2004•Journal of Clinical OncologyRequires access

Feasibility and preliminary efficacy of R-CHOP-14 in patients with diffuse large B-Cell lymphoma (DLBCL)

Jeffrey L. Halaas, Craig H. Moskowitz, Ariela Noy, C. S. Portlock, Steve M. Horwitz, David J. Straus, O. O’Connor, Joachim Yahalom, Andrew David Zelenetz

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Abstract

6584 Background: Standard first line therapy for DLBCL is CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). Studies have shown that the addition of rituximab (R) or shortening the interval between cycles to two weeks improves survival. These studies prompted our institution, MSKCC, to treat newly diagnosed patients with DLBCL ineligible or refusing protocol-based therapy with R-CHOP-14. This retrospective review reports our experience with this regimen. Methods: We retrospectively identified patients with DLBCL without significant co-morbidities treated at MSKCC with R-CHOP-14. Patients received filgrastim and prophylactic sulfamethoxazole/trimethoprim, fluconazole and anti-herpes antibiotics. Erythropoietin was given per institutional guidelines. Patients received involved field radiation therapy to sites of early stage disease or bulky or symptomatic sites of disease and intrathecal prophylaxis if indicated. Results: In total, 49 patients were included for analysis. The median age was 52 (14/49 > 60); 20/49 with KPS ≤ 70%; 26/49 with elevated LDH; 18/49 ≥2 extranodal sites and 71% had advanced stage. According to the International Prognostic Index (IPI) 30.6% patients had low risk disease, 22.4% low-intermediate risk, 28.6% high-intermediate risk, and 18.4% high risk disease. Ninety-two percent of patients received 6 cycles of R-CHOP-14. Seventy-three percent of courses were delivered within 14 days and the planned dose was given in greater than 96% cycles for R, cyclophosphamide and doxorubicin but 67.5% for vincristine (VCR). Ten patients were hospitalized a total of 21 times; neutropenic fever occurred in 3.6% (9/252) of cycles given. Among evaluable patients 37/45 (82.2%) achieved a CR/CRu and 1 patient had refractory disease. Of 7 patients with refractory/relapsed disease, 4 are alive. Progression free survival at 18 months is 89%. Conclusions: Administration of R-CHOP-14 is feasible and early results show favorable efficacy. Most cycles can be delivered on time and at full dose except for VCR, which was dose-reduced in one third of cycles. Early results are encouraging and warrant comparison to R-CHOP-21. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho Biotech IDEC Ligand; Ortho Biotech; Schering-Plough Clinical Lymphoma Clinical Lymphoma

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6584 Background: Standard first line therapy for DLBCL is CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). Studies have shown that the addition of rituximab (R) or shortening the interval between cycles to two weeks improves survival. These studies prompted our institution, MSKCC, to treat newly diagnosed patients with DLBCL ineligible or refusing protocol-based therapy with R-CHOP-14. This retrospective review reports our experience with this regimen. Methods: We retrospectively identified patients with DLBCL without significant co-morbidities treated at MSKCC with R-CHOP-14. Patients received filgrastim and prophylactic sulfamethoxazole/trimethoprim, fluconazole and anti-herpes antibiotics. Erythropoietin was given per institutional guidelines. Patients received involved field radiation therapy to sites of early stage disease or bulky or symptomatic sites of disease and intrathecal prophylaxis if indicated. Results: In total, 49 patients were included for analysis. The median age was 52 (14/49 > 60); 20/49 with KPS ≤ 70%; 26/49 with elevated LDH; 18/49 ≥2 extranodal sites and 71% had advanced stage. According to the International Prognostic Index (IPI) 30.6% patients had low risk disease, 22.4% low-intermediate risk, 28.6% high-intermediate risk, and 18.4% high risk disease. Ninety-two percent of patients received 6 cycles of R-CHOP-14. Seventy-three percent of courses were delivered within 14 days and the planned dose was given in greater than 96% cycles for R, cyclophosphamide and doxorubicin but 67.5% for vincristine (VCR). Ten patients were hospitalized a total of 21 times; neutropenic fever occurred in 3.6% (9/252) of cycles given. Among evaluable patients 37/45 (82.2%) achieved a CR/CRu and 1 patient had refractory disease. Of 7 patients with refractory/relapsed disease, 4 are alive. Progression free survival at 18 months is 89%. Conclusions: Administration of R-CHOP-14 is feasible and early results show favorable efficacy. Most cycles can be delivered on time and at full dose except for VCR, which was dose-reduced in one third of cycles. Early results are encouraging and warrant comparison to R-CHOP-21. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho Biotech IDEC Ligand; Ortho Biotech; Schering-Plough Clinical Lymphoma Clinical Lymphoma

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Available abstract

6584 Background: Standard first line therapy for DLBCL is CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). Studies have shown that the addition of rituximab (R) or shortening the interval between cycles to two weeks improves survival. These studies prompted our institution, MSKCC, to treat newly diagnosed patients with DLBCL ineligible or refusing protocol-based therapy with R-CHOP-14. This retrospective review reports our experience with this regimen. Methods: We retrospectively identified patients with DLBCL without significant co-morbidities treated at MSKCC with R-CHOP-14. Patients received filgrastim and prophylactic sulfamethoxazole/trimethoprim, fluconazole and anti-herpes antibiotics. Erythropoietin was given per institutional guidelines. Patients received involved field radiation therapy to sites of early stage disease or bulky or symptomatic sites of disease and intrathecal prophylaxis if indicated. Results: In total, 49 patients were included for analysis. The median age was 52 (14/49 > 60); 20/49 with KPS ≤ 70%; 26/49 with elevated LDH; 18/49 ≥2 extranodal sites and 71% had advanced stage. According to the International Prognostic Index (IPI) 30.6% patients had low risk disease, 22.4% low-intermediate risk, 28.6% high-intermediate risk, and 18.4% high risk disease. Ninety-two percent of patients received 6 cycles of R-CHOP-14. Seventy-three percent of courses were delivered within 14 days and the planned dose was given in greater than 96% cycles for R, cyclophosphamide and doxorubicin but 67.5% for vincristine (VCR). Ten patients were hospitalized a total of 21 times; neutropenic fever occurred in 3.6% (9/252) of cycles given. Among evaluable patients 37/45 (82.2%) achieved a CR/CRu and 1 patient had refractory disease. Of 7 patients with refractory/relapsed disease, 4 are alive. Progression free survival at 18 months is 89%. Conclusions: Administration of R-CHOP-14 is feasible and early results show favorable efficacy. Most cycles can be delivered on time and at full dose except for VCR, which was dose-reduced in one third of cycles. Early results are encouraging and warrant comparison to R-CHOP-21. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho Biotech IDEC Ligand; Ortho Biotech; Schering-Plough Clinical Lymphoma Clinical Lymphoma

Key concepts: Medicine, Vincristine, Rituximab, International Prognostic Index, Surgery, Internal medicine, CHOP, Regimen

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