Pegfilgrastim primary prophylaxis in patients with non-Hodgkin lymphoma: results from an integrated analysis.

Severe neutropenia and febrile neutropenia (FN) are serious, dose-limiting side effects of chemotherapy for aggressive non-Hodgkin lymphoma (NHL). Observational data suggest that with current practice neutropenia management up to 23% of patients receiving CHOP-like regimens experience FN, and around half of patients do not receive the planned relative dose intensity (RDI). In this integrated analysis we assessed the efficacy of pegfilgrastim for preventing FN and related outcomes in patients with NHL. A literature search was used to identify chemotherapy regimens with an FN risk ≥15% that are used to treat lymphoma. Search results were then used to identify clinical trials in which these regimens were administered with pegfilgrastim primary prophylaxis. Individual patient data were available for three trials meeting the inclusion criteria, and these were combined in an integrated analysis. The primary outcome measure was the incidence of FN in any cycle. A total of 282 patients were included in the analysis [mean age 65 years (SD ± 12.5 years); 172 (61%) aged ≥ 65 years]. All patients had NHL and 244 (87%) received RCHOP-21. The incidence of FN in any cycle was 16% (95% CI 12-20%) (13% in patients aged <65 years; 18% in patients aged ≥65 years). Chemotherapy dose delays >3 days occurred in 26% (95% CI 20-31%) of patients, and was relatively consistent across age groups. Chemotherapy dose reductions ≥10% were seen in 43% (95% CI 37-49%) of patients and were more frequent in the elderly. Overall, 83% (95% CI 78-87%) of patients received ≥90% RDI (89% of patients aged <65 years; 78% of patients aged ≥65 years). In this integrated analysis of NHL patients at higher risk of FN receiving pegfilgrastim primary prophylaxis, the overall incidence of FN was 16% and a high proportion of both younger and elderly patients achieved RDI ≥90%.

Use of pegfilgrastim support on day 9 to maintain relative dose intensity of chemotherapy in breast cancer patients receiving a day 1 and 8 CMF regimen

AIM: In several commonly used regimens, chemotherapy doses are split across different days of the cycle. We aimed to determine the feasibility of growth factor support with once-per-cycle pegfilgrastim in this setting. METHODS: This phase II study in breast cancer patients assessed the utility of a single 6 mg subcutaneous dose of pegfilgrastim administered on day 9 of an intravenous (IV) "split" CMF (cyclophosphamide 600 mg/m(2), methotrexate 40 mg/m(2) and 5-fluorouracil 600 mg/m(2)) chemotherapy regimen administered on days 1 and 8 and repeated every 28 days for 6 cycles. RESULTS: Fifty-eight patients were enrolled, with 49 completing the study. For the primary endpoint, 48 patients (83%) received >or=85% of the relative dose intensity (RDI) of chemotherapy over all 6 cycles (95% confidence interval [CI], 71-91%). Across all chemotherapy cycles, 41 patients (71%) received all scheduled cycles on time and most patients (n=49, 84%) received >or=85% of the planned dose of all chemotherapy agents in all cycles. In total, 295/319 cycles (92%) were delivered on schedule and >or=85% of the planned dose of all chemotherapy agents were administered in 309/319 cycles (97%). Febrile neutropenia was reported in only 2 patients (3%). There were no grade 4 adverse events related to pegfilgrastim. DISCUSSION: Day 9 pegfilgrastim administration was well tolerated and provided effective protection against neutropenia in patients receiving IV CMF on days 1 and 8, allowing chemotherapy to be delivered on time and at the scheduled dose in most patients (AU)

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Neutrophil recovery in elderly breast cancer patients receiving adjuvant anthracycline-containing chemotherapy with pegfilgrastim support.

Shortening duration of chemotherapy-induced neutropenia may reduce risk of infection and aid subsequent chemotherapy delivery. Cycle 1 neutrophil recovery was evaluated in 59 elderly women with breast cancer receiving adjuvant FEC100 (5-fluorouracil 500 mg/m(2), epirubicin 100mg/m(2) and cyclophosphamide 500 mg/m(2)) and randomized to pegfilgrastim primary prophylaxis (PP) from cycle 1, or secondary prophylaxis (SP, i.e., subsequent to a neutropenic event [no G-CSF in cycle 1]). In cycle 1, grade 4 neutropenia occurred in 77% (PP; N=30) and 72% (SP; N=29). Duration of grade 3-4 neutropenia was shorter with pegfilgrastim than without. Mean absolute neutrophil count (ANC) recovered above 1.0 x 10(9)/L by day 9 (pegfilgrastim) versus days 16-18 (without). At last observation (> or =day 14+/-2), no PP patient had ANC <1.0 x 10(9)/L versus approximately 25% of those receiving no pegfilgrastim. In conclusion, cycle 1 pegfilgrastim improved recovery from severe neutropenia in elderly breast cancer patients receiving adjuvant FEC100.