Abstract | BACKGROUND: METHODS: In a phase 2 study, patients (aged ≥18 years) at 35 centres in the USA were given temsirolimus 25 mg/week, and rituximab 375 mg/m(2) per week for 4 weeks during the first cycle and thereafter a single dose of rituximab every other 28-day cycle. Both drugs were administered intravenously. Responding patients after six cycles could continue treatment for a total of 12 cycles, and were then observed without additional maintenance treatment. The primary endpoint was the proportion of patients with either rituximab-sensitive or rituximab-refractory disease who had at least a partial response. The analyses were done on all patients who were treated. The study was registered with ClinicalTrials.gov, number NCT00109967. FINDINGS: 71 patients with mantle cell lymphoma were enrolled and 69 were assessable and were included in the final analysis. The overall response rate (ORR) was 59% (41 of 69 patients)-13 (19%) patients had complete responses and 28 (41%) had partial responses. The ORR was 63% (30 of 48; 95% CI 47-76) for rituximab-sensitive patients, and 52% (11 of 21; 30-74) for rituximab-refractory patients. The most common treatment-related grade 3 or 4 adverse events in rituximab-sensitive and rituximab-refractory patients were thrombocytopenia (eight [17%] and eight [38%], respectively), neutropenia (ten [21%] and five [24%], respectively), fatigue (eight [17%] and two [10%], respectively), leucopenia (six [13%] and three [14%], respectively), pneumonia (five [10%] and two [10%], respectively), lymphopenia (five [10%] and two [10%], respectively), pneumonitis (four [8%] and none, respectively), oedema (four [8%] and none, respectively), dyspnoea (three [6%] and two [10%], respectively), and hypertriglyceridaemia (three [6%] and two [10%], respectively). INTERPRETATION: FUNDING: National Institutes of Health and the Predolin Foundation.
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Authors | Stephen M Ansell, Hui Tang, Paul J Kurtin, Patricia A Koenig, David J Inwards, Keith Shah, Steven C Ziesmer, Andrew L Feldman, Radha Rao, Mamta Gupta, Charles Erlichman, Thomas E Witzig |
Journal | The Lancet. Oncology
(Lancet Oncol)
Vol. 12
Issue 4
Pg. 361-8
(Apr 2011)
ISSN: 1474-5488 [Electronic] England |
PMID | 21440503
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 Elsevier Ltd. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal, Murine-Derived
- Rituximab
- temsirolimus
- Sirolimus
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal, Murine-Derived
(administration & dosage, adverse effects, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Female
- Humans
- Lymphoma, Mantle-Cell
(drug therapy, mortality)
- Male
- Middle Aged
- Recurrence
- Rituximab
- Sirolimus
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
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