Results of a Phase II trial of gemcitabine, mitoxantrone, and rituximab in relapsed or refractory mantle cell lymphoma

• Published in: Investigational new drugs Vol. 27; no. 5; pp. 476 - 481
• Main Authors: Garbo, Lawrence E., Flynn, Patrick J., MacRae, Margaret A., Rauch, Mary A., Wang, Yunfei, Kolibaba, Kathryn S.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.10.2009; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal, Murine-Derived; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Chemotherapy; Clinical trials; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease; Drugs; Female; Humans; Lymphoma; Lymphoma, Mantle-Cell - drug therapy; Lymphoma, Mantle-Cell - pathology; Male; Medicine; Medicine & Public Health; Middle Aged; Mitoxantrone - administration & dosage; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Neoplasm Staging; Neutropenia; Oncology; Patients; Pharmacology; Pharmacology/Toxicology; Phase II Studies; Prognosis; Prospective Studies; Radiation therapy; Response rates; Rituximab; Salvage Therapy; Stem cell transplantation; Survival Rate; Toxicity; Treatment Outcome; Phase II; Multicenter; Lymphoma; Community-based
• ISSN: 0167-6997; 1573-0646
• DOI: 10.1007/s10637-008-9191-7

Summary Background : Gemcitabine (G) has shown activity in mantle cell lymphoma (MCL) as a single agent. The combination of mitoxantrone (M) and rituximab (R) is also active in MCL. The primary objective of this study was to determine the efficacy of G+M+R in relapsed or refractory MCL. Patients and Methods : Sixteen patients were enrolled between April 2005 and January 2007, 88% had Stage IV MCL, Median patient age was 74 years. Patients received gemcitabine 900 mg/m 2 IV (30–60 min infusion) on Days 1 and 8, mitoxantrone 10 mg/m 2 IV (5–10 min infusion) on day 1, and rituximab 375 mg/m 2 IV on Day 1 (max 400 mg/hour) of the 21-day cycle. Patients received a median of 6 cycles (range, 1–8). Results : Best responses were CR 20% (95%CI, 0, 40.2), PR 27% (95%CI, 4.3, 49.1), SD 40% (95%CI, 15.2, 64.8), and PD 13% (95%CI, 0, 30.5). Median survival and PFS have not been reached with a median follow-up of 10.7 months. The most common Grade 3–4 toxicities were neutropenia (100%), thrombocytopenia (67%), leukopenia (53%), and anemia (33%). The study was closed early due to slow accrual owing to an alternative treatment which became available at the time. Conclusion : The combination of G+M+R in MCL was well-tolerated with manageable toxicity using growth factors to minimize neutropenia; further studies are warranted.