Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925)

Abstract

Introduction. The EORTC 22922/10925 trial investigated the potential survival benefit and toxicity of elective irradiation of the internal mammary and medial supraclavicular (IM-MS) nodes Accrual completed in January 2004 and first results are expected in 2012. We present the toxicity reported until year 3 after treatment. Patients and methods. At each visit, toxicity was reported but severity was not graded routinely. Toxicity rates and performance status (PS) changes at three years were compared by χ² tests and logistic regression models in all the 3 866 of 4 004 patients eligible to the trial who received the allocated treatment. Results. Only lung (fibrosis; dyspnoea; pneumonitis; any lung toxicities) (4.3% vs. 1.3%; p < 0.0001) but not cardiac toxicity (0.3% vs. 0.4%; p = 0.55) significantly increased with IM-MS treatment. No significant worsening of the PS was observed (p = 0.79), suggesting that treatment-related toxicity does not impair patient's daily activities. Conclusions. IM-MS irradiation seems well tolerated and does not significantly impair WHO PS at three years. A follow-up period of at least 10 years is needed to determine whether cardiac toxicity is increased after radiotherapy.

Acknowledgements

This study was supported by grants number 2U10 CA11488-22 through 5U10 CA011488-39 from the National Cancer Institute (Bethesda, Maryland, USA). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. The work of Dr. O. Matzinger as Emmanuel Vanderschueren Fellow at the EORTC Headquarters was supported by the Vlaamse Liga Tegen Kanker.

The following institutions and physicians contributed patients to EORTC trial 22922-10925: Dr. P. H. P. Poortmans (Bernard Verbeeten Instituut, Tilburg, The Netherlands); Pr. W. Van Den Bogaert (Universitair Ziekenhuis Gasthuisberg, Leuven, Belgium); Dr. C. Kirkove (Cliniques Universitaires Saint Luc, Brussels, Belgium); Pr. V. G. Budach (Charite Universitaetsmedizin Berlin – Campus Mitte, Berlin, Germany); Pr. Philippe Maingon (Centre George François.Leclerc, Dijon; France); Dr. Maria Carla Valli (Ospedale Sant Anna, Como, Italy); Dr. J. J. F. M. Immerzeel (Radiotherapeutisch Instituut Stedendriehoek En Omstreken, Deventer, The Netherlands); Dr C. Warlam-Rodenhuis (Universitair Medisch Centrum, Academisch Ziekenhuis, Utrecht, The Netherlands); Dr. C. Le Pechoux (Institut Gustave Roussy, Villejuif, France); Pr. M. Bamberg (Universitaetsklinikum Tuebingen, Tuebingen, Germany); Dr. G. Van Tienhoven (Academisch Medisch Centrum, Amsterdam, The Netherlands); Pr. C. Glanzmann, Pr. U. M Lutolf (Universitaetsspital, Zurich, Switzerland); Dr. A. Fourquet (Institut Curie, Paris, France); Pr. A. Kuten (Rambam Medical Center, Haifa, Israël); Dr. P. Quetin (Centre Paul Strauss, Strasbourg, France); Dr. R. Baeza (Instituto de Radiomedicina, Santiago, Chile); Dr. M. David (Nottingham City Hospital, Nottingham, United Kingdom); Dr. J. Jobsen (Medisch Spectrum Twente, Enschede, The Netherlands); Dr. M.-P. Sunyach (Centre Leon Berard, Lyon, France); Pr. H. Bartelink, Dr. N. Russell (The Netherlands Cancer Institute, Antoni Van Leeuwenhoekziekenhuis, Amsterdam, The Netherlands); Pr. R. O. Mirimanoff (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland); Pr. M. Bolla (C. H. R. De Grenoble-La Tronche, Grenoble, France); Pr. M. Beauduin (Hospital De Jolimont, Haine St. Paul, Belgium); Dr. R. Pfeffer (Chaim Sheba Medical Center, Tel-Hashomer, Israël); Dr. J.-L. Lagrange (C. H. U. Henri Mondor, Creteil, France); Dr. J.-M. Dilhuydy (Institut Bergonie, Bordeaux, France); Dr Chenal, Dr. M. Benchalal (Centre Eugene Marquis, Rennes, France); Dr. P. Huget (Algemeen Ziekenhuis Sint, Augustinus, Wilrijk, Belgium); Dr. A. Courdi (Centre Antoine Lacassagne, Nice, France); Pr. J.-F. Bosset (C. H. R. De Besancon-Hospital Jean Mini-joz, Besancon, France); Dr. A. Kobierska (Medical University of Gdansk, Gdansk, Poland); Dr. E. Senkus-Konefka (Medical University of Gdansk, Gdansk, Poland); Pr J. Kurtz, Dr. S. Balmer-Majno (Hospital Cantonal Universitaier de Geneve, Geneve, Switzerland); Dr. S. Koswig, Dr. H. Krebs (CharitéUniversitaetsmedizin Berlin-Campus Berlin-Buch, Berlin, Germany); Dr. R. Bongartz (Universitaetskliniken Koeln, Koeln, Germany); Dr. H. Struik-mans (Medisch Centrum Haaglanden, Den Haag, The Netherlands); Dr. F. Amalric (Polyclinique Clairval, Marseille, France); Dr. W. V. Dolsma (University Medical Center Groningen, Groningen, The Netherlands); Dr. J. J. Jager (Maastro-Maastricht Radiation Oncology, Maastricht, The Netherlands); Dr. K. Stellamans (Cazk Groeninghe-Campus Maria's Voorzienigheid, Kortrijk, Belgium); Dr. M. Guenzi (Istituto Nazionale Per Ricerca Sul Cancro, Genova, Italy); Pr. M. Stuschke (Universitaetsklinikum-Essen, Essen, Germany); Dr S. Villa, Dr. A. Boladeras (Institut Catala d’Oncologia, Barcelona, Spain); Dr. H. Basic (Clinical Center University Sarajevo, Sarajevo, Bosnia); Dr. L. Badinez (Clinica Alemana de Santiago, Santiago, Chile); Dr. I. Silva (Instituto Portugues de Oncologia, Porto, Portugal); Dr. H. M. Muller (Streekziekenhuizen Gooi-Noord Blaricum, The Netherlands); Dr. V. Strnad (Universitaet ErlangenNurnberg, Erlangen, Germany).

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.