The IELSG-19 randomized study comparing chlorambucil (C) alone versus the combination of C and rituximab (R) versus the sole R is the largest prospective randomized trial ever conducted in MALT lymphoma. Main contributors were the Italian Lymphoma Foundation, the GELA group, Cancer Research UK, the Catalan Hematology Group and the Oncology Institute of Southern Switzerland. All MALT lymphoma pts with localized disease at any extranodal site who did not respond or were not suitable to local therapy (including H.pylori-negative gastric lymphomas) or those who failed antibiotic therapy were eligible, as well as those with disseminated or multifocal MALT lymphoma. The present analysis refers to 424 evaluable pts. One hundred thirty seven pts were randomized to C, 140 to C plus R and 147 pts to R alone. Stomach was the primary lymphoma site in 179 pts (42.2%), while 245 pts (57.8%) had a non-gastric presentation. In 120 pts (30.5%) lymphoma involved more than 1 extranodal site. Lymph node involvement was present in 154 pts (36.3%); 168 pts (42.6%) had advanced stage (Ann Arbor III-IV). ECOG performance status was reported in 393 pts and was 0 in 297 them (70%). According to the international prognostic index (IPI), 66 pts (17%) had intermediate-high risk and only 9 a high risk score (2%). B-symptoms were present in 43 of 294 pts (10.9%) and LDH levels were higher than normal in 42 (10.7%) of 393 pts. Median age was 61 years (range, 26-81). After a median follow-up of 3.2 years, EFS was 66%, PFS 74% and OS 94%. At multivariate analysis, nodal involvement, B-symptoms, lower levels of serum protein concentration and unfavourable IPI scores were independently associated with shorter EFS and PFS, after adjustment by treatment arm. Analysis of prognostic variables is ongoing to identify the main predictive factors and to develop a MALT-lymphoma specific prognostic system.

ANALYSIS OF PROGNOSTIC FACTORS IN 424 MALT LYMPHOMA PATIENTS TREATED IN THE IELSG-19 MULTICENTER RANDOMISED STUDY / A., Conconi; C., Thieblemont; D., Laszlo; V., Torri; R., Bouabdallah; A., Tucci; U., Vitolo; Martelli, Maurizio; B., Coiffier; C., Sebban; I., Floriani; P., Johnson; A., Lopez Guillermo; E., Porro; G., Martinelli; E., Zucca. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 22 (suppl 4):(2011), pp. 183-183. ((Intervento presentato al convegno 11th International Conference on Malignant Lymphoma tenutosi a Lugano, SWITZERLAND nel JUN 15-18, 2011 [10.1093/annonc/mdr224].

ANALYSIS OF PROGNOSTIC FACTORS IN 424 MALT LYMPHOMA PATIENTS TREATED IN THE IELSG-19 MULTICENTER RANDOMISED STUDY

MARTELLI, Maurizio;
2011

Abstract

The IELSG-19 randomized study comparing chlorambucil (C) alone versus the combination of C and rituximab (R) versus the sole R is the largest prospective randomized trial ever conducted in MALT lymphoma. Main contributors were the Italian Lymphoma Foundation, the GELA group, Cancer Research UK, the Catalan Hematology Group and the Oncology Institute of Southern Switzerland. All MALT lymphoma pts with localized disease at any extranodal site who did not respond or were not suitable to local therapy (including H.pylori-negative gastric lymphomas) or those who failed antibiotic therapy were eligible, as well as those with disseminated or multifocal MALT lymphoma. The present analysis refers to 424 evaluable pts. One hundred thirty seven pts were randomized to C, 140 to C plus R and 147 pts to R alone. Stomach was the primary lymphoma site in 179 pts (42.2%), while 245 pts (57.8%) had a non-gastric presentation. In 120 pts (30.5%) lymphoma involved more than 1 extranodal site. Lymph node involvement was present in 154 pts (36.3%); 168 pts (42.6%) had advanced stage (Ann Arbor III-IV). ECOG performance status was reported in 393 pts and was 0 in 297 them (70%). According to the international prognostic index (IPI), 66 pts (17%) had intermediate-high risk and only 9 a high risk score (2%). B-symptoms were present in 43 of 294 pts (10.9%) and LDH levels were higher than normal in 42 (10.7%) of 393 pts. Median age was 61 years (range, 26-81). After a median follow-up of 3.2 years, EFS was 66%, PFS 74% and OS 94%. At multivariate analysis, nodal involvement, B-symptoms, lower levels of serum protein concentration and unfavourable IPI scores were independently associated with shorter EFS and PFS, after adjustment by treatment arm. Analysis of prognostic variables is ongoing to identify the main predictive factors and to develop a MALT-lymphoma specific prognostic system.
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