Rituximab and CHOP Chemotherapy Plus GM-CSF for Previously Untreated Diffuse Large B-Cell Lymphoma in the Elderly: A Wisconsin Oncology Network Study

• Published in: Clinical lymphoma, myeloma and leukemia Vol. 10; no. 5; pp. 379 - 384
• Main Authors: Chang, Julie E, Seo, Songwong, Kim, Kyungmann M, Werndli, Jae E, Bottner, Wayne A, Rodrigues, Gilberto A, Sanchez, Federico A, Saphner, Thomas J, Longo, Walter L, Kahl, Brad S
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2010
• Subjects: Aged; Aged, 80 and over; Antibodies, Monoclonal, Murine-Derived - administration & dosage; Antibodies, Monoclonal, Murine-Derived - adverse effects; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cyclophosphamide - administration & dosage; Cyclophosphamide - adverse effects; Disease-Free Survival; DLBCL; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Drug Synergism; Female; Granulocyte-macrophage colony-stimulating factor; Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage; Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects; Hematology, Oncology and Palliative Medicine; Humans; Lymphoma, Large B-Cell, Diffuse - drug therapy; Male; Middle Aged; Prednisone - administration & dosage; Prednisone - adverse effects; Rituximab; Sargramostim; Toxicity; Treatment Outcome; Vincristine - administration & dosage; Vincristine - adverse effects; DLBCL; Sargramostim; Granulocyte-macrophage colony-stimulating factor; Toxicity
• ISSN: 2152-2650; 2152-2669
• DOI: 10.3816/CLML.2010.n.071

Abstract Purpose Human recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF) may potentiate rituximab activity by upregulating CD20 expression and activating effector cells necessary for antibody-dependent cellular cytotoxicity. GM-CSF was combined with standard rituximab + CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone) chemotherapy (R-CHOP) in the treatment of elderly patients with de novo diffuse large B-cell lymphoma (DLBCL). Patients and Methods Thirty-eight patients over the age of 60 years with newly diagnosed DLBCL were treated with R-CHOP every 21 days for 6–8 cycles and GM-CSF 250 μg/m2 per day on days 3–10. Patients were evaluated for response after cycles 4, 6, and 8. The primary endpoint was the rate of complete response, and secondary endpoints were progression-free survival (PFS), event-free survival, and overall survival (OS). Results Thirty-eight patients were enrolled, with a median age of 72 years, and 29% of patients having high-risk disease (International Prognostic Index [IPI] score ≥ 4). A complete or unconfirmed complete response (CR) was achieved in 53% of patients. After a median follow-up of 51.1 months, the 3-year PFS and OS were 78% and 84%. Twenty-one percent of patients discontinued protocol treatment because of chemotherapy-related toxicity and 16% because of GM-CSF toxicity. Dose intensity for planned chemotherapy cycles was 81.1%. Conclusion These data suggest that survival outcomes may be modestly improved when GM-CSF is combined with R-CHOP in the treatment of elderly DLBCL. GM-CSF had toxicity precluding planned administration in 16% of patients, which may limit usefulness of this agent. Further investigation of GM-CSF in combination with rituximab-containing chemotherapy is warranted.