Gastrointestinal stromal tumor

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 Eric Marks, MD
Boston University
Boston, MA
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 Elizabeth J. Davis, MD
Vanderbilt University
Nashville, TN
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11 regimens on this page
15 variants on this page


Guidelines

ESMO/EURACAN

Older

NCCN

Neoadjuvant therapy

Imatinib monotherapy

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Regimen

Study Evidence
Eisenberg et al. 2009 (RTOG 0132) Phase II

Biomarker eligibility criteria

  • Kit (CD117) positive

Targeted therapy

28-day cycle for 2 to 3 cycles; stopped on the day prior to surgery

Subsequent treatment

References

  1. RTOG 0132: Eisenberg BL, Harris J, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M. Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol. 2009 Jan 1;99(1):42-7. contains verified protocol link to PMC article PubMed
    1. Update: Wang D, Zhang Q, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M, Eisenberg BL. Phase II trial of neoadjuvant/adjuvant imatinib mesylate for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumors: long-term follow-up results of Radiation Therapy Oncology Group 0132. Ann Surg Oncol. 2012 Apr;19(4):1074-80. Epub 2011 Dec 28. Erratum in: Ann Surg Oncol. 2012 Jul;19(7):2420. link to PMC article PubMed

Adjuvant therapy

Imatinib monotherapy

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Regimen variant #1, 12 months of treatment

FDA-recommended dose
Study Years of enrollment Evidence Comparator Comparative Efficacy
Dematteo et al. 2009 (ACOSOG Z9001) 2002-2007 Phase III (E-RT-esc) Placebo Superior RFS
Joensuu et al. 2012 (SSG XVIII/AIO) 2004-2008 Phase III (C) Imatinib x 36 mos Seems to have inferior OS

Treatment is started within 12 weeks after surgery. While this is the FDA-recommended dose, it is noted that the optimal treatment duration is unknown.

Biomarker eligibility criteria

  • Kit (CD117) positive

Preceding treatment

Targeted therapy

12-month course

Regimen variant #2, 2 years of treatment

Study Evidence
Eisenberg et al. 2009 (RTOG 0132) Phase II

Biomarker eligibility criteria

  • Kit (CD117) positive

Preceding treatment

Targeted therapy

2-year course

Regimen variant #3, 3 years of treatment

FDA-recommended dose
Study Years of enrollment Evidence Comparator Comparative Efficacy
Joensuu et al. 2012 (SSG XVIII/AIO) 2004-2008 Phase III (E-RT-esc) Imatinib x 12 mos Seems to have superior OS

Treatment is to be started within 12 weeks after surgery. While this is the FDA-recommended dose, it is noted that the optimal treatment duration is unknown.

Biomarker eligibility criteria

  • Kit (CD117) positive

Preceding treatment

Targeted therapy

36-month course

References

  1. RTOG 0132: Eisenberg BL, Harris J, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M. Phase II trial of neoadjuvant/adjuvant imatinib mesylate (IM) for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumor (GIST): early results of RTOG 0132/ACRIN 6665. J Surg Oncol. 2009 Jan 1;99(1):42-7. contains verified protocol link to PMC article PubMed
    1. Update: Wang D, Zhang Q, Blanke CD, Demetri GD, Heinrich MC, Watson JC, Hoffman JP, Okuno S, Kane JM, von Mehren M, Eisenberg BL. Phase II trial of neoadjuvant/adjuvant imatinib mesylate for advanced primary and metastatic/recurrent operable gastrointestinal stromal tumors: long-term follow-up results of Radiation Therapy Oncology Group 0132. Ann Surg Oncol. 2012 Apr;19(4):1074-80. Epub 2011 Dec 28. Erratum in: Ann Surg Oncol. 2012 Jul;19(7):2420. link to PMC article PubMed
  2. ACOSOG Z9001: Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. Epub 2009 Mar 18. link to original article contains verified protocol link to PMC article PubMed
  3. SSG XVIII/AIO: Joensuu H, Eriksson M, Sundby Hall K, Hartmann JT, Pink D, Schütte J, Ramadori G, Hohenberger P, Duyster J, Al-Batran SE, Schlemmer M, Bauer S, Wardelmann E, Sarlomo-Rikala M, Nilsson B, Sihto H, Monge OR, Bono P, Kallio R, Vehtari A, Leinonen M, Alvegård T, Reichardt P. One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial. JAMA. 2012 Mar 28;307(12):1265-72. link to original article contains verified protocol PubMed
    1. Update: Joensuu H, Eriksson M, Sundby Hall K, Reichardt A, Hartmann JT, Pink D, Ramadori G, Hohenberger P, Al-Batran SE, Schlemmer M, Bauer S, Wardelmann E, Nilsson B, Sihto H, Bono P, Kallio R, Junnila J, Alvegård T, Reichardt P. Adjuvant imatinib for high-risk GI stromal tumor: analysis of a randomized trial. J Clin Oncol. 2016 Jan 20;34(3):244-50. Epub 2015 Nov 2. link to original article PubMed

