Gemcitabine Clinical Trial
Official title:
GDPE/CEOPE Compared With CEOPE as the First-line Therapy for Newly Diagnosed Patients With Peripheral T-Cell Lymphoma
Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. There is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by National Comprehensive Cancer Network (NCCN) for those patients. Former studies confirmed that GDP (Gemcitabine, Dexamethasone, and Cis-platinum) is superior with CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisone). Combination with etoposide can improve the outcome of some patients with high risk factors. The aim of our study is to compare the response and survival rate of GDPE/CEOPE (gemcitabine, cis-platinum, etoposide, and dexamethasone/cyclophosphamide, vincristine, pharmorubicin, etoposide, and prednisone) with those of CEOPE regimen, looking forward to its superiority in efficacy and safety for the newly diagnosed adult patients with PTCL.
Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year
PFS (progression-free survival) and OS (overall survival) for these patients received classic
CHOP regimen is less than 30%. High-dose intensive chemotherapy doesn't demonstrate better
response. At present, there is no standardized treatment protocol for this kind of lymphoma.
So, clinical trials are encouraged by NCCN for those patients.
For the less efficacy of CHOP or CHOP-like regimen, multi-drug combination strategy has been
the therapy tendency in PTCL. Zhang et al, reported that GDP compared with CHOP as the
therapy strategy for PTCL-NOS (Not Otherwise Specified). The response rate was 78.57% in GDP
group and 60.00% in CHOP group, respectively. DFS (disease-free survival) was 9.79 and 4.2
months in above two groups. They concluded that GDP is superior to CHOP. The main side-effect
of two regimens is hematological toxicity. Combination with etoposide can improve the outcome
of some patients with high risk factors. Furthermore, high-dose combined with ASCT
(autologous stem cell transplantation) has been the first-line therapy for PTCL. Some
refractory/relapsed patients with PTCL will benefit from allogeneic bone marrow
transplantation. However, about 30% patients with PTCL have no chance to receive ASCT for
multiple reasons. So, it is urgent to explore new combination-therapy regimen to improve the
outcome for patients with PTCL.
The aim of our study is to compare the response and survival rate of GDPE/CEOPE (gemcitabine,
cis-platinum, etoposide, and dexamethasone/cyclophosphamide, vincristine, pharmorubicin,
etoposide, and prednisone) with those of CEOPE (/cyclophosphamide, vincristine,
pharmorubicin, etoposide, and prednisone ) regimen, looking forward to its superiority in
efficacy and safety for the newly diagnosed adult patients with PTCL.
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