Dataset Information

Gemcitabine, cisplatin, prednisone, and thalidomide for relapse and refractory peripheral T-cell lymphoma: a retrospective study from China.

ABSTRACT: Background:Peripheral T-cell lymphoma (PTCL) is often prone to relapse and progression even after formal first-line treatment, and there is no standard regimen for second-line treatment. What is more, the activity of thalidomide against this type of lymphoma is unknown. Purpose:The objective of this study was to evaluate the efficacy and safety of GDPT regimen in the treatment of relapsed/refractory peripheral T-cell lymphoma. Patients and methods:In this retrospective study, gemcitabine, cisplatin, prednisone, and thalidomide (GDPT) combination regimen was used as salvage protocol for PTCL that failed in first-line treatment for 29 patients and it was scheduled to give 6 cycles of GDPT therapy in order to better evaluate the efficacy unless there was evidence of disease progression, unacceptable toxicities, or refusal by the patient. Results:After a total of 106 cycles of GDPT regimen were administered, the result showed that the disease control rate (DCR) achieved 82.8% and overall response rate (ORR) reached 69.0% with 34.5% complete remission (CR) and 34.5% partial remission (PR). The median progression-free survival (PFS) was 10.0 months (95% CI 6.6-13.4) and median OS was 28.0 months (95% CI 19.2-36.8). And the 1-year PFS rate and 1-year OS rate were 43.6% and 64.6%, respectively. Both hematologic and non-hematologic toxicities were moderate and well tolerated. There was no treatment-related death. Conclusion:Thalidomide in combination with gemcitabine, cisplatin, prednisone regimen is a new promising approach to treating patients with relapse and refractory PTCL.

SUBMITTER: Liu X

PROVIDER: S-EPMC6749983 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Gemcitabine, cisplatin, prednisone, and thalidomide for relapse and refractory peripheral T-cell lymphoma: a retrospective study from China.

Liu Xiangli X Shang YuFeng Y Li Ling L Zhang Xudong X Li Zhaoming Z Zhang Mingzhi M

Cancer management and research 20190909

<h4>Background</h4>Peripheral T-cell lymphoma (PTCL) is often prone to relapse and progression even after formal first-line treatment, and there is no standard regimen for second-line treatment. What is more, the activity of thalidomide against this type of lymphoma is unknown.<h4>Purpose</h4>The objective of this study was to evaluate the efficacy and safety of GDPT regimen in the treatment of relapsed/refractory peripheral T-cell lymphoma.<h4>Patients and methods</h4>In this retrospective stud ...[more]