Metastatic or unresectable disease

Avapritinib monotherapy

Regimen

FDA-recommended dose
Study Evidence
Heinrich et al. 2019 (NAVIGATOR) Phase I

Patients in this study either had the PDGFRA D842V mutation or already had treatment failure with imatinib and ≥1 additional tyrosine kinase inhibitor

Biomarker eligibility criteria

  • Gene: PDGFRA
  • Alteration: D842V

Chemotherapy

Avapritinib (Ayvakit) 300 mg PO once per day on an empty stomach (at least 1 hour before and 2 hours after a meal)

Continued indefinitely

References

  1. Abstract: Heinrich MC, Jones RL, Von Mehren M, Bauer S, Kang YK, Schoffski P, Eskens F, Mir O, Cassier PA, Serrano C, Tap WD, Trent JC, Rutkowski P, Patel S, Chawla SP, Meiri E, Zhou T, Mamlouk KK, Roche M, George S. Clinical activity of avapritinib in ≥ fourth-line (4L+) and PDGFRA Exon 18 gastrointestinal stromal tumors (GIST). J Clin Oncol. 2019 May 20. link to abstract

Imatinib monotherapy

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Regimen variant #1, standard-dose (400 mg/day)

FDA-recommended dose
Study Years of enrollment Evidence Comparator Comparative Efficacy
Demetri et al. 2002 2000-2001 Phase III (C) Imatinib; higher-dose (600 mg/day) Did not meet primary endpoint of ORR
Verweij et al. 2004 (EORTC 62005) 2001-2002 Phase III (C) Imatinib; high-dose Did not meet primary endpoint of PFS (*)
Blay et al. 2007 (BFR14) 2002-2004 Phase III (C) 1. Imatinib; 1 year
2. Imatinib; 3 years 		Superior PFS
Blanke et al. 2015 (SWOG S0502) 2008-2009 Phase III (C) Bevacizumab & Imatinib Not reported
Blay et al. 2015 (ENESTg1) 2009-2011 Phase III (C) Nilotinib Superior PFS
Kang et al. 2013 (RIGHT) 2010-2013 Phase III (E-esc) Placebo Superior PFS

Note: Efficacy reported for EORTC 62005 is based on the 2017 update. BFR14 had two separate comparisons, to one year and to three years of imatinib versus continuous (this arm); the efficacy outcome was the same in both reports.

Targeted therapy

Continued indefinitely

Regimen variant #2, higher-dose (600 mg/day)

Study Years of enrollment Evidence Comparator Comparative Efficacy
Demetri et al. 2002 2000-2001 Phase III (E-esc) Imatinib; standard-dose (400 mg/day) Did not meet primary endpoint of ORR

Targeted therapy

Continued indefinitely

Regimen variant #3, high-dose (800 mg/day)

