Summary of clinical trials where imatinib mesylate (Gleevec, Novartis) was tested in patients with adenoid cystic carcinoma of salivary glands
| Type of trial | Enrolled patients | c-KIT expression by IHC | KIT or PDFRA mutations | Imatinib dose | Results | Reference |
| Multicentre single arm, two stage phase II clinical trial | Patients (N=16) with unresectable or metastatic AdCC | Present | NP | 400 mg×2 daily | No evidence of objective response in 15 assessable patients. Early termination after completion of the first stage | Hotte et al, 2005107 |
| Phase II study with combination of imatinib mesylate and cisplatin | N=14 | Present | NP | 800 mg as single agent; 400 mg in combination with cisplatin 80 mg/m2 | Of the 12 assessable patients, 2 developed DP with imatinib as single agent and left the study; 1 had a documented PR; 4 had reduction in tumour size; the others showed SD (but short follow-up) | Slevin et al, 2004108 |
| Pilot study | Patients (N=5) with metastatic AdCC | Present | No | 400 mg×2 daily | DP in 2/5; DOD in 3/5. | Lin et al, 2005105 |
| Phase II study for advanced AdCC of head and neck salivary glands | Patients (N= 10) with locally advanced or metastatic AdCC | Present | NP | 400 mg (increased to 600 mg in 3 patients and to 800 mg in 1 patient) | 2/10 patients with SD; 8/10 patients stopped the treatment after 2–14 months due to DP | Pfeffer et al, 2007106 |
| Multicentre phase II trial | Patients (N=8) with recurrent or metastatic AdCC | Present | NP | 400 mg×2 daily | Among the 6 assessable patients, 3 showed SD after 3 months of follow-up, one had a PR | Faivre et al, 2005104 |
DOD, death of disease; DP, disease progression; IHC, immunohistochemistry; NP, not performed; PR, partial response; SD, stable disease.