Table 1.
Patient Characteristics
| Pt | Age/ Sex | Diagnosis | Regimen | Number of prior lines of therapy | Number of doses of Peg received prior to switching | Remission status prior to receiving Erwinia | Reason for change | Number of Erwinia cycles |
|---|---|---|---|---|---|---|---|---|
| 1 | 29/M | T-ALL | C10403 | 0 | 2 | Morpholo gic CR (MRD not assessed) | SOB, chest discomfort, flushing, facial/throat swelling | 5 |
| 2 | 23/M | B-ALL | AALL07P1 | 1 | 2 | MRD+CR | Anaphylaxis | 4 |
| 3 | 20/M | B-ALL | NYII | 0 | 3 | MRD negative CR | Hypotensio n, SOB, facial swelling | 6 |
| 4 | 59/M | T-ALL | MSKCC 12-266 |
0 | 4 | MRD negative CR | Rash, Hives, SOB | 3 |
| 5 | 28/M | B-ALL | MSKCC 12-266 |
0 | 2 | MRD negative CR | Hypotensio n, diaphoresis, tachycardia, and nausea | 4 |
| 6 | 72/F | B-ALL | MSKCC 12-266 |
0 | 1 | MRD negative CR | SOB, flushing, rash | 1 |
| 7 | 33/M | B-ALL | MSKCC 12-266 |
0 | 2 | MRD negative CR | Tachycardia, hypotension , syncope, LOC | 5 |
| 8 | 55/M | B-ALL | MSKCC 12-266 |
0 | 1 | Morpholo gic CR (MRD not assessed) | Hepatotoxic ity with grade 4 hyperbilirub inemia | 4 |
| 9 | 44/M | B-ALL | MSKCC 12-266 |
0 | 2 | MRD negative CR | SOB, blurred vision, diaphoresis | 3* |
| 10 | 54/M | T-ALL | MSKCC 12-266 | 0 | 2 | MRD negative CR | Hypotensio n, tachycardia, flushing, hives | 1* |
| AST median (range) | ALT median (range) | Tbili median (range) | Amylase median (range) | Lipase median (range) | TG median (range) | Fibrinogen median (range) | Thrombosis/ Hemorrhage | Hypersensitivity to Erwinia |
|---|---|---|---|---|---|---|---|---|
| 23 (16–57) | 44 (23–102) | 0.4 (0.2–0.7) | 33 (29–39) | 16 (11–25) | 288 (189–683) | 231 (144–305) | No/No | No |
| 35 (22–56) | 66 (29–70) | 0.6 (0.6–0.9) | 37 (28–50) | NR | NR | 149 (106–335) | No/No | No |
| 57 (40–60) | 77 (59–112) | 0.9 (0.6–1) | 28 (23–53) | NR | NR | 137 (77–176) | No/No | No |
| 19 (16–38) | 24 (14–44) | 0.5 (0.2–0.9) | 45 (27–55) | 34 (30–49) | 159 (93–318) | 311 (206–440) | No/No | No |
| 29 (16–57) | 41 (22–69) | 0.4 (0.2–0.8) | 66 (56–131) | 34 (23–47) | 246 (80–819) | 170 (102–247) | No/No | No |
| 33 (21–36) | 53 (40–54) | 0.3 (0.3–0.4) | 36 (29–36) | 35 (29–37) | 196 (195–330) | 219 (219–325) | No/No | No |
| 26 (13–72) | 59 (36–157) | 0.6 (0.4–1.0) | 76 (35–102) | 47 (30–84) | 839 (144–2180) | 180 (128–276) | No/No | No |
| 26 (16–109) | 25 (14–99) | 1.0 (0.7–1.3) | 74 (51–102) | 30 (23–54) | 200 (67–386) | 186 (134–309) | No/No | No |
| 9 (7–20) | 12 (11–16) | 0.5 (0.4–0.7) | 12 (8–16) | 24 (23–61) | 535 (167–2076) | 185 (178–207) | No/No | No |
| 87 (64–119) | 128 (68–243) | 0.4 (0.3–0.7) | 71 (51–84) | 61 (41–70) | 446 (380–667) | 158 (125–245) | No/No | No |
Pt = Patient; Peg = Pegaspargase; M = male; F = female; T-ALL = T-cell acute lymphoblastic leukemia; B-ALL = B-cell acute lymphoblastic leukemia; C10403 = CALBG 10403 protocol; CR = complete remission; MRD = minimal residual disease; MSKCC 12-266 = A Berlin-Frankfurt-Munster modeled, pediatric inspired multiagent chemotherapy regimen for newly diagnosed patients with ALL (NCT01920737); SOB = Shortness of breath; LOC = Loss of consciousness;
*
= Patients still receiving treatment;
AST = Aspartate transaminase; ALT = Alanine transaminase; Tbili = Total bilirubin; TG = triglycerides