Solange Peters1, Rolf A Stahel2, Urania Dafni3, Santiago Ponce Aix4, Bartomeu Massutí5, Oliver Gautschi6, Linda Coate7, Ana López Martín8, Robbert van Heemst9, Thierry Berghmans10, Peter Meldgaard11, Manuel Cobo Dols12, Javier Garde Noguera13, Alessandra Curioni-Fontecedro2, Daniel Rauch14, Michael T Mark15, Sinead Cuffe16, Bonne Biesma17, Arjen M J van Henten18, Óscar Juan Vidal19, Ramón Palmero Sanchez20, José Carlos Villa Guzmán21, Ricardo Collado Martin22, Sergio Peralta23, Amelia Insa24, Yvonne Summers25, István Láng26, Anne Horgan27, Fortunato Ciardiello28, Sander de Hosson29, Remge Pieterman30, Harry J M Groen31, Paul M van den Berg32, Christoph C Zielinski33, Yojena Chittazhathu Kurian Kuruvilla34, Adriana Gasca-Ruchti34, Marie Kassapian35, Silvia Novello36, Valter Torri37, Zoi Tsourti35, Vanesa Gregorc38, Egbert F Smit39. 1. University Hospital of Lausanne (CHUV), Lausanne, Switzerland. Electronic address: Solange.Peters@chuv.ch. 2. University Hospital Zürich, Clinic of Oncology, Zürich, Switzerland. 3. Frontier Science Foundation-Hellas and National and Kapodistrian University of Athens, Athens, Greece. 4. University Hospital 12 de Octubre, Madrid, Spain. 5. Alicante University Hospital, Alicante, Spain. 6. Swiss Group for Clinical Cancer Research and Cantonal Hospital Lucerne, Switzerland. 7. Cancer Trials Ireland and Mid-Western Regional Hospital, Limerick, Ireland. 8. University Hospital Severo Ochoa, Madrid, Spain. 9. Deventer Hospital, Deventer, The Netherlands. 10. Institute Jules Bordet, Brussels, Belgium. 11. Aarhus University Hospital, Aarhus, Denmark. 12. University Hospital Virgen de la Victoria, Malaga, Spain. 13. Hospital Arnau Vilanova, Valencia, Spain. 14. Cantonal Hospital, Thun, Switzerland. 15. Cantonal Hospital, Chur, Switzerland. 16. Cancer Trials Ireland and St. James's Hospital, Dublin, Ireland. 17. Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. 18. Maxima Medical Centre, Eindhoven, The Netherlands. 19. Hospital La Fe, Valencia, Spain. 20. Hospital Duran i Reynalds, Barcelona, Spain. 21. General University Hospital, Ciudad Real, Spain. 22. Hospital San Pedro de Alcantara, Spain. 23. Hospital Sant Joan de Reus, Spain. 24. University Hospital, Valencia, Spain. 25. Christie Hospital Manchester, United Kingdom. 26. National Institute of Oncology, Budapest, Hungary. 27. Cancer Trials Ireland and University Hospital Waterford, Ireland. 28. Second University of Naples, Naples, Italy. 29. Wilhelmina Hospital, Assen, The Netherlands. 30. Ommelander Hospital Group, Winschoten, The Netherlands. 31. University Medical Center Groningen, The Netherlands. 32. Maasstad Hospital, Rotterdam, The Netherlands. 33. Central European Cooperative Oncology Group and Comprehensive Cancer Center of the Medical University, Vienna, Austria. 34. European Thoracic Oncology Platform Coordinating Office, Bern, Switzerland. 35. Frontier Science Foundation-Hellas, Athens, Greece. 36. University of Turin, Department of Clinical and Biological Sciences, Turin, Italy. 37. Mario Negri Institute for Pharmacological Research, Milan, Italy. 38. IRCCS Scientific Institute Ospedale San Raffaele, Milan, Italy. 39. Cancer Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
Abstract
INTRODUCTION:Docetaxel and erlotinib are registered second-line treatments for wild-type EGFR NSCLC. Previous studies suggested a predictive value of the VeriStrat test in second-line therapy of NSCLC, classifying patients as either VeriStrat good or VeriStrat poor. EMPHASIS-lung aimed at exploring this predictive effect in patients with squamous cell NSCLC. The trial closed prematurely because of low accrual and results from other trials. Our analysis includes an exploratory combined analysis with results from the PROSE trial. METHODS: EMPHASIS-lung was a randomized phase III multicenter trial exploring