Primary Cutaneous Lymphoma: Recommendations for Clinical Trial Design and Staging Update from the ISCL, USCLC, and EORTC

Blood ◽  
2021 ◽  
Author(s):  
Elise A. Olsen ◽  
Sean Whittaker ◽  
Rein Willemze ◽  
Lauren Pinter-Brown ◽  
Francine M Foss ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Task Force ◽  
Clinical Trial Design ◽  
The United States ◽  
Cutaneous Lymphoma ◽  
European Organization ◽  
Design Assessment ◽  
Cutaneous Lymphomas ◽  
Number Of Patients ◽  
Primary Cutaneous Lymphoma

The number of patients with primary cutaneous lymphoma (PCL) relative to other non-Hodgkin lymphomas (NHLs) is small and the number of subtypes large. Although clinical trial guidelines have been published for mycosis fungoides/Sézary syndrome (MF/SS), the most common type of PCL, none exist for the other PCLs. In addition, staging in the PCLs has been evolving based on new data on potential prognostic factors, diagnosis, and assessment methods of both skin and extracutaneous disease and a desire to align the latter with the Lugano guidelines for all NHLs. The International Society for Cutaneous Lymphomas (ISCL), the United States Cutaneous Lymphoma Consortium (USCLC), and the Cutaneous Lymphoma Task Force of the European Organization for the Research and Treatment of Cancer (EORTC) now propose updated staging and guidelines for the study design, assessment, endpoints and response criteria in clinical trials for all the PCLs in alignment with that of the Lugano guidelines. These recommendations provide standardized methodology that should facilitate planning and regulatory approval of new treatments for these lymphomas worldwide, encourage cooperative investigator-initiated trials, and help to assess the comparative efficacy of therapeutic agents tested across sites and studies.

Revisions to the staging and classification of mycosis fungoides and Sézary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC)

Blood ◽  
2007 ◽  
Vol 110 (6) ◽  
pp. 1713-1722 ◽  
Author(s):  
Elise Olsen ◽  
Eric Vonderheid ◽  
Nicola Pimpinelli ◽  
Rein Willemze ◽  
Youn Kim ◽  
...  
Keyword(s):  
Mycosis Fungoides ◽  
Cell Biology ◽  
Task Force ◽  
Prognostic Significance ◽  
Staging System ◽  
Cutaneous Lymphoma ◽  
Sézary Syndrome ◽  
Sezary Syndrome ◽  
European Organization ◽  
Cutaneous Lymphomas

Abstract The ISCL/EORTC recommends revisions to the Mycosis Fungoides Cooperative Group classification and staging system for cutaneous T-cell lymphoma (CTCL). These revisions are made to incorporate advances related to tumor cell biology and diagnostic techniques as pertains to mycosis fungoides (MF) and Sézary syndrome (SS) since the 1979 publication of the original guidelines, to clarify certain variables that currently impede effective interinstitution and interinvestigator communication and/or the development of standardized clinical trials in MF and SS, and to provide a platform for tracking other variables of potential prognostic significance. Moreover, given the difference in prognosis and clinical characteristics of the non-MF/non-SS subtypes of cutaneous lymphoma, this revision pertains specifically to MF and SS. The evidence supporting the revisions is discussed as well as recommendations for evaluation and staging procedures based on these revisions.

scholarly journals EORTC, ISCL, and USCLC consensus recommendations for the treatment of primary cutaneous CD30-positive lymphoproliferative disorders: lymphomatoid papulosis and primary cutaneous anaplastic large-cell lymphoma*

Blood ◽  
2011 ◽  
Vol 118 (15) ◽  
pp. 4024-4035 ◽  
Author(s):  
Werner Kempf ◽  
Katrin Pfaltz ◽  
Maarten H. Vermeer ◽  
Antonio Cozzio ◽  
Pablo L. Ortiz-Romero ◽  
...  
Keyword(s):  
Anaplastic Large Cell Lymphoma ◽  
Cell Lymphoma ◽  
Large Cell ◽  
The United States ◽  
Lymphoproliferative Disorders ◽  
Cutaneous Lymphoma ◽  
European Organization ◽  
Lymphomatoid Papulosis ◽  
Cutaneous Lymphomas ◽  
Large Cell Lymphoma

AbstractPrimary cutaneous CD30+ lymphoproliferative disorders (CD30+ LPDs) are the second most common form of cutaneous T-cell lymphomas and include lymphomatoid papulosis and primary cutaneous anaplastic large-cell lymphoma. Despite the anaplastic cytomorphology of tumor cells that suggest an aggressive course, CD30+ LPDs are characterized by an excellent prognosis. Although a broad spectrum of therapeutic strategies has been reported, these have been limited mostly to small retrospective cohort series or case reports, and only very few prospective controlled or multicenter studies have been performed, which results in a low level of evidence for most therapies. The response rates to treatment, recurrence rates, and outcome have not been analyzed in a systematic review. Moreover, international guidelines for staging and treatment of CD30+ LPDs have not yet been presented. Based on a literature analysis and discussions, recommendations were elaborated by a multidisciplinary expert panel of the Cutaneous Lymphoma Task Force of the European Organization for Research and Treatment of Cancer, the International Society for Cutaneous Lymphomas, and the United States Cutaneous Lymphoma Consortium. The recommendations represent the state-of-the-art management of CD30+ LPDs and include definitions for clinical endpoints as well as response criteria for future clinical trials in CD30+ LPDs.

