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


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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Available from: Malik Juweid, Sep 17, 2015
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    • "applications/docs/ctcaev3.pdf), except thrombocytopenia (Grade 3 or 4) if recovery to 50 9 10 9 /l within 14 d in the absence of platelet transfusion or bleeding and neutropenia (Grade 3 or 4) if recovery to 1 9 10 9 /l within 14 d in absence of fever or infection. Response was assessed every 8 weeks (Cheson et al, 2007). Twenty-three patients with CD30-positive HL were enrolled and received XmAb â 2513 therapy. "
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    ABSTRACT: Keywords:Hodgkin lymphoma;monoclonal antibodies;clinical trials;therapy;immunotherapy
    British Journal of Haematology 10/2014; 168(6). DOI:10.1111/bjh.13152 · 4.71 Impact Factor
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    • "On an intent-to-treat basis, objective responses (CR and PR) were observed in 4 of 46 patients (9%; 2 CR, 2 PR) and 13 patients had SD (28%; Table 5), resulting in a disease control rate of 37% (Figure 1A). The response scores for these patients were consistent between the 1999 and 2007 (revised) response criteria [11,15]. On independent pathology review, 3 of the responders were confirmed to have DLBCL while one partial responder had a diffuse variant of Grade 2 follicular lymphoma. "
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    ABSTRACT: Patients with DLBCL who are ineligible for or have relapsed after aggressive salvage chemotherapy have a poor prognosis. CD40 is expressed on multiple B-cell neoplasms including DLBCL and is a potential target for immunotherapy. Dacetuzumab (SGN-40), a non-blocking, partial agonist, humanized IgG1, anti-CD40 monoclonal antibody, has previously demonstrated anti-lymphoma activity in a phase I study. A phase II study was undertaken to evaluate the rate and duration of objective responses and safety of single-agent dacetuzumab in relapsed DLBCL. Forty-six adult patients with relapsed/refractory DLBCL received up to 12 cycles of intravenous dacetuzumab using intrapatient dose-escalation to a target dose of 8 mg/kg/week in an initial 5-week cycle, followed by 4-week cycles of 8 mg/kg/week. Study endpoints included rate and duration of objective responses, safety, survival, pharmacokinetics, immunogenicity, and exploratory correlative studies. Overall response rate was 9% and disease control rate (complete remission + partial remission + stable disease) was 37%. Common non-hematologic adverse events (AEs) included fatigue, headache, chills, fever, and nausea. The most frequent Grade 3–4 non-hematologic AE was deep venous thrombosis (3 patients). Grade 3–4 lymphopenia (41%), neutropenia (13%), or thrombocytopenia (19%) occurred without associated infection or bleeding. Reversible ocular events, including conjunctivitis and ocular hyperemia, occurred in 8 patients (17%). Patient-specific factors, including Fc-gamma-RIIIa polymorphism, did not appear to correlate with antitumor activity. Single-agent dacetuzumab has modest activity and manageable toxicity in unselected patients with relapsed DLBCL. Combination regimens and robust methods of patient selection may be necessary for further development. Trial registration identifier NCT00435916.
    Journal of Hematology & Oncology 06/2014; 7(1):44. DOI:10.1186/1756-8722-7-44 · 4.81 Impact Factor
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    • "The 2007 revised guidelines of the International Harmonization Project were adopted to describe the response criteria for DLBCL [7]. CR was defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if these were present before therapy. "
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    ABSTRACT: Background We investigated factors that influence outcomes in diffuse large B-cell lymphoma (DLBCL) patients treated with rituximab combined with the CHOP regimen (R-CHOP) followed by upfront autologous stem cell transplantation (Auto-SCT). Methods We retrospectively evaluated survival differences between subgroups based on the age-adjusted International Prognostic Index (aaIPI) and revised-IPI (R-IPI) at diagnosis, disease status, and positron emission tomographic/computerized tomographic (PET/CT) status at transplantation in 51 CD20-positive DLBCL patients treated with R-CHOP followed by upfront Auto-SCT. Results Patients had either stage I/II bulky disease (5.9%) or stage III/IV disease (94.1%). The median patient age at diagnosis was 47 years (range, 22-66 years); 53.3% and 26.7% had high-intermediate and high risks according to aaIPI, respectively. At the time of Auto-SCT, 72.5% and 27.5% experienced complete (CR) and partial remission (PR) after R-CHOP, respectively. The median time from diagnosis to Auto-SCT was 7.27 months (range, 3.4-13.4 months). The 5-year overall (OS) and progression-free survival (PFS) were 77.3% and 72.4%, respectively. The 5-year OS and PFS rates according to aaIPI, R-IPI, and PET/CT status did not differ between the subgroups. More importantly, the 5-year OS and PFS rates of the patients who achieved PR at the time of Auto-SCT were not inferior to those of the patients who achieved CR (P=0.223 and 0.292, respectively). Conclusion Survival was not influenced by the aaIPI and R-IPI at diagnosis, disease status, or PET/CT status at transplantation, suggesting that upfront Auto-SCT might overcome unfavorable outcomes attributed to PR after induction chemoimmunotherapy.
    Blood Research 06/2014; 49(2):107-14. DOI:10.5045/br.2014.49.2.107
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