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Chinese Medical Journal ; (24): 1767-1775, 2018.
Article in English | WPRIM | ID: wpr-775145


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, NCT01340443;

Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , China , Cyclophosphamide , Doxorubicin , Female , Follow-Up Studies , Humans , Lymphoma, Follicular , Drug Therapy , Lymphoma, Large B-Cell, Diffuse , Drug Therapy , Male , Middle Aged , Prospective Studies , Rituximab , Therapeutic Uses , Vincristine
Article in Chinese | WPRIM | ID: wpr-269560


<p><b>OBJECTIVE</b>To investigate the expression of human epidermal growth factor receptor 2 (HER-2/neu) in hepatocellular carcinoma (HCC) patients and its clinical significance.</p><p><b>METHODS</b>The expressions of HER-2/neu were detected by SP immunohistochemistry method in 30 patients with HCC, 10 with portal cirrhosis of the liver and 10 with normal liver.</p><p><b>RESULTS</b>The positivity rate of HER-2/neu was markedly higher in HCC patients than in those with portal cirrhosis and normal liver (Chi(2)=6.482, P=0.032). The expression of HER-2/neu was closely correlated to portal cirrhosis of the liver (P=0.041), tumor invasion (P=0.028) and Edmondson grades (P=0.012). The average survival time was significant shorter in patients with HER-2/neu-positive tumor than in those with HER-2/neu-negative tumor (P=0.036).</p><p><b>CONCLUSION</b>The expression of HER-2/neu may play a role in the invasion, metastasis and progression of HCC. The patients positive for HER-2/neu in the HCC tissues have generally poor prognosis.</p>

Adult , Aged , Aged, 80 and over , Carcinoma, Hepatocellular , Genetics , Metabolism , Female , Humans , Liver Neoplasms , Genetics , Metabolism , Male , Middle Aged , Neoplasm Metastasis , Prognosis , Receptor, ErbB-2 , Genetics , Metabolism
Article in Chinese | WPRIM | ID: wpr-640367


Objective To evaluate the efficacy and toxicity of weekly docetaxel and cisplatin in previously untreated patients with advanced non-small-cell lung carcinoma. Methods Between January 2002 and December 2003 ,34 patients with pathologically comfirmed advanced non-small-cell lung carcinoma who had not received treatment were enrolled. The mean age was under 66 years. The patients received intravenous infusions of docetaxel(25 mg/m2,dayl ,8,15) with dexamethasone premedication and cisplatin(25 mg/m2,dayl ,8,15) ,followed by a week of rest. The remedies which were less than 6 regimens lasted to disease progression or severe toxicity. Therapeutic effect was evaluated by CT scan every two courses . The patients were followed up for 24 months. Descriptive statistics and SPSSIO. 0 software were used to analyse the results. Results 34 patients finished 90 courses. The mean was 2. 6 courses. All patients were followed up. Two patients achieved complete responses, ten patients achieved partial responses, ten patients achieved stable disease. An objective response rate of 35. 29% (95% confidence interval 19. 25%-51. 33% )was obtained. Patients life quality was significantly improved. The median time to progression was 4. 1 months, and median overall survival was 11 months. The 1-year survival rate was 47. 06% , the 2-year survival rate was 11.76% . Toxicities were mild. Grade 3 to 4 neutropenia (11.76%), anemia (5.88%), hyponatremia (5.88%), alopecie (17.64%) and nausea/vomiting (5. 88% ) were observed. Conclusion Weekly Cisplatin plus docetaxel is an effective and well-tolerated regimen in chemo-naive patients with advanced NSCLC. Well-designed clinical trials should be conducted.