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Infection Study Group
Goals, Mission and Annual Meeting Minutes
Chair:
J Peter Donnelly, PhD
Co-ordinator, Studies in Supportive Care
Department of Haematology
Radboud University Nijmegen Medical Centre & Nijmegen University Centre for Infectious Diseases
Geert Grooteplein Zuid 8
6525 GA Nijmegen
The Netherlands
Phone: +31-24-361-9987
Fax: +31-24-354-2080
p.donnelly@usa.net |
Co Chair:
Bernardo L Rapoport, MD
The Medical Oncology Centre of Rosebank
Postal address:
PO Box 2040
Parklands 2121 South AfricaTel: +27-11-880-4169
Fax: +27-11-788-7346
Mobile: +27-82-444-5473
brapoport@icon.co.za or brapoport@rapoport.co.za |
Co Chair:
Ronald Feld, MD, FRCP, FACP
Department of Medical Oncology & Hematology
Professor of Medicine, University of Toronto
Princess Margaret HoSpital
PMH 5th Floor 202
610 University Avenue
Toronto, ON M5G 2M9 CANADA
Phone: 416-946-2260 Fax: 416-946-6546
ronald.feld@uhn.on.ca |
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Status of Survey 2
Survey 2 has a required sample size of 1000 first febrile neutropenic episodes. And accrual was reached in February 2005 with last CRFs receipt in May 2005. Data validation and analysis is in process; the number of eligible episodes is over 1200 with over than 1000 first episodes. The sample has been divided into a derivation set and a validation set with a stratification for MASCC score, underlying cancer and observed further neutropenia duration.
The analysis will first show the identification of a model for further neutropenia duration (with the use of chemotherapy related variables as well as patient and tumor related factors) and secondly will look at the addition in a risk prediction model of an estimate of further neutropenia duration.
For the first model, it has been decided to attribute to the chemotherapy regimen a score describing the aggressiveness of the chemotherapy in terms of inducing neutropenia. This score is obtained by summing up individual scores associated with each cytotoxic drug. The chosen scores for each drug (from 0 to 4) were presented and reviewed by the investigators.
The calculation of the observed further neutropenia duration is also a key problem for the analysis as it is not always accurately documented by frequent blood counts. Three methods are then being used to determine the duration of the neutropenia:
Survey 2 has a required sample size of 1000 first febrile neutropenic episodes. And accrual was reached in February 2005 with last CRFs receipt in May 2005. Data validation and analysis is in process; the number of eligible episodes is over 1200 with over than 1000 first episodes. The sample has been divided into a derivation set and a validation set with a stratification for MASCC score, underlying cancer and observed further neutropenia duration. The analysis will first show the identification of a model for further neutropenia duration (with the use of chemotherapy related variables as well as patient and tumor related factors) and secondly will look at the addition in a risk prediction model of an estimate of further neutropenia duration. For the first model, it has been decided to attribute to the chemotherapy regimen a score describing the aggressiveness of the chemotherapy in terms of inducing neutropenia. This score is obtained by summing up individual scores associated with each cytotoxic drug. The chosen scores for each drug (from 0 to 4) were presented and reviewed by the investigators. The calculation of the observed further neutropenia duration is also a key problem for the analysis as it is not always accurately documented by frequent blood counts. Three methods are then being used to determine the duration of the neutropenia:
-observed duration on the basis of available neutrophil counts
-use of white blood cell counts for assessing neutropenia together with neutrophil counts
-use of imputation methods for missing data
Status of Survey 3
Survey 3 will focus on fungal infections occurring in febrile neutropenic patients. The objective is to identify among selected patients those at risk for developing fungal infection. The rationale behind the study is that empiric or pre-emptive antifungal treatment is given broadly and often to patients who don't need it exposing them to toxic (and expensive) drugs. The availability of a model that identifies patients who are not at risk of developing a fungal infection would be of great help in the management of neutropenic patients persistently febrile despite the initiation of empiric antibiotic treatment.
This protocol has been under discussion for several years mainly because of lack of funding for the study to be carried out in full. Nevertheless, the study has started with four institutions actively recruiting patients. Other institutions are ready to start and others have indicated an interest to participate. Main eligibility criteria of subjects are:
1)febrile neutropenic adult cancer patient with acute myeloid leukemia or myelodysplasic syndrome treated with myeloablative chemotherapy
2) any malignancy treated with allogeneic stem cell transplantation or undergoing a mini-transplant with an expected further neutropenia duration of at least 10 days
3) a MASCC score predicting a high risk patient (<21).
Eligibility criteria were discussed among those present at the meeting. It was decided to also include subjects that have
4) acute lymphoblastic leukemia and are treated with myeloablative chemotherapy.
New investigators are welcomed to participate in the study. Practical information regarding participation can be obtained by contacting the coordinating institution (J. Klastersky:jean.klastersky@bordet.be or M.Paesmans:marianne.paesmans@bordet.be).
 Fungal Infection Research Study - click here
The next meeting will be held in Athens, in January 2006, during the 7th Febrile Neutropenia meeting. The exact date and place of the meeting will be posted on the MASCC web site.
Go to Survey 1 & 2 click here
The Study Group for Infectious Diseases has been created with the goal of conducting research on the management of infections occurring in cancer patients, and therefore mainly on the management of febrile neutropenia. Two large multinational multicentric surveys have been designed by the Study Group.
The first one (survey 1) focused mainly on the identification of prognostic factors for the outcome of the febrile episode with the ultimate goal of selecting, at presentation, patients at low-risk for development of a serious medical complication.
The second one (survey 2) is ongoing and has, as first objective, the modelisation of the time to neutrophil recovery at fever onset.
The Study Group is chaired by Jean Klastersky, founding president of MASCC; the members are coming from a large variety of countries and continents. The daily management (data managing and analyses) of the surveys is taken in charge at Institut Bordet (Data Centre) with the collaboration of participating institutions.
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