Study Years of enrollment Evidence Comparator Comparative Efficacy
Van Oosterom et al. 2001 2000 Phase 1, <20 pts in this cohort
Verweij et al. 2003 NR Phase II
Verweij et al. 2004 (EORTC 62005) 2001-2002 Phase III (E-RT-esc) Imatinib; standard-dose Did not meet primary endpoint of PFS (*)
Blanke et al. 2008 (SWOG S0033) 2001-2002 Phase III (E-RT-esc) Imatinib; standard-dose with pre-planned dose-escalation at progression Did not meet primary endpoints of PFS/OS
Blanke et al. 2015 (SWOG S0502) 2008-2009 Phase III (C) Bevacizumab & Imatinib Not reported
Blay et al. 2015 (ENESTg1) 2009-2011 Phase III (C) Nilotinib Superior PFS

Note: this was the MTD in Van Oosterom et al. 2001. In some studies, high-dose imatinib was offered to patients with KIT exon 9 mutations in ENESTg1 and SWOG S0502; all other patients received standard-dose imatinib. Efficacy reported for EORTC 62005 is based on the 2017 update.

Targeted therapy

Continued indefinitely

Protocol variant #4, standard-dose with pre-planned dose-escalation at progression

Study Years of enrollment Evidence Comparator Comparative Efficacy
Blanke et al. 2008 (SWOG S0033) 2001-2002 Phase III (C) Imatinib; high-dose (800 mg/day) Did not meet primary endpoints of PFS/OS

Targeted therapy

Continued indefinitely

Patients who progressed could receive high-dose therapy, as follows:

Targeted therapy

Continued indefinitely

References

  1. Phase 1: van Oosterom AT, Judson I, Verweij J, Stroobants S, Donato di Paola E, Dimitrijevic S, Martens M, Webb A, Sciot R, Van Glabbeke M, Silberman S, Nielsen OS; EORTC Soft Tissue and Bone Sarcoma Group. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. Lancet. 2001 Oct 27;358(9291):1421-3. link to original article contains protocol PubMed
  2. Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80. link to original article contains verified protocol PubMed
  3. Verweij J, van Oosterom A, Blay JY, Judson I, Rodenhuis S, van der Graaf W, Radford J, Le Cesne A, Hogendoorn PC, di Paola ED, Brown M, Nielsen OS; EORTC Soft Tissue and Bone Sarcoma Group. Imatinib mesylate (STI-571 Glivec, Gleevec) is an active agent for gastrointestinal stromal tumours, but does not yield responses in other soft-tissue sarcomas that are unselected for a molecular target: results from an EORTC Soft Tissue and Bone Sarcoma Group phase II study. Eur J Cancer. 2003 Sep;39(14):2006-11. link to original article contains verified protocol PubMed
  4. EORTC 62005: Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34. link to original article contains protocol PubMed
    1. Update: Zalcberg JR, Verweij J, Casali PG, Le Cesne A, Reichardt P, Blay JY, Schlemmer M, Van Glabbeke M, Brown M, Judson IR; EORTC Soft Tissue and Bone Sarcoma Group; Italian Sarcoma Group; Australasian Gastrointestinal Trials Group. Outcome of patients with advanced gastro-intestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg. Eur J Cancer. 2005 Aug;41(12):1751-7. link to original article PubMed
    2. Update: Casali PG, Zalcberg J, Le Cesne A, Reichardt P, Blay JY, Lindner LH, Judson IR, Schöffski P, Leyvraz S, Italiano A, Grünwald V, Pousa AL, Kotasek D, Sleijfer S, Kerst JM, Rutkowski P, Fumagalli E, Hogendoorn P, Litière S, Marreaud S, van der Graaf W, Gronchi A, Verweij J; EORTC Soft Tissue and Bone Sarcoma Group; Italian Sarcoma Group; Australasian Gastrointestinal Trials Group. 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. J Clin Oncol. 2017 May 20;35(15):1713-1720. Epub 2017 Mar 31. link to original article PubMed
  5. BFR14: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D; French Sarcoma Group. 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. J Clin Oncol. 2007 Mar 20;25(9):1107-13. link to original article contains protocol PubMed
    1. Update: Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Pérol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. Epub 2010 Sep 21. link to original article contains protocol PubMed
  6. SWOG S0033: Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. 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. J Clin Oncol. 2008 Feb 1;26(4):626-32. link to original article contains verified protocol PubMed
  7. Meta-analysis: Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010 Mar 1;28(7):1247-53. Epub 2010 Feb 1. link to original article link to PMC article PubMed
  8. RIGHT: Kang YK, Ryu MH, Yoo C, Ryoo BY, Kim HJ, Lee JJ, Nam BH, Ramaiya N, Jagannathan J, Demetri GD. 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. Lancet Oncol. 2013 Nov;14(12):1175-82. Epub 2013 Oct 18. link to original article link to PMC article contains verified protocol PubMed NCT01151852
  9. ENESTg1: Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Pápai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. Epub 2015 Apr 14. link to original article link to PMC article contains verified protocol PubMed NCT00785785
  10. SWOG S0502: Blanke CD, Rankin C, Corless C, Eary JF, Mulder K, Okuno SH, George S, Heinrich M. S0502: A SWOG phase III randomized study of imatinib, with or without bevacizumab, in patients with untreated metastatic or unresectable gastrointestinal stromal tumors. Oncologist. 2015 Dec;20(12):1353-4. Epub 2015 Nov 17. contains verified protocol link to PMC article PubMed


