Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China: A Prospective, Multicenter, Noninterventional Study / 中华医学杂志(英文版)

Background@#Prospective real-life data on the safety and effectiveness of rituximab in Chinese patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) are limited. This real-world study aimed to evaluate long-term safety and effectiveness outcomes of rituximab plus chemotherapy (R-chemo) as first-line treatment in Chinese patients with DLBCL or FL. Hepatitis B virus (HBV) reactivation management was also investigated.@*Methods@#A prospective, multicenter, single-arm, noninterventional study of previously untreated CD20-positive DLBCL or FL patients receiving first-line R-chemo treatment at 24 centers in China was conducted between January 17, 2011 and October 31, 2016. Enrolled patients underwent safety and effectiveness assessments after the last rituximab dose and were followed up for 3 years. Effectiveness endpoints included progression-free survival (PFS) and overall survival (OS). Safety endpoints were adverse events (AEs), serious AEs, drug-related AEs, and AEs of special interest. We also reported data on the incidence of HBV reactivation.@*Results@#In total, 283 previously untreated CD20-positive DLBCL and 31 FL patients from 24 centers were enrolled. Three-year PFS was 59% (95% confidence interval [CI]: 50-67%) for DLBCL patients and 46% (95% CI: 20-69%) for FL patients. For DLBCL patients, multivariate analyses showed that PFS was not associated with international prognostic index, tumor maximum diameter, HBV infection status, or number of rituximab treatment cycles, and OS was only associated with age >60 years (P < 0.05). R-chemo was well tolerated. The incidence of HBV reactivation in hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative/hepatitis B core antibody-positive patients was 13% (3/24) and 4% (3/69), respectively.@*Conclusions@#R-chemo is effective and safe in real-world clinical practice as first-line treatment for DLBCL and FL in China, and that HBV reactivation during R-chemo is manageable with preventive measures and treatment.@*Trial Registration@#ClinicalTrials.gov, NCT01340443; https://clinicaltrials.gov/ct2/show/NCT01340443.

Study of the correlation between the colorectal cancer Chinese medicine syndrome types and (excision repair cross-complementing 1, ERCC1) gene polymorphisms / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To explore the correlation between excision repair cross-complementing 1 (ERCC1) C8092A and C19007T gene polymorphisms and different Chinese medicine (CM) syndrome types of colorectal cancer (CC).</p><p><b>METHODS</b>Ninety-nine patients with CC were syndrome typed as dampness-heat accumulation syndrome, qi stagnation with blood stasis syndrome, Pi-Shen yang deficiency syndrome, and Gan-Shen yin deficiency syndrome. The gene polymorphisms of excision repair cross-complementing 1 (ERCC1) C8092A and C19007T in different CM syndrome types of CC were examined by polymorphisms chain reaction amplification and direct sequencing, and analyzed statistically.</p><p><b>RESULTS</b>The frequencies of C8092A genotype and allele in different CM syndrome types had no statistical difference (P > 0.05). The frequencies of C19007T genotype and allele in different CM syndrome types had statistical difference (P < 0.05). Of them, there was no statistical difference in the frequencies between dampness-heat accumulation syndrome and qi stagnation with blood stasis syndrome, or between Pi-Shen yang deficiency syndrome and Gan-Shen yin deficiency syndrome (P > 0.05). There was statistical difference between dampness-heat accumulation syndrome and Pi-Shen yang deficiency syndrome as well as Gan-Shen yin deficiency syndrome (P < 0.05). There was statistical difference between qi stagnation with blood stasis syndrome and Pi-Shen yang deficiency syndrome as well as Gan-Shen yin deficiency syndrome (P < 0.05).</p><p><b>CONCLUSION</b>ERCC1 C19007T gene polymorphisms might be associated with CM syndrome types of CC, which needed to be further studied.</p>