Abstract # Abstract Text:

Transcription

1 Page 1 of 6 Abstract # MAP plus maintenance pegylated interferon α-2b (MAP-IFN) versus MAP alone in patients (pts) with resectable high-grade osteosarcoma and good histological response to preoperative MAP: First results of the EURAMOS- 1 good response randomization. Stefan S. Bielack, Sigbjorn Smeland, Jeremy Whelan, Neyssa Marina, Jane Hook, Gordana Jovic, Mark D. Krailo, Trude Butterfass-Bahloul, Thomas Kühne, Mikael Eriksson, Lisa A. Teot, Hans Gelderblom, Leo Kager, Kirsten Sundby Hall, Richard Greg Gorlick, R. Lor Randall, Pancras C. W. Hogendoorn, Gabriele Calaminus, Matthew Robert Sydes, Mark L. Bernstein; Klinikum Stuttgart, Olgahospital, Cooperative Osteosarcoma Study Group (COSS), Stuttgart, Germany; Oslo University Hospital, The Norwegian Radium Hospital, Scandinavian Sarcoma Group, Oslo, Norway; University College London Hospitals NHS Foundation Trust, United Kingdom; Stanford University, School of Medicine, Palo Alto, CA; MRC Clinical Trials Unit, ; Children's Oncology Group, Arcadia, CA; Center for Clinical Trials, University of Muenster, Muenster, Germany; University Children s Hospital Basel, Basel, Switzerland; Skane University Hospital and Lund University, Lund, Sweden; Children's Hospital Boston, Boston, MA; Department of Clinical Oncology, Leiden University Medical Center, Leiden, Netherlands; St Anna's Children's Hospital, Vienna, Austria; The Children's Hospital, Bronx, NY; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Department of Pathology, Leiden University Medical Center, Leiden, Netherlands; University Hospital of Muenster, Muenster, Germany; IWK Health Center, Dalhousie University, Halifax, NS Abstract Text: Background: EURAMOS 1 (NCT ) is an international Phase III randomized controlled trial (RCT) investigating treatment optimization in osteosarcoma on the basis of histological response to preoperative chemotherapy (CT). It is the largest RCT conducted in this rare cancer. In pts with good response to induction CT (GR; <10% viable tumor at resection), efficacy of maintenance therapy with pegylated interferon α 2b (IFN) was investigated. Methods: Pts 40yrs with resectable localized or primary metastatic high-grade extremity or axial osteosarcoma were eligible for registration at diagnosis. Eligibility for randomization included: i) receipt of 2 cycles preop methotrexate, doxorubicin, cisplatin (MAP); ii) complete macroscopic resection of primary tumor; iii) no disease progression. GR pts were randomized (1:1) after surgery to 4 cycles MAP ± IFN. IFN was given μg/kg/wk post CT to 2yr post registration. Primary endpoint: event free survival (EFS); secondary: overall survival (OS), toxicity, quality of life. The trial design sought improved 3yr EFS from 70% to 80% (80% power, 2-sided alpha 5%). Final analysis planned after 147 EFS events pts were registered (Apr 2005 to Jun 2011) from 17 countries, 326 sites. Of 2080 with recorded histological response to preop CT, 1034 had a GR of whom 715 consented to randomization (358 MAP, 357 MAP-IFN). Median follow-up is 3.1 yrs. The final analysis of EFS is planned for Feb 2013 when the planned number of events will have been reported. Final results will be presented for EFS: an estimate of relative treatment effect (using a Cox Model if hazards are proportional or Restricted Mean Survival Time if not) and the two arms compared using a logrank test. In addition, an estimate of the accumulating treatment effect on OS will be presented for context (IDMC agreed). Toxicity data will also be presented.

