P Quaglino1, H M Prince2, R Cowan3, M Vermeer4, E Papadavid5, M Bagot6, O Servitjie7, E Berti8, E Guenova9, R Stadler10, C Querfeld11, A M Busschots12, E Hodak13, A Patsatsi14, J Sanches15, M Maule16, J Yoo17, M Kevin17, P Fava1, S Ribero1, L Zocchi1, M Rubatto1, M T Fierro1, U Wehkamp18, M Marshalko19, C Mitteldorf20, O Akilov21, P Ortiz-Romero22, T Estrach23, L Vakeva24, P A Enz25, M Wobser26, M Bayne27, C Jonak28, M Rubeta29, A Forbes30, A Bates31, M Battistella6, R Amel-Kashipaz17, B Vydianath17, A Combalia23, E Georgiou14, E Hauben12, E K Hong32, M Jost18, R Knobler28, I Amitay-Laish13, D Miyashiro15, J Cury-Martins15, X Martinez11, C Muniesa7, H Prag-Naveh13, A Stratigos5, V Nikolaou5, K Quint4, C Ram-Wolff6, K Rieger32, R Stranzenbach10, Á Szepesi19, S Alberti-Violetti8, E Felicity17, L Cerroni33, W Kempf34, S Whittaker35, R Willemze4, Y Kim32, J J Scarisbrick17,36. 1. Dermatologic Clinic, University of Turin Medical School, Turin, Italy. 2. Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia. 3. Christie Hospital, Manchester, UK. 4. Leiden University Medical Centre, Leiden, the Netherlands. 5. Athens University Medical School, Athens, Greece. 6. Hospital St Louis, Paris, France. 7. Hospital Universitari de Bellvitge, Barcelona, Spain. 8. University of Milano, Milan, Italy. 9. University Hospital Zurich, Zurich, Switzerland. 10. Johannes Wesling University Medical Centre, Minden, Germany. 11. City of Hope National Medical Center and Beckman Research Institute, Duarte, CA, USA. 12. Belgium University Hospitals Leuven, Leuven, Belgium. 13. Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel. 14. Aristotle University of Thessaloniki in Papageorgiou General Hospital, Thessaloniki, Greece. 15. University of São Paulo Medical School, São Paulo, SP, Brazil. 16. Cancer Epidemiology Unit, Department of Medical Sciences, University of Turin, Turin, Italy. 17. University Hospitals Birmingham, Birmingham, UK. 18. University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany. 19. Semmelweis University, Budapest, Hungary. 20. HELIOS Klinikum Hildesheim GmbH, University Medical Center Göttingen, Göttingen, Germany. 21. University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. 22. Hospital 12 de Octubre, Madrid, Spain. 23. Hospital Clinico, University of Barcelona, Barcelona, Spain. 24. Helsinki University Central Hospital, Helsinki, Finland. 25. Hospital Italiano De Buenos Aires, Buenos Aires, Argentina. 26. University Hospital Wuerzburg, Wuerzburg, Germany. 27. Poole Hospital, Poole, UK. 28. Department of Dermatology, Medical University of Vienna, Vienna, Austria. 29. Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK. 30. Torbay Hospital, Torbay, UK. 31. University Hospital Southampton, Southampton, UK. 32. Stanford University, Stanford, CA, USA. 33. Department of Dermatology, Research Unit Dermatopathology, Medical University of Graz, Graz, Austria. 34. Kempf und Pfaltz, Histologische Diagnostik, Zurich, Switzerland. 35. Kings College London, Guy's and St Thomas' NHS Foundation Trust, London, UK. 36. European Co-ordinating PROCLIPI Centre for PROCLIPI, University Hospitals Birmingham, Birmingham, UK.
Abstract
BACKGROUND: The PROspective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study is a prospective analysis of an international database. Here we examine front-line treatments and quality of life (QoL) in patients with newly diagnosed mycosis fungoides (MF). OBJECTIVES: To identify (i) differences in first-line approaches according to tumour-nodes-metastasis-blood (TNMB) staging; (ii) parameters related to a first-line systemic approach and (iii) response rates and QoL measures. METHODS: In total, 395 newly diagnosed patients with early-stage MF (stage IA-IIA) were recruited from 41 centres in 17 countries between 1 January 2015 and 31 December 2018 following central clinicopathological review. RESULTS: The most common first-line therapy was skin-directed therapy (SDT) (322 cases, 81·5%), while a smaller percentage (44 cases, 11·1%) received systemic therapy. Expectant observation was used in 7·3%. In univariate analysis, the use of systemic therapy was significantly associated with higher clinical stage (IA, 6%; IB, 14%; IIA, 20%; IA-IB vs. IIA, P < 0·001), presence of plaques (T1a/T2a, 5%; T1b/T2b, 17%; P < 0·001), higher modified Severity Weighted Assessment Tool (> 10, 15%; ≤ 10, 7%; P = 0·01) and folliculotropic MF (FMF) (24% vs. 12%, P = 0·001). Multivariate analysis demonstrated significant associations with the presence of plaques (T1b/T2b vs. T1a/T2a, odds ratio 3·07) and FMF (odds ratio 2·83). The overall response rate (ORR) to first-line SDT was 73%, while the ORR to first-line systemic treatments was lower (57%) (P = 0·027). Health-related QoL improved significantly both in patients with responsive disease and in those with stable disease. CONCLUSIONS: Disease characteristics such as presence of plaques and FMF influence physician treatment choices, and SDT was superior to systemic therapy even in patients with such disease characteristics. Consequently, future treatment guidelines for early-stage MF need to address these issues.
BACKGROUND: The PROspective Cutaneous Lymphoma International Prognostic Index (PROCLIPI) study is a prospective analysis of an international database. Here we examine front-line treatments and quality of life (QoL) in patients with newly diagnosed mycosis fungoides (MF). OBJECTIVES: To identify (i) differences in first-line approaches according to tumour-nodes-metastasis-blood (TNMB) staging; (ii) parameters related to a first-line systemic approach and (iii) response rates and QoL measures. METHODS: In total, 395 newly diagnosed patients with early-stage MF (stage IA-IIA) were recruited from 41 centres in 17 countries between 1 January 2015 and 31 December 2018 following central clinicopathological review. RESULTS: The most common first-line therapy was skin-directed therapy (SDT) (322 cases, 81·5%), while a smaller percentage (44 cases, 11·1%) received systemic therapy. Expectant observation was used in 7·3%. In univariate analysis, the use of systemic therapy was significantly associated with higher clinical stage (IA, 6%; IB, 14%; IIA, 20%; IA-IB vs. IIA, P < 0·001), presence of plaques (T1a/T2a, 5%; T1b/T2b, 17%; P < 0·001), higher modified Severity Weighted Assessment Tool (> 10, 15%; ≤ 10, 7%; P = 0·01) and folliculotropic MF (FMF) (24% vs. 12%, P = 0·001). Multivariate analysis demonstrated significant associations with the presence of plaques (T1b/T2b vs. T1a/T2a, odds ratio 3·07) and FMF (odds ratio 2·83). The overall response rate (ORR) to first-line SDT was 73%, while the ORR to first-line systemic treatments was lower (57%) (P = 0·027). Health-related QoL improved significantly both in patients with responsive disease and in those with stable disease. CONCLUSIONS: Disease characteristics such as presence of plaques and FMF influence physician treatment choices, and SDT was superior to systemic therapy even in patients with such disease characteristics. Consequently, future treatment guidelines for early-stage MF need to address these issues.
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