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Alternating vs continuous FOLFIRI in advanced colorectal cancer (ACC): a randomized GISCAD trial

Abs 3505. Alternating vs continuous FOLFIRI in advanced colorectal cancer (ACC): a randomized GISCAD trial. Roberto Labianca Ospedali Riuniti – Bergamo, Italy. Floriani I, Cortesi E, Isa L, Zaniboni A, Marangolo M, Frontini L, Barni S, Beretta GD, Sobrero A. RATIONALE.

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Alternating vs continuous FOLFIRI in advanced colorectal cancer (ACC): a randomized GISCAD trial

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  1. Abs 3505 Alternating vs continuous FOLFIRI in advanced colorectal cancer (ACC): a randomized GISCAD trial Roberto Labianca Ospedali Riuniti – Bergamo, Italy Floriani I, Cortesi E, Isa L, Zaniboni A, Marangolo M, Frontini L, Barni S, Beretta GD, Sobrero A

  2. RATIONALE • Pre-clinical data (Sobrero, 2000) Intermittent (2 month pauses) vs continuous exposure of HCT-8 cell cultures to 5FU appears to double the time to the development of drug resistance • Clinical data (Douillard, 2000) FOLFIRI vs De Gramont RR 35% PFS 6.7 m OS 17.4 m

  3. AIM To evaluate whether intermittent FOLFIRI is at least as effective as continuous FOLFIRI (chemotherapy given until progression in both arms) in advanced, previously untreated, colorectal cancer patients

  4. ACCRUAL • First random: July, 2001 • Last random: June, 2005 • Total number of patients: 337 • Eligible patients: 331 (Arm A 163 / Arm B 168) • Participating centres: 27

  5. E V A L U A T I O N E V A L U A T I O N A FOLFIRI x 2 m FOLFIRI x 2 m STOP x 2 m RANDOM CR, PR, SD B FOLFIRI x 2 m FOLFIRI x 4 m II line (OHP) Every 4 m until PD PD

  6. ENDPOINTS Primary • Overall Survival (OS) Secondary • Progression Free Survival (PFS) • Toxicity

  7. INCLUSION CRITERIA • Histologically/cytologically proven ACC • No previous CT for advanced disease • Measurable disease • PS 0-2 (ECOG) / Age 18-75 yrs • No RT on target lesions • Normal renal, hepatic and bone marrow functions • Written informed consent

  8. EXCLUSION CRITERIA • Serious concomitant diseases • CNS metastases • Other malignancies • More than 4 weeks between screening and start of therapy

  9. STATISTICAL ASSUMPTIONS • Delta for accepting non inferiority of intermittent treatment: 4 mos (from a median survival of 15 mos to 11), which can be translated in an upper limit of 95% CI of the HR equal to 1.36 • Alpha: 2.5%, one-sided • Power : 80%, • Required events: 301 • Intention to treat on eligible patients

  10. PATIENT CHARACTERISTICS

  11. PATIENT CHARACTERISTICS

  12. TREATMENT COMPLIANCE

  13. OBJECTIVE RESPONSE

  14. PFS Median f-up: 30 m Median time to PD: Arm A 6.2 m Arm B 6.5 m Cox analysis (after adjustment for gender, age and site): HR: 1.01 (0.78-1.27)

  15. OS Median f-up: 30 m Median survival time: Arm A 16.9 m Arm B 17.6 m Cox analysis (after adjustment for gender, age and site): HR: 1.03 (0.78-1.35)

  16. II LINE THERAPY (%)

  17. CONCLUSIONS At the present time, our results suggest: • a non inferiority of intermittent versus continuous treatment for both PFS and OS • a similar toxicity profile We are planning further studies on this strategy, including also biologicals

  18. THANKS TO: • All our patients, who gave their precious contribution for advancing independent clinical research • The following centres, for their professional involvement:Bergamo(Beretta),Gorgonzola(Isa),Roma-Policlinico(Cortesi),Brescia(Zaniboni) ,Genova(Sobrero),Ravenna(Marangolo),Monza(Frontini),Treviglio(Barni),Avellino(Nicolella),Candiolo(Aglietta),Padova(Pasetto),Roma-FBF(Corsi),Lecco(Ucci),MI-Sacco(Piazza),Noale(D’Andrea),Faenza(Gambi),Roma-S.Andrea(Bossoni),Mantova(Aitini),Pesaro(Giordano),Biella(Clerico),Roma-Celio(Astorre),Sesto SG(Scanzi),MI-OSCB(Martignoni),Pavia(Bernardo),Bolzano(Graiff),Rho (Pavia),S.Donato Mil.(Luporini)

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