List of efficacy variables and criteria for considering patients as responders, high responders, or nonresponders
| Efficacy variables and change considered significant for response to treatment . | Criteria defining high responders . | Criteria defining responders . | ||
|---|---|---|---|---|
| Clinical variables | ||||
| Performance status (ECOG PS) | Improvement of PS if initial value was ≥1 or stability of PS if initial value was 0 | No 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 variables | Improvement 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 variables | Improvement 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 others | Improvement 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%) | ||||
| Efficacy variables and change considered significant for response to treatment . | Criteria defining high responders . | Criteria defining responders . | ||
|---|---|---|---|---|
| Clinical variables | ||||
| Performance status (ECOG PS) | Improvement of PS if initial value was ≥1 or stability of PS if initial value was 0 | No 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 variables | Improvement 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 variables | Improvement 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 others | Improvement 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.