The treatment algorithm below shows the ESMO recommended treatment pathway.1
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1. Casali PG, et al. Ann Oncol. 2022;33(1):20–33.
2. GLIVEC Summary of Product Characteristics. March 2023.
3. AYVAKYT Summary of Product Characteristics. June 2023.
4. SUTENT Summary of Product Characteristics. August 2021.
5. STIVARGA Summary of Product Characteristics. March 2023.
6. QINLOCK Summary of Product Characteristics. June 2023
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Line of therapy.
All lines in patients with PDGFRA mutations.
Indication
As monotherapy for the treatment of adult patients with unresectable or metastatic GIST harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.
Posology
Treatment should be continued until disease progression or unacceptable toxicity.
Line of therapy
Usually first line.
Indication
The treatment of adult patients with KIT (CD 117) positive unresectable and/or metastatic GIST.
(Also for adjuvant treatment after surgery).
Posology
In clinical trials, treatment with Glivec was continued until disease progression. At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months). The effect of stopping after achieving a response has not been investigated.
Line of therapy
Second.
Indication
The treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.
Posology
50 mg once daily, for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) a complete cycle of 6 weeks.
Line of therapy
Third.
Indication
For oncotherapy in adults with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
Posology
160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy. This 4-week cycle should continue as long as benefit is observed or until unacceptable toxicity occurs.
Line of therapy
Fourth.
Indication
Treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
Posology
Treatment with ripretinib should continue as long as benefit is observed or until unacceptable toxicity.
| LINK | CITATION | TITLE |
|---|---|---|
| PUBLICATION | Kang YK, et al. Lancet Oncol. 2021;39(28):3128–3139. | Avapritinib versus regorafenib in locally advanced unresectable or metastatic GI stromal tumor: a randomized, open-label phase III study. |
| PUBLICATION | Blanke CD, et al. J Clin Oncol. 2008;26(4):626–632. | Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. |
| PUBLICATION | Raut CP, et al. JAMA Oncol. 2018;4(12):e184060. | Efficacy and tolerability of 5-year adjuvant imatinib treatment for patients with resected intermediate- or high-risk primary gastrointestinal stromal tumor: the PERSIST-5 clinical trial. |
| PUBLICATION | Joensuu H, et al. J Clin Oncol. 2020;38(15_suppl):11503–11503. | Three versus one year of adjuvant imatinib for high-risk gastrointestinal stromal tumor (GIST): survival analysis of a randomized trial after 10 years of follow-up. |
| PUBLICATION | Casali P, et al. J Clin Oncol. 2017;35(15):1713–1720. | Ten-year progression-free and overall survival in patients with unresectable or metastatic GI stromal tumors: long-term analysis of the European Organisation for Research and Treatment of Cancer, Italian Sarcoma Group, and Australasian Gastrointestinal Trials Group Intergroup phase III randomized trial on imatinib at two dose levels. |
| PUBLICATION | Blay JY, et al. J Clin Oncol. 2007;25(9):1107–1113. | Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. |
| PUBLICATION | Kang YK, et al. Lancet Oncol. 2013;14(12):1175–1182. | Resumption of imatinib to control metastatic or unresectable gastrointestinal stromal tumours after failure of imatinib and sunitinib (RIGHT): a randomised, placebo-controlled, phase 3 trial. |
| PUBLICATION | Demetri GD, et al. Clin Cancer Res. 2012;18(11):3170–3179. | Complete longitudinal analyses of the randomized, placebo-controlled, phase III trial of sunitinib in patients with gastrointestinal stromal tumor following imatinib failure. |
| PUBLICATION | Demetri GD, et al. Lancet. 2013;381(9863):295–302. | Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib: an international, multicentre, prospective, randomised, placebo-controlled phase 3 trial (GRID). |
| PUBLICATION | Poole CD, et al. Gastric Cancer. 2015;18(3):627–634. | Health utility of patients with advanced gastrointestinal stromal tumors (GIST) after failure of imatinib and sunitinib: findings from GRID, a randomized, double-blind, placebo-controlled phase III study of regorafenib versus placebo. |
| PUBLICATION | Komatsu Y, et al. Int J Clin Oncol. 2015;20(5):905–912. | Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. |
| PUBLICATION | Blay JY, et al. Lancet Oncol. 2020;21(7):923–934. | Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. |
| PUBLICATION | Bauer S, et al. Clin Cancer Res. 2021;27(23):6333–6342. | Clinical activity of ripretinib in patients with advanced gastrointestinal stromal tumor harboring heterogeneous KIT/PDGFRA mutations in the phase III INVICTUS study. |
References
1. Casali PG, et al. Ann Oncol. 2022;33(1):20–33.
2. GLIVEC Summary of Product Characteristics. March 2023.
3. AYVAKYT Summary of Product Characteristics. June 2023.
4. SUTENT Summary of Product Characteristics. August 2021.
5. STIVARGA Summary of Product Characteristics. March 2023.
6. QINLOCK Summary of Product Characteristics. June 2023
Line of therapy.