TNM classification system for primary cutaneous lymphomas other than mycosis fungoides and Sézary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the Cutaneous Lymphoma Task Force of the European Organization of Research and Treatment of Cancer (EORTC)

Blood ◽  
2007 ◽  
Vol 110 (2) ◽  
pp. 479-484 ◽  
Author(s):  
Youn H. Kim ◽  
Rein Willemze ◽  
Nicola Pimpinelli ◽  
Sean Whittaker ◽  
Elise A. Olsen ◽  
...  
Keyword(s):  
Mycosis Fungoides ◽  
International Society ◽  
Classification System ◽  
Task Force ◽  
Tnm Classification ◽  
Cutaneous Lymphoma ◽  
Sézary Syndrome ◽  
European Organization ◽  
Tnm System ◽  
Cutaneous Lymphomas

Abstract Currently availabel staging systems for non-Hodgkin lymphomas are not useful for clinical staging classification of most primary cutaneous lymphomas. The tumor, node, metastases (TNM) system used for mycosis fungoides (MF) and Sézary syndrome (SS) is not appropriate for other primary cutaneous lymphomas. A usable, unified staging system would improve the communication about the state of disease, selection of appropriate management, standardization of enrollment/response criteria in clinical trials, and collection/analysis of prospective survival data. Toward this goal, during the recent meetings of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC), the representatives have established a consensus proposal of a TNM classification system applicable for all primary cutaneous lymphomas other than MF and SS. Due to the clinical and pathologic heterogeneity of the cutaneous lymphomas, the currently proposed TNM system is meant to be primarily an anatomic documentation of disease extent and not to be used as a prognostic guide.

scholarly journals BIOMARKER AND CLINICAL TRIAL DESIGN SUPPORT FOR DISEASE-MODIFYING THERAPIES: REPORT OF A SURVEY OF THE EU/US: ALZHEIMER’S DISEASE TASK FORCE

2018 ◽  
pp. 1-7
Author(s):  
J. Cummings ◽  
N. Fox ◽  
B. Vellas ◽  
P. Aisen ◽  
G. Shan
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Trial Design ◽  
Task Force ◽  
Clinical Trial Design ◽  
Disease Modification ◽  
Disease Modifying Therapies ◽  
Disease Modifying ◽  
The Eu

BACKGROUND: Disease-modifying therapies are urgently needed for the treatment of Alzheimer’s disease (AD). The European Union/United States (EU/US) Task Force represents a broad range of stakeholders including biopharma industry personnel, academicians, and regulatory authorities. OBJECTIVES: The EU/US Task Force represents a community of knowledgeable individuals who can inform views of evidence supporting disease modification and the development of disease-modifying therapies (DMTs). We queried their attitudes toward clinical trial design and biomarkers in support of DMTs. DESIGN/SETTING/PARTICIANTS: A survey of members of the EU/US Alzheimer’s Disease Task Force was conducted. Ninety-three members (87%) responded. The details were analyzed to understand what clinical trial design and biomarker data support disease modification. MEASUREMENTS/RESULTS/CONCLUSIONS: Task Force members favored the parallel group design compared to delayed start or staggered withdrawal clinical trial designs to support disease modification. Amyloid biomarkers were regarded as providing mild support for disease modification while tau biomarkers were regarded as providing moderate support. Combinations of biomarkers, particularly combinations of tau and neurodegeneration, were regarded as providing moderate to marked support for disease modification and combinations of all three classes of biomarkers were regarded by a majority as providing marked support for disease modification. Task Force members considered that evidence derived from clinical trials and biomarkers supports clinical meaningfulness of an intervention, and when combined with a single clinical trial outcome, nearly all regarded the clinical trial design or biomarker evidence as supportive of disease modification. A minority considered biomarker evidence by itself as indicative of disease modification in prevention trials. Levels of evidence (A,B,C) were constructed based on these observations. CONCLUSION: The survey indicates the view of knowledgeable stakeholders regarding evidence derived from clinical trial design and biomarkers in support of disease modification. Results of this survey can assist in designing clinical trials of DMTs.

Cancer clinical trial accrual patterns among community cancer centers in the United States

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6041-6041
Author(s):  
J. A. Lee ◽  
M. A. Mathiason ◽  
C. A. Czeczok ◽  
J. K. Keller ◽  
R. S. Go
Keyword(s):  
Clinical Trial ◽  
Data Management ◽  
Cancer Patients ◽  
The United States ◽  
Cooperative Groups ◽  
Medical Support ◽  
Cancer Centers ◽  
Number Of Patients ◽  
Clinical Trial Accrual ◽  
The U.S

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.

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