Introduction. PTL has a poor prognosis with a 5-yr overall survival of 40-55%. Causes of failures are: contralateral testis, CNS and extranodal relapses. The IELSG 10/IIL study is a prospective phase II international trial for stage I or II PTL aimed at defining a standard treatment for PTL. Methods. Between June 2001 and December 2006, 53 pts with untreated stage I-II PTL were enrolled. Treatment was: R-CHOP21 (R 375 mg/mq, Ctx 750mg/mq, Doxo 50 mg/mq, Vcr 1.4 mg/mq d 1 and Pdn 40 mg/mq dd 1-5) for 6 or 8 (in stage II pts with slow response) courses; intrathecal methotrexate (IT MTX) 15 mg for 4 doses in courses 1 and 2; after chemotherapy 30Gy scrotal RT to the contralateral testis was planned to all pts reserving 30-36Gy on loco-regional nodes for stage II disease. Results. To date 49 pts who have completed the treatment are evaluable. Median age was 65 years (range 22-80); 38 stage I and 11 stage II; 3 had bilateral testicular involvement; 5 LDH > normal and 2 B symptoms. All received R-chemotherapy as planned. Forty-six (94%) pts received adequate CNS prophylaxis (at least 4 IT MTX); 3 less than 4 IT because of poor tolerance or toxicity. Scrotal RT ± nodal RT was given to 44 pts (90%); 5 did not perform it (3 refusals, 1 progressive disease and 1 bilateral orchiectomy). Forty-eight pts (98%) achieved a CR and 1 progressed after 4 R-CHOP. With a median follow-up of 36 months, 3- yr OS, 3-yr PFS and 3-yr EFS were: 87% (95% CI 69-96%), 84% (95% CI 65-93%) and 79% (95% CI 60-90%) respectively. Seven pts relapsed or progressed: 2 in nodal sites, 3 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 is 2.5% (95% CI 0-7%). No contralateral testis relapses were observed. Five patients died: three because of DLBCL, 1 of heart failure and one of acute myeloid leukemia 21 months off therapy while in CR. No toxic deaths occurred during treatment. Main grade 3-4 toxicities were: hematological 26% and neurological 14%. Conclusions. This is the first prospective study in PTL with RCHOP and complete CNS and scrotal prophylaxis. Contralateral testis relapses were not observed and the incidence of CNS relapse seems to be reduced. These results compare favourably with those previously reported in the literature. However, if further relapses will be observed after a longer follow-up, there would be a need for innovative strategies to address the issue of systemic and CNS relapSES.
Prospective IELSG/IIL study in primary diffuse large B-cell lymphoma of the testis (PTL): Improved outcome with Rituximab (R)-CHOP with CNS and contralateral testis prophylaxis / U., Vitolo; Martelli, Maurizio; G., Martinelli; I., Baldi; M., Balzarotti; A., Chiappella; A., Conconi; P., De Masi; F., Merli; L., Orsucci; V., Pavone; U., Ricardi; V., Secondo; S., Storti; A., Tucci; E., Zucca; E., Gallo. - In: HAEMATOLOGICA. - ISSN 0390-6078. - 92 (SUPPL. 3):(2007), pp. 7-7. (Intervento presentato al convegno 41st Congress of the Italian-Society-of-Hematology tenutosi a Bologna, ITALY nel OCT 14-17, 2007).
Prospective IELSG/IIL study in primary diffuse large B-cell lymphoma of the testis (PTL): Improved outcome with Rituximab (R)-CHOP with CNS and contralateral testis prophylaxis
MARTELLI, Maurizio;
2007
Abstract
Introduction. PTL has a poor prognosis with a 5-yr overall survival of 40-55%. Causes of failures are: contralateral testis, CNS and extranodal relapses. The IELSG 10/IIL study is a prospective phase II international trial for stage I or II PTL aimed at defining a standard treatment for PTL. Methods. Between June 2001 and December 2006, 53 pts with untreated stage I-II PTL were enrolled. Treatment was: R-CHOP21 (R 375 mg/mq, Ctx 750mg/mq, Doxo 50 mg/mq, Vcr 1.4 mg/mq d 1 and Pdn 40 mg/mq dd 1-5) for 6 or 8 (in stage II pts with slow response) courses; intrathecal methotrexate (IT MTX) 15 mg for 4 doses in courses 1 and 2; after chemotherapy 30Gy scrotal RT to the contralateral testis was planned to all pts reserving 30-36Gy on loco-regional nodes for stage II disease. Results. To date 49 pts who have completed the treatment are evaluable. Median age was 65 years (range 22-80); 38 stage I and 11 stage II; 3 had bilateral testicular involvement; 5 LDH > normal and 2 B symptoms. All received R-chemotherapy as planned. Forty-six (94%) pts received adequate CNS prophylaxis (at least 4 IT MTX); 3 less than 4 IT because of poor tolerance or toxicity. Scrotal RT ± nodal RT was given to 44 pts (90%); 5 did not perform it (3 refusals, 1 progressive disease and 1 bilateral orchiectomy). Forty-eight pts (98%) achieved a CR and 1 progressed after 4 R-CHOP. With a median follow-up of 36 months, 3- yr OS, 3-yr PFS and 3-yr EFS were: 87% (95% CI 69-96%), 84% (95% CI 65-93%) and 79% (95% CI 60-90%) respectively. Seven pts relapsed or progressed: 2 in nodal sites, 3 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 is 2.5% (95% CI 0-7%). No contralateral testis relapses were observed. Five patients died: three because of DLBCL, 1 of heart failure and one of acute myeloid leukemia 21 months off therapy while in CR. No toxic deaths occurred during treatment. Main grade 3-4 toxicities were: hematological 26% and neurological 14%. Conclusions. This is the first prospective study in PTL with RCHOP and complete CNS and scrotal prophylaxis. Contralateral testis relapses were not observed and the incidence of CNS relapse seems to be reduced. These results compare favourably with those previously reported in the literature. However, if further relapses will be observed after a longer follow-up, there would be a need for innovative strategies to address the issue of systemic and CNS relapSES.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
