PRALATREXATE IN COMBINATION WITH BORTEZOMIB FOR RELAPSED OR REFRACTORY PERIPHERAL T CELL LYMPHOMA IN ELDERLY PATIENTS : A PILOT TRIAL
(Abstract release date: 05/19/16)
EHA Library. Lee S. 06/09/16; 134612; PB1712
Dr. Seung-Shin Lee
Contributions
Contributions
Abstract
Abstract: PB1712
Type: Publication Only
Background
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of aggressive lymphoma with poor prognosis and there is no efficacious standard regimen for the relapsed or refractory disease. Particularly, elderly patients generally have impaired bone marrow function, altered drug metabolism, comorbidities, and poor functional status. Therefore, the treatment of elderly patients with relapsed or refractory PTCL remains a challenge for clinicians.
Aims
a recent report demonstrated that the combination of pralatrexate and bortezomib enhanced efficacy compared with that of either agent alone in vitro and in vivo models of T cell malignancy. Hence, we performed a pilot study that evaluated the response rate, duration of response and safety profile of this combination regimen in elderly patients with relapsed or refractory PTCL.
Methods
Five elderly patients (age ≥65 years) with relapsed or refractory PTCLs, who progressed following one or more prior chemotherapy, were investigated. The histological subtypes were consisted of 2 PTCL-NOS, 2 AITL, and 1 NK/T cell. Two patients were previously treated with methotrexate-containing chemotherapy. Pralatrexate (15 mg/m2) and bortezomib (1.3mg/m2) were administered intravenously on day 1, 8 and 15 and repeated every 28 days for 4 cycles. Concomitant medications were included that vitamin B12 (1 mg) was injected within 14 days before pralatrexate infusion and oral 45mg of leucovorin was taken during entire days of chemotherapy. The interim and final response were assessed according to the revised International Workshop Criteria (IWC).
Results
All 5 patients are men with median age of 71 years (range: 67 – 74). The number of prior systemic therapies ranges 1 to 5. Of 5 patients, two achieved partial response (PR) after 2 cycles and one achieved complete response (CR) after 4 cycles which have lasted 8 months until now. Another patient with interim PR progressed after 3 cycles. Two responders had no history of prior methotrexate-containing treatment and histologically all PTCL-NOS. Three other patients progressed after one or 2 cycles. The most common adverse events were mucositis and anorexia. Four patients complained of mucositis, but only 1 week delay of treatment was required for grade 3 mucositis in one patient. Generally most patients tolerated combination therapy. All patients were treated with planned pralatrexate without dose reduction or discontinuation due to toxicity. Only one dose of bortezomib was omitted due to peripheral neuropathy among all patients and one episode of herpes zoster occurred. None of the patients postponed treatment due to hematologic adverse events.
Conclusion
Combination therapy with pralatrexate and bortezomib could be used effectively and safely as a salvage therapy for relapsed or refractory PTCL in elderly patients. Larger studies are needed for evaluating benefit of combination therapy over single pralatrexate therapy.
Session topic: E-poster
Keyword(s): Bortezomib, Elderly, Peripheral T-cell lymphoma
Type: Publication Only
Background
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of aggressive lymphoma with poor prognosis and there is no efficacious standard regimen for the relapsed or refractory disease. Particularly, elderly patients generally have impaired bone marrow function, altered drug metabolism, comorbidities, and poor functional status. Therefore, the treatment of elderly patients with relapsed or refractory PTCL remains a challenge for clinicians.
Aims
a recent report demonstrated that the combination of pralatrexate and bortezomib enhanced efficacy compared with that of either agent alone in vitro and in vivo models of T cell malignancy. Hence, we performed a pilot study that evaluated the response rate, duration of response and safety profile of this combination regimen in elderly patients with relapsed or refractory PTCL.
Methods
Five elderly patients (age ≥65 years) with relapsed or refractory PTCLs, who progressed following one or more prior chemotherapy, were investigated. The histological subtypes were consisted of 2 PTCL-NOS, 2 AITL, and 1 NK/T cell. Two patients were previously treated with methotrexate-containing chemotherapy. Pralatrexate (15 mg/m2) and bortezomib (1.3mg/m2) were administered intravenously on day 1, 8 and 15 and repeated every 28 days for 4 cycles. Concomitant medications were included that vitamin B12 (1 mg) was injected within 14 days before pralatrexate infusion and oral 45mg of leucovorin was taken during entire days of chemotherapy. The interim and final response were assessed according to the revised International Workshop Criteria (IWC).
Results
All 5 patients are men with median age of 71 years (range: 67 – 74). The number of prior systemic therapies ranges 1 to 5. Of 5 patients, two achieved partial response (PR) after 2 cycles and one achieved complete response (CR) after 4 cycles which have lasted 8 months until now. Another patient with interim PR progressed after 3 cycles. Two responders had no history of prior methotrexate-containing treatment and histologically all PTCL-NOS. Three other patients progressed after one or 2 cycles. The most common adverse events were mucositis and anorexia. Four patients complained of mucositis, but only 1 week delay of treatment was required for grade 3 mucositis in one patient. Generally most patients tolerated combination therapy. All patients were treated with planned pralatrexate without dose reduction or discontinuation due to toxicity. Only one dose of bortezomib was omitted due to peripheral neuropathy among all patients and one episode of herpes zoster occurred. None of the patients postponed treatment due to hematologic adverse events.
Conclusion
Combination therapy with pralatrexate and bortezomib could be used effectively and safely as a salvage therapy for relapsed or refractory PTCL in elderly patients. Larger studies are needed for evaluating benefit of combination therapy over single pralatrexate therapy.
