De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity: A United Kingdom National Cancer Research Institute Trial

Paul Fields; William Townsend; Andrew Webb; Nicholas Counsell; Christopher Pocock; Paul Smith; Andrew Jack; Nadjet El-Mehidi; Peter W. Johnson; John Radford; David C. Linch; David Cunnningham

doi:10.1200/JCO.2013.49.7586

De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity: A United Kingdom National Cancer Research Institute Trial

Paul Fields, William Townsend, Andrew Webb, Nicholas Counsell, Christopher Pocock, Paul Smith, Andrew Jack, Nadjet El-Mehidi, Peter W. Johnson, John Radford, David C. Linch, David Cunnningham

Research output: Contribution to journal › Article › peer-review

83 Citations (Scopus)

Abstract

Purpose The treatment of patients with diffuse large B-cell lymphoma (DLBCL) with cardiac comorbidity is problematic, because this group may not be able to receive anthracycline-containing chemoimmunotherapy. We designed a single-arm phase II multicenter trial of rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone (R-GCVP) in patients considered unfit for anthracycline-containing chemoimmunotherapy because of cardiac comorbidity.

Patients and Methods Sixty-one of 62 patients received R-GCVP, administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle. Median age was 76.5 years. All patients had advanced disease; 27 (43.5%) had left ventricular ejection fraction of 50%, and 35 (56.5%) had borderline ejection fraction of > 50% but 55% and comorbid cardiac risk factors such as ischemic heart disease, diabetes mellitus, or hypertension. Primary end point was overall response rate at the end of treatment.

Results Thirty-eight patients (61.3%; 95% CI, 49.2 to 73.4) achieved disease response (complete response [CR], n = 18; undocumented/unconfirmed CR, n = 6; partial response, n = 14). Two-year progression-free survival for all patients was 49.8% (95% CI, 37.3 to 62.3), and 2-year overall survival was 55.8% (95% CI, 43.3 to 68.4). Thirty-four patients experienced grade 3 hematologic toxicity. There were 15 cardiac events, of which seven were grade 1 to 2, five were grade 3 to 4, and three were fatal, reflecting the poor cardiac status of the study population.

Conclusion Our phase II multicenter trial showed that the R-GCVP regimen is an active, reasonably well-tolerated treatment for patients with DLBCL for whom anthracycline-containing immunochemotherapy was considered unsuitable because of coexisting cardiac disease.

Original language	English
Pages (from-to)	282-287
Number of pages	6
Journal	Journal of Clinical Oncology
Volume	32
Issue number	4
DOIs	https://doi.org/10.1200/JCO.2013.49.7586
Publication status	Published - 1 Feb 2014

Keywords

NON-HODGKINS-LYMPHOMA
ELDERLY-PATIENTS
RISK-FACTORS
CHOP
CHEMOTHERAPY
DOXORUBICIN
REGIMEN
OLDER

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Fields, P., Townsend, W., Webb, A., Counsell, N., Pocock, C., Smith, P., Jack, A., El-Mehidi, N., Johnson, P. W., Radford, J., Linch, D. C., & Cunnningham, D. (2014). De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity: A United Kingdom National Cancer Research Institute Trial. Journal of Clinical Oncology, 32(4), 282-287. https://doi.org/10.1200/JCO.2013.49.7586

@article{8f60243a423344edb9d96643dec63120,

title = "De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity: A United Kingdom National Cancer Research Institute Trial",

abstract = "Purpose The treatment of patients with diffuse large B-cell lymphoma (DLBCL) with cardiac comorbidity is problematic, because this group may not be able to receive anthracycline-containing chemoimmunotherapy. We designed a single-arm phase II multicenter trial of rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone (R-GCVP) in patients considered unfit for anthracycline-containing chemoimmunotherapy because of cardiac comorbidity.Patients and Methods Sixty-one of 62 patients received R-GCVP, administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle. Median age was 76.5 years. All patients had advanced disease; 27 (43.5%) had left ventricular ejection fraction of 50%, and 35 (56.5%) had borderline ejection fraction of > 50% but 55% and comorbid cardiac risk factors such as ischemic heart disease, diabetes mellitus, or hypertension. Primary end point was overall response rate at the end of treatment.Results Thirty-eight patients (61.3%; 95% CI, 49.2 to 73.4) achieved disease response (complete response [CR], n = 18; undocumented/unconfirmed CR, n = 6; partial response, n = 14). Two-year progression-free survival for all patients was 49.8% (95% CI, 37.3 to 62.3), and 2-year overall survival was 55.8% (95% CI, 43.3 to 68.4). Thirty-four patients experienced grade 3 hematologic toxicity. There were 15 cardiac events, of which seven were grade 1 to 2, five were grade 3 to 4, and three were fatal, reflecting the poor cardiac status of the study population.Conclusion Our phase II multicenter trial showed that the R-GCVP regimen is an active, reasonably well-tolerated treatment for patients with DLBCL for whom anthracycline-containing immunochemotherapy was considered unsuitable because of coexisting cardiac disease.",

keywords = "NON-HODGKINS-LYMPHOMA, ELDERLY-PATIENTS, RISK-FACTORS, CHOP, CHEMOTHERAPY, DOXORUBICIN, REGIMEN, OLDER",

author = "Paul Fields and William Townsend and Andrew Webb and Nicholas Counsell and Christopher Pocock and Paul Smith and Andrew Jack and Nadjet El-Mehidi and Johnson, {Peter W.} and John Radford and Linch, {David C.} and David Cunnningham",

year = "2014",

month = feb,

day = "1",

doi = "10.1200/JCO.2013.49.7586",

language = "English",

volume = "32",

pages = "282--287",

journal = "Journal of Clinical Oncology",

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publisher = "American Society of Clinical Oncology",

