Author Contributions: Dr Oettle had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Oettle, Neuhaus, Langrehr, Riess.
Acquisition of data: Oettle, Post, Neuhaus, Gellert, Langrehr, Ridwelski, Schramm, Fahlke, Zuelke, Burkart, Gutberlet, Kettner, Schmalenberg, Weigang-Koehler, Bechstein, Niedergethmann, Schmidt-Wolf, Roll.
Analysis and interpretation of data: Oettle, Neuhaus, Langrehr, Roll, Doerken, Riess.
Drafting of the manuscript: Oettle, Neuhaus.
Critical revision of the manuscript for important intellectual content: Post, Gellert, Langrehr, Ridwelski, Schramm, Fahlke, Zuelke, Burkart, Gutberlet, Kettner, Schmalenberg, Weigang-Koehler, Bechstein, Niedergethmann, Schmidt-Wolf, Roll, Doerken, Riess.
Statistical analysis: Oettle, Roll.
Obtained funding: Niedergethmann.
Administrative, technical, or material support: Neuhaus, Gellert, Langrehr, Schramm, Zuelke, Gutberlet, Kettner, Weigang-Koehler, Bechstein, Schmidt-Wolf, Riess.
Study supervision: Post, Langrehr, Niedergethmann, Doerken.
Financial Disclosures: Dr Oettle reports receiving compensation for providing clinical lectures for Lilly and Sanofi-Aventis between 2.5 and 5 years ago. During the past 5 years Dr Oettle reports receiving grant support for clinical research projects from the German branches of the following pharmaceutical companies: Amgen, Antisense Therapeutics, Caremark/Fresenius Kabi GmbH, GlaxoSmithKline, LogoMed, Medac, Merck KG (Darmstadt, Germany), Novartis, Orion Clinical, Janssen Cilag/Ortho Biotech, Quintiles, Hoffmann-La Roche, Sanofi-Aventis, and Ribosepharm. Dr Riess reports receiving compensation for providing clinical lectures and funding by Amgen, AstraZeneca, Bayer, Falk, GlaxoSmithKline, Instrumentation Laboratory, Lilly, Merck KG, Mitsubishi Pharma, Novartis, Octapharm, Organon, Pfizer, Ribosepharm, Roche, Sanofi-Aventis, Shire, ZLB Behring. No disclosures were reported by the other authors of this article.
Funding/Support: This trial was supported in part by a grant from Lilly Deutschland, Bad Homburg, Germany.
Role of the Sponsor: CONKO-001 was an investigator-initiated trial. Lilly Deutschland had no role in the design and conduct nor the collection, analysis, or interpretation of the data but had the right for an unbinding review of the manuscript.
Data Monitoring: SKM, now i3 Research SKM Oncology, Wiesbaden, Germany.
Independent Statistical Analysis: The statistical analysis was performed independent of the sponsor at Charité School of Medicine, Campus Virchow-Klinikum, Berlin, Germany.
CONKO-001 Study Sites and Investigators (Authors not included): Germany: Charité School of Medicine, Campus Virchow-Klinikum (U. Pelzer, J. Stieler, I. Diettrich, K. Lueck, S. Bischoff, H. Naether) and Campus Berlin-Buch (A. Kretzschmar, S. Micheel), Berlin; University Hospital, Mannheim (M. Farag-Soliman, S. Koegel, A. Hochhaus); Sana Hospital Lichtenberg, Berlin (K. Zippel); University Hospital, Magdeburg (C. Schmidt, K. Zierau, Kubina, A. Hribaschek); Wald Hospital, Gera (F. Arnold, T. Manger); University Hospital, Regensburg (S. Kuemmel, H. J. Schlitt, M. Steinbauer); University Hospital, Tuebingen (M. Gregor, R. Teichmann, C. Burkart); University Hospital, Bonn (C. Ziske, S. Herz, M. Gorschlueter, A. Glasmacher); Bremen Mitte Hospital, Bremen (S. Rotermund); City Hospital, Magdeburg (B. Bilsing); University Hospital, Jena (G. Triebkorn, R. Masri Zada, J. Schmuecker); Nord Hospital, Nuremberg (C. Falge); University Hospital, Frankfurt am Main (K. Obert, K. Grabowski, C. Gog); University Hospital, Freiburg (U. Hopt, A. Zaehringer); DRK Hospital, Luckenwalde (U. Fleck); Humaine Hospital, Bad Saarow (C. Reudelsterz, H. Fuß, C. Hammer); Henriettenstiftung Hospital, Hannover (S. Kuebler, J. Jaehne); Diakoniekrankenhaus, Rotenburg (C. Schlichting); Israelite Hospital, Hamburg (P. Layer, C. Fibbe); City Hospital, Dessau (T. Schulze); St. Marien Hospital, Hamm (H. Duerk, A. Hermening); University Hospital, Duesseldorf (D. Graf, A. Erhardt); Knappschaftskrankenhaus, Puettlingen (K. Faßbinder, M. Maier); Katharinenhospital, Stuttgart (J. Schleicher, D. Assmann); Marienkrankenhaus, Hamburg (G. Wacker-Backhaus); City Hospital, Hildesheim (B. Sievers); St. Elisabeth and St. Barbara Hospital, Halle (K. Stadelmann, B. Opitz); City Hospital, Esslingen (R. Eckert, T. Renz); Marienkrankenhaus, Nordhorn (U. Sauer); Ostalb Hospital, Aalen (R. Schnaitmann); University Hospital, Rostock (G. Hartung, J. Emmrich, D. Wolff, M. Leithaeuser); District Hospital, Aschersleben (D. Messinger, T. Deist); University Hospital, Kiel (M. Pohl, F. Gieseler, M. Leibl); Vivantes Hospital, Berlin (M. Wilhelmy, A. C. Mayr, A. Holzgreve); City Hospital, Memmingen (A. Pfeiffer); University Hospital, Leipzig (K. Schoppmeyer); City Hospital, Hof (F.-W. Busch, T. Zahn); District Hospital, Mittweida (E. Gnehrich, M. Doerne); Asklepios Hospital, Parchim (K. Skusa); Missionsaerztliche Klinik, Wuerzburg (B. Jany); City Hospital, Eberswalde (A. Marquart); District Hospital, Altenburg (E. Schmidt); Medical Outpatient Clinic, Wuerzburg (M. Goebeler, H. Rueckle-Lanz); Central Hospital, Bremen (M. Strohbach); Westpfalz Hospital, Kaiserslautern (H. Link); Humaine Hospital, Dresden (B. Brockmann); University Hospital, Gießen (H. Pralle);K. Bickel, Helios Hospital, Gotha (K. Bickel); Uckermark Hospital, Schwedt (B. Bartels); City Hospital, Hanau (M. Burk); University Hospital, Wuerzburg (W. Burghardt); City Hospital, Landshut (A. Holstege, R. Matzberger); University Hospital, Dresden (C. Haag); Friederikenstift, Hannover (A. Heer-Sonderhoff, I. Zander); Central Hospital Reinkenheide, Bremen (M. Arens); Deister-Weser Hospital, Bad Muender (B. Foudi); Carl Thiem Hospital, Cottbus (I. Gastinger); City Hospital, Zeitz (J. Truckenbrodt); General Hospital Barmbeck, Hamburg (T. Faak, S. Tiede); DRK City Hospital, Neuwied (S. Neuß, K.-L. Heuser); Evangelic Hospital, Unna (G. Steinmeister); University Hospital, Erlangen (M. Lindenberg, A. Wein, T. Meyer, W. Brueckl); Marienhospital, Stuttgart (C. Jaeger, C. Denzlinger); and Private Practices in Wuerzburg (R. Schlag, E. Kagerbauer), Berlin (F. Strohbach, M. Schweigert, M. Kindler, I. Blau, H. Ihle, K. Ulbrich, F. Ludwig, H. Lenk, H. Matthes, B. Mohr, A. Eilers-Loennecker), Potsdam (G. Guenther, A. Sauer), Erfurt (U. Hauch), Hildesheim (B. Sievers), Braunschweig (M. Adler, O. Marschal), Schwerin (A.-R. Valdix); Hamburg (S. Mueller-Hagen), Goslar (H. W. Tessen), Hilden (A. Tsamalouk), Bayreuth (A. Huebner), Cottbus (U. von Gruenhagen, H. Lindow, L. Gaier), Fuerth (J. Wilke, T. Drescher), and Waldsassen (W. Fortelny). Austria: Landeskrankenhaus, Salzburg (M. Schachner, M. Moik, C. Rass).
Acknowledgment: We express our gratitude to the many participating patients who gave their consent to be treated with an investigational chemotherapy in the trial setting, and we thank all investigators and research support staff at the participating centers for their valuable contribution to the study. We also wish to acknowledge the assistance of the German Cancer Society and its medical and surgical working groups, Arbeitsgemeinschaft Internistische Onkologie (Medical Oncology Working Group) and Chirurgische Arbeitsgemeinschaft Onkologie (Working Group of Surgical Oncologists). We are indebted to Axel Hinke, PhD, independent statistician, Scientific Institute for Medical Statistics, for expert statistical advice and Volker Bartsch, MD, MSc, independent freelance medical writer, for preparing the manuscript. We are very grateful to Michael Arning, MD, PhD, Lilly Deutschland, for his helpful collaboration and effective support throughout the study. Dr Arning acted as a liaison agent between Lilly and Dr Oettle's study group, providing the group with valuable advice but having no influence on the design of the study and the evaluation of the study data. Dr Arning is now with GlaxoSmithKline. Dr Hinke received no compensation for his statistical advice. Dr Bartsch received payment for preparing the manuscript from Lilly Deutschland as part of the study funding (receiving instructions exclusively from Dr Oettle).