Adjuvant chemoimmunotherapy with LMF + BCG in node-negative and node-positive breast cancer patients: 10 year results |
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| Affiliation: | 1. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy;2. U.O. Chirurgia Generale ad Indirizzo Senologico, S.S. Terapia Molecolare e Farmacogenomica – Dipartimento di Chirurgia, Azienda Ospedaliera Istituti Ospitalieri, 26100 Cremona, Italy;3. U.O. di Anatomia Patologica, Azienda Istituti Ospitalieri di Cremona, Viale Concordia 1, 26100 Cremona, Italy;4. Section of Pharmacology and University Center DIFF – Drug Innovation Forward Future, Department of Molecular and Translational Medicine, University of Brescia, Viale Europa 11, 25124 Brescia, Italy;5. Oncologia Medica, Spedali Civili di Brescia, Università di Brescia, Italy;6. Weatherall Molecular Oncology Laboratories, Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, OX3 9DS Oxford, UK;7. Peter MacCallum Cancer Centre, St Andrews Place, East Melbourne, Victoria 3002, Australia;8. Department of Medical, Surgical and Neuroscience, Unit of General and Minimally Invasive Surgery, University of Siena, Viale Bracci 11, 53100 Siena, Italy;9. Department of Medical, Surgery and Health Sciences, University of Trieste, Piazza Ospitale 1, 34129 Trieste, Italy;1. Department of Surgery, Medical University of Vienna, Vienna, Austria;2. Department of Gynecology and Obstetrics, Medical University of Vienna, Vienna, Austria;3. Core Unit for Medical Statistics and Informatics, Section of Clinical Biometrics, Medical University of Vienna, Vienna, Austria;4. Department of Cranio-, Maxillofacial and Oral Surgery, Medical University of Vienna, Vienna, Austria;5. Clinical Division of Oncology, Department of Medicine 1, Medical University of Vienna, Vienna, Austria;6. Clinical Institute of Pathology, Medical University of Vienna, Vienna, Austria;1. Division of Breast, Department of Surgery, College of Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;2. Department of Clinical Epidemiology and Biostatics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;3. Cancer Biostatistics Branch, Research Institute for National Cancer Control and Evaluation, Research Institute and Hospital, National Cancer Center, Goyang, Korea;4. Division of Breast and Endocrine Surgery, Department of Surgery, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea;5. Department of Surgery, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea;6. Department of Surgery, Yonsei University College of Medicine, Seoul, Korea;7. Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea;8. Department of Surgery, Seoul National University College of Medicine, Seoul, Korea;9. Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea;10. Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea;1. Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA;2. Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA;3. Population Health Shared Resource, University of Colorado Cancer Center, Aurora, CO, USA;4. Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA;5. Department of Health Systems, Management, and Policy, University of Colorado Anschutz Medical Campus, Aurora, CO, USA |
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| Abstract: | A total of 254 patients with stages T1–3a/N0–1/M0 operable breast cancer were randomized to either surgery alone or surgery plus adjuvant chemoimmunotherapy (LMF + BCG). Ten-year results are presented for RFS (relapse-free survival) and OAS (overall survival) in the whole patient population as well as in the most important menopausal and nodal subgroups.LMF + BCG significantly increased RFS in the whole patient population as well as in node-positive women. The earlier impressive RFS and OAS gains for node-negative patients were fading after 5 and 8 years respectively, leaving marginal trends in favour of the LMF + BCG treated women. Node-positive patients treated with LMF + BCG continue to demonstrate a marginal gain in RFS up to 10 years. This gain is nearly exclusively expressed in postmenopausal node-positive women, an observation which can be made in the node-negative patient group as well. Despite the still continuing increase in RFS, no OAS benefit was observed for node-positive women with LMF + BCG at any time of the study.Dose still remains a critical factor in cancer therapy. However, at 10 years of follow-up, a full dose of LMF (⩾90%) during the six cycles no longer affects OAS favourably.There was no indication of any adverse long-term toxicity of LMF + BCG in our study after a median follow-up of 10 years, especially no increase of second tumours.In the node-negative patient population, the presence or absence of intramammary lymphatic infiltration seems to be a significant prognostic factor within this nodal subgroup. |
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