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Fields, P, Townsend, W, Webb, A, Counsell, N, Pocock, C, Smith, P, Jack, A, El-Mehidi, N, Johnson, PW, Radford, J, Linch, DC & Cunnningham, D 2014, 'De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity: A United Kingdom National Cancer Research Institute Trial', Journal of Clinical Oncology, vol. 32, no. 4, pp. 282-287. https://doi.org/10.1200/JCO.2013.49.7586

De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity: A United Kingdom National Cancer Research Institute Trial. / Fields, Paul; Townsend, William; Webb, Andrew et al.
In: Journal of Clinical Oncology, Vol. 32, No. 4, 01.02.2014, p. 282-287.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity

T2 - A United Kingdom National Cancer Research Institute Trial

AU - Fields, Paul

AU - Townsend, William

AU - Webb, Andrew

AU - Counsell, Nicholas

AU - Pocock, Christopher

AU - Smith, Paul

AU - Jack, Andrew

AU - El-Mehidi, Nadjet

AU - Johnson, Peter W.

AU - Radford, John

AU - Linch, David C.

AU - Cunnningham, David

PY - 2014/2/1

Y1 - 2014/2/1

N2 - Purpose The treatment of patients with diffuse large B-cell lymphoma (DLBCL) with cardiac comorbidity is problematic, because this group may not be able to receive anthracycline-containing chemoimmunotherapy. We designed a single-arm phase II multicenter trial of rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone (R-GCVP) in patients considered unfit for anthracycline-containing chemoimmunotherapy because of cardiac comorbidity.Patients and Methods Sixty-one of 62 patients received R-GCVP, administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle. Median age was 76.5 years. All patients had advanced disease; 27 (43.5%) had left ventricular ejection fraction of 50%, and 35 (56.5%) had borderline ejection fraction of > 50% but 55% and comorbid cardiac risk factors such as ischemic heart disease, diabetes mellitus, or hypertension. Primary end point was overall response rate at the end of treatment.Results Thirty-eight patients (61.3%; 95% CI, 49.2 to 73.4) achieved disease response (complete response [CR], n = 18; undocumented/unconfirmed CR, n = 6; partial response, n = 14). Two-year progression-free survival for all patients was 49.8% (95% CI, 37.3 to 62.3), and 2-year overall survival was 55.8% (95% CI, 43.3 to 68.4). Thirty-four patients experienced grade 3 hematologic toxicity. There were 15 cardiac events, of which seven were grade 1 to 2, five were grade 3 to 4, and three were fatal, reflecting the poor cardiac status of the study population.Conclusion Our phase II multicenter trial showed that the R-GCVP regimen is an active, reasonably well-tolerated treatment for patients with DLBCL for whom anthracycline-containing immunochemotherapy was considered unsuitable because of coexisting cardiac disease.

AB - Purpose The treatment of patients with diffuse large B-cell lymphoma (DLBCL) with cardiac comorbidity is problematic, because this group may not be able to receive anthracycline-containing chemoimmunotherapy. We designed a single-arm phase II multicenter trial of rituximab, gemcitabine, cyclophosphamide, vincristine, and prednisolone (R-GCVP) in patients considered unfit for anthracycline-containing chemoimmunotherapy because of cardiac comorbidity.Patients and Methods Sixty-one of 62 patients received R-GCVP, administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle. Median age was 76.5 years. All patients had advanced disease; 27 (43.5%) had left ventricular ejection fraction of 50%, and 35 (56.5%) had borderline ejection fraction of > 50% but 55% and comorbid cardiac risk factors such as ischemic heart disease, diabetes mellitus, or hypertension. Primary end point was overall response rate at the end of treatment.Results Thirty-eight patients (61.3%; 95% CI, 49.2 to 73.4) achieved disease response (complete response [CR], n = 18; undocumented/unconfirmed CR, n = 6; partial response, n = 14). Two-year progression-free survival for all patients was 49.8% (95% CI, 37.3 to 62.3), and 2-year overall survival was 55.8% (95% CI, 43.3 to 68.4). Thirty-four patients experienced grade 3 hematologic toxicity. There were 15 cardiac events, of which seven were grade 1 to 2, five were grade 3 to 4, and three were fatal, reflecting the poor cardiac status of the study population.Conclusion Our phase II multicenter trial showed that the R-GCVP regimen is an active, reasonably well-tolerated treatment for patients with DLBCL for whom anthracycline-containing immunochemotherapy was considered unsuitable because of coexisting cardiac disease.

KW - NON-HODGKINS-LYMPHOMA

KW - ELDERLY-PATIENTS

KW - RISK-FACTORS

KW - CHOP

KW - CHEMOTHERAPY

KW - DOXORUBICIN

KW - REGIMEN

KW - OLDER

U2 - 10.1200/JCO.2013.49.7586

DO - 10.1200/JCO.2013.49.7586

M3 - Article

SN - 0732-183X

VL - 32

SP - 282

EP - 287

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 4

ER -

Fields P, Townsend W, Webb A, Counsell N, Pocock C, Smith P et al. De Novo Treatment of Diffuse Large B-Cell Lymphoma With Rituximab, Cyclophosphamide, Vincristine, Gemcitabine, and Prednisolone in Patients With Cardiac Comorbidity: A United Kingdom National Cancer Research Institute Trial. Journal of Clinical Oncology. 2014 Feb 1;32(4):282-287. doi: 10.1200/JCO.2013.49.7586