Session topic: E-poster
Keyword(s): Bortezomib, Elderly, Peripheral T-cell lymphoma
Abstract: PB1712
Type: Publication Only
Background
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of aggressive lymphoma with poor prognosis and there is no efficacious standard regimen for the relapsed or refractory disease. Particularly, elderly patients generally have impaired bone marrow function, altered drug metabolism, comorbidities, and poor functional status. Therefore, the treatment of elderly patients with relapsed or refractory PTCL remains a challenge for clinicians.
Aims
a recent report demonstrated that the combination of pralatrexate and bortezomib enhanced efficacy compared with that of either agent alone in vitro and in vivo models of T cell malignancy. Hence, we performed a pilot study that evaluated the response rate, duration of response and safety profile of this combination regimen in elderly patients with relapsed or refractory PTCL.
Methods
Five elderly patients (age ≥65 years) with relapsed or refractory PTCLs, who progressed following one or more prior chemotherapy, were investigated. The histological subtypes were consisted of 2 PTCL-NOS, 2 AITL, and 1 NK/T cell. Two patients were previously treated with methotrexate-containing chemotherapy. Pralatrexate (15 mg/m2) and bortezomib (1.3mg/m2) were administered intravenously on day 1, 8 and 15 and repeated every 28 days for 4 cycles. Concomitant medications were included that vitamin B12 (1 mg) was injected within 14 days before pralatrexate infusion and oral 45mg of leucovorin was taken during entire days of chemotherapy. The interim and final response were assessed according to the revised International Workshop Criteria (IWC).
Results
All 5 patients are men with median age of 71 years (range: 67 – 74). The number of prior systemic therapies ranges 1 to 5. Of 5 patients, two achieved partial response (PR) after 2 cycles and one achieved complete response (CR) after 4 cycles which have lasted 8 months until now. Another patient with interim PR progressed after 3 cycles. Two responders had no history of prior methotrexate-containing treatment and histologically all PTCL-NOS. Three other patients progressed after one or 2 cycles. The most common adverse events were mucositis and anorexia. Four patients complained of mucositis, but only 1 week delay of treatment was required for grade 3 mucositis in one patient. Generally most patients tolerated combination therapy. All patients were treated with planned pralatrexate without dose reduction or discontinuation due to toxicity. Only one dose of bortezomib was omitted due to peripheral neuropathy among all patients and one episode of herpes zoster occurred. None of the patients postponed treatment due to hematologic adverse events.
Conclusion
Combination therapy with pralatrexate and bortezomib could be used effectively and safely as a salvage therapy for relapsed or refractory PTCL in elderly patients. Larger studies are needed for evaluating benefit of combination therapy over single pralatrexate therapy.
Session topic: E-poster
Keyword(s): Bortezomib, Elderly, Peripheral T-cell lymphoma
Type: Publication Only
Background
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of aggressive lymphoma with poor prognosis and there is no efficacious standard regimen for the relapsed or refractory disease. Particularly, elderly patients generally have impaired bone marrow function, altered drug metabolism, comorbidities, and poor functional status. Therefore, the treatment of elderly patients with relapsed or refractory PTCL remains a challenge for clinicians.
Aims
a recent report demonstrated that the combination of pralatrexate and bortezomib enhanced efficacy compared with that of either agent alone in vitro and in vivo models of T cell malignancy. Hence, we performed a pilot study that evaluated the response rate, duration of response and safety profile of this combination regimen in elderly patients with relapsed or refractory PTCL.
Methods
Five elderly patients (age ≥65 years) with relapsed or refractory PTCLs, who progressed following one or more prior chemotherapy, were investigated. The histological subtypes were consisted of 2 PTCL-NOS, 2 AITL, and 1 NK/T cell. Two patients were previously treated with methotrexate-containing chemotherapy. Pralatrexate (15 mg/m2) and bortezomib (1.3mg/m2) were administered intravenously on day 1, 8 and 15 and repeated every 28 days for 4 cycles. Concomitant medications were included that vitamin B12 (1 mg) was injected within 14 days before pralatrexate infusion and oral 45mg of leucovorin was taken during entire days of chemotherapy. The interim and final response were assessed according to the revised International Workshop Criteria (IWC).
Results
All 5 patients are men with median age of 71 years (range: 67 – 74). The number of prior systemic therapies ranges 1 to 5. Of 5 patients, two achieved partial response (PR) after 2 cycles and one achieved complete response (CR) after 4 cycles which have lasted 8 months until now. Another patient with interim PR progressed after 3 cycles. Two responders had no history of prior methotrexate-containing treatment and histologically all PTCL-NOS. Three other patients progressed after one or 2 cycles. The most common adverse events were mucositis and anorexia. Four patients complained of mucositis, but only 1 week delay of treatment was required for grade 3 mucositis in one patient. Generally most patients tolerated combination therapy. All patients were treated with planned pralatrexate without dose reduction or discontinuation due to toxicity. Only one dose of bortezomib was omitted due to peripheral neuropathy among all patients and one episode of herpes zoster occurred. None of the patients postponed treatment due to hematologic adverse events.
Conclusion
Combination therapy with pralatrexate and bortezomib could be used effectively and safely as a salvage therapy for relapsed or refractory PTCL in elderly patients. Larger studies are needed for evaluating benefit of combination therapy over single pralatrexate therapy.
Session topic: E-poster
Keyword(s): Bortezomib, Elderly, Peripheral T-cell lymphoma
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