PMID: 31571985

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Project description:AimTo compare the outcomes of GDPT [gemcitabine (G), cisplatin (D), prednisone (P), thalidomide (T)] versus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in treating newly diagnosed PTCL (peripheral T-cell lymphoma).MethodsAn open-label prospective clinical trial with 153 newly diagnosed PTCL patients conducted between January 2010 and December 2018 was designed. Patients were randomly assigned to the GDPT (77 cases) and CHOP (76 cases) groups. Patients in each group were further divided into four subgroups: PTCL, not otherwise specified (PTCL-NOS); anaplastic large cell lymphoma (ALCL), angioimmunoblastic T cell lymphoma (AITL), and other types subgroup, in accordance with pathological patterns. Based on expression of RRM1, TOP2A, TUBB3, and ERCC1, patients were divided into groups with high and low gene expression levels. Clinical characteristics, side effects, efficacy, progression-free survival (PFS), and overall survival (OS) were compared.ResultsThere were no significant differences in the basic clinical features or side effects between the GDPT and CHOP groups. The overall response rate (ORR) of the GDPT group was better than that of the CHOP group (66.3% versus 50.0%, p = 0.042), as was the complete remission (CR) rate (42.9% versus 27.6%, p = 0.049). Patients in the GDPT group had a longer PFS and OS than the CHOP group. The 4-year PFS and OS rates in the GDPT group were both superior to those in the CHOP group (63.6% versus 53.0% for PFS, p = 0.035; 66.8% versus 53.6% for OS, p = 0.039). In the GDPT group, the difference in CR between the four subgroups was statistically significant (p = 0.046). In the CHOP group, differences in both CR and ORR among the four subgroups were statistically significant (p < 0.001 and p = 0.005, respectively). There were also statistically significant differences in CR between patients treated with CHOP and GDPT in the PTCL-NOS subgroup, AITL subgroup, and the other types subgroup (p = 0.015; p = 0.003; p = 0.005, respectively). The data also showed a significant difference in OS among the four subgroups within the GDPT group (p = 0.001). The OS of AITL was shorter than that of the other three subgroups. Four subgroups of CHOP showed a significant difference in PFS (p = 0.019). There was no statistical association between responses and the gene expression levels of RRM1, ERCC1, TUBB3, and TOP2A.ConclusionThe GDPT group had better response rates and prolonged patient PFS and OS. As a promising new regimen, GDPT is expected to become the first-line therapy for PTCL. New agents should be applied to patients who do not achieve good responses with previous treatment, such as those diagnosed with angioimmunoblastic T cell lymphoma.Trial registrationThis open randomized prospective clinical trial was registered at ClinicalTrials.gov (NCT01664975).

Project description:BackgroundPatients with peripheral T-cell lymphomas (PTCLs) have inferior progression-free survival (PFS) and overall survival (OS) compared with patients who have aggressive B-cell non-Hodgkin lymphoma. Because PTCLs over express multidrug resistance gene 1/P-glycoprotein (MDR-1/P-gp), we devised platinum, etoposide, gemcitabine, and methylprednisolone (PEGS) with agents that are not substrates of the efflux pump. Gemcitabine was included because of its excellent single-agent activity in PTCL.MethodsPatients who had PTCL with stage II bulky disease, stage III or IV disease with extra-nodal, nodal, and transformed cutaneous presentations were eligible. Patients received intravenous cisplatin 25 mg/m(2) on days 1 through 4, etoposide 40 mg/m(2) on days 1 through 4, gemcitabine 1000 mg/m(2) on day 1, and methylprednisolone 250 mg on days 1 through 4 of a 21-day cycle for 6 cycles.ResultsIn total, 34 patients were enrolled, 33 were eligible, and 79% were newly diagnosed. Histologic types were PTCL not otherwise specified (n = 15), anaplastic lymphoma kinase (ALK)-negative anaplastic large cell lymphoma (n = 4), angioimmunoblastic T-cell lymphoma (n = 6), or other T-cell non-Hodgkin lymphomas (n = 8). Adverse events included 1 grade 5 infection with grade 3 or 4 neutropenia and 9 grade 4 hematologic toxicities. The overall response rate was 39% (47% in PTCL not otherwise specified, 33% in angioimmunoblastic T-cell lymphoma, 25% in ALK-negative and 38% in other T-cell non-Hodgkin lymphomas). The PFS rate at 2 years was 12% (95% confidence interval, 0.1%-31%), and the median PFS was 7 months. The OS rate at 2 years was 30% (95% confidence interval, 8%-54%), and the median OS was 17 months. Immunohistochemical analysis of P-gp expression revealed strong positivity in a subset of lymphoma cells (n = 6) and tumor endothelium (n = 25).ConclusionsOverall, PEGS was well tolerated, but OS was not considered promising given the design-specified targets. These results may serve as a benchmark for future comparisons for non-CHOP regimens.

Dataset Information

Gemcitabine, cisplatin, prednisone, and thalidomide for relapse and refractory peripheral T-cell lymphoma: a retrospective study from China.

Publications

Gemcitabine, cisplatin, prednisone, and thalidomide for relapse and refractory peripheral T-cell lymphoma: a retrospective study from China.

Similar Datasets

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