The Reporting of Risk of FN and Reduced Dose Intensity Reported in RCT

A systematic review of reported hematologic toxicity in RCT conducted over the past decade in early-stage breast cancer (ESBC) and non-Hodgkin's lymphoma (NHL) was recently completed (46). This review showed that many studies fail to report rates entirely, whereas those reporting rates of toxicity did so using varying measures and providing widely varying results for commonly studied regimens. This review also showed that 53% of RCTs reported no data on relative dose intensity (RDI). Of the 18% of ESBC studies and the 34% of NHL studies reporting mean or median RDIs, 32 and 42% of the study cohorts, respectively, received an RDI of <85%. Recent studies of more intensive regimens for both ESBC and NHL suggest that, although such regimens are associated with encouraging results, the risk of FN associated with these treatment schedules is substantial (47).

Fig. 3. Graphic representation of the relationship between the duration of severe neutropenia (ANC <500 cells/mm3) and the incidence of febrile neutropenia (FN). Data were derived from a retrospective analysis of two phase 3 RCTs of breast cancer chemotherapy comparing filgrastim and pegfil-grastim. The odds ratio for FN was 2.28 per day of severe neutropenia (45).

Graph Filgrastim And Anc

Fig. 4. Bar graphs illustrating the frequency of febrile neutropenia (FN) (A) and the frequency of reduced dose intensity <85% of reference standards (B) in approx 20,000 women with breast cancer receiving various adjuvant chemotherapy regimens from a large practice-based survey (48). The risk of FN and reduced relative dose intensity (RDI) were generally greater in older women (black shading) than in younger women (gray shading). AC, Adriamycin + cyclophosphamide; ACT, Adriamycin + cyclophosphamide followed by taxol; ATC, Adriamycin + cyclophosphamide + taxotere; CAF, cyclophosphamide + Adriamycin + 5-fluorouracil; CMF, cyclophosphamide + methotrexate + 5-fluo-rouracil; SEQ, sequential agents. Where appropriate, schedules of every 21 d or every 28 d are indicated. (Figure 4B, data from ref. 48.)

Fig. 4. Bar graphs illustrating the frequency of febrile neutropenia (FN) (A) and the frequency of reduced dose intensity <85% of reference standards (B) in approx 20,000 women with breast cancer receiving various adjuvant chemotherapy regimens from a large practice-based survey (48). The risk of FN and reduced relative dose intensity (RDI) were generally greater in older women (black shading) than in younger women (gray shading). AC, Adriamycin + cyclophosphamide; ACT, Adriamycin + cyclophosphamide followed by taxol; ATC, Adriamycin + cyclophosphamide + taxotere; CAF, cyclophosphamide + Adriamycin + 5-fluorouracil; CMF, cyclophosphamide + methotrexate + 5-fluo-rouracil; SEQ, sequential agents. Where appropriate, schedules of every 21 d or every 28 d are indicated. (Figure 4B, data from ref. 48.)

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