Background. Diffuse large B-cell lymphoma (DLBCL) of the testis (PTL) is a rare presentation of extranodal lymphoma at poor prognosis with a 5-yr overall survival of 40-55%. Contralateral testis, CNS and extranodal sites relapses are the main cause of failures. Aims. the IELSG10 study is a prospective phase II international trial for stage I or II PTL. It aimed at defining a standard treatment for PTL with a combined treatment of R-CHOP, intrathecal methotrexate and prophylactic scrotal radiotherapy (RT) with the addition, in stage II, of loco-regional RT. The trial was conducted by International Extranodal Lymphoma Study Group (IELSG) and Intergruppo Italiano Linfomi (IIL). The present analysis provides the final results of the whole study. Methods. Between June 2001 and December 2006, 53 untreated patients with stage I-II PTL were enrolled from 31 centres. Treatment was: R-CHOP21 (Rituximab 375 mg/mq, Cyclophosphamide 750 mg/mq, Doxorubicine 50 mg/mq, Vincristine 1.4mg/mq d 1 and Prednisone 40 mg/mq dd 1-5) for 6 or 8 (in stage II patients with slow response) courses; intrathecal methotrexate (IT-MTX) 15mg for 4 doses in courses 1 and 2; after chemotherapy 30Gy scrotal RT to the contralateral testis was planned to all patients reserving 30-36 Gy on loco-regional nodes for stage II disease. Results. median age was 64 years (22-80); 40 stage I and 13 stage II; 4 had bilateral testicular involvement and 6 LDH > normal. All received R-chemotherapy as planned. Fifty patients received adequate CNS prophylaxis (at least 4 IT-MTX); 3 less than 4 IT because of toxicity. Scrotal RT was given to 49 patients; 4 did not perform it (2 refusals, 1 progressive disease and 1 bilateral orchiectomy). Eight of the 13 stage II patients received nodal RT as planned. Fifty-two patients (98%) achieved a CR and 1 progressed after 4 R-CHOP. With a median follow-up of 36 months, 3-yr OS and 3-yr PFS (including progressions and deaths from any causes) were: 86% (95% CI 70-93%) and 82% (95% CI 66-91%) respectively. Eight patients relapsed or progressed: 2 in nodal sites, 4 in extranodal +/– nodal sites and 2 in CNS (1 isolated meningeal and 1 meningeal + nodal relapse). The actuarial risk of CNS relapse at 3 years was only 2% (95% CI 0-6%). No contralateral testis relapses were observed. Eight patients died: three because of DLBCL, 1 of heart failure, 1 of colon carcinoma and one of acute myeloid leukemia 4 and 21 months off therapy while in CR. The most severe (grade 3-4) toxicities were: leukopenia 27% and neurologic 13%. Infections were recorded in only 2 patients, no other extrahematological toxicities were observed. No toxic deaths occurred during treatment. Conclusions. the results showed that this combined treatment with R-CHOP21 and complete CNS and scrotal prophylaxis improves the outcome of PTL compared with data reported into the literature. An effective systemic control of the disease with no contralateral testis relapses and a reduced incidence of CNS relapse was achieved in a prospective population of PTL, mainly elderly, with a treatment with a low toxic profile.

PRIMARY DIFFUSE LARGE B-CELL LYMPHOMA OF THE TESTIS: IMPROVED OUTCOME WITH RITUXIMAB-CHOP WITH CNS AND CONTRALATERAL TESTIS PROPHYLAXIS. FINAL RESULTS OF IELSG 10 STUDY / Vitolo, . U.; E., Zucca; A., Chiappella; Martelli, Maurizio; M., Balzarotti; G., Benevolo; P., De Masi; A., Filippi; M. K., Gospodarowicz; A., Lopez Guillermo; G., Martinelli; F., Merli; T., Perrone; P., Pregno; A. H., Sarris; S., Storti; F., Cavalli. - In: HAEMATOLOGICA. - ISSN 0390-6078. - 93 (SUPPL. 1):(2008), pp. 160-160. (Intervento presentato al convegno 13th Congress of the European-Hematology-Association tenutosi a Copenhagen, DENMARK nel JUN 12-15, 2008).

