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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

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

slide2

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

slide3

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

slide4

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
slide5

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

slide6

ENDPOINTS

Primary

  • Overall Survival (OS)

Secondary

  • Progression Free Survival (PFS)
  • Toxicity
slide7

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
slide8

EXCLUSION CRITERIA

  • Serious concomitant diseases
  • CNS metastases
  • Other malignancies
  • More than 4 weeks between screening and start of therapy
slide9

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
slide16

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)

slide17

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)

slide19

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

slide20

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)