Efficacy, safety, and cost efficiency of rituximab, gemcitabine, dexamethasone, and oxaliplatin (RGDOx) in B-cell NHL: Report of the prospective multicentric trial NCT01019863.

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8581 Background: Cisplatinum-based 2nd line therapy is poorly tolerated. We evaluated the activity and toxicity of an outpatient RGDOx regimen Methods: Patients (pts) with CD20+ NHL, without limitation of age, general condition or prior treatments, were eligible for up to 8 biweekly cycles of rituximab 375 mg/m², gemcitabine 1000 mg/m², oxaliplatin 100 mg/m² on day 1 and dexamethasone 40mg/day orally on day 1- 3. Toxicity was reported according to NCI criteria. Response was assessed at mid and end of treatment. Pts were followed up to 24 months. Costs were collected on per diem canadian interprovincial rates and hospital pharmacy medication costs as of Oct. 2011. Results: The planned 50 pts were included from 2009 to Jan. 2013. Two died before starting therapy and were not included in this analysis; 17 females, 31 males, median age 70 (47 - 86) yrs with relapsed (37) or refractory (11) B-NHL (DLBCL 25, FL 8, MCL 11, Richter 2 and CLL 2). 83% had stage III/IV disease, aaIPI / FLIPI ≥2 (85%), median Charlson co-morbidity score of 4, average 2 (1-8) previous treatment lines, 47 previously treated with rituximab and 9 with cisplatin. A total of 250 cycles were given. This was well tolerated. Common grade I-II AE: Sensory neuropathy 66%, diarrhea 36% asthenia 35%, and bone pain 18%. Grade III/IV: Lymphopenia 12%, neutropenia 3% and thrombocytopenia 4%. Two died after 1 and 3 cycles, before documenting response. The overall response was 57% (n=46, CR 40%, PR 17%, PD: 43%). DLCBL (40%, 8%, 52%), FL (38%, 25%, 38%), MCL (50%, 20%, 30%). The median survival was 18.4 months (n=48) and disease-free median survival among responders was 15.7 months (n=27). Refractoriness to previous treatment or response lasting less than 12 months was associated with poorer outcome. Previous cisplatin therapy tended to predict lower response. Average 6-cycle course was associated with 4.8 days of hospitalization, 0.7 medical visits for iatrogenic side effects and 7.3 visits for additional laboratory tests. Mean cost for 6 cycles of RGDOX was $Can 54,991 with a median cost per life year of $Can 35,863. Conclusions: RGDOx is safe, effective and cost-effective for relapsing/refractory B-Cell NHL. Clinical trial information: NCT01019863.

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