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Overview Recently Resected Patient Extending Adjuvant GLIVEC Recurrence Post Adjuvant Therapy Metastatic Patient With Progression After GI/Surgeon Diagnosis About GIST
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KIT+ GIST : Recently Resected Patient

Recently Resected Patient/GLIVEC and KIT+ GIST
1,2
61 years old
3 months since diagnosis		 Gastric KIT+ GIST Original tumor: 3 cm
Mitotic rate: >5/50 HPFs		 16% RISK OF RECURRENCE3

Successfully resected patients may be convinced they are cancer free. They need to know:

  • GIST has malignant potential, even after resection1,4
  • GLIVEC is the only approved adjuvant therapy for KIT+ GIST5,6
  • The National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) recommend at least 36 months of imatinib therapy following resection in patients with significant risk of recurrence1,7 *
  • Adjuvant therapy with GLIVEC can significantly lower the risk of tumor recurrence5,8

Make an informed decision regarding postsurgical treatment with GLIVEC

Risk of Recurrence

1 IN 2 PATIENTS EXPERIENCE RECURRENCE OF GIST FOLLOWING SURGERY 1 ,2

Rates of metastases or tumor-related death in GIST 3,a

MITOTIC RATE
(HPFs)		 TUMOR SIZE
(cm)		 GASTRIC
GIST		 JEJUNAL AND
ILEAL GIST		 DUODENAL GIST RECTAL
GIST
≤5/50 ≤2 0% 0% 0% 0%
>2 ≤5 1.9% 4.3% 8.3% 8.5%
>5 ≤10 3.6% 24% 34%b 57%b
>10 12% 52%
>5/50 ≤2 0%b 50%b N/Ac 54%
>2 ≤5 16% 73% 50% 52%
>5 ≤10 55% 85% 86%b 71%b
>10 86% 90%

a
 Based on previously published long-term follow-up studies on 1055 gastric, 629 small intestinal, 144 duodenal, and 111 rectal GISTs.
b
 Denotes tumor categories with very small numbers of cases. Some data combined, or missing, due to a small number of cases.
c
 No tumors of such category were included in the study. Note that small intestinal and other intestinal GISTs show a markedly worse prognosis in many mitosis and size categories than gastric GISTs.
HPFs=high-power fields.
Adapted from Miettinen and Lasota, 2006.3
  • In accordance with current guidelines, mitotic rate, tumor site, and tumor size should be considered in risk assessments1,4
    • Tumors localized in the small intestine are more aggressive than gastric tumors of equal size and mitotic count3,5,6
  • Consider additional factors, including surgical margins and whether tumor rupture has occurred4
  • Depending on mitotic rate and anatomic location, a GIST of any size can have malignant potential3

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References

  1. The NCCN Soft Tissue Sarcoma Clinical Practice Guidelines in Oncology (Version 3.2012). ©2012 National Comprehensive Cancer Network, Inc.http://www.nccn.org . Accessed November 30, 2012. To view the most recent and complete version of the guidelines, go online to www.nccn.org.
  2. Reichardt P, Blay J-Y, von Mehren M. Towards global consensus in the treatment of gastrointestinal stromal tumor. Expert Rev Anticancer Ther. 2010;10(2):221-232.
  3. Miettinen M, Lasota J. Gastrointestinal stromal tumors: pathology and prognosis at different sites. Semin Diagn Pathol. 2006;23(2):70-83.
  4. The ESMO/European Sarcoma Network Working Group. Gastrointestinal stromal tumors: ESMO clinical practice guidelines of diagnosis, treatment and follow-up. Ann Oncol. 2012;23(supp7):vii49-vii55.
  5. Fletcher CDM, Berman JJ, Corless C, et al. Diagnosis of gastrointestinal stromal tumors: a consensus approach. Hum Pathol.2002;33(5):459-465.
  6. Demetri GD, von Mehren M, Antonescu CR, et al. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010;8(suppl 2):S1-S41.

Adjuvant GLIVEC vs Placebo Study Design

Z9001 TRIAL:ADJUVANT GLIVEC (IMATINIB) VS PLACEBO

Prior to the SSG trial, the Z9001 adjuvant trial broadened the GLIVEC indication to include adjuvant therapy.

