Abstract
17508 Background: Second line chemotherapeutic regimens in NHL are mainly based on cisplatin (DDP) and are frequently employed as cytoreductive regimens for preparation to high dose chemotherapy (HDC). The substitution of DDP with oxaliplatin in DHAP-like regimens can result in a lower toxicity and higher activity. In R/R CD20+ NHL the synergistic activity of Rituximab with chemotherapy has been shown to improve the outcome. We assessed the tolerability and efficacy of R-DHAOX (Rituximab 375 mg/m2, i.v. day 1, Dexametasone 40 mg i.v. days 1–4, Oxaliplatin 130 mg/m2 i.v. day 2 and Cytarabine 2000 mg/m2 i.v. twice a day, day 3) regimen in a fase II study including 35 pts (M/F = 22/13; median age 55 yrs, range 38–74) affected by R/R CD20+ NHL and enrolled from November 2002 until September 2005. 34 (97%) pts were staged III-IV. 31 pts (89%) were relapsed and 4 (11%) refractory. International Prognostics Index at relapse (s-IPI) was >2 for 10 (71%) DLBCL, 2 (14%) FL and 2 (29%) MCL. A total of 147 cycles were administered (range 1–7). Dose reduction due to Oxaliplatin neuropathy or Cytarabine haematological toxicity occurred in 13% and in 58% of pts, respectively. NCI G3-G4 toxicities were thrombocytopenia (58%), neutropenia (55%), anaemia (13%), infection (10%) and neurotoxicity (3%). No renal failure was observed. Results spitted according to histology were summarised in the table . R-DHAOX had significant clinical activity both in FL and MCL patients (overall response rates (OR) of 93% and 86%, respectively), as well as in DLBCL (OR of 79%) despite the very high S-IPI score observed. R-DHAOX allowed adequate stem cell harvest with G-CSF mobilisation in 25/35 (71%) pts. Three-yrs projected overall survival, according to the histology, were 71% for FL, 67% for MCL and 28% for DLBCL. These data suggested that the R-DHAOX is a novel combination highly effective for R/R CD20+ NHL. [Table: see text] No significant financial relationships to disclose.
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