Results of a phase I study of bendamustine in combination with ofatumumab, carboplatin, and etoposide (BOCE) for refractory or relapsed aggressive B-cell non-Hodgkin lymphomas (NHL).

Authors

null

Sameh Gaballa

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

Organizations

Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, Thomas Jefferson University, Philadelphia, PA

Research Funding

Pharmaceutical/Biotech Company

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 Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lymphoma and Plasma Cell Disorders

Track

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sub Track

Lymphoma

Clinical Trial Registration Number

NCT01458366

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 8556)

DOI

10.1200/jco.2014.32.15_suppl.8556

Abstract #

8556

Poster Bd #

243

Abstract Disclosures