Phase II

Bumming, 2003⁵⁵

400 mg/d
[mean = 10.7 mo]

17
57 [10-74]
88% M

All patients were high risk or overtly malignant GIST (metastatic disease at presentation)

# of prior surgeries
0 = 1 pt
1-3 = 14 pts
> 4 = 2 pts

non-surgical therapy not stated

Tu response: CT RECIST or PET

Neoadjuvant

1

100% (5pts)

100%
(1 pt)

Adjuvant

5

Palliative

11

73%
(8 pts)

9%
(1 pt)

18%
(2 pts)

Retrospective reviews

Rutkowski, 2003⁵⁶

400-800 mg/d
[median followup 7 mos for patients receiving imatinib and 23 mo overall]

35
55  [36-79]
69% M

Patients with C-KIT+ GIST that had liver metastases as documented in the database; all patients underwent surgery

57% complete resection

17% microscopically incomplete resection

26% open biopsy only

Tu response: CT RECIST

Surgery

3

Imatinib

32

50%

37.5%

12.5%

Scaife, 2003⁵⁷

76% 400 mg  imatinib
6% 600 mg Imatinib
18% 800 mg imatinib

17
56 [35-76]
59% M

Unresectable intraabdominal c-KIT+ GISTS by CD117 immunohistochemisty.

Patients who received imatinib pre-operatively (neo-adjuvantly) and then underwent surgical exploration for tumor resection.

Tu response: Radiographic change on CT (criteria unclear), PET, or peri-operative pathological specimens;
Feasibility of surgical resection after treatment with imatinib.

CT:  17

6%

70%

18%

6%

PET:  17

55%

27%

2%

0%

[median followup from imatinib treatment to resection = 10mo; median followup after surgery = 6mos]

Pathology: 17

12%

65%

18%

6%

94% (complete resection)

Wu, 2003⁵⁸

400-800 mg/d
[median followup 18 mo with range 4-81]

57
61 [42-83]
51% M

Diagnosed with GIST and receiving a related surgical resection

OS: Kaplan- Meier
Tu response: criteria unclear

All patients who underwent surgery, regardless of use of imatinib.

57

82% complete resections

Patients who underwent surgery and were exposed to imatinib in the adjuvant (for high risk disease; N = 3) or palliative (metastatic disease at resection or relapse; N = 26) settings

29

Not clearly stated