All lines in patients with PDGFRA mutations.
Indication
As monotherapy for the treatment of adult patients with unresectable or metastatic GIST harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.
Posology
Treatment should be continued until disease progression or unacceptable toxicity.
Line of therapy
Usually first line.
Indication
The treatment of adult patients with KIT (CD 117) positive unresectable and/or metastatic GIST.
(Also for adjuvant treatment after surgery).
Posology
In clinical trials, treatment with Glivec was continued until disease progression. At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months). The effect of stopping after achieving a response has not been investigated.
Line of therapy
Second.
Indication
The treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.
Posology
50 mg once daily, for 4 consecutive weeks, followed by a 2-week rest period (Schedule 4/2) a complete cycle of 6 weeks.
Line of therapy
Third.
Indication
For oncotherapy in adults with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
Posology
160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy. This 4-week cycle should continue as long as benefit is observed or until unacceptable toxicity occurs.
Line of therapy
Fourth.
Indication
Treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
Posology
Treatment with ripretinib should continue as long as benefit is observed or until unacceptable toxicity.
| LINK | CITATION | TITLE |
|---|---|---|
| PUBLICATION | Kang YK, et al. Lancet Oncol. 2021;39(28):3128–3139. | Avapritinib versus regorafenib in locally advanced unresectable or metastatic GI stromal tumor: a randomized, open-label phase III study. |
| PUBLICATION | Blanke CD, et al. J Clin Oncol. 2008;26(4):626–632. | Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. |
| PUBLICATION | Raut CP, et al. JAMA Oncol. 2018;4(12):e184060. | Efficacy and tolerability of 5-year adjuvant imatinib treatment for patients with resected intermediate- or high-risk primary gastrointestinal stromal tumor: the PERSIST-5 clinical trial. |
| PUBLICATION | Joensuu H, et al. J Clin Oncol. 2020;38(15_suppl):11503–11503. | Three versus one year of adjuvant imatinib for high-risk gastrointestinal stromal tumor (GIST): survival analysis of a randomized trial after 10 years of follow-up. |
| PUBLICATION | Casali P, et al. J Clin Oncol. 2017;35(15):1713–1720. | Ten-year progression-free and overall survival in patients with unresectable or metastatic GI stromal tumors: long-term analysis of the European Organisation for Research and Treatment of Cancer, Italian Sarcoma Group, and Australasian Gastrointestinal Trials Group Intergroup phase III randomized trial on imatinib at two dose levels. |
| PUBLICATION | Blay JY, et al. J Clin Oncol. 2007;25(9):1107–1113. | Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. |
| PUBLICATION | Kang YK, et al. Lancet Oncol. 2013;14(12):1175–1182. | Resumption of imatinib to control metastatic or unresectable gastrointestinal stromal tumours after failure of imatinib and sunitinib (RIGHT): a randomised, placebo-controlled, phase 3 trial. |
| PUBLICATION | Demetri GD, et al. Clin Cancer Res. 2012;18(11):3170–3179. | Complete longitudinal analyses of the randomized, placebo-controlled, phase III trial of sunitinib in patients with gastrointestinal stromal tumor following imatinib failure. |
| PUBLICATION | Demetri GD, et al. Lancet. 2013;381(9863):295–302. | Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib: an international, multicentre, prospective, randomised, placebo-controlled phase 3 trial (GRID). |
| PUBLICATION | Poole CD, et al. Gastric Cancer. 2015;18(3):627–634. | Health utility of patients with advanced gastrointestinal stromal tumors (GIST) after failure of imatinib and sunitinib: findings from GRID, a randomized, double-blind, placebo-controlled phase III study of regorafenib versus placebo. |
| PUBLICATION | Komatsu Y, et al. Int J Clin Oncol. 2015;20(5):905–912. | Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. |
| PUBLICATION | Blay JY, et al. Lancet Oncol. 2020;21(7):923–934. | Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. |
| PUBLICATION | Bauer S, et al. Clin Cancer Res. 2021;27(23):6333–6342. | Clinical activity of ripretinib in patients with advanced gastrointestinal stromal tumor harboring heterogeneous KIT/PDGFRA mutations in the phase III INVICTUS study. |
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