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EORTC STBSG. Predicting toxicity for patients with advanced Gastrointestinal Stromal Tumors (GIST) treated with imatinib mesylate : an EORTC/ISG/AGITG randomized trial.

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EORTCSTBSG

Predicting toxicity for patients with advanced Gastrointestinal Stromal Tumors (GIST) treated with imatinib mesylate : an EORTC/ISG/AGITG randomized trial

M. Van Glabbeke, J. Verweij, P.G. Casali, J. Simes,A. Le Cesne, P. Reichardt, R. Issels, J.R. Judson,A.T. van Oosterom, J.-Y. Blay

material
Material
  • Randomized phase III study comparing daily doses of imatinib (400 mg od vs 400 mg bid) for the treatment of patients with advanced GIST
  • 946 patients randomized
  • 942 patients started therapy
  • 310 patients still under therapy
  • Follow-up
    • Median: 42 months (3.5 years)
    • At 1, 2, 3 and 4 years: 99%, 90%, 81% and 4%
methods
Methods
  • Prognostic factors analyses
  • End-points (binary) : occurrence of
    • Grade 3-4 anemia, neutropenia
    • Grade 2-4 edema, fatigue, nausea, diarrhea, skin rash
  • Investigated co-factors
    • Imatinib dose
    • Age, sex, PS, baseline laboratory parameters
    • Time since GIST diagnosis, site of origin, lesion size
    • Prior therapies
  • Logistic univariate / multivariate regression models
    • Univariate model: select variables if P < 0.05
    • Multivariate model: keep variable if P < 0.01
cumulative incidence of toxicities non hemato grade 2 hemato grade 3
Cumulative incidence of toxicities(non hemato.grade 2+, hemato. grade 3+)

400 mg o.d.

400 mg b.i.d.

Edema - Skin rash - Fatigue - Nausea - Diarrhea

Anemia - Neutropenia

multivariate models non hematological grade 2 toxicities
Multivariate models : non hematological grade 2+ toxicities

++ : P < 0.01, --- : P < 0.001, +++ : P < 0.001, ++++ : P < 0.0001

multivariate models hematological grade 3 toxicities
Multivariate models : hematological grade 3+ toxicities

-- : P < 0.01, ---- : P < 0.0001 , ++++ : P < 0.0001

interactive risk calculator
Interactive risk calculator

www.eortc.be / tools / imatinibtoxicity

  • Interactive version
  • Downloads(Excel)
  • For PC
  • For PDA
validation
Validation
  • Validation data set
    • EORTC phase I-II trial of imatinib
    • 91 patients with advanced or metastatic sarcoma
    • Daily doses: 400 mg, 600 mg, 800 mg, 1000 mg
  • Patients classified in “risk group” according to probability of each toxicity estimated with the model
    • < 20%, 20-40%, > 40% or < 20%, > 20%
  • Comparison with the observed proportion of events
    • Within the expected range for 10/13 risk groups (> 10 pts)
    • Overlap with the 95% confidence interval in all groups
    • Underestimation of edema & nausea (low risk groups)
    • Underestimation in male patients ?
conclusion i
Conclusion (I)
  • All toxicities are highly dose dependent, except neutropenia
  • Anemia and neutropenia only depend on baseline hematological factors
  • Risk of non hematological toxicity increase with age, poor PS and in female
    • Confirmation of other series
  • Other factors
    • Prior chemotherapy (fatigue)
    • Small lesions (rash)
    • Identified GI origin (diarrhea)
conclusions ii
Conclusions (II)
  • Interactive risk calculator to estimate the risk of toxicity for individual patients
  • May be used in the clinic
  • Available on the internet (Excel spreadsheet)
  • May be used to customized treatment ?
  • Validation
    • Based on a limited data set
    • Underestimate of edema and nausea in male patients ?
    • Should be validated on larger data series