Validity of the MAGIC study: sufficient for recommendations?

作者: Doris Henne-Bruns , Franz Porzsolt , Katrin Bauer

DOI: 10.5754/HGE13116

关键词:

摘要: According to the recommendations of German S3 guideline, perioperative chemotherapy is an integral part treatment concept for advanced gastric cancer. The leading trial which examined effects MAGIC study. An examination validity this study with a standardized method revealed shortcomings in six areas: design, protocol, selection patients, randomization / homogeneity patient groups, quality surgical care and statistical evaluation. These their influence on results are described paper reveal importance these discussion guidelines committees.

参考文章(15)
Xavier Paoletti, Koji Oba, Tomasz Burzykowski, Stefan Michiels, Yasuo Ohashi, Jean-Pierre Pignon, Philippe Rougier, Junichi Sakamoto, Daniel Sargent, Mitsuru Sasako, Eric Van Cutsem, Marc Buyse, Benefit of Adjuvant Chemotherapy for Resectable Gastric Cancer A Meta-analysis JAMA. ,vol. 303, pp. 1729- 1737 ,(2010) , 10.1001/JAMA.2010.534
John M. Lachin, Statistical considerations in the intent-to-treat principle. Controlled Clinical Trials. ,vol. 21, pp. 167- 189 ,(2000) , 10.1016/S0197-2456(00)00046-5
Stuart J. Pocock, Richard Simon, Sequential Treatment Assignment with Balancing for Prognostic Factors in the Controlled Clinical Trial Biometrics. ,vol. 31, pp. 103- 115 ,(1975) , 10.2307/2529712
Catherine de Martel, Silvia Franceschi, Infections and cancer: established associations and new hypotheses. Critical Reviews in Oncology Hematology. ,vol. 70, pp. 183- 194 ,(2009) , 10.1016/J.CRITREVONC.2008.07.021
John S. Macdonald, Stephen R. Smalley, Jacqueline Benedetti, Scott A. Hundahl, Norman C. Estes, Grant N. Stemmermann, Daniel G. Haller, Jaffer A. Ajani, Leonard L. Gunderson, J. Milburn Jessup, James A. Martenson, Chemoradiotherapy after Surgery Compared with Surgery Alone for Adenocarcinoma of the Stomach or Gastroesophageal Junction The New England Journal of Medicine. ,vol. 345, pp. 725- 730 ,(2001) , 10.1056/NEJMOA010187
D. H. Roukos, G. Baltogiannis, D. Cassioumis, J. R. Siewert, J. D. Roder, Prognostic relevance of systematic lymph node dissection in gastric carcinoma British Journal of Surgery. ,vol. 82, pp. 1287- 1289 ,(2005) , 10.1002/BJS.1800820954
Neil W Scott, Gladys C McPherson, Craig R Ramsay, Marion K Campbell, The method of minimization for allocation to clinical trials Controlled Clinical Trials. ,vol. 23, pp. 662- 674 ,(2002) , 10.1016/S0197-2456(02)00242-8
David Cunningham, William H Allum, Sally P Stenning, Jeremy N Thompson, Cornelis JH Van de Velde, Marianne Nicolson, J Howard Scarffe, Fiona J Lofts, Stephen J Falk, Timothy J Iveson, David B Smith, Ruth E Langley, Monica Verma, Simon Weeden, YKS Viswanath Chua, Yu Jo, MAGIC Trial participants, Nick Wadd, None, Perioperative Chemotherapy versus Surgery Alone for Resectable Gastroesophageal Cancer The New England Journal of Medicine. ,vol. 355, pp. 11- 20 ,(2006) , 10.1056/NEJMOA055531
Ilfet Songun, Hein Putter, Elma Meershoek-Klein Kranenbarg, Mitsuru Sasako, Cornelis JH van de Velde, Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial The Lancet Oncology. ,vol. 11, pp. 439- 449 ,(2010) , 10.1016/S1470-2045(10)70070-X