (PMID: 8076484) Ann Oncol. 1997 Jun;8(6):575-81. (PMID: 9261527) Obstet Gynecol Clin North Am. 1996 Dec;23(4):895-916. (PMID: 8989780) J Infect Dis. 1998 Feb;177(2):361-7. (PMID: 9466522) Arch Virol. 2003 Aug;148(8):1445-53. (PMID: 12898324) N Engl J Med. 2007 May 10;356(19):1944-56. (PMID: 17494927) J Clin Oncol. 2015 Jul 20;33(21):2376-83. (PMID: 26077242) Br J Cancer. 2010 Mar 30;102(7):1123-8. (PMID: 20354531) J Clin Oncol. 2012 Dec 10;30(35):4344-51. (PMID: 23150707) N Engl J Med. 2001 Apr 12;344(15):1125-31. (PMID: 11297703) Radiology. 1994 Oct;193(1):251-4. (PMID: 8090901) N Engl J Med. 1998 Mar 26;338(13):853-60. (PMID: 9516219) Am J Clin Pathol. 2005 Jul;124(1):20-3. (PMID: 15923158) Dis Colon Rectum. 2001 Apr;44(4):506-12. (PMID: 11330577) J Natl Cancer Inst. 2012 Oct 17;104(20):1591-8. (PMID: 23042932) JAMA. 2008 Aug 27;300(8):945-51. (PMID: 18728268) J Pathol. 1996 Dec;180(4):378-82. (PMID: 9014857) Br J Cancer. 2012 Nov 20;107(11):1864-8. (PMID: 23093229) Dis Colon Rectum. 2001 Oct;44(10):1496-502. (PMID: 11598480) J Clin Oncol. 1996 Dec;14(12):3121-5. (PMID: 8955657) Ann Intern Med. 2008 May 20;148(10):728-36. (PMID: 18490686) Lancet Oncol. 2010 Jan;11(1):21-8. (PMID: 19897418) Int J Colorectal Dis. 2006 Mar;21(2):135-42. (PMID: 15864603) JAMA. 2010 Jul 21;304(3):334-9. (PMID: 20639567) Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1101-5. (PMID: 9169819) Eur J Cancer. 2000 Apr;36(6):754-8. (PMID: 10762748) Int J Radiat Oncol Biol Phys. 1999 Apr 1;44(1):127-31. (PMID: 10219805) J Natl Cancer Inst. 2003 Dec 3;95(23):1772-83. (PMID: 14652239) J Clin Oncol. 1996 Sep;14(9):2527-39. (PMID: 8823332) N Engl J Med. 2006 Feb 9;354(6):567-78. (PMID: 16467544) Ann Intern Med. 2009 Jan 20;150(2):125-31. (PMID: 19047022) Lancet Oncol. 2013 May;14 (6):516-24. (PMID: 23578724) MMWR Recomm Rep. 2006 Sep 22;55(RR-14):1-17; quiz CE1-4. (PMID: 16988643) |
| معلومات مُعتمدة: | U10 CA029511 United States CA NCI NIH HHS; U24 CA180803 United States CA NCI NIH HHS; UM1 CA121947 United States CA NCI NIH HHS |
| المشرفين على المادة: | PQX0D8J21J (Cetuximab) Q20Q21Q62J (Cisplatin) U3P01618RT (Fluorouracil) |
| SCR Disease Name: | Anal Canal Carcinoma |
| تواريخ الأحداث: | Date Created: 20161213 Date Completed: 20170802 Latest Revision: 20220331 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC5455422 |
| DOI: | 10.1200/JCO.2016.69.1642 |
| PMID: | 27937092 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1527-7755 |
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| DOI: | 10.1200/JCO.2016.69.1642 |