Conference
THE IELSG-32 TRIAL: RANDOMIZED PHASE II TRIAL ON PRIMARY CHEMOTHERAPY WITH HIGH-DOSE METHOTREXATE AND HIGH-DOSE CYTARABINE WITH OR WITHOUT THIOTEPA, AND WITH OR WITHOUT RITUXIMAB, FOLLOWED BY BRAIN IRRADIATION VS HIGH-DOSE CHEMOTHERAPY SUPPORTED BY AUTOLOGOUS STEM CELLS TRANSPLANTATION FOR IMMUNOCOMPETENT PATIENTS WITH NEWLY DIAGNOSED PRIMARY CNS LYMPHOMA
| العنوان: | THE IELSG-32 TRIAL: RANDOMIZED PHASE II TRIAL ON PRIMARY CHEMOTHERAPY WITH HIGH-DOSE METHOTREXATE AND HIGH-DOSE CYTARABINE WITH OR WITHOUT THIOTEPA, AND WITH OR WITHOUT RITUXIMAB, FOLLOWED BY BRAIN IRRADIATION VS HIGH-DOSE CHEMOTHERAPY SUPPORTED BY AUTOLOGOUS STEM CELLS TRANSPLANTATION FOR IMMUNOCOMPETENT PATIENTS WITH NEWLY DIAGNOSED PRIMARY CNS LYMPHOMA |
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| المؤلفون: | Ferreri, Ajm, Cwynarski, K, Pulczynski, E, Ponzoni, M, Politi, Ls, Ambrosetti, A, Vitolo, U, Ilariucci, F, Balzarotti, M, Fabbri, A, Tucci, A, Pisani, F, Levis, A, Cabras, Mg, D'Arco, M, Zaccaria, A, Angrilli, F, GUARINI, Anna, Imola, M, MARTELLI, Maurizio, Cervetti, J, Zaja, F, Pinto, A, Liberati, M, Morra, E, Cortellazzo, Sf, Bassan, R, Foppoli, M, Citterio, G, Sassone, M, Scarfo, L, Cavalli, F, Finke, J, Reni, M, Zucca, E, Illerhaus, G. |
| المساهمون: | Ferreri, Ajm, Cwynarski, K, Pulczynski, E, Ponzoni, M, Politi, L, Ambrosetti, A, Vitolo, U, Ilariucci, F, Balzarotti, M, Fabbri, A, Tucci, A, Pisani, F, Levis, A, Cabras, Mg, D'Arco, M, Zaccaria, A, Angrilli, F, Guarini, Anna, Imola, M, Martelli, Maurizio, Cervetti, J, Zaja, F, Pinto, A, Liberati, M, Morra, E, Cortellazzo, Sf, Bassan, R, Foppoli, M, Citterio, G, Sassone, M, Scarfo, L, Cavalli, F, Finke, J, Reni, M, Zucca, E, Illerhaus, G. |
| سنة النشر: | 2015 |
| المجموعة: | Sapienza Università di Roma: CINECA IRIS |
| الوصف: | Introduction: IELSG #32 is an international randomized phase II trial addressing the tolerability and efficacy of adding rituximab (R)±thiotepa (TT) to methotrexate (MTX)-cytarabine (ARAC) combination, followed by a 2nd randomization comparing consolidation with WBRT or HDC/ASCT in pts with PCNSL (NCT01011920). Herein, we report re- sults of the first randomization. Methods: HIV-neg pts 18-70 yo and ECOG PS ≤3 (PS ≤2 if age 66-70) with new histology-proven PCNSL and measurable disease were randomly assigned to receive 4 courses of MTX 3.5 g/m2 d1+ARAC 2 g/m2 x2/d d2-3 (arm A); or MTX-ARAC+R 375 mg/m2 d-5 & 0 (arm B); or MTX-ARAC-R+TT 30 mg/m2 d4 (arm C). ASC were collected after the 2nd course. Response was assessed after 2nd & 4th courses; pts with responsive disease were further ran- domized between WBRT and BCNU-TT conditioned/ASCT. Histology and neuroimaging were centrally reviewed. Primary endpoints were CRR (1st random) and 2-year FFS (2nd random). Sample size was esti- mated on the basis of 2nd random: with P0 65% and P1 85% (one-sided test; 5%; 95%), 52 patients/arm required. Results: 227 pts (median age 58 ys; 18-70) were enrolled in 52 centers of 5 countries; 8 pts were ex- cluded due to misdiagnosis, systemic disease or concomitant cancer. No differences in clinical presentation among 3 arms (A 75; B 69; C 75) were observed (Table 1). 733/876 (84%) planned courses were delivered. G4 hematological toxicity was more common in arm C, but infective complications were similar in the 3 arms. G4 non-hematological toxicities were rare. Chemotherapy was interrupted due to toxicity in 21 (9%) pts; 13 (6%) pts died of toxicity. ASC were successfully collected in 152/161 (94%) pts. Arm C was significantly more active, with a CRR of 49% and an ORR of 87%; 118 pts (A 35; B 35; C 48) were referred to 2nd random. At a median follow-up of 20 months (7-60), 111 pts remain failure-free (A 25; B 37; C 49), with 2-yr FFS of 34±6%, 52±6% and 64±6% (p=0.0006), respectively. 124 pts are alive (A 31; B 41; C 52), with ... |
| نوع الوثيقة: | conference object |
| وصف الملف: | STAMPA |
| اللغة: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/wos/WOS:000365776300039; ispartofbook:45th Congress of the Italian-Society-of-Hematology; 45th Congress of the Italian-Society-of-Hematology; volume:100; firstpage:17; lastpage:17; numberofpages:1; journal:HAEMATOLOGICA; http://hdl.handle.net/11573/1017272; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84920147335; https://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=MarkedList&qid=21&SID=N29wn1MEl1zhNM73pVF&page=1&doc=5&colName=WOS |
| الاتاحة: | http://hdl.handle.net/11573/1017272 https://apps.webofknowledge.com/full_record.do?product=WOS&search_mode=MarkedList&qid=21&SID=N29wn1MEl1zhNM73pVF&page=1&doc=5&colName=WOS |
| رقم الانضمام: | edsbas.C0F0F1AC |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |