Topics:
adverse event, bone pain, cancer, advanced, chemotherapy regimen, cough, diarrhea, dizziness, drowsiness, fever, filgrastim

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

Table 5.

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).

F5-150

Not related to neutropenia.

F5-151

No. of patients (percentage).

F5-152

Numbers in brackets represent number of events that were grade 3.

ρThis event was grade 4.

View Large

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).

Copyright © 1997 American Society of Hematology
1997
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