Patient characteristics
| Patient . | 1 . | 2 . | 3 . | 4 . | 5 . | 6 . | 7 . | 8 . |
|---|---|---|---|---|---|---|---|---|
| Age, y | 8 | 19 | 8 | 4 | 16 | 2 | 4 | 3 |
| Sex | M | M | F | M | M | F | F | F |
| Immunophenotype/protocol risk | T-ALL HR | ETP-ALL HR | B-ALL SR/HR | B-ALL LR | B-ALL SR/HR | Rel KMT2Ar B-ALL HR | B-ALL LR | B-ALL SR/HR |
| Symptoms of initial PEGASP reaction | Emesis, itching eyes, chest pain, hypotension, lip swelling, flushing requiring ICU admission | Emesis, oxygen desaturation, rash | Hypotension, oxygen desaturation, facial and throat swelling, hives | Cough, rash on face, emesis, lip and eye swelling | Throat and facial tightness, nausea (no emesis) | Lip, tongue and eye swelling, itching, hives | Emesis, swollen eyes and lips | Face redness, emesis and lip swelling, hypotension requiring ICU admission |
| Initial reaction CTCAE grade | 4 | 3 | 4 | 3 | 3 | 2 | 3 | 4 |
| Premedication at initial reaction | HC | HC, Ran, Diphen | Unknown | HC, Ran, Diphen | HC, Ran, Diphen | Unknown | HC, Ran, Diphen | HC, Ran, Diphen |
| Antibodies around time of initial reaction | PEG−ASP+, Erwinaze− | PEG−ASP+, Erwinaze− | PEG−ASP+, Erwinaze−(2.5 mo after initial reaction) | PEG−ASP+, PEG+, Erwinaze− | PEG−ASP+, Erwinaze− | Unknown | PEG−ASP+, Erwinaze− | PEG−ASP+, Erwinaze− |
| Anti-PEG−ASP OD: 0.1405 | PEG−ASP OD: 0.6110 | PEG−ASP OD: 0.3675 | PEG−ASP OD: 0.3487 | PEG−ASP OD: 0.2843 | PEG−ASP OD: 0.2584 | PEG−ASP OD: 0.3365 | ||
| PEG OD: 0.4030 | ||||||||
| Time from initial reaction to desensitization, days | 150 | 119 | 224 | 4 | 193 | Unknown | 143 | 90 |
| Interval Erwinaze between reaction and desensitization | Yes | Yes | Yes | No | Yes | Unknown | Yes | No |
| Presence of antibodies before desensitization | PEG−ASP −, PEG NA, Erwinaze− | PEG−ASP+, PEG+, Erwinaze+ | PEG−ASP−, PEG−, Erwinaze− | PEG−ASP+, PEG+, Erwinaze− | PEG−ASP+, PEG+, Erwinaze− | PEG−ASP−, PEG−, Erwinaze− | PEG−ASP+, PEG+, Erwinaze+ | PEG−ASP−PEG−, Erwinaze− |
| PEG-ASP OD: 0.0345 | PEG-ASP OD: 0.6546 | PEG-ASP OD: 0.0855 | PEG-ASP OD: 0.3160 | PEG-ASP OD: 0.122 | PEG-ASP OD: 0.0099 | PEG-ASP OD: 0.6374 | PEG-ASP OD: 0.0579 | |
| PEG OD: 0.757 | PEG OD: 0.1005 | PEG OD: 0.4375 | PEG OD: 0.188 | PEG OD: 0.0260 | PEG OD: 0.6880 | PEG OD: 0.098 | ||
| Number of desensitized doses received | 7 | 1 | 4 | 1 | 3 | 2 | 1 | 1 |
| Symptoms during desensitization | None | Rash at end of infusion but received planned dose | None | Rash × 3 during infusion. Received planned dose over 12 hours | None | None | Rash during infusion, unable to complete infusion; infused 916 units/m2 | None |
| Reason dose not repeated | N/A | Thrombosis, progressive leukemia | N/A | Unable to maintain activity >0.1 for a week | N/A | N/A | Did not tolerate infusion | N/A |
| Estimated day 14 activity after 1st desensitized dose ≥0.1 IU/mL | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| Patient . | 1 . | 2 . | 3 . | 4 . | 5 . | 6 . | 7 . | 8 . |
|---|---|---|---|---|---|---|---|---|
| Age, y | 8 | 19 | 8 | 4 | 16 | 2 | 4 | 3 |
| Sex | M | M | F | M | M | F | F | F |
