Revised Response Criteria for Malignant Lymphoma

University of Cologne, Köln, North Rhine-Westphalia, Germany
Journal of Clinical Oncology (Impact Factor: 18.43). 03/2007; 25(5):579-86. DOI: 10.1200/JCO.2006.09.2403
Source: PubMed

ABSTRACT Standardized response criteria are needed to interpret and compare clinical trials and for approval of new therapeutic agents by regulatory agencies.
The International Working Group response criteria (Cheson et al, J Clin Oncol 17:1244, 1999) were widely adopted, but required reassessment because of identified limitations and the increased use of [18F]fluorodeoxyglucose-positron emission tomography (PET), immunohistochemistry (IHC), and flow cytometry. The International Harmonization Project was convened to provide updated recommendations.
New guidelines are presented incorporating PET, IHC, and flow cytometry for definitions of response in non-Hodgkin's and Hodgkin's lymphoma. Standardized definitions of end points are provided.
We hope that these guidelines will be adopted widely by study groups, pharmaceutical and biotechnology companies, and regulatory agencies to facilitate the development of new and more effective therapies to improve the outcome of patients with lymphoma.

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    • "The use of PET/CT in HL Hodgkin Lymphoma is 18 FFDG avid in 97–100% of cases (Weiler-Sagie et al, 2010). Staging patients with FDG PET-CT is more accurate than CT alone (Cheson et al, 2007) and the availability of a baseline scan increases the reliability of subsequent response assessment (Quarles van Ufford et al, 2010; Barrington et al, 2011). Contrast-enhanced CT may be done as part of the PET-CT examination or at a separate visit, depending on local imaging arrangements. "
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    ABSTRACT: The guideline group was selected to be representative of UK-based medical experts and patients' representatives. MEDLINE and EMBASE were searched systematically for publications in English from January 1990 to June 2013 using the key words Hodgkin, Lymphoma, Treatment, Chemotherapy and Radiotherapy. References from relevant publications were also searched. The writing group produced the draft guideline, which was subsequently revised by consensus by members of the Haemato-Oncology Task Force of the British Committee for Standards in Haematology (BCSH). The guideline was then reviewed by a sounding board of approximately 50 UK haematologists and the BCSH and comments incorporated where appropriate. The 'GRADE' system was used to quote levels and grades of evidence, details of which can be found in Appendix I. The objective of this guideline is to provide healthcare professionals with clear guidance on the management of patients with classical Hodgkin Lymphoma (HL). The guidance may not be appropriate for all patients with HL and in all cases individual patient circumstances may dictate an alternative approach.
    British Journal of Haematology 04/2014; 166(1). DOI:10.1111/bjh.12878 · 4.96 Impact Factor
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    • "Patients could continue therapy until disease progression or unacceptable toxicity occurred. Response was assessed by computerized tomography (CT) scan according to the revised response criteria for malignant lymphoma (Cheson et al, 2007). A total of 25 patients also underwent positron emission tomography (PET) for response evaluation. "
    British Journal of Haematology 03/2014; 166(2). DOI:10.1111/bjh.12849 · 4.96 Impact Factor
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    • "Analysis excludes the second retreatment for 3 systemic anaplastic large cell lymphoma patients. a Best response (according to Cheson 2007 "
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    ABSTRACT: Brentuximab vedotin is a CD30-directed antibody-drug conjugate. Retreatment with brentuximab vedotin monotherapy was investigated in patients with CD30-positive Hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (ALCL) who relapsed after achieving complete or partial remission (CR or PR) with initial brentuximab vedotin therapy in a previous study ( NCT00947856). Twenty-one patients with HL and 8 patients with systemic ALCL were retreated; 3 patients with systemic ALCL were retreated twice. Patients generally received brentuximab vedotin 1.8 mg/kg intravenously approximately every 3 weeks over 30 minutes as an outpatient infusion. The primary objectives of this study were to assess safety and to estimate antitumor activity of brentuximab vedotin retreatment. The objective response rate was 60% (30% CR) in HL patients and 88% (63% CR) in systemic ALCL patients. The estimated median duration of response for patients with an objective response was 9.5 months (range, 0.0+ to 28.0+ months) at the time of study closure. Of the 19 patients with objective response, 7 patients had not had an event of disease progression or death at the time of study closure; duration of response for these patients ranged from 3.5 to 28 months. Of the 11 patients with CR, 45% had response durations of over 1 year.Adverse events (AEs) occurring in >=25% of patients during the retreatment period were generally similar in type and frequency to those observed in the pivotal trials of brentuximab vedotin monotherapy, with the exception of peripheral neuropathy, which is known to have a cumulative effect. Grade 3 or higher events were observed in 48% of patients; these were generally transient and managed by dose modifications or delays. Deaths due to AEs occurred in 3 HL patients; none were considered to be related to brentuximab vedotin retreatment. With the exception of a higher rate of peripheral motor neuropathy, retreatment with brentuximab vedotin was associated with similar side effects seen in the pivotal trials. Retreatment with brentuximab vedotin monotherapy is associated with response rates in 68% (39% CR) of patients with relapsed HL and systemic ALCL.Trial registration: United States registry and results database NCT00947856.
    Journal of Hematology & Oncology 03/2014; 7(1):24. DOI:10.1186/1756-8722-7-24 · 4.93 Impact Factor
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