Time to secondary resistance (TSR) after interruption of imatinib: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival.

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Abstracts

2009 ASCO Annual Meeting

Time to secondary resistance (TSR) after interruption of imatinib: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival.

Sub-category:

Gastrointestinal Stromal Tumors

Category:

Sarcoma

Meeting:

2009 ASCO Annual Meeting

Session Type and Session Title:

Oral Presentation, Sarcoma

Abstract No:

10508

Citation:

J Clin Oncol 27:15s, 2009 (suppl; abstr 10508)

Author(s):

F. Duffaud, I. Ray-Coquard, B. Bui, A. Adenis, M. Rios, F. Bertucci, S. Chabaud, D. Perol, J. Blay, A. LeCesne, French Sarcoma Group; Hôpital la Timone, Marseille, France; Centre Léon Berard, Lyon, France; Institut Bergonié, Bordeaux, France; Centre Oscar Lambret, Lille, France; Centre Alexis Vautrin, Nancy, France; Institut Paoli-Calmettes, Marseille, France; Institut Gustave Roussy, Villejuif, France

Abstract:

Background: We previously demonstrated that imatinib mesylate (IM, Gleevec/Glivec; Novartis Pharma) must not be interrupted after 1 and 3 years (yr) in responding patients (pts) and has to be given continuously until disease progression (PD) or intolerance. The impact of IM re-introduction at progression remains unknown regarding the impact of the interruption on the TSR. Methods: This prospective national multicenter BFR14 study was initiated in June 2002. After 1, 3, and 5 yrs of IM 400mg/day, pts free from progression were randomly offered to continue (C arm) or interrupt (I arm) IM. Pts allocated to the I arm could restart IM (same dose) in case of PD. Primary endpoint was PFS. Pts declining randomization proceed with IM. Results: As of December 2008, 415 pts were included in this trial. Fifty-eight, 50 and 12 (ongoing) non progressive pts at 1, 3 and 5 yrs respectively were randomized in the I and C arm. Pt characteristics were well balanced between the two arms. The median time to progression (TTP) were 7.3 months (m) (rate of relapse: 91% of pts) and 9.4 m (rate of relapse: 84%) in the I arms after 1 and 3 years of treatment. In contrast the median TTP were 31.4 m and not reached in the C arms after 1 and 3 yrs of IM treatment respectively. IM reintroduction in the I arm after a re-progression allowed again a tumor control in 93% (43/46) of pts. The median follow-up from randomization is 56 m and 25 m at 1 and 3 yrs respectively. TSR after randomization to IM (first progression in the C arm, 2^nd progression in the I arm) was not significantly different between the two arms (the 2-yrs TSR is similar in both arms 63% and 62% in the I and C arm respectively for the 1-yr randomization, 83.5% and 84.3% for the 3-yr randomization) but the rate of secondary resistance decrease over time in both arms: 40% or relapse in the 2 yrs following the 1 yr randomization vs less than 20% or relapse in the 2 yrs following the 3-yrs randomization. Conclusions: The majority of responding pts relapsed when IM was stopped after 1 and 3 yrs of treatment but response is reinduced in 93% of patients after IM reintroduction. TSR was not significantly affected by treatment interruption in this series of pts.

Abstract Disclosures

Faculty and Discussant Disclosures

Annual Meeting Planning Committee Disclosures

2009 Annual Meeting Proceedings Part I Errata

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy and are designated with a caret symbol (^) here and in the print version.

Associated Presentation(s):

1. Time to secondary resistance (TSR) after interruption of Imatinib: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival

Meeting: 2009 ASCO Annual Meeting
Presenter: Florence Duffaud, MD
Session: Sarcoma (Oral Presentation)

Other Abstracts in this Sub-Category:

		1. In vitro activity of sorafenib against imatinib- and sunitinib-resistant kinase mutations associated with drug-resistant GI stromal tumors. Meeting: 2009 ASCO Annual Meeting Abstract No: 10500 First Author: M. C. Heinrich Category: Sarcoma - Gastrointestinal Stromal Tumors
		2. Evaluation of the presence of IGF1R overexpression in wild-type and kinase mutant GI stromal tumors. Meeting: 2009 ASCO Annual Meeting Abstract No: 10506 First Author: C. L. Corless Category: Sarcoma - Gastrointestinal Stromal Tumors
		3. Masatinib mesylate in imatinib-naive locally advanced or metastatic gastrointestinal stromal tumor (GIST): Results of the French Sarcoma Group phase II trial. Meeting: 2009 ASCO Annual Meeting Abstract No: 10507 First Author: A. Le Cesne Category: Sarcoma - Gastrointestinal Stromal Tumors
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Abstracts by F. Duffaud:

		1. 5-fluorouracil in head and neck cancer patients: A population pharmacokinetics study. Meeting: 2010 ASCO Annual Meeting Abstract No: e13098 First Author: C. Mercier Category: Developmental Therapeutics - Clinical Pharmacology and Immunotherapy - Pharmacology/Pharmacokinetics
		2. A national registry for the off-label use of targeted therapies in patients (pts) with malignant mesenchymal tumors: A retrospective study from the GSF-GETO. Meeting: 2010 ASCO Annual Meeting Abstract No: 10097 First Author: J. Bay Category: Sarcoma - Soft Tissue
		3. Antitumor activity of pemetrexed (Pem) in second-line advanced/metastatic osteosarcomas: A multicenter phase II study. Meeting: 2010 ASCO Annual Meeting Abstract No: 10076 First Author: N. Bin Bui Category: Sarcoma - Bone Tumors
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Presentations by F. Duffaud:

		1. Gastrointestinal stromal tumor (GIST) of the rectum and pararectal space: A French Sarcoma Group (FSG) retrospective review. Meeting: 2010 ASCO Annual Meeting Presenter: Florence Duffaud Session: Sarcoma (General Poster Session)
		2. Time to secondary resistance (TSR) after interruption of Imatinib: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival Meeting: 2009 ASCO Annual Meeting Presenter: Florence Duffaud, MD Session: Sarcoma (Oral Presentation)
		3. A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). Meeting: 2008 ASCO Annual Meeting Presenter: Florence Duffaud, MD, PhD Session: Sarcoma (Oral Presentation)
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Educational Book Manuscripts by F. Duffaud:

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