the differential effect of second-line erlotinib versus docetaxel on progression-free survival (PFS) in VeriStrat good versus VeriStrat poor patients with squamous cell NSCLC. RESULTS:A total of 80 patients were randomized, with 72.5% categorized as VeriStrat good. Patient characteristics were balanced between VeriStrat status and treatment groups. The median PFS times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 4.1 and 1.6 months, respectively, versus 1.9 and 2.1 months, respectively, in the VeriStrat poor cohort. The median overall survival (OS) times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 7.8 and 8.4 months, respectively, and 4.4 and 5.2 months, respectively, in the VeriStrat poor cohort. An additional exploratory analysis was performed; in it, 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis, contributing with 45 PFS and 41 OS events. CONCLUSIONS: The final analysis of EMPHASIS-lung did not show a differential effect on PFS for erlotinib versus docetaxel stratified by VeriStrat status. Similarly, in the combined analysis, no significant treatment by VeriStrat status interaction was observed (interaction p = 0.24 for PFS and 0.45 for OS, stratified by study).
RCT Entities:
INTRODUCTION:Docetaxel and erlotinib are registered second-line treatments for wild-type EGFRNSCLC. Previous studies suggested a predictive value of the VeriStrat test in second-line therapy of NSCLC, classifying patients as either VeriStrat good or VeriStrat poor. EMPHASIS-lung aimed at exploring this predictive effect in patients with squamous cell NSCLC. The trial closed prematurely because of low accrual and results from other trials. Our analysis includes an exploratory combined analysis with results from the PROSE trial. METHODS: EMPHASIS-lung was a randomized phase III multicenter trial exploring the differential effect of second-line erlotinib versus docetaxel on progression-free survival (PFS) in VeriStrat good versus VeriStrat poor patients with squamous cell NSCLC. RESULTS: A total of 80 patients were randomized, with 72.5% categorized as VeriStrat good. Patient characteristics were balanced between VeriStrat status and treatment groups. The median PFS times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 4.1 and 1.6 months, respectively, versus 1.9 and 2.1 months, respectively, in the VeriStrat poor cohort. The median overall survival (OS) times with docetaxel and erlotinib treatment in the VeriStrat good cohort were 7.8 and 8.4 months, respectively, and 4.4 and 5.2 months, respectively, in the VeriStrat poor cohort. An additional exploratory analysis was performed; in it, 47 patients from the squamous cell subgroup of PROSE were included in a combined analysis, contributing with 45 PFS and 41 OS events. CONCLUSIONS: The final analysis of EMPHASIS-lung did not show a differential effect on PFS for erlotinib versus docetaxel stratified by VeriStrat status. Similarly, in the combined analysis, no significant treatment by VeriStrat status interaction was observed (interaction p = 0.24 for PFS and 0.45 for OS, stratified by study).
Authors: Consuelo Buttigliero; Frances A Shepherd; Fabrice Barlesi; Brian Schwartz; Sergey Orlov; Adolfo G Favaretto; Armando Santoro; Vera Hirsh; Rodryg Ramlau; Adele R Blackler; Joanna Roder; David Spigel; Silvia Novello; Wallace Akerley; Giorgio V Scagliotti Journal: Oncologist Date: 2018-08-23
Authors: Siow Ming Lee; Sunil Upadhyay; Conrad Lewanski; Stephen Falk; Geraldine Skailes; Penella J Woll; Matthew Hatton; Rohit Lal; Richard Jones; Elizabeth Toy; Robin Rudd; Yenting Ngai; Alex Edwards; Allan Hackshaw Journal: Eur J Cancer Date: 2019-09-06 Impact factor: 9.162
Authors: Niki Karachaliou; Manuel Fernandez-Bruno; Jillian Wilhelmina Paulina Bracht; Rafael Rosell Journal: Transl Cancer Res Date: 2019-01 Impact factor: 1.241