J B Auliac1, C Chouaid2, L Greillier, L Greiller3, I Monnet4, H Le Caer5, L Falchero6, R Corre7, R Descourt8, S Bota9, H Berard10, R Schott11, A Bizieux12, P Fournel13, A Labrunie14, B Marin14, A Vergnenegre15. 1. Department of Pneumology, Quesnay Hospital, Mantes La Jolie, France. Electronic address: jb.auliac@ch-mantes-la-jolie.fr. 2. Department of Pneumology, Saint Antoine Hospital, Paris, France. 3. Multidisciplinary Oncology and Therapeutic Innovations, AP-HM, Marseilles, France. 4. Service de pneumologie, CHI, Creteil, France. 5. CH de Draguignan, Draguignan, France. 6. CH Villefranche Sur Saone, Villefranche-sur-Saone, France. 7. Pneumology, CHU Pontchaillou, Rennes, France. 8. CHU Morvan, Brest, France. 9. Hôpital Charles Nicolle, Rouen, France. 10. Pneumology, HIA, Toulon, France. 11. Centre Paul Strauss, Strasbourg, France. 12. CHD La Roche Sur Yon, La Roche Sur Yon, France. 13. Institut de Cancérologie de la Loire, Saint Priest En Jarez, France. 14. CEBIMER, CHU limoges, Limoges, France. 15. CHU Limoges, Limoges, France.
Abstract
BACKGROUND: Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer (NSCLC), but preliminary studies suggest that sequential administration might be effective. OBJECTIVE: To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC. METHODS: In an open-label phase II trial, patients with advanced NSCLC, EGFR wild-type or unknown, PS 0-2, in whom initialcisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d (day 2-16)+docetaxel (75 mg/m(2) d1) (arm ED) or docetaxel (75 mg/m(2) d1) alone (arm D) (21-day cycle). The primary endpoint was the progression-free survival rate at 15 weeks (PFS 15). Secondary endpoints included PFS, overall survival (OS), the overall response rate (ORR) and tolerability. Based on a Simon optimal two-stage design, the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages. RESULTS:147 patients were randomized (median age: 60±8 years, PS 0/1/2: 44/83/20 patients; males: 78%). The ED strategy was rejected, with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D, respectively, median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months. CONCLUSION:Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status.
RCT Entities:
BACKGROUND: Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer (NSCLC), but preliminary studies suggest that sequential administration might be effective. OBJECTIVE: To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC. METHODS: In an open-label phase II trial, patients with advanced NSCLC, EGFR wild-type or unknown, PS 0-2, in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d (day 2-16)+docetaxel (75 mg/m(2) d1) (arm ED) or docetaxel (75 mg/m(2) d1) alone (arm D) (21-day cycle). The primary endpoint was the progression-free survival rate at 15 weeks (PFS 15). Secondary endpoints included PFS, overall survival (OS), the overall response rate (ORR) and tolerability. Based on a Simon optimal two-stage design, the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages. RESULTS: 147 patients were randomized (median age: 60±8 years, PS 0/1/2: 44/83/20 patients; males: 78%). The ED strategy was rejected, with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D, respectively, median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months. CONCLUSION: Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status.
Authors: Takehito Shukuya; Keita Mori; Joseph M Amann; Erin M Bertino; Gregory A Otterson; Peter G Shields; Satoshi Morita; David P Carbone Journal: J Thorac Oncol Date: 2016-08-03 Impact factor: 15.609
Authors: Adrian D Vickers; Katherine B Winfree; Gebra Cuyun Carter; Urpo Kiiskinen; Min-Hua Jen; Donald Stull; James A Kaye; David P Carbone Journal: BMC Cancer Date: 2019-04-15 Impact factor: 4.430