Learn about the pivotal study that demonstrated significant improvement with 1 year of adjuvant GLIVEC in a broad spectrum of resected KIT+ GIST patients(N=713) 1,2

Read about current recommendations, see the 3 year trial

Study Objective Establish whether GLIVEC extends recurrence-free survival when administered in the adjuvant setting 2
Study Description GLIVEC at 400 mg/day vs matching placebo in a Phase 3, double-blind, randomized, multicenter study 2
Inclusion Criteria Resected patients with confirmed KIT+ GIST and tumor size ≥3 cm 2
Median Follow-up 19.7 months1
Primary End Point Recurrence-free survival defined as the time from date of randomization to the date of recurrence or death from any cause 2

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References

  1. DeMatteo RP, Ballman KV, Antonescu CR, et al; for the American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097-1104.
  2. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2012.

Efficacy Data

LOWER THE RISK OF RECURRENCE FOLLOWING RESECTION OF PRIMARY
KIT+ GIST...
98% OF PATIENTS ON GLIVEC ACHIEVED RECURRENCE-FREE SURVIVAL AT 1 YEAR1

GLIVEC reduced the risk of recurrence by 88%1,*

GLIVEC significantly Improved Recurrence-Free Survival (RFS)1
GLIVEC significantly Improved Recurrence-Free Survival (RFS)

  • The trial examined tumor sizes ranging from 3 cm to ≥10 cm1
  • The significant difference was similar across all tumor size categories1

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adjuvant trial


*Relative risk reduction.

Reference

  1. DeMatteo RP, Ballman KV, Antonescu CR, et al; for the American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097-1104.

Risks and Benefits

ENABLE PATIENTS TO UNDERSTAND RECURRENCE RISK AND ADJUVANT TREATMENT BENEFITS

Adjuvant treatment post resection significantly improves clinical outcomes1,2

  • While on treatment, only 1 recurrence event was observed, compared with 41 events on placebo2
  • Discuss with patients their individual risk tolerance prior to making a treatment decision
    • An 8.5% risk of tumor recurrence may be acceptable for one patient but may be too high for another

The optimal treatment duration with GLIVEC in the adjuvant setting is unknown.1

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Question

In terms of the risk of recurrence, at what percentage you would call the risk significant?

References

  1. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2012.
  2. DeMatteo RP, Ballman KV, Antonescu CR, et al; for the American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097-1104.

GIST=gastrointestinal stromal tumor.

Treatment algorithm
for KIT+ GIST

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Prescribing
GLIVEC

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GLIVEC Product
Characteristics

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GLIVEC Safety
and Tolerability

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* NCCN recommends use in intermediate-risk and high-risk KIT+ GIST patients, whereas ESMO suggests use in patients with high risk.

References

  1. The NCCN Soft Tissue Sarcoma Clinical Practice Guidelines in Oncology (Version 3.2012). ©2012 National Comprehensive Cancer Network, Inc.http://www.nccn.org. Accessed November 30, 2012. To view the most recent and complete version of the guidelines, go online to www.nccn.org.
  2. Reichardt P, Blay J-Y, von Mehren M. Towards global consensus in the treatment of gastrointestinal stromal tumor. Expert Rev Anticancer Ther. 2010;10(2):221-232.
  3. Miettinen M, Lasota J. Gastrointestinal stromal tumors: pathology and prognosis at different sites. Semin Diagn Pathol. 2006;23(2):70-83.
  4. Fletcher CDM, Berman JJ, Corless C, et al. Diagnosis of gastrointestinal stromal tumors: a consensus approach. Hum Pathol. 2002;33(5):459-465.
  5. Glivec® (imatinib) summary of product characteristics. West Sussex, UK: Novartis Europharm Limited; 2012.
  6. Sutent® (sunitinib malate) summary of product characteristics. Sandwich, Kent, UK: Pfizer Ltd; 2012.
  7. The ESMO/European Sarcoma Network Working Group. Gastrointestinal stromal tumors: ESMO clinical practice guidelines of diagnosis, treatment and follow-up. Ann Oncol. 2012;23(supp7):vii49-vii55.
  8. DeMatteo RP, Ballman KV, Antonescu CR, et al; for the American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097-1104.

GLIVEC and KIT+ GIST

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