Table 1.

List of efficacy variables and criteria for considering patients as responders, high responders, or nonresponders

Efficacy variables and change considered significant for response to treatmentCriteria defining high respondersCriteria defining responders
Clinical variables
    Performance status (ECOG PS)Improvement of PS if initial value was ≥1 or stability of PS if initial value was 0No change of PS < 2 or improvement of PS ≥ 2
Nutritional/functional variables (see reference for methods)
    Body weight (kg) by electronic scale (increase ≥ 5%)Improvement of at least three nutritional/functional variables with stability of the other variablesImprovement of at least three nutritional/functional variables plus stability of 1 and worsening of 1 or improvement of at least 3 plus stability of the other 2 or improvement of at least 2 plus stability of the other 3
    LBM by bioimpedentiometry (increase ≥10%)
    Appetite by VAS (increase ≥2 units)
    REE by indirect calorimetry (decrease ≥10%)
    Grip strength by dynamometer (increase ≥30%)
Laboratory variables (see reference for methods)
    Serum levels of IL-6 and TNF-α (decrease ≥25%)Improvement of three or more laboratory variables (including at least proinflammatory cytokines and ROS) independently from the changes of the other variablesImprovement of at least two laboratory variables (including at least proinflammatory cytokines and ROS) independently from the changes of the other variables
    Serum levels of leptin (increase ≥100%)
    Blood levels of ROS (decrease ≥80 FORT U)
    Erythrocyte levels of GPx (increase ≥2,000 IU)
Quality of life questionnaires
    EORTC QLQ-C30 version 3 (score increase ≥25%)Improvement of the scores of (at least) two or more quality of life questionnaires and no worsening of the othersImprovement of the scores of at least one quality of life questionnaire with no change of the others or worsening of no more than 1
    EQ-5D (score increase ≥25%)
    MSFI-SF (score increase ≥25%)
  • NOTE: Patients who did not meet the above criteria were considered nonresponders.

    Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; VAS, visual analogue scale; REE, resting energy expenditure; GPx, glutathione peroxidase; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer QLQ-C30; EQ-5D, Euro QL-5D; MSFI-SF, multidimensional fatigue symptom inventory-short form.