The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T‐cell lymphoma with analysis of biomarkers

Abstract

We compared the efficacy and safety of gemcitabine, cisplatin, prednisone and thalidomide (GDPT) with standard CHOP regimen (cyclophosphamide, doxorubicin, vincristine, prednisone) for patients with newly diagnosed peripheral T-cell lymphoma (PTCL) in a prospective randomized controlled and open-label clinical trial. Between July 2010 and June 2016, 103 patients were randomly allocated into two groups, of whom 52 were treated with GDPT therapy and 51 with CHOP therapy. The 2-year progression-free survival (PFS) and overall survival (OS) rates were better in the GDPT group than in the CHOP group (57% vs. 35% for 2-year PFS, P = 0·0035; 71% vs 50% for 2-year OS, P = 0·0001). The complete remission rate (CRR) and the overall response rate (ORR) in the GDPT group were higher than in the CHOP group (52% vs. 33%, P = 0·044 for CRR; 67% vs. 49%, P = 0·046 for ORR). Haemocytopenia was the predominant adverse effect, and acute toxicity was moderate, tolerable and well managed in both arms. mRNA expression of ERCC1, RRM1, TUBB3 and TOP2A genes varied among patients but the difference did not reach statistical significance, mainly due to the relatively small sample size. The precise characters of these biomarkers remain to be identified. In conclusion, GDPT is a promising new regimen as potential first-line therapy against PTCL. This study was registered at www.clinicaltrials.gov as #NCT01664975.

Current status and progress of lymphoma management in China

“…In mainland China, some new regimens were explored as first-line therapy against PTCL. Li et al [41] compared the efficacy and safety of GDPT (gemcitabine, cisplatin, prednisone and thalidomide) with standard CHOP regimen for patients with newly diagnosed PTCL. 103 patients were randomly allocated into the GDPT group or CHOP group [41].…”

“…Li et al [41] compared the efficacy and safety of GDPT (gemcitabine, cisplatin, prednisone and thalidomide) with standard CHOP regimen for patients with newly diagnosed PTCL. 103 patients were randomly allocated into the GDPT group or CHOP group [41]. Patients receiving GDPT chemotherapy achieved significant higher 2-year PFS rate (57 vs 35%, p = 0.0035) and OS rate (71 vs 50%, p = 0.0001) than those receiving CHOP chemotherapy [41].…”

“…103 patients were randomly allocated into the GDPT group or CHOP group [41]. Patients receiving GDPT chemotherapy achieved significant higher 2-year PFS rate (57 vs 35%, p = 0.0035) and OS rate (71 vs 50%, p = 0.0001) than those receiving CHOP chemotherapy [41]. The CR rate (52 vs 33%, p = 0.0001) and the ORR (67 vs. 49%, p = 0.046) in the GDPT group were higher than in the CHOP group [41].…”

“…The CR rate (52 vs 33%, p = 0.0001) and the ORR (67 vs. 49%, p = 0.046) in the GDPT group were higher than in the CHOP group [41]. Haemocytopenia was the predominant adverse effect [41]. Endostatin (endostar) is an endogenous inhibitor of angiogenesis.…”

Recent advances in understanding and managing T-cell lymphoma

“…Thalidomide, a prototype drug of this class, was evaluated for combination treatment. A combination of gemcitabine, cisplatin, prednisone, and thalidomide (GDPT) was compared with CHOP for patients with newly diagnosed PTCL 111 . In total, 103 patients were randomly allocated into two groups; 52 received GDPT and 51 received CHOP.…”