PRIMARY DIFFUSE LARGE B-CELL LYMPHOMA OF THE TESTIS: IMPROVED OUTCOME WITH RITUXIMAB-CHOP WITH CNS AND CONTRALATERAL TESTIS PROPHYLAXIS. FINAL RESULTS OF IELSG 10 STUDY

MARTELLI, Maurizio;
2008

Abstract

Background. Diffuse large B-cell lymphoma (DLBCL) of the testis (PTL) is a rare presentation of extranodal lymphoma at poor prognosis with a 5-yr overall survival of 40-55%. Contralateral testis, CNS and extranodal sites relapses are the main cause of failures. Aims. the IELSG10 study is a prospective phase II international trial for stage I or II PTL. It aimed at defining a standard treatment for PTL with a combined treatment of R-CHOP, intrathecal methotrexate and prophylactic scrotal radiotherapy (RT) with the addition, in stage II, of loco-regional RT. The trial was conducted by International Extranodal Lymphoma Study Group (IELSG) and Intergruppo Italiano Linfomi (IIL). The present analysis provides the final results of the whole study. Methods. Between June 2001 and December 2006, 53 untreated patients with stage I-II PTL were enrolled from 31 centres. Treatment was: R-CHOP21 (Rituximab 375 mg/mq, Cyclophosphamide 750 mg/mq, Doxorubicine 50 mg/mq, Vincristine 1.4mg/mq d 1 and Prednisone 40 mg/mq dd 1-5) for 6 or 8 (in stage II patients with slow response) courses; intrathecal methotrexate (IT-MTX) 15mg for 4 doses in courses 1 and 2; after chemotherapy 30Gy scrotal RT to the contralateral testis was planned to all patients reserving 30-36 Gy on loco-regional nodes for stage II disease. Results. median age was 64 years (22-80); 40 stage I and 13 stage II; 4 had bilateral testicular involvement and 6 LDH > normal. All received R-chemotherapy as planned. Fifty patients received adequate CNS prophylaxis (at least 4 IT-MTX); 3 less than 4 IT because of toxicity. Scrotal RT was given to 49 patients; 4 did not perform it (2 refusals, 1 progressive disease and 1 bilateral orchiectomy). Eight of the 13 stage II patients received nodal RT as planned. Fifty-two patients (98%) achieved a CR and 1 progressed after 4 R-CHOP. With a median follow-up of 36 months, 3-yr OS and 3-yr PFS (including progressions and deaths from any causes) were: 86% (95% CI 70-93%) and 82% (95% CI 66-91%) respectively. Eight patients relapsed or progressed: 2 in nodal sites, 4 in extranodal +/– nodal sites and 2 in CNS (1 isolated meningeal and 1 meningeal + nodal relapse). The actuarial risk of CNS relapse at 3 years was only 2% (95% CI 0-6%). No contralateral testis relapses were observed. Eight patients died: three because of DLBCL, 1 of heart failure, 1 of colon carcinoma and one of acute myeloid leukemia 4 and 21 months off therapy while in CR. The most severe (grade 3-4) toxicities were: leukopenia 27% and neurologic 13%. Infections were recorded in only 2 patients, no other extrahematological toxicities were observed. No toxic deaths occurred during treatment. Conclusions. the results showed that this combined treatment with R-CHOP21 and complete CNS and scrotal prophylaxis improves the outcome of PTL compared with data reported into the literature. An effective systemic control of the disease with no contralateral testis relapses and a reduced incidence of CNS relapse was achieved in a prospective population of PTL, mainly elderly, with a treatment with a low toxic profile.
2008
13th Congress of the European-Hematology-Association
04 Pubblicazione in atti di convegno::04d Abstract in atti di convegno
PRIMARY DIFFUSE LARGE B-CELL LYMPHOMA OF THE TESTIS: IMPROVED OUTCOME WITH RITUXIMAB-CHOP WITH CNS AND CONTRALATERAL TESTIS PROPHYLAXIS. FINAL RESULTS OF IELSG 10 STUDY / Vitolo, . U.; E., Zucca; A., Chiappella; Martelli, Maurizio; M., Balzarotti; G., Benevolo; P., De Masi; A., Filippi; M. K., Gospodarowicz; A., Lopez Guillermo; G., Martinelli; F., Merli; T., Perrone; P., Pregno; A. H., Sarris; S., Storti; F., Cavalli. - In: HAEMATOLOGICA. - ISSN 0390-6078. - 93 (SUPPL. 1):(2008), pp. 160-160. (Intervento presentato al convegno 13th Congress of the European-Hematology-Association tenutosi a Copenhagen, DENMARK nel JUN 12-15, 2008).
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/485117
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