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De Novo Treatment of Diffuse Large B-Cell Lymphoma with Rituximab

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De Novo Treatment of Diffuse Large B-Cell Lymphoma with Rituximab Published Ahead of Print on November 12, 2013 as 10.1200/JCO.2013.49.7586 The latest version is at http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2013.49.7586 JOURNAL OF CLINICAL ONCOLOGY ORIGINAL REPORT 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 A. Fields, William Townsend, Andrew Webb, Nicholas Counsell, Christopher Pocock, Paul Smith, Andrew Jack, Nadjet El-Mehidi, Peter W. Johnson, John Radford, David C. Linch, and David Cunnningham Paul A. Fields, Guys and St Thomas’ and King’s College Hospitals; William ABSTRACT Townsend, Nicholas Counsell, Paul Smith, and Nadjet El-Mehidi, Cancer Purpose Research UK and University College The treatment of patients with diffuse large B-cell lymphoma (DLBCL) with cardiac comorbidity is London Cancer Trials Centre; David C. problematic, because this group may not be able to receive anthracycline-containing chemoim- Linch, University College London Hospi- munotherapy. We designed a single-arm phase II multicenter trial of rituximab, gemcitabine, tal; David Cunnningham, Royal Marsden cyclophosphamide, vincristine, and prednisolone (R-GCVP) in patients considered unfit for Hospital, London; Andrew Webb, Royal anthracycline-containing chemoimmunotherapy because of cardiac comorbidity. Sussex Cancer Centre, Brighton; Chris- topher Pocock, Kent and Canterbury Patients and Methods Hospital, Kent; Andrew Jack, St James Sixty-one of 62 patients received R-GCVP, administered on day 1 with gemcitabine repeated on Hospital, Leeds; Peter W. Johnson, day 8 of a 21-day cycle. Median age was 76.5 years. All patients had advanced disease; 27 (43.5%) Southampton General Hospital, South- had left ventricular ejection fraction of Յ 50%, and 35 (56.5%) had borderline ejection fraction of ampton; and John Radford, Christie Ͼ Յ Hospital, Manchester, United Kingdom. 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. Published online ahead of print at www.jco.org on November 12, 2013. Results Thirty-eight patients (61.3%; 95% CI, 49.2 to 73.4) achieved disease response (complete response Supported in part by Roche, Amgen, Eli ϭ ϭ ϭ Lilly, UK National Cancer Research [CR], n 18; undocumented/unconfirmed CR, n 6; partial response, n 14). Two-year Institute, National Institute for Health progression-free survival for all patients was 49.8% (95% CI, 37.3 to 62.3), and 2-year overall Research Cancer Research Network, survival was 55.8% (95% CI, 43.3 to 68.4). Thirty-four patients experienced grade Ն 3 hematologic and Cancer Research UK (trial No. toxicity. There were 15 cardiac events, of which seven were grade 1 to 2, five were grade 3 to 4, CRUK/07/007); by Kings Health Partners and three were fatal, reflecting the poor cardiac status of the study population. Biomedical Research Centre (P.A.F.); by Biomedical Research Centre at Univer- Conclusion sity College London Hospitals (D.C.L.); Our phase II multicenter trial showed that the R-GCVP regimen is an active, reasonably and by Biomedical Research Centre well-tolerated treatment for patients with DLBCL for whom anthracycline-containing immunochem- Royal Marsden National Health Service otherapy was considered unsuitable because of coexisting cardiac disease. Trust (D.C.). Presented at the 53rd Annual Meeting J Clin Oncol 31. © 2013 by American Society of Clinical Oncology of the American Society of Hematol- ogy, San Diego, CA, December 10-13, 2011. (rituximab, cyclophosphamide, doxorubicin, INTRODUCTION Authors’ disclosures of potential con- vincristine, and prednisolone) chemoimmuno- flicts of interest and author contribu- Diffuse large B-cell lymphoma (DLBCL) is the com- therapy, which results in 5-year survival among pa- tions are found at the end of this tients age Ͼ 65 years in the region of 60%.4 article. monest type of non-Hodgkin lymphoma (NHL), with an incidence that increases with age to Ͼ 100 However, patients with concomitant cardiac co- Clinical trial information: NCT00971763. cases per 100,000 in people age Ͼ 80 years.1 By the morbidities that precluded the use of anthracyclines Corresponding author: Paul A. Fields, year 2015, the population age Ͼ 65 years is predicted were often excluded from the studies that proved the MBChB, FRCP, FRCPath, PhD, Guys Ͼ 2 5-7 and St Thomas’ Hospital, 4th Floor to rise by 22%, and that age 80 years by 50%, efficacy of chemoimmunotherapy. Thomas Guy House, St Thomas’s St, indicating that many more patients will present Doxorubicin is one of the key components of London SE1 9RT, United Kingdom; with attendant comorbid illnesses, making cura- the R-CHOP regimen, but it is known to be associ- e-mail: paul.fi[email protected]. tive treatment approaches problematic. In a series ated with an increased