Abstract
Background: We have previously reported that same day dosing (SDD) of pegfilgrastim (PG) did not result in an increased incidence of negative outcomes as compared to filgrastim (G) administered the next day. (
Purpose/Methods: This study aims to assess the efficacy and safety of SDD of PG among older cancer patients for severity of neutropenia (grade 4), infection/neutropenia- related hospitalization, incidence of delayed administration (or dose reduction) of chemotherapy or any unplanned MD visits due to leukopenia (table). G administered subsequent to chemotherapy served as the control group. Patients ≥ 65 years with solid tumors who received fractionated dose chemotherapy at our institution between January 2001 and March 2004 were reviewed retrospectively. Patients who received chemotherapy initially at substandard doses were excluded.
Results: Patient demographics indicated that the two groups were evenly matched, with similar mean baseline absolute neutropenic counts (ANC). Distribution of cancer diagnoses is as follows: PG: breast (7), lung (8), GI (18) and others (2); G: breast (5), lung (9), GI (7) and others (4). Twenty-six (87%) and 21 (84%) patients had stage IV cancer in the PG and G groups, respectively. The mean ANC nadirs for PG and G were 2790±2190 cells/mm³ and 1820±1930 cells/mm³, respectively (p=0.01). For the outcome endpoints, although certain trends seemed to favor SDD of PG, none of the odd ratios (OR) performed reached statistical significance. Doses of PG and G were generally well-tolerated by all patients.
Conclusion: Concurrent administration of PG showed safety and efficacy at least comparable to G in elderly patients receiving fractionated dose chemotherapy. Such administration schedule has the potential to further simplify the outpatient management of chemotherapy-induced neutropenia, providing the needed convenience for elderly patients as well as caregivers. However, further prospective study is warranted.
| . | PG . | G . | p-value; OR (95% CI) . |
|---|---|---|---|
| data were analyzed based on cycles | |||
| No. patients | 30 | 25 | |
| No. cycles | 59 | 54 | |
| Age (range) | 68.8 (65–79) | 68.3 (65–72) | |
| Gender (female) | 18 (60%) | 15 (60%) | |
| ANC before chemo±SD(cells/mm³) | 4530±1850 | 4790±2600 | p=0.539 |
| ANC nadir±SD (cells/mm³) | 2790±2190 | 1820±1930 | p=0.01 |
| Severe Neutropenia (grade IV) | 9 (15%) | 15 (28%) | OR=0.47; (0.19, 1.18) |
| Unplanned MD visit | 7 (12%) | 3 (5.6%) | OR=2.28; (0.56, 9.34) |
| Chemo delayed/dose reduced | 9 (15%) | 11 (20%) | OR=0.70; (0.27, 1.86) |
| Hospitalization | 7 (12%) | 5 (9.3%) | OR=1.32; (0.39, 4.44) |
| . | PG . | G . | p-value; OR (95% CI) . |
|---|---|---|---|
| data were analyzed based on cycles | |||
| No. patients | 30 | 25 | |
| No. cycles | 59 | 54 | |
| Age (range) | 68.8 (65–79) | 68.3 (65–72) | |
| Gender (female) | 18 (60%) | 15 (60%) | |
| ANC before chemo±SD(cells/mm³) | 4530±1850 | 4790±2600 | p=0.539 |
| ANC nadir±SD (cells/mm³) | 2790±2190 | 1820±1930 | p=0.01 |
| Severe Neutropenia (grade IV) | 9 (15%) | 15 (28%) | OR=0.47; (0.19, 1.18) |
| Unplanned MD visit | 7 (12%) | 3 (5.6%) | OR=2.28; (0.56, 9.34) |
| Chemo delayed/dose reduced | 9 (15%) | 11 (20%) | OR=0.70; (0.27, 1.86) |
| Hospitalization | 7 (12%) | 5 (9.3%) | OR=1.32; (0.39, 4.44) |
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