Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA
Sameh Gaballa , Neil David Palmisiano , Aakanksha Asija , Andrew E. Chapman , Jennifer K. Cloud , Joanne E. Filicko-O'Hara , Lewis J. Rose , Michael J. Ramirez , Onder Alpdogan , Neal Flomenberg , Barbara Pro , Elena Gitelson , Mark Adam Weiss
Background: No salvage regimen has shown clear superiority in relapsed NHL. Bendamustine has single agent activity in relapsed aggressive NHL. We conducted a phase I trial using a novel RICE-like salvage regimen in which ofatumumab was substituted for rituximab and bendamustine replaced ifosfamide, combined with carboplatin and etoposide (BOCE) Methods: Patients (pts) with relapsed or refractory aggressive B NHL were eligible. The design was a standard 3+3 design using escalating doses of bendamustine [70, 90, and 120 mg/m2 D1-2] with ofatumumab (cycle 1: 300 mg D1, 1000 mg D3, cycle 2 and 3: 1000 mg D1), carboplatin AUC 5 D2 and etoposide 100mg/m2 D1-3. Results: Eleven pts were enrolled (7M/4F). Median age was 62 (range 53-75), 5 pts (45%) had diffuse large B NHL, 4 pts (36%) had grade 3 follicular NHL, 1 pt (9%) had mantle cell NHL, and 1 pt (9%) had transformed CLL. Five pts (46%) had refractory disease and 6 pts (56%) had relapsed disease. All pts with refractory disease were refractory to rituximab. All pts had stage III or IV disease. sAAIPI was: low-int 55%, high-int 36%, high risk 9%. ORR was 64% [CR: 5 pts (46%); PR: 2 pts (18%)]. Two pts (18%) had progressive disease and 1 pt (9%) had stable disease. Five pts (46%) subsequently underwent an allogeneic transplant. Four pts (36%) died, all of progressive disease. After a median follow-up of 6 months, the estimated 12-months OS is 63.5% DLT was not reached. Grade III-IV toxicity included neutropenia (82%), thrombocytopenia (64%), anemia (64%), lymphopenia (27%), febrile neutropenia (27%), hyponatremia (18%), and hypophosphatemia (18%). Six serious adverse events were reported in 4 pts including acute kidney injury, urinary tract infection, pleural effusion, GI bleeding, thromboembolic event and febrile Infusion related reactions occurred in 27% of pts (all grade I-II). Conclusions: The BOCE regimen is well tolerated in pts with relapsed or refractory aggressive NHL. A phase II trial with bendamustine at the dose of 120mg/m2 is ongoing. The advantage of this regimen over other commonly used salvage strategies is that it can be administered safely in the outpatient setting. Clinical trial information: NCT01458366.
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Abstract Disclosures
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