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| © 2005 Elsevier Ltd. All rights reserved. |
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ECCO 13 - the European Cancer Conference
Paris, France, 30 October - 3 November 2005
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Abstract 713:
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| Interruption of Imatinib (IM) in responding patients after one year treatment does not influence overall survival of patients with advanced GIST: Updated results of the French Sarcoma Group randomized phase III BFR14 trial |
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Citation: European Journal of Cancer Supplements Volume 3, No. 2, October 2005, Page 202
A. Le Cesne1, I. Ray-Coquard2, B. Bui3, F. Duffaud4, N. Deligny5, D. Cupissol6, J.O. Bay7, C. Perol8, C. Delbaldo1, J.Y. Blay2
1Institut Gustave Roussy, Medecine, Villejuif, France
2Centre Léon Bérard, Medecine, Lyon, France
3Institut Bergonié, Medecine, Bordeaux, France
4La Timone, Medecine, Marseille, France
5Centre Oscar Lambret, Medecine, Lille, France
6Centre Val d'Aurelle, Medecine, Montpellier, France
7Centre Jean Perrin, Medecine, Clermont-Ferrand, France
8Centre Léon Bérard, Statistique, Lyon, France
Background: IM (Gleevec/Glivec®; Novartis Pharma) the front-line treatment (Tx) for advanced GIST seems to be given continuously until disease progression (PD) or intolerance. IM interruption in responding patients (pts) was significantly associated with a poor PFS. The impact of IM re-introduction was evaluated both on response and overall survival.
Methods: This prospective multicenter BFR14 study was initiated in June 2002. After 1 year of IM 400 mg/day, 58 pts free from progression were randomly offered to continue or interrupt Tx until PD. Pts allocated to the interruption (I) arm could restart IM (same dose) in case of PD. Primary endpoint was progression-free survival (PFS); secondary endpoints were OS, quality of life (QoL), secondary response after IM re-introduction, identification of molecular determinants of response. Survival data were compared using the log-rank test.
Results: Patient characteristics were well balanced between the two arms. Current median follow-up after inclusion and randomization are 21 and 12 months respectively. 24/32 pts (75%) in arm I versus 6/26 pts (23%) in continuous (C) arm experienced PD. (P < 10–4) with a median of 6 months (95% CI, 3–9) for arm I. IM reintroduction (median: 5.7 months after randomization) allowed tumor control (OR or SD) in 19/22 evaluated pts (86%). One-year OS rates were 93% and 95% for arms I and C, respectively (P = 0.6), with no significant difference in QoL.
Conclusions: IM reintroduction in GIST patients was safe and allowed a similar tumor control rate than in front-line treatment (86%). The one year OS rates were 93% and 95% for the experimental and control arms, respectively (p = 0.6) A transient interruption of IM in elderly patients will advanced GIST and/or in patients exhibiting a grade 3–4 toxicity could be a therapeutic option. GIST mutational analysis of the 58 randomized patients is ongoing. A new randomization (same schedule) is planned after 3 years of IM in non progressive patients
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