Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001–02)

T Aparicio,S Lavaudenes,Jeanmarc Phelip,E Maillard,J L Jouve,D Gargot,M Gasmi,Christophe Locher,Xavier Adhoute,P J Michel,F Khemissa,Thierry Lecomte,J Provencal,Gilles Breysacher,J L Legoux,Celine Lepere, J Charneau, J Cretin, L Chone,A Azzedine,Olivier Bouche,I Sobhani,L Bedenne,Emmanuel Mitry, For Ffcd Investigators, P Amoyal,D Auby,J B Bachet,Mathieu Baconnier, Robert Benoit, O Berthelet, A Bidault, C Bineau, Gilbert Bordes,N Bouarioua, E Boucher, O Boulat, Denis Cleau,Patrice Couzigou, Emmanuel Cuillerier, I Cumin,Bernard Denis,F Di Fiore, V Derias, J Ezenfis,R Faroux, A Gagnaire,Gilles Gatineausailliant, Bruce Rafael Mellado Garcia,D Genet, A Gueye,Pascal Hammel,Jean Paul Lagasse,Bruno Landi, C Lepage, Celine Lobry, C Lombardbohas, M Mabro, R Mackiewicz, J P Martin,Xavier Moncoucy, F Morvan, M U Mozer, M Pauwels,Fabien Petitlaurent, P Pouderoux, Patricia Prost, A M Queuniet, M Ramdani,Christine Rebischung,Philippe Rougier, M Schnee,J F Seitz, L Stefani, J Taieb, E Terrebonne, P Texereau, J Thaury,D Tougeron, A Weber,F Ricard, F Bonnetain, F Masskouri, C Choine, F Guiliani,G Le Pessec, H Fattouh, N Le Provost, C Girault, Med Dr Rer Soc Frank Schneider

Annals of Oncology（2016）

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摘要

Metastatic colorectal cancer (mCRC) frequently occurs in elderly patients. However, data from a geriatric tailored randomized trial about tolerance to and the efficacy of doublet chemotherapy (CT) with irinotecan in the elderly are lacking. The benefit of first-line CT intensification remains an issue in elderly patients. Elderly patients (75+) with previously untreated mCRC were randomly assigned in a 2 x 2 factorial design (four arms) to receive 5-FU (5-fluorouracil)-based CT, either alone (FU: LV5FU2 or simplified LV5FU2) or in combination with irinotecan [IRI: LV5FU2-irinotecan or simplified LV5FU2-irinotecan (FOLFIRI)]. The CLASSIC arm was defined as LV5FU2 or LV5FU2-irinotecan and the SIMPLIFIED arm as simplified LV5FU2 or FOLFIRI. The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), safety and objective response rate (ORR). From June 2003 to May 2010, 71 patients were randomly assigned to LV5FU2, 71 to simplified LV5FU2, 70 to LV5FU2-irinotecan and 70 to FOLFIRI. The median age was 80 years (range 75-92 years). No significant difference was observed for the median PFS: FU 5.2 months versus IRI 7.3 months, hazard ratio (HR) = 0.84 (0.66-1.07), P = 0.15 and CLASSIC 6.5 months versus SIMPLIFIED 6.0 months, HR = 0.85 (0.67-1.09), P = 0.19. The ORR was superior in IRI (P = 0.0003): FU 21.1% versus IRI 41.7% and in CLASSIC (P = 0.04): CLASSIC 37.1% versus SIMPLIFIED 25.6%. Median OS was 14.2 months in FU versus 13.3 months in IRI, HR = 0.96 (0.75-1.24) and 15.2 months in CLASSIC versus 11.4 months in SIMPLIFIED, HR = 0.71 (0.55-0.92). More patients presented grade 3-4 toxicities in IRI (52.2% versus 76.3%). In this elderly population, adding irinotecan to an infusional 5-FU-based CT did not significantly increase either PFS or OS. Classic LV5FU2 was associated with an improved OS compared with simplified LV5FU2. NCT00303771.

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关键词

elderly,colorectal cancer,chemotherapy,geriatric oncology

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