| Immunophenotype/protocol risk | T-ALL HR | ETP-ALL HR | B-ALL SR/HR | B-ALL LR | B-ALL SR/HR | Rel KMT2Ar B-ALL HR | B-ALL LR | B-ALL SR/HR |
| Symptoms of initial PEGASP reaction | Emesis, itching eyes, chest pain, hypotension, lip swelling, flushing requiring ICU admission | Emesis, oxygen desaturation, rash | Hypotension, oxygen desaturation, facial and throat swelling, hives | Cough, rash on face, emesis, lip and eye swelling | Throat and facial tightness, nausea (no emesis) | Lip, tongue and eye swelling, itching, hives | Emesis, swollen eyes and lips | Face redness, emesis and lip swelling, hypotension requiring ICU admission |
| Initial reaction CTCAE grade | 4 | 3 | 4 | 3 | 3 | 2 | 3 | 4 |
| Premedication at initial reaction | HC | HC, Ran, Diphen | Unknown | HC, Ran, Diphen | HC, Ran, Diphen | Unknown | HC, Ran, Diphen | HC, Ran, Diphen |
| Antibodies around time of initial reaction | PEG−ASP+, Erwinaze− | PEG−ASP+, Erwinaze− | PEG−ASP+, Erwinaze−(2.5 mo after initial reaction) | PEG−ASP+, PEG+, Erwinaze− | PEG−ASP+, Erwinaze− | Unknown | PEG−ASP+, Erwinaze− | PEG−ASP+, Erwinaze− |
| Anti-PEG−ASP OD: 0.1405 | PEG−ASP OD: 0.6110 | PEG−ASP OD: 0.3675 | PEG−ASP OD: 0.3487 | PEG−ASP OD: 0.2843 | PEG−ASP OD: 0.2584 | PEG−ASP OD: 0.3365 | ||
| PEG OD: 0.4030 | ||||||||
| Time from initial reaction to desensitization, days | 150 | 119 | 224 | 4 | 193 | Unknown | 143 | 90 |
| Interval Erwinaze between reaction and desensitization | Yes | Yes | Yes | No | Yes | Unknown | Yes | No |
| Presence of antibodies before desensitization | PEG−ASP −, PEG NA, Erwinaze− | PEG−ASP+, PEG+, Erwinaze+ | PEG−ASP−, PEG−, Erwinaze− | PEG−ASP+, PEG+, Erwinaze− | PEG−ASP+, PEG+, Erwinaze− | PEG−ASP−, PEG−, Erwinaze− | PEG−ASP+, PEG+, Erwinaze+ | PEG−ASP−PEG−, Erwinaze− |
| PEG-ASP OD: 0.0345 | PEG-ASP OD: 0.6546 | PEG-ASP OD: 0.0855 | PEG-ASP OD: 0.3160 | PEG-ASP OD: 0.122 | PEG-ASP OD: 0.0099 | PEG-ASP OD: 0.6374 | PEG-ASP OD: 0.0579 | |
| PEG OD: 0.757 | PEG OD: 0.1005 | PEG OD: 0.4375 | PEG OD: 0.188 | PEG OD: 0.0260 | PEG OD: 0.6880 | PEG OD: 0.098 | ||
| Number of desensitized doses received | 7 | 1 | 4 | 1 | 3 | 2 | 1 | 1 |
| Symptoms during desensitization | None | Rash at end of infusion but received planned dose | None | Rash × 3 during infusion. Received planned dose over 12 hours | None | None | Rash during infusion, unable to complete infusion; infused 916 units/m2 | None |
| Reason dose not repeated | N/A | Thrombosis, progressive leukemia | N/A | Unable to maintain activity >0.1 for a week | N/A | N/A | Did not tolerate infusion | N/A |
| Estimated day 14 activity after 1st desensitized dose ≥0.1 IU/mL | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
Underlined symptoms are those associated with desensitization failure when combined with persistent anti-PEG asparaginase antibodies.
CTCAE, common terminology criteria for adverse events, version 3, allergic reaction; Diphen, diphenhydramine; HC, hydrocortisone; HR, high-risk; ICU, intensive care unit; LR, low risk; N/A, not applicable; OD, optical density; OSH, outside hospital; PEG, polyethylene glycol; PEG-ASP, pegaspargase; Ran, ranitidine; Rel, relapsed; SR, standard risk.