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Data Supporting Glivec Blood Level Testing

Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal Tumors (GIST)
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Facilitating the optimization of GLIVEC therapy with blood level testing

  • Data show that GLIVEC plasma levels differ substantially from patient to patient 1,2*
  • GLIVEC plasma trough levels above 1100 ng/mL have been shown to correlate with significantly better clinical outcomes 1,2
  • Blood level testing for patients with GIST may help optimize clinical benefit from GLIVEC 1,2


*Based on data from patients in both dosage groups (400 mg and 600mg).1,2

GLIVEC plasma trough levels above 1100 ng/mL have been shown to correlate with significantly better clinical outcomes1,2
  • Improved rates of clinical benefit were observed in patients with GLIVEC trough levels >1100 ng/mL 1,2
  • Lower rates of clinical benefit were associated with low GLIVEC trough levels (<1100 ng/mL) 1,2
  • Faster time to progression (TTP) was associated with GLIVEC trough levels <1100 ng/mL 1,2

Data show that GLIVEC plasma trough levels above 1100 ng/mL are important for achieving response to treatment1,2

  Overall clinical benefit rates by GLIVEC plasma trough levels in patients with GIST (by quartile)1*

Clinical Benefit Rates by Glivec Plasma Trough Levels in GIST Patients
A randomized phase II study (B2222), in which 147 patients with unresectable/metastatic KIT+ GIST were randomized 1:1 to GLIVEC at 400 mg/day versus 600 mg/day. GLIVEC plasma levels were analyzed in a subset of patients for whom PK at steady state (day 29) was available; 73 patients (n=34 at 400 mg/day; n=39 at 600 mg/day) were analyzed and grouped into quartiles according to GLIVEC trough plasma concentrations (TPC) (Q1: Cmin <1110 ng/mL; Q2+Q3: Cmin ≥1110 - <2040 ng/mL; Q4: Cmin ≥2040 ng/mL) for correlation with clinical outcomes. Correlation was tested between GLIVEC TPC quartiles and overall responses (OR=CR+PR), TTP, overall survival (OS), and KIT mutations.1 *Clinical benefit was defined as complete response (CR) plus partial response (PR) plus stable disease (SD).1
  Overall clinical benefit rates by GLIVEC plasma trough levels for GIST patients with KIT Exon 11 mutations (by quartile)2*
Clinical Benefit by Glivec Plasma Trough Levels for GIST Patients with KIT Exon 11 Mutations
The study description for the top chart above also applies to this chart. GLIVEC Cmin values were grouped into quartiles for the correlation analysis with KIT mutation status. Patients with KIT Exon 11 mutations demonstrated significantly better rates of clinical benefit in the upper quartiles (Q2-Q4) than in Quartile 1 (<1100 ng/mL; P=0.009).2 * Clinical benefit was defined as CR+PR+SD.2
GLIVEC blood level testing may help identify and manage inadequate trough levels

GIST ALLIANCE provides easy access to GLIVEC blood level testing

Find out how to access Glivec blood level testing for your GIST patients >>

References:

1.
Demetri GD, Wang Y, Wehrle E, Blanke C, Joensuu H, von Mehren M. Correlation of imatinib plasma levels with clinical benefit in patients (Pts) with unresectable/metastatic gastrointestinal stromal tumors (GIST). Presented at: ASCO Gastrointestinal Cancers Symposium; January 25-27, 2008; Orlando, FL. Abstract 3 and Slides.
2.
von Mehren M, Wang Y, Joensuu H, Blanke CD, Wehrle E, Demetri GD. Imatinib pharmacokinetics (PK) and its correlation with clinical response in patients with unresectable/metastatic gastrointestinal stromal tumor (GIST). J Clin Oncol. 2008;26(suppl):Abstract 4523.