Introduction: So far prognostic models developed for follicular lymphoma (FL) have been based on retrospective analysis of archive data. The F2-study was designed as a complement of the International Follicular Lymphoma Prognostic Factors Project with the aim of validating FLIPI and verifying whether a prognostic collection of data would allow the development of a more accurate prognostic index. Patients and Methods: Patients were registered in the study regardless their planned treatment. Study sample was calculated on the following statistical considerations: i) each risk factor has a prevalence of at least 10%; ii) the 5-yr survival of the remaining subjects is 70%; iii) the odds ratio is 2 for death with the risk factor compared to that without. A sample size of 900 assessable patients was planned. The primary focus of the study was Survival (OS) (specifically, at 5 years). Subsequently the study Executive Committee decided to consider Progression Free Survival (PFS) as an additional primary outcome measure. Variables to be used for score definition were selected by means of a bootstrap resampling procedures (N=250) on Cox proportional hazard regression analysis with backward elimination set at 0.10. Analyses to select the model minimizing the misclassification error were performed, and proportionality of the risks, overfitting and calibration of the model were also checked. Results: Between January 2003 and May 2005 1,093 patients were registered by 69 European and American Institutions; 1,057 fitted inclusion criteria; 942 received antilymphoma therapy, and 931 were assessable for FLIPI. After a median follow-up of 38 months, 292 events for PFS evaluation were recorded. In addition to FLIPI, in univariate analysis 11 variables significantly influencing PFS were found. Multivariate analysis showed that Beta2-microglobulin > ULN, Hemoglobin < 12 g/dL, Age > 60 years, Maximum diameter of the largest involved node > 6 cm and bone marrow involvement were factors independently predictive for PFS. Using these 5 variables, a prognostic model was devised to identify 3 groups at different risk. The 3-yr PFS rate was 92%, 70% and 50% for patients at low, intermediate and high risk respectively (Logrank=65.9, p<0.00001). The model was also predictive in the group of patients treated with (p<0.0001) or without (p<0.0001) Rituximab. The 3-yr survival rate was 99%, 96% and 84% for patients at low, intermediate and high risk respectively (p<0.00001). Conclusions: The F2 study demonstrates that a web-based world-wide collection of data is feasible, allows the opportunity to analyze a relevant and quite complete set of significant data, and is undoubtedly a powerful instrument for investigating the prognosis of FL. The F2 prognostic index seems a promising new tool for the identification of patients at different risk of disease progression.

F2 prognostic index / M., Federico; M., Bellei; L., Marcheselli; S., Luminari; A., Lopez Guillermo; U., Vitolo; B., Pro; Martelli, Maurizio; P., Soubeyran; S., Cortelazzo; G., Martinelli; S., Pileri; P., Mclaughlin; P., Solal Celigny. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 19 (SUPPL. 4):(2008), pp. 101-102. (Intervento presentato al convegno 10th International Conference on Malignant Lymphoma tenutosi a Lugano, SWITZERLAND nel JUN 04-07, 2008) [10.1093/annonc/mdn216].

F2 prognostic index

MARTELLI, Maurizio;
2008

Abstract

Introduction: So far prognostic models developed for follicular lymphoma (FL) have been based on retrospective analysis of archive data. The F2-study was designed as a complement of the International Follicular Lymphoma Prognostic Factors Project with the aim of validating FLIPI and verifying whether a prognostic collection of data would allow the development of a more accurate prognostic index. Patients and Methods: Patients were registered in the study regardless their planned treatment. Study sample was calculated on the following statistical considerations: i) each risk factor has a prevalence of at least 10%; ii) the 5-yr survival of the remaining subjects is 70%; iii) the odds ratio is 2 for death with the risk factor compared to that without. A sample size of 900 assessable patients was planned. The primary focus of the study was Survival (OS) (specifically, at 5 years). Subsequently the study Executive Committee decided to consider Progression Free Survival (PFS) as an additional primary outcome measure. Variables to be used for score definition were selected by means of a bootstrap resampling procedures (N=250) on Cox proportional hazard regression analysis with backward elimination set at 0.10. Analyses to select the model minimizing the misclassification error were performed, and proportionality of the risks, overfitting and calibration of the model were also checked. Results: Between January 2003 and May 2005 1,093 patients were registered by 69 European and American Institutions; 1,057 fitted inclusion criteria; 942 received antilymphoma therapy, and 931 were assessable for FLIPI. After a median follow-up of 38 months, 292 events for PFS evaluation were recorded. In addition to FLIPI, in univariate analysis 11 variables significantly influencing PFS were found. Multivariate analysis showed that Beta2-microglobulin > ULN, Hemoglobin < 12 g/dL, Age > 60 years, Maximum diameter of the largest involved node > 6 cm and bone marrow involvement were factors independently predictive for PFS. Using these 5 variables, a prognostic model was devised to identify 3 groups at different risk. The 3-yr PFS rate was 92%, 70% and 50% for patients at low, intermediate and high risk respectively (Logrank=65.9, p<0.00001). The model was also predictive in the group of patients treated with (p<0.0001) or without (p<0.0001) Rituximab. The 3-yr survival rate was 99%, 96% and 84% for patients at low, intermediate and high risk respectively (p<0.00001). Conclusions: The F2 study demonstrates that a web-based world-wide collection of data is feasible, allows the opportunity to analyze a relevant and quite complete set of significant data, and is undoubtedly a powerful instrument for investigating the prognosis of FL. The F2 prognostic index seems a promising new tool for the identification of patients at different risk of disease progression.
2008
10th International Conference on Malignant Lymphoma
04 Pubblicazione in atti di convegno::04d Abstract in atti di convegno
F2 prognostic index / M., Federico; M., Bellei; L., Marcheselli; S., Luminari; A., Lopez Guillermo; U., Vitolo; B., Pro; Martelli, Maurizio; P., Soubeyran; S., Cortelazzo; G., Martinelli; S., Pileri; P., Mclaughlin; P., Solal Celigny. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 19 (SUPPL. 4):(2008), pp. 101-102. (Intervento presentato al convegno 10th International Conference on Malignant Lymphoma tenutosi a Lugano, SWITZERLAND nel JUN 04-07, 2008) [10.1093/annonc/mdn216].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/485104
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