In the article by Basser et al entitled “Randomized, Blinded, Placebo-Controlled Phase I Trial of Pegylated Recombinant Human Megakaryocyte Growth and Development Factor With Filgrastim After Dose-Intensive Chemotherapy in Patients With Advanced Cancer,” which appeared in the May 1, 1996 issue (Vol 89, No 9, pp 3118-3128), corrections should be noted. In Table 5 the numbers were misaligned and figure legends 1 and 2 contained errors. The corrected table and figure legends are printed below
Nonhematologic Adverse Events in 41 Patients Who Received Study Drug
| . | Placebo + Filgrastim (n = 10) . | PEG-rHuMGDF* + Filgrastim (n = 31) . |
|---|---|---|
| Local | ||
| Injection site reaction | 0 (0)5-151 | 2 (6) |
| Systemic | ||
| Lethargy/drowsiness | 1 (10) | 17 (55) |
| Hot flushes/fever5-150 | 6 (60) [1]5-152 | 8 (26) |
| Bone pain | 3 (30) | 8 (26) |
| Neurologic | ||
| Headache | 6 (60) | 13 (42) |
| Dizziness | 3 (30) | 12 (38) |
| Respiratory | ||
| Cough | 1 (10) | 8 (26) |
| Dypsnea | 3 (30) | 12 (38) [3] |
| Gastrointestinal | ||
| Nausea and/or vomiting | 9 (90) [1] | 22 (71) [4] |
| Diarrhea | 3 (30) | 15 (48) [2] |
| Mucositis | 5 (50) | 8 (26) |
| Metabolic | ||
| Hypokalemia | 2 (20) | 5 (16) |
| Thromboembolic | ||
| Thrombophlebitis | 0 (0) | 1 (3) |
| Pulmonary embolism | 0 (0) | 1 (3) [1]ρ |
| . | Placebo + Filgrastim (n = 10) . | PEG-rHuMGDF* + Filgrastim (n = 31) . |
|---|---|---|
| Local | ||
| Injection site reaction | 0 (0)5-151 | 2 (6) |
| Systemic | ||
| Lethargy/drowsiness | 1 (10) | 17 (55) |
| Hot flushes/fever5-150 | 6 (60) [1]5-152 | 8 (26) |
| Bone pain | 3 (30) | 8 (26) |
| Neurologic | ||
| Headache | 6 (60) | 13 (42) |
| Dizziness | 3 (30) | 12 (38) |
| Respiratory | ||
| Cough | 1 (10) | 8 (26) |
| Dypsnea | 3 (30) | 12 (38) [3] |
| Gastrointestinal | ||
| Nausea and/or vomiting | 9 (90) [1] | 22 (71) [4] |
| Diarrhea | 3 (30) | 15 (48) [2] |
| Mucositis | 5 (50) | 8 (26) |
| Metabolic | ||
| Hypokalemia | 2 (20) | 5 (16) |
| Thromboembolic | ||
| Thrombophlebitis | 0 (0) | 1 (3) |
| Pulmonary embolism | 0 (0) | 1 (3) [1]ρ |
There was no difference in the frequency of any toxicity between patients given placebo and those administered PEG-rHuMGDF (Fisher's Exact test).
Not related to neutropenia.
No. of patients (percentage).
Numbers in brackets represent number of events that were grade 3.
ρThis event was grade 4.
Fig 1. Median platelet counts after chemotherapy for patients given PEF-rHuMGDF 0.03 (▴, n = 3), 0.1 μg/kg (▪, n = 3), 0.3 μg/kg (▾, n = 3), 1.0 μg/kg (♦, n = 11), 3.0 μg/kg (•, n = 7), or 5.0 μg/kg (□, n = 4), and placebo (▵, n = 10). The horizontal bar indicates a platelet count of 100 × 109/L.
Fig 2. (A) shows platelet recovery for all patients given PEG-rHuMGDF (▪, n = 25) and those given placebo (▵, n = 10). (B) shows the Kaplan-Meier plot of the probability of recovery to baseline platelet counts in these groups. The median time to baseline counts was 18 days for PEG-rHuMGDF and 22 days for placebo (P = .014, log rank test).
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