In 2003 the IIL started a phase III study to compare R-CHOP vs R-miniCEOP regimens for the initial treatment of elderly patients with B-DLCL. The study was also aimed at assessing the usefullness of a Multidimensional Evaluation Scale (MES) to prospectively identify patients eligible to full doses chemotherapy. MES questionnaire included comorbidity, ADL, IADL and geriatric syndrome scales. Main inclusion criteria were age ‡ 65 years, stage II-IV, non-frail status based on MES rules. Eligible patients were randomized between 6 courses of R-CHOP-21 and R-miniCEOP-21 (vinblastine 5mg/sqm instead of vincristine; epidoxorubicin 50mg/sqm instead of doxorubicin). Study was closed on dec 2006 after enrollment of 288 patients: 236 patients were non frail at MES and were randomized; 2 patients were excluded (stage I disease; concomitant neoplasia). The clinical characteristics of the 234 randomized cases (R-CHOP: 114; R-mini-CEOP: 120) were median age 71 years, M/F 1.1, Stage IIIIV 69%, > 1 ENS 27%, aaIPI 2-3 47%. CR rate was 74% and 65% of in the R-CHOP and R-miniCEOP arms, respectively (p=0.233). Toxicity was similar in the two arms. After a median follow-up of 18 months, 2-yrs EFS and OS were 52% and 70%, with no differences between study arms. Analysis of MES data did not identify any comorbid condition, or ADL, or IADL scores of prognostic relevance. Among 53 non randomized frail patients, curative treatment was planned in 28 cases; for these cases a worst outcome was observed compared to non-frail patients (2yr OS of 46% vs 70%; p=0.007). In conclusion MES represents a valid tool for identifying elderly patients with B-DLCL eligible to full doses chemotherapy and its use is recommended for future trials. The addition of Rituximab to a less intensive chemotherapy regimen (mini-CEOP) represent a good alternative to standard R-CHOP for the treatment of elderly patient with B-DLCL

Phase III randomized trial comparing R-chop vs R-miniceop in elderly patients with diffuse large B-cell lymphoma (B-DLCL) prospectively selected by a multidimensional evaluation scale / F., Merli; S., Luminari; A., Tucci; P., Pregno; M., Musso; Martelli, Maurizio; C., Stelitano; L., Baldini; P., Mazza; D., Vallisa; F., Salvi; E., Barbolini; A. M., Liberati; C., Bottelli; F., Ilariucci; M., Federico. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 19 (SUPPL. 4):(2008), pp. 148-148. (Intervento presentato al convegno 10th International Conference on Malignant Lymphoma tenutosi a Lugano, SWITZERLAND nel JUN 04-07, 2008) [10.1093/annonc/mdn237].

Phase III randomized trial comparing R-chop vs R-miniceop in elderly patients with diffuse large B-cell lymphoma (B-DLCL) prospectively selected by a multidimensional evaluation scale

MARTELLI, Maurizio;
2008

Abstract

In 2003 the IIL started a phase III study to compare R-CHOP vs R-miniCEOP regimens for the initial treatment of elderly patients with B-DLCL. The study was also aimed at assessing the usefullness of a Multidimensional Evaluation Scale (MES) to prospectively identify patients eligible to full doses chemotherapy. MES questionnaire included comorbidity, ADL, IADL and geriatric syndrome scales. Main inclusion criteria were age ‡ 65 years, stage II-IV, non-frail status based on MES rules. Eligible patients were randomized between 6 courses of R-CHOP-21 and R-miniCEOP-21 (vinblastine 5mg/sqm instead of vincristine; epidoxorubicin 50mg/sqm instead of doxorubicin). Study was closed on dec 2006 after enrollment of 288 patients: 236 patients were non frail at MES and were randomized; 2 patients were excluded (stage I disease; concomitant neoplasia). The clinical characteristics of the 234 randomized cases (R-CHOP: 114; R-mini-CEOP: 120) were median age 71 years, M/F 1.1, Stage IIIIV 69%, > 1 ENS 27%, aaIPI 2-3 47%. CR rate was 74% and 65% of in the R-CHOP and R-miniCEOP arms, respectively (p=0.233). Toxicity was similar in the two arms. After a median follow-up of 18 months, 2-yrs EFS and OS were 52% and 70%, with no differences between study arms. Analysis of MES data did not identify any comorbid condition, or ADL, or IADL scores of prognostic relevance. Among 53 non randomized frail patients, curative treatment was planned in 28 cases; for these cases a worst outcome was observed compared to non-frail patients (2yr OS of 46% vs 70%; p=0.007). In conclusion MES represents a valid tool for identifying elderly patients with B-DLCL eligible to full doses chemotherapy and its use is recommended for future trials. The addition of Rituximab to a less intensive chemotherapy regimen (mini-CEOP) represent a good alternative to standard R-CHOP for the treatment of elderly patient with B-DLCL
2008
10th International Conference on Malignant Lymphoma
04 Pubblicazione in atti di convegno::04d Abstract in atti di convegno
Phase III randomized trial comparing R-chop vs R-miniceop in elderly patients with diffuse large B-cell lymphoma (B-DLCL) prospectively selected by a multidimensional evaluation scale / F., Merli; S., Luminari; A., Tucci; P., Pregno; M., Musso; Martelli, Maurizio; C., Stelitano; L., Baldini; P., Mazza; D., Vallisa; F., Salvi; E., Barbolini; A. M., Liberati; C., Bottelli; F., Ilariucci; M., Federico. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 19 (SUPPL. 4):(2008), pp. 148-148. (Intervento presentato al convegno 10th International Conference on Malignant Lymphoma tenutosi a Lugano, SWITZERLAND nel JUN 04-07, 2008) [10.1093/annonc/mdn237].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/485109
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