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Randomized Controlled Trial
. 2024 Jul;131(2):299-304.
doi: 10.1038/s41416-024-02738-z. Epub 2024 Jun 11.

Survival of patients with ruptured gastrointestinal stromal tumour treated with adjuvant imatinib in a randomised trial

Heikki Joensuu  1 , Annette Reichardt  2 , Mikael Eriksson  3 , Peter Hohenberger  4 , Kjetil Boye  5 , Silke Cameron  6 , Lars H Lindner  7 , Philipp J Jost  8   9 , Sebastian Bauer  10   11 , Jochen Schütte  12   13 , Stefan Lindskog  14   15 , Raija Kallio  16 , Panu M Jaakkola  17 , Dorota Goplen  18 , Eva Wardelmann  19 , Peter Reichardt  2
Affiliations
Randomized Controlled Trial

Survival of patients with ruptured gastrointestinal stromal tumour treated with adjuvant imatinib in a randomised trial

Heikki Joensuu et al. Br J Cancer. 2024 Jul.

Abstract

Background: Patients with ruptured gastrointestinal stromal tumour (GIST) have poor prognosis. Little information is available about how adjuvant imatinib influences survival.

Methods: We explored recurrence-free survival (RFS) and overall survival (OS) of patients with ruptured GIST who participated in a randomised trial (SSG XVIII/AIO), where 400 patients with high-risk GIST were allocated to adjuvant imatinib for either 1 year or 3 years after surgery. Of the 358 patients with confirmed localised GIST, 73 (20%) had rupture reported. The ruptures were classified retrospectively using the Oslo criteria.

Results: Most ruptures were major, four reported ruptures were reclassified unruptured. The 69 patients with rupture had inferior RFS and OS compared with 289 patients with unruptured GIST (10-year RFS 21% vs. 55%, OS 59% vs. 78%, respectively). Three-year adjuvant imatinib did not significantly improve RFS or OS of the patients with rupture compared with 1-year treatment, but in the largest mutational subset with KIT exon 11 deletion/indel mutation OS was higher in the 3-year group than in the 1-year group (10-year OS 94% vs. 54%).

Conclusions: About one-fifth of ruptured GISTs treated with adjuvant imatinib did not recur during the first decade of follow-up. Relatively high OS rates were achieved despite rupture.

Clinical trial registration: NCT00116935.

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Conflict of interest statement

HJ has a consulting/advisory role in Orion Pharma, Neutron Therapeutics, and Maud Kuistila Foundation, has received research grants from Mersana Therapeutics and Defence Therapeutics, and has stock ownership in Orion Pharma and Sartar Therapeutics. ME has received consulting fees from Blueprint Medicines and institutional research funding from Novartis. PH has received honoraria and research support from Novartis. KB has had a consulting or advisory roles for Bayer, GSK, Incyte, Deciphera, and NEC Oncoimmunity; invited speaker roles for Lilly, Novartis, and Deciphera Pharmaceuticals, LLC; and institutional research funding from Lilly and Merck. PJJ has had a consulting or advisory role, received honoraria, research funding, and/or travel/accommodation expenses from Bayer, Boehringer, Novartis, Pfizer, Servier, Roche, BMS and Celgene, Pierre Fabre, Janssen/Johnson&Johnson, MSD, Merck, and AstraZeneca. SB has received institutional research funding from Blueprint Medicines, Incyte, and Novartis, honoraria from PharmaMar, Eli Lilly & Co, and Novartis, has an advisory role in Adcendo, Bayer, Blueprint Medicines, Böhringer Ingelheim, Daiichi Sankyo, Deciphera, Eli Lilly & Co, GSK, Exelixis, Nanobiotix, Novartis, and Roche, and has received travel support from PharmaMar. PMJ has received honoraria from Ipsen, MSD, and Orion Pharma. EW has received honoraria from Bayer, Novartis, Roche, Bristol Myers Squibb, and Boehringer Ingelheim. PR has received honoraria for participation in Advisory Boards for Bayer, Novartis, Roche, Deciphera, Mundibiopharma, PharmaMar, Blueprint Medicines, GSK, Boehringer Ingelheim and for lectures for Deciphera, PharmaMar, and Boehringer Ingelheim. The remaining authors declare no potential conflicts.

Figures

Fig. 1
Fig. 1
CONSORT diagram of the study population.
Fig. 2
Fig. 2. Survival outcomes of patients with and without tumour rupture.
Upper panel: recurrence-free survival; lower panel: overall survival. Five-year and 10-year survival rates are shown. Patients alive are indicated with a bar.
Fig. 3
Fig. 3. Influence of the duration of adjuvant imatinib on survival outcomes of patients with tumour rupture.
Upper panel: recurrence-free survival; lower panel: overall survival. Five-year and 10-year survival rates are shown. Patients alive are indicated with a bar.
Fig. 4
Fig. 4. Influence of the duration of adjuvant imatinib on survival outcomes of patients with KIT exon 11 deletion/indel mutation and with tumour rupture.
Upper panel: recurrence-free survival; lower panel: overall survival. Five-year and 10-year survival rates are shown. Patients alive are indicated with a bar.
See this image and copyright information in PMC

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