Introduction. Third generation regimens such as MACOP-B or VACOP-B (M/VACOP-B) in combination with involved-field radiotherapy (IFRT) seem to improve lymphoma-free survival of PMLBCL. The superiority of R-CHOP over CHOP-like regimens has been demonstrated in younger low risk DLBCL. Recently, the addition of Rituximab to CHOP has also improved the survival of PMBLCL. Aims. To evaluate the effectiveness and safety of Rituximab added to the standard M/VACOP-B regimens (R-M/VACOP-B) ± IFRT in PMLBCL. Patients and Methods. At this time, a total of 45 patients with PMLBCL have been treated in six participating centers between February 2002 and July 2006. The median age was 38 years (range 17-66); 24/21 (53%) were females; 32 patients had stage II and 13 stage IV; 42 (95%) presented a bulky disease; LDH was increased in 31 (69%) and 24(55%) had a superior vena cava syndrome. According to the age-adjusted IPI score, 30 patients had an IPI = 0-1 and 15 an IPI = 2-3. All patients were treated with standard MACOP-B (35 patients) or VACOP-B (10 patients) regimens plus six cycles of Rituximab (375mg/m2) given at weeks 3,5,7,9,11,13. Thirty-one patients (69%) received mediastinal IFRT at a median dose of 36 Gy. The response was evaluated in all patients after 6 cycles of chemo-immunotherapy, at the end of the planned chemotherapy and after IFRT. Results. The response rate after 6 cycles of the planned R-M/VACOP-B regimen was CR/CRu = 20 (44%), PR = 24 (53%) and NR = 1 (3%). Three/45 patients received an early intensification therapy followed by HDT-ASCT because considered low responders (less than PR or progressive disease) during M/VACOP-B chemotherapy. At the end of the chemo-immunotherapy program, 26/42(62%) patients witnessed a CR/Cru,15(36%) aPR and 1 (2%) patient progressed. Eight/15(53%) PR patients obtained a CR/CRu following IFRT for an overall CR/CRu rate of 80% (34/42). Three patients relapsed from CR/Cru and one progressed from PR at 4,12,12,19 months and died of progressive disease despite salvage therapy. After a median follow-up of 25 months, the 3-year OS and PFS were 80% and 84%, respectively. No significant differences in terms of PFS and OS were associated with the IPI score. In a our historical group of 92 pts with PMBCL treated with MACOP-B+IFRT without Rituximab the 5-yrs OS and PFS were 87% and 81% respectively. Discussion. R-M/VACOP-B are active therapeutic regimens devoid of severe toxicity in PMBCL. Consolidation radiotherapy seems to improve the quality of response. Further studies are required to demonstrate if the addition of Rituximab to M/VACOP-B regimens may truly improve the response rate and survival of PMBCL.

RITUXIMAB DOES NOT IMPROVE SURVIVAL OF PATIENTS TREATED WITH M/VACOP-B PLUS RADIOTHERAPY IN PRIMARY MEDIASTINAL LARGE B-CELL LYMPHOMA (PMLBCL): A PHASE II STUDY OF INTERGRUPPO ITALIANO LINFOMI (IIL) / Martelli, Maurizio; V., Stefoni; E., Russo; G., Cabras; A., Rossi; E., Brusamolino; A., Levis; B., Botto; V., Naso; E., Finolezzi; DI ROCCO, Alice; Foa, Roberto; P. L., Zinzani. - In: HAEMATOLOGICA. - ISSN 0390-6078. - 93 (SUPPL. 1)(2008), pp. 309-309. ((Intervento presentato al convegno 13th Congress of the European-Hematology-Association tenutosi a Copenhagen, DENMARK nel JUN 12-15, 2008.

RITUXIMAB DOES NOT IMPROVE SURVIVAL OF PATIENTS TREATED WITH M/VACOP-B PLUS RADIOTHERAPY IN PRIMARY MEDIASTINAL LARGE B-CELL LYMPHOMA (PMLBCL): A PHASE II STUDY OF INTERGRUPPO ITALIANO LINFOMI (IIL)

MARTELLI, Maurizio;DI ROCCO, Alice;FOA, Roberto;
2008

Abstract

Introduction. Third generation regimens such as MACOP-B or VACOP-B (M/VACOP-B) in combination with involved-field radiotherapy (IFRT) seem to improve lymphoma-free survival of PMLBCL. The superiority of R-CHOP over CHOP-like regimens has been demonstrated in younger low risk DLBCL. Recently, the addition of Rituximab to CHOP has also improved the survival of PMBLCL. Aims. To evaluate the effectiveness and safety of Rituximab added to the standard M/VACOP-B regimens (R-M/VACOP-B) ± IFRT in PMLBCL. Patients and Methods. At this time, a total of 45 patients with PMLBCL have been treated in six participating centers between February 2002 and July 2006. The median age was 38 years (range 17-66); 24/21 (53%) were females; 32 patients had stage II and 13 stage IV; 42 (95%) presented a bulky disease; LDH was increased in 31 (69%) and 24(55%) had a superior vena cava syndrome. According to the age-adjusted IPI score, 30 patients had an IPI = 0-1 and 15 an IPI = 2-3. All patients were treated with standard MACOP-B (35 patients) or VACOP-B (10 patients) regimens plus six cycles of Rituximab (375mg/m2) given at weeks 3,5,7,9,11,13. Thirty-one patients (69%) received mediastinal IFRT at a median dose of 36 Gy. The response was evaluated in all patients after 6 cycles of chemo-immunotherapy, at the end of the planned chemotherapy and after IFRT. Results. The response rate after 6 cycles of the planned R-M/VACOP-B regimen was CR/CRu = 20 (44%), PR = 24 (53%) and NR = 1 (3%). Three/45 patients received an early intensification therapy followed by HDT-ASCT because considered low responders (less than PR or progressive disease) during M/VACOP-B chemotherapy. At the end of the chemo-immunotherapy program, 26/42(62%) patients witnessed a CR/Cru,15(36%) aPR and 1 (2%) patient progressed. Eight/15(53%) PR patients obtained a CR/CRu following IFRT for an overall CR/CRu rate of 80% (34/42). Three patients relapsed from CR/Cru and one progressed from PR at 4,12,12,19 months and died of progressive disease despite salvage therapy. After a median follow-up of 25 months, the 3-year OS and PFS were 80% and 84%, respectively. No significant differences in terms of PFS and OS were associated with the IPI score. In a our historical group of 92 pts with PMBCL treated with MACOP-B+IFRT without Rituximab the 5-yrs OS and PFS were 87% and 81% respectively. Discussion. R-M/VACOP-B are active therapeutic regimens devoid of severe toxicity in PMBCL. Consolidation radiotherapy seems to improve the quality of response. Further studies are required to demonstrate if the addition of Rituximab to M/VACOP-B regimens may truly improve the response rate and survival of PMBCL.
File allegati a questo prodotto
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11573/485103
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact