Technology Assessment: Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy, Part 2. Imatinib for Gastrointestinal Stromal Tumors (GISTs). Table 8

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Table 8. Tumor Characteristics Predictive of Disease Response or Survival

Characteristic	Prognostic Factor	Studies Indicating an Association and Quality	Strength of Association with Tumor Response	Strength of Association with Survival
c-kit mutation	c-kit mutation present vs. absent	Debiec-Rychter, et al., 2004 (quality = 6/6)⁵⁹	TTP: patients with C kit mutations less likely to progress (p = 0.03)	patients with c-kit mutations with longer OS (p = 0.015)
	Exon 11 mutation	Debiec-Rychter, et al., 2004 (quality = 6/6)⁵⁹ Heinrich, et al., 2003 (quality = 6/6)⁴⁷	EFS: c-kit exon 11 mutation with median EFS 849d; all other mutations EFS 327d HR 0.17 (0.10-0.29) p < 0.0001^a	HR 0.04 (0.01-0.12) p < 0.0001^a
	Exon 9 mutation	Heinrich, et al., 2003 (quality = 6/6)⁴⁷		HR 0.31(0.11-0.89) p = 0.0289^a
Other genes	Gene SPRY4 (found to be downregulated by imatinib in in vitro pre-clinical studies)	Frolov, et al., 2003 (quality = 1/6)⁶⁰	SPRY4 was "dramatically" decreased in 4/5 patients with PR, expressed at high levels in the 2/2 non-responders, and initially decreased then returned to high levels in the 1/5 PR patient who had an early relapse
Other genes	Gene MAFbx (found to be upregulated by imatinib in in vitro pre-clinical studies)	Frolov, et al., 2003 (quality = 1/6)⁶⁰	Variable responses (2/5 PR patients had included levels of MAFbx; initially increased and then returned to pre-treatment levels in the patient with PR but early relapse; not changed at all in the one PD patient)
Pathology	GIST vs. other STS	Verweij, et al., 2003 (quality = 6/6)⁴⁸	GIST with 73% DFS at 1yr Median TTP STS = 58d

Abbreviations: TTP = time to progression; OS = overall survival; EFS = event free survival; HR = hazard ratio; STS = soft tissue sarcomas; DFS = disease-free survival.

Note:
^a. In this study hazard rations greater than one are predictive of poorer prognosis.

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