risk of cardiac toxicity, par- © 2013 by American Society of Clinical of 6,388 patients age Ն 65 years with DLBCL, ticularly congestive heart failure, with increasing Oncology cardiac risk factors were common; 32% patients cumulative dose.8 More recently, it was also shown 0732-183X/13/3199-1/$20.00 had diabetes mellitus (DM), and 73% had hyper- in a large US study that the risk of cardiomyopathy is DOI: 10.1200/JCO.2013.49.7586 tension.3 The treatment of choice for newly diag- greatly enhanced by the attendant cardiac risk fac- nosed patients with advanced DLBCL is R-CHOP tor of hypertension.3 As a result, patients with © 2013 by American Society of Clinical Oncology 1 Information downloaded from jco.ascopubs.org and provided by at UCL Library Services on November 22, 2013 from Copyright © 2013 American Society128.40.163.112 of Clinical Oncology. All rights reserved. Copyright 2013 by American Society of Clinical Oncology Fields et al pre-existing cardiac comorbidity are often excluded from treatment with with no evidence of hematologic toxicity; dose then remained at 1,000 mg/m2 for R-CHOP and therefore may not receive curative therapy. However, there all subsequent cycles. Rituximab 375 mg/m2 was administered as an intravenous infusion on day 1 of each cycle, with appropriate premedication (acetaminophen have been few, if any, studies that have prospectively recruited patients 2 with DLBCL with cardiac comorbidities, thus reducing the chances of 1 g and chlorphenramine 10 mg intravenously). Cyclophosphamide 750 mg/m and vincristine 1.4 mg/m2 (maximum dose 2 mg) were administered intrave- defining a curative treatment regimen for this group of patients. One nously on day 1 of each cycle, and prednisolone 100 mg was administered orally for potential way forward is to find another drug that can be substituted for the first 5 days of each cycle. Growth factor support (pegfilgrastim 6 mg subcuta- doxorubicin. Gemcitabine is a chemotherapeutic drug that in combina- neously) was mandated for all patients and administered on day 9 of each cycle. tion with platinum and methylprednislone has shown promising efficacy Patients considered to be at high risk for CNS relapse received intrathecal metho- in the setting of both relapsed/refractory NHL and HL.9 Importantly, the trexate 12.5 mg for three cycles. Radiotherapy to residual masses or original sites of drug seems to be associated with minimal cardiac adverse effects and disease bulk was permitted according to local policies, but it was specified in the protocol that radiotherapy not be administered within 1 month of the last dose seems safe in the setting of ischemic heart disease (IHD) and other cardiac of gemcitabine. risk factors such as DM and hypertension. The following dose reductions for gemcitabine, vincristine, and cyclo- Therefore, we developed a trial for patients who were considered phosphamide were advised in the event of hematologic toxicity: Gemcitabine unfit for conventional curative treatment with R-CHOP chemoim- was reduced to 75% dose, if absolute neutrophil count (ANC) 0.5 to 0.9 ϫ munotherapy on the basis of the presence of poor cardiac ejection 109/L or platelets 50 to 74 ϫ 109/L on the day of treatment; day 1 dose was Ͻ ϫ 9 Ͻ ϫ 9 fraction or borderline ejection with attendant comorbidities such as delayed if ANC 0.5 10 /L or platelets 50 10 /L; day 8 dose was IHD, DM, or hypertension, where the drug doxorubicin was replaced omitted in this instance. In the event of dose-limiting hematologic toxicity, gemcitabine dose escalation did not proceed in subsequent cycles. Cyclophos- by gemcitabine in the R-CHOP combination. The aim of the trial was phamide and vincristine doses were both reduced to 75% dose if ANC 0.5 to to develop a regimen to treat this group of patients with a curative 0.9 ϫ 109/L or platelets 50 to 74 ϫ 109/L on the day of treatment, with delay of approach without causing cardiac toxicity. treatment if ANC Ͻ 0.5 ϫ 109/L or platelets Ͻ 50 ϫ 109/L. Patients were assessed for adverse events and toxicity at each clinic visit. Interim response assessment was made after the third cycle of treatment with PATIENTS AND METHODS physical examination and contrast-enhanced CT scans of neck, thorax, abdo- men, and pelvis. Final response assessment was made with physical examina- tion and CT scan at end of treatment. In patients with bone marrow We performed a two-stage, multicenter, phase II, open-label, nonrandomized, involvement at baseline, repeat bone marrow biopsy was performed at end of single-arm trial. The trial was conducted in accordance with the Declaration of treatment. Patients underwent follow-up with regular clinical review, and CT Helsinki and the principles of Good Clinical Practice and was monitored by an scans of the neck, chest, abdomen, and pelvis were performed 3 and 12 months independent data monitoring committee.
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