Efficacy and safety of rituximab combined with ESHAP chemotherapy for the treatment of relapsed/refractory aggressive B-cell non-Hodgkin lymphoma.

Background: We evaluated the efficacy and safety of adding rituximab to nonanthracycline ESHAP (etoposide/methylprednisolone/cytarabine/cisplatin) chemotherapy for relapsed/refractory aggressive non-Hodgkin lymphoma (NHL).

Patients And Methods: Patients with intermediate- or high-grade NHL were to receive 6 rituximab doses and 6 ESHAP cycles. Rituximab 375 mg/m(2) was administered 1 week and 1 day before cycle 1 of standard ESHAP (etoposide 40 mg/m(2) on days 1-4; methylprednisolone 500 mg/m(2) on days 1-5; cytarabine 200 mg/m(2) on day 5; and cisplatin 25 mg/m(2) on days 1-4). Rituximab was repeated before the third and fifth 21-day ESHAP cycles (on days 48 and 90 of protocol, respectively), followed by 2 additional rituximab doses after cycle 6 (on days 134 and 141 of protocol). Use of growth factors was permitted. Thirteen patients were enrolled (median age, 56 years); all had previously treated NHL, 12 (92%) had diffuse large B-cell lymphoma, 10 (77%) had stage III/IV disease, and 2 (15%) had chemotherapy-refractory disease.

Results: The most common grade 3/4 toxicities were neutropenia and thrombocytopenia, with 3 cases of febrile neutropenia. Seven patients exhibited complete response (CR) and 3 had partial response, for an objective response rate of 77%. Median duration of response for all responders was 14 months (range, 2-51 months). Among 6 patients completing all 6 cycles, 4 (67%) had a CR, 1 had a partial response, and 1 had progressive disease. Three of the 4 CRs have remained for a median of 48 months (range, 46-51 months).

Conclusion: Rituximab plus ESHAP led to durable responses with acceptable toxicity in patients with relapsed/refractory aggressive NHL, most of whom had advanced disease.