Linsitinib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Von Mehren et al. 2020 2012-2013 Phase II

Patients in this study had wild-type GIST and had previously failed treatment with at least one prior TKI

Targeted therapy

  • Linsitinib 150mg PO twice daily

Continued indefinitely

References

  1. Von Mehren M, George S, Heinrich M, Schuetze S, Yap J, Yu J, Abbott A, Litwin S, Crowley J, Belinsky M, Janeway K, Hornick J, Flieder D, Chugh R, Rink L, Van den Abbeele A; Linsitinib (OSI-906) for the Treatment of Adult and Pediatric Wild-Type Gastrointestinal Stromal Tumors, a SARC Phase II Study. Clin Cancer Res. 2020 April; 15;26(8):1837-1845.Epub 2019 Dec 2. link to original article Pubmed NCT01560260

Regorafenib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Demetri et al. 2012 (GRID) 2011 Phase III (E-RT-esc) Placebo Superior PFS

Patients in this study already had treatment failure with imatinib and sunitinib.

Targeted therapy

28-day cycles

References

  1. GRID: Demetri GD, Reichardt P, Kang YK, Blay JY, Rutkowski P, Gelderblom H, Hohenberger P, Leahy M, von Mehren M, Joensuu H, Badalamenti G, Blackstein M, Le Cesne A, Schöffski P, Maki RG, Bauer S, Nguyen BB, Xu J, Nishida T, Chung J, Kappeler C, Kuss I, Laurent D, Casali PG; GRID study investigators. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):295-302. Epub 2012 Nov 22. contains verified protocol link to PMC article PubMed

Pazopanib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Mir et al. 2016 (PAZOGIST) 2011-2013 Randomized Phase II (E-esc) Best supportive care Seems to have superior PFS

Targeted therapy

Continued indefinitely

References

  1. PAZOGIST: Mir O, Cropet C, Toulmonde M, Cesne AL, Molimard M, Bompas E, Cassier P, Ray-Coquard I, Rios M, Adenis A, Italiano A, Bouché O, Chauzit E, Duffaud F, Bertucci F, Isambert N, Gautier J, Blay JY, Pérol D; PAZOGIST study group of the French Sarcoma Groupe-Groupe d'Etude des Tumeurs Osseuses (GSF-GETO). Pazopanib plus best supportive care versus best supportive care alone in advanced gastrointestinal stromal tumours resistant to imatinib and sunitinib (PAZOGIST): a randomised, multicentre, open-label phase 2 trial. Lancet Oncol. 2016 May;17(5):632-41. Epub 2016 Apr 5. link to original article contains protocol PubMed NCT01323400

Regorafenib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Demetri et al. 2012 (GRID) 2011 Phase III (E-RT-esc) Placebo Superior PFS

Patients in this study already had treatment failure with imatinib and sunitinib.

