CHOP chemotherapy with preemptive granulocyte colony-stimulating factor in elderly patients with aggressive non-Hodgkin's lymphoma: a dose-intensity analysis.
This prospective trial was designed to determine the safety and efficacy of full-dose, on-time chemotherapy in elderly patients with aggressive non-Hodgkin's lymphoma. Twenty patients (median age, 71 years; range, 66 to 80 years) were enrolled in a phase II, multicenter trial to receive cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) supported by granulocyte colony-stimulating factor (G-CSF). CHOP was given in standard doses. Six cycles were planned every 21 days, with G-CSF starting on day 3 and continuing until the absolute neutrophil count was greater than 10,000/microL. Consolidation radiation therapy was permitted. Restaging was performed following cycles 4 and 6. By the age-adjusted International Prognostic Index, four patients were low, 10 were low-intermediate, four were high-intermediate, and two were high risk. Eighteen cases completed all 6 cycles. The average cycle length for all 112 cycles was 21.7 days. The dose intensities (corrected for delay) for each agent were cyclophosphamide 97.3%, doxorubicin 97.3%, vincristine 91.5%, and prednisone 97.3%. Treatment-related complications included grade 4 leukopenia and grade 4 thrombocytopenia in 11.6% and 3.6% of cycles, respectively. Hospitalization for neutropenia and fever was needed for 7.1% of cycles. There was no grade 3/4 cardiac toxicity. No treatment-related mortality occurred. All toxicities were reversible. There were 12 (60%) complete responses, four (20%) gallium-negative partial responses, and four patients (20%) with progressive disease. With a median follow-up of 2.29 years, progression-free and overall survival rates at 2 years are 42% (90% confidence interval: 23%-61%) and 66% (90% confidence interval: 47%-85%), respectively. Using preemptive G-CSF, full-dose CHOP can be administered safely to elderly patients.
Jacobson
J O
JO
North Shore Cancer Center, Peabody, MA 01960, USA. jacobson@nsmc.partners.org
Grossbard
M
M
Shulman
L N
LN
Neuberg
D
D
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000009:adverse effects / Q000627:therapeutic use*
D016179:Granulocyte Colony-Stimulating Factor; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone