An Observational Study of Anaemia Management in Patients with NHL Receiving CHOP-14 or -21 (With or Without Rituximab)

Background: CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) therapy is standard treatment for aggressive Non-Hodgkin’s Lymphoma (NHL), and frequently results in myelosuppression. The resulting febrile neutropenia (FN) and chemotherapy-induced anaemia (CIA) may be treated with Granulocyte Colony Stimulating Factor (G-CSF) and Erythropoiesis-Stimulating Agents (ESAs), respectively. IMPACT is an observational study, ongoing since February 2007, to examine supportive care management practices in NHL patients undergoing CHOP chemotherapy. Since the beginning of this study, European treatment guidelines for use of ESAs in CIA changed: from initiation at 11 g/dL with the goal to achieve hemoglobin (Hb) within 11–13 g/dL, to, as of February 2008, initiation at 10 g/dL and target range of 10–12 g/dL. This planned interim analysis describes anaemia and transfusion outcomes from this ongoing study as of April 2008.

Methods: European patients with diffuse large-B-cell lymphoma (DLBCL), planning at least 3 cycles of CHOP-14 or -21 +/− rituximab were included in the study. This subset analysis evaluated only those patients not participating in a clinical trial. Patients were retrospectively or prospectively followed up to the end of chemotherapy treatment to a maximum of 8 chemotherapy cycles. CIA treatment was according to local standard of care, either with or without ESAs. Data were collected on Hb at ESA initiation, reasons for ESA treatment, Hb achieved during the ESA treatment phase, Hb level at first transfusion, and transfusion incidence.

Results: For this interim analysis, data were available for 454 patients (mean age 60.5 [SD 14.8] years and 54% male), of whom 64% received CHOP-21; 35% of patients received treatment for CIA comprising ESA and/or transfusion. Among patients who received ESAs (N=112), the most frequent reasons for initiating treatment included Hb level (79%) or perceived risk of CIA (24%). Forty-one percent of ESA-treated patients had Hb levels <10 g/dL at ESA initiation; overall, the mean (SD) Hb at initiation was 10.16 (1.22) g/dL. The median (Q1, Q3) chemotherapy cycle at which patients received their initial dose of ESA was 3 (1, 4). Among patients treated with ESAs, 61% achieved a Hb level between 10–12 g/dL during the ESA treatment phase; and 27% experienced a Hb rate of rise ³1g/dL in 14 days. Twenty percent (n=22) of ESA-treated patients received transfusions. Among these, the mean (SD) Hb level at first transfusion was 9.15 (0.94) g/dL; 36% (n=8) of ESA-treated patients received their first transfusion in cycle 1.

Conclusions: While the number of the patients available for this interim analysis is small, the results do provide some perspective on anaemia treatment in this population. European patients with DLBCL receiving CHOP-14 or -21 may experience treatment-related anaemia that can be managed with ESAs.