Targeted therapy

28-day cycles

References

  1. GRID: Demetri GD, Reichardt P, Kang YK, Blay JY, Rutkowski P, Gelderblom H, Hohenberger P, Leahy M, von Mehren M, Joensuu H, Badalamenti G, Blackstein M, Le Cesne A, Schöffski P, Maki RG, Bauer S, Nguyen BB, Xu J, Nishida T, Chung J, Kappeler C, Kuss I, Laurent D, Casali PG; GRID study investigators. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):295-302. Epub 2012 Nov 22. contains verified protocol link to PMC article PubMed

Ripretinib monotherapy

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Regimen

FDA-recommended dose
Study Years of enrollment Evidence Comparator Comparative Efficacy
Blay et al. 2020 (INVICTUS) 2018 Phase III (E-RT-esc) Placebo Superior PFS

Targeted therapy

Continued indefinitely

References

  1. INVICTUS: Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schöffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. Epub 2020 Jun 5. Erratum in: Lancet Oncol. 2020 Jul;21(7):e341. link to original article contains protocol PubMed NCT03353753

Sorafenib monotherapy

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Regimen

Study Evidence
Kindler et al. 2011 Phase II
Park et al. 2012 Phase II

Targeted therapy

Continued indefinitely

References

  1. Abstract: Kindler HL, Campbell NP, Wroblewski K, Maki RG, D’Adamo DR, Chow WA, Gandara DR, Antonescu C, Stadler WM, Vokes EE. Sorafenib (SOR) in patients (pts) with imatinib (IM) and sunitinib (SU)-resistant (RES) gastrointestinal stromal tumors (GIST): Final results of a University of Chicago Phase II Consortium trial. 2011. 29 (15_suppl) 10009-10009. link to original article (abstract only)
  2. Park SH, Ryu MH, Ryoo BY, Im SA, Kwon HC, Lee SS, Park SR, Kang BY, Kang YK; Korean gastrointestinal stromal tumors study group. Sorafenib in patients with metastatic gastrointestinal stromal tumors who failed two or more prior tyrosine kinase inhibitors: a phase II study of Korean gastrointestinal stromal tumors study group. Invest New Drugs. 2012 Dec; 30(6) 2377-83. Epub 2012 Jan 25.link to original article PubMed

Sunitinib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Demetri et al. 2006 (A6181004) 2003-2005 Phase III (E-RT-esc) Placebo Superior TTP
Adenis et al. 2014 2009-2011 Randomized Phase II (C) Masitinib Seems to have inferior OS

Patients had treatment failure with imatinib.

Targeted therapy

  • Sunitinib (Sutent) 50 mg PO once per day on days 1 to 28
    • Dose may be decreased to 37.5 mg or 25 mg depending on tolerability

42-day cycles

References

  1. A6181004: Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. link to original article contains verified protocol PubMed
    1. Update: Demetri GD, Garrett CR, Schöffski P, Shah MH, Verweij J, Leyvraz S, Hurwitz HI, Pousa AL, Le Cesne A, Goldstein D, Paz-Ares L, Blay JY, McArthur GA, Xu QC, Huang X, Harmon CS, Tassell V, Cohen DP, Casali PG. Complete longitudinal analyses of the randomized, placebo-controlled, phase III trial of sunitinib in patients with gastrointestinal stromal tumor following imatinib failure. Clin Cancer Res. 2012 Jun 1;18(11):3170-9. link to original article link to PMC article PubMed
  2. Adenis A, Blay JY, Bui-Nguyen B, Bouché O, Bertucci F, Isambert N, Bompas E, Chaigneau L, Domont J, Ray-Coquard I, Blésius A, Van Tine BA, Bulusu VR, Dubreuil P, Mansfield CD, Acin Y, Moussy A, Hermine O, Le Cesne A. Masitinib in advanced gastrointestinal stromal tumor (GIST) after failure of imatinib: a randomized controlled open-label trial. Ann Oncol. 2014 Sep;25(9):1762-9. Epub 2014 Jul 25. link to original article link to PMC article PubMed
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