Abstract
Patients with relapsed aggressive non-Hodgkin lymphoma (NHL) are often treated with platinum-based chemoimmunotherapy regimens in preparation for autologous stem cell transplant. We sought to reduce toxicity and maintain efficacy by using oxaliplatin with rituximab, cytarabine and dexamethasone (ROAD) in a phase II clinical trial in patients who had relapsed after one prior regimen. ROAD was delivered q21 days and consisted of rituximab 375 mg/m2 IV weekly x 4 doses (cycle 1 only); dexamethasone 40 mg PO/IV d2 - 5; oxaliplatin 130 mg/m2 IV day 2; cytarabine 2000 mg/m2 IV × two doses on days 2 to 3; and pegfilgrastim 6 mg SC on day 4. Forty-five eligible patients were accrued between 2006 and 2008. Patient characteristics were a median age of 69 years; 96% had received prior rituximab; 53% were within one year of diagnosis. The median number of cycles received was 2 (range, 1-6). Forty-four % received ROAD as an outpatient. The overall response rate was 71% with 27% (12/45) CR and 44% (20/45) PR. Forty-four % (20/45) of all patients and 69% (18/26) of patients whom responded after 2 cycles proceeded to transplant. Median overall survival was 26 mos (95% CI: 7.3 mos-not reached) and median progression-free survival was 11 mos (95% CI: 6-104 mos). There was no grade 3/4 nephrotoxicity; the rate of grade 3/4 neuropathy was 4%. Forty-two percent of all patients and 69% of patients transplanted remain alive at 5 years. ROAD represents an acceptable salvage therapeutic option for patients with relapsed aggressive NHL.
© 2017 Wiley Periodicals, Inc.
MeSH terms
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Aged
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Antigens, CD20 / immunology*
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Cytarabine / administration & dosage
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Cytarabine / adverse effects
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Cytarabine / therapeutic use
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Dexamethasone / administration & dosage
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Dexamethasone / adverse effects
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Dexamethasone / therapeutic use
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Disease-Free Survival
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Drug Administration Schedule
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Drug-Related Side Effects and Adverse Reactions / epidemiology
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Drug-Related Side Effects and Adverse Reactions / etiology*
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Female
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Filgrastim
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Follow-Up Studies
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Granulocyte Colony-Stimulating Factor / administration & dosage
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Granulocyte Colony-Stimulating Factor / adverse effects
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Granulocyte Colony-Stimulating Factor / therapeutic use
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Humans
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Kaplan-Meier Estimate
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Lymphoma, B-Cell / drug therapy*
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Lymphoma, B-Cell / immunology
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Lymphoma, B-Cell / mortality
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Lymphoma, B-Cell / pathology
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Male
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Organoplatinum Compounds / administration & dosage
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Organoplatinum Compounds / adverse effects
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Organoplatinum Compounds / therapeutic use
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Oxaliplatin
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Polyethylene Glycols
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Recombinant Proteins / administration & dosage
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Recombinant Proteins / adverse effects
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Recombinant Proteins / therapeutic use
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Rituximab / administration & dosage
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Rituximab / adverse effects
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Rituximab / therapeutic use
Substances
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Antigens, CD20
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Organoplatinum Compounds
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Recombinant Proteins
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Cytarabine
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Oxaliplatin
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Granulocyte Colony-Stimulating Factor
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pegfilgrastim
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Polyethylene Glycols
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Rituximab
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Dexamethasone
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Filgrastim