Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Imatinib alternating with regorafenib compared to imatinib alone for the first-line treatment of advanced gastrointestinal stromal tumor : The AGITG ALT-GIST intergroup randomized phase II trial: Clinical Studies

Yip, Desmond ; Zalcberg, John ; Blay, Jean Yves ; Eriksson, Mikael LU orcid ; Espinoza, David ; Price, Timothy ; Marreaud, Sandrine ; Italiano, Antoine ; Steeghs, Neeltje and Boye, Kjetil , et al. (2025) In British Journal of Cancer 132(10). p.897-904
Abstract

Background: To determine if an alternating regimen of the tyrosine kinase inhibitors imatinib and regorafenib improved outcomes in patients with advanced gastrointestinal stromal tumors. Methods: ALTGIST (NCT02365441) was a randomized phase II study of standard treatment of imatinib (Arm A) compared with an experimental alternating regimen of imatinib and regorafenib (Arm B). Primary outcome was best objective tumor response (OTR) at nine months. Results: Seventy-six eligible patients (Arm A 36, Arm B 40) enrolled were evaluable. Median follow-up was 46.0 months (range 6.5–64.6). Best responses and OTR were similar at 9 months. Eighteen (50.0%) Arm A patients and twelve (30.0%) Arm B patients discontinued treatment due to progressive... (More)

Background: To determine if an alternating regimen of the tyrosine kinase inhibitors imatinib and regorafenib improved outcomes in patients with advanced gastrointestinal stromal tumors. Methods: ALTGIST (NCT02365441) was a randomized phase II study of standard treatment of imatinib (Arm A) compared with an experimental alternating regimen of imatinib and regorafenib (Arm B). Primary outcome was best objective tumor response (OTR) at nine months. Results: Seventy-six eligible patients (Arm A 36, Arm B 40) enrolled were evaluable. Median follow-up was 46.0 months (range 6.5–64.6). Best responses and OTR were similar at 9 months. Eighteen (50.0%) Arm A patients and twelve (30.0%) Arm B patients discontinued treatment due to progressive disease. No Arm A patients stopped protocol therapy due to unacceptable toxicity, with 12 (30.0%) stopping in Arm B. Twelve (33.2%) Arm A patients and 12 (30.0%) Arm B patients experienced at least one serious adverse event, mostly grade 3. Secondary endpoints of PFS at 1 and OS at 1 year were not statistically different. Conclusions: Alternation of imatinib and regorafenib did not impact on 9 months objective response nor on the secondary objectives of PFS and OS. Patients in the alternating arm experienced more toxicity and protocol discontinuations. Clinical trial registration: NCT02365441.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
British Journal of Cancer
volume
132
issue
10
pages
8 pages
publisher
Nature Publishing Group
external identifiers
  • scopus:105001001781
  • pmid:40133509
ISSN
0007-0920
DOI
10.1038/s41416-025-02983-w
language
English
LU publication?
yes
id
04547d04-af44-4316-8bc8-7b1e4b51c41a
date added to LUP
2025-09-10 10:44:30
date last changed
2025-12-03 18:38:01
@article{04547d04-af44-4316-8bc8-7b1e4b51c41a,
  abstract     = {{<p>Background: To determine if an alternating regimen of the tyrosine kinase inhibitors imatinib and regorafenib improved outcomes in patients with advanced gastrointestinal stromal tumors. Methods: ALTGIST (NCT02365441) was a randomized phase II study of standard treatment of imatinib (Arm A) compared with an experimental alternating regimen of imatinib and regorafenib (Arm B). Primary outcome was best objective tumor response (OTR) at nine months. Results: Seventy-six eligible patients (Arm A 36, Arm B 40) enrolled were evaluable. Median follow-up was 46.0 months (range 6.5–64.6). Best responses and OTR were similar at 9 months. Eighteen (50.0%) Arm A patients and twelve (30.0%) Arm B patients discontinued treatment due to progressive disease. No Arm A patients stopped protocol therapy due to unacceptable toxicity, with 12 (30.0%) stopping in Arm B. Twelve (33.2%) Arm A patients and 12 (30.0%) Arm B patients experienced at least one serious adverse event, mostly grade 3. Secondary endpoints of PFS at 1 and OS at 1 year were not statistically different. Conclusions: Alternation of imatinib and regorafenib did not impact on 9 months objective response nor on the secondary objectives of PFS and OS. Patients in the alternating arm experienced more toxicity and protocol discontinuations. Clinical trial registration: NCT02365441.</p>}},
  author       = {{Yip, Desmond and Zalcberg, John and Blay, Jean Yves and Eriksson, Mikael and Espinoza, David and Price, Timothy and Marreaud, Sandrine and Italiano, Antoine and Steeghs, Neeltje and Boye, Kjetil and Underhill, Craig and Gebski, Val and Simes, John and Gelderblom, Hans and Joensuu, Heikki}},
  issn         = {{0007-0920}},
  language     = {{eng}},
  number       = {{10}},
  pages        = {{897--904}},
  publisher    = {{Nature Publishing Group}},
  series       = {{British Journal of Cancer}},
  title        = {{Imatinib alternating with regorafenib compared to imatinib alone for the first-line treatment of advanced gastrointestinal stromal tumor : The AGITG ALT-GIST intergroup randomized phase II trial: Clinical Studies}},
  url          = {{http://dx.doi.org/10.1038/s41416-025-02983-w}},
  doi          = {{10.1038/s41416-025-02983-w}},
  volume       = {{132}},
  year         = {{2025}},
}