2 Page 2 of 6 Title:MAP plus maintenance pegylated interferon α-2b (MAP-IFN) versus MAP alone in patients (pts) with resectable high-grade osteosarcoma and good histological response to preoperative MAP: First results of the EURAMOS-1 good response randomization. Submitter's Address:S.Bielack@klinikum-stuttgart.de Is this a late-breaking abstract?yes If your late-breaking abstract is deemed acceptable for publication only, would you like to have it automatically withdrawn?yes Is this abstract a clinical trial?yes Is this clinical trial registered?yes Registry Name:Clinicaltrials.gov Registration Number:NCT Research Funding Source:Other Research Funding Source Name:NIH, European funding via European Science Foundation EUROCORES (EU FP6) Did the trial accrue its first patient before or after April 29, 2004?After Would like to be considered for a Merit Award:No Trial Type:Phase III Research Category:Clinical Continued Trial Accrual:No Recieved Grant funding:no Relevant to geriatric oncology:no Sponsor: Mark L. Bernstein, MD First Author Presenting Author Stefan S. Bielack, MD PhD Klinikum Stuttgart, Olgahospital, Cooperative Osteosarcoma Study Group (COSS) Stuttgart, Germany Phone Number: S.Bielack@klinikum-stuttgart.de Second Author Sigbjorn Smeland, MD PhD Oslo University Hospital, The Norwegian Radium Hospital, Scandinavian Sarcoma Group Oslo, Norway Phone Number: sibjorn.smeland@radiumhospital.no Third Author Jeremy Whelan, MD University College London Hospitals NHS Foundation Trust

3 Page 3 of 6 Phone Number: jeremy.whelan@uclh.nhs.uk Fourth Author Neyssa Marina, MD MS Stanford University, School of Medicine Palo Alto, CA Phone Number: Fax Number: neyssa.marina@stanford.edu Fifth Author Jane Hook, MBBChir MRC Clinical Trials Unit Phone Number: jmhook@doctors.org.uk Sixth Author Gordana Jovic, PhD MRC Clinical Trials Unit Phone Number: goj@ctu.mrc.ac.uk Seventh Author Mark D. Krailo, PhD Children's Oncology Group Arcadia, CA Phone Number: Fax Number: mkrailo@childrensoncologygroup.org Eighth Author Trude Butterfass-Bahloul, MD Center for Clinical Trials, University of Muenster Muenster,

4 Page 4 of 6 Germany Phone Number: +49 (0) butterft@ukmuenster.de Ninth Author Thomas Kühne, MD University Children s Hospital Basel Spitalstrasse 33 Basel, Switzerland Phone Number: thomas.kuehne@ukbb.ch Tenth Author Mikael Eriksson, MD PhD Skane University Hospital and Lund University Lund, Sweden Phone Number: MIKAEL.ERIKSSON@MED.LU.SE Eleventh Author Lisa A. Teot, MD Children's Hospital Boston Boston, MA Phone Number: lisa.teot@childrens.harvard.edu Twelfth Author Hans Gelderblom, MD PhD Department of Clinical Oncology, Leiden University Medical Center Albinusdreef 2 Leiden, Netherlands Phone Number: Fax Number: a.j.gelderblom@lumc.nl Thirteenth Author Leo Kager, MD St Anna's Children's Hospital

5 Page 5 of 6 Kinderspitalgasse 6 Vienna, Austria Phone Number: leo.kager@stanna.at Fourteenth Author Kirsten Sundby Hall, MD PhD Oslo University Hospital, The Norwegian Radium Hospital, Scandinavian Sarcoma Group Oslo, Norway Phone Number: / Kirsten.Sundby.Hall@oslo-universitetssykehus.no Fifteenth Author Richard Greg Gorlick, MD The Children's Hospital Bronx, NY Phone Number: Fax Number: rgorlick@montefiore.org Sixteenth Author R. Lor Randall, MD Huntsman Cancer Institute, University of Utah 2000 Circle of Hope Salt Lake City, UT Phone Number: r.lor.randall@hci.utah.edu Seventeenth Author Pancras C. W. Hogendoorn, MD PhD Department of Pathology, Leiden University Medical Center Leiden, Netherlands Phone Number: p.c.w.hogendoorn@lumc.nl Eighteenth Author Gabriele Calaminus, MD

6 Page 6 of 6 University Hospital of Muenster Albert-Schweitzer-Strasse 33 Muenster, Germany Phone Number: gabriele.calaminus@ukmuenster.de Nineteenth Author Matthew Robert Sydes, CStat MRC Clinical Trials Unit Aviation House 125 Kingsway Phone Number: 44 (0) Fax Number: 44 (0) matthew.sydes@ctu.mrc.ac.uk Twentieth Author Mark L. Bernstein, MD IWK Health Center, Dalhousie University Halifax, NS B3K 6R8 Canada Phone Number: mark.bernstein@iwk.nshealth.ca