Search

Background: The aim of this study was to evaluate the safety and survival outcomes of anti-programmed cell death (PD)-1/programmed cell death-ligand 1 (PD-L1) monotherapy in patients with advanced non-small cell lung cancer (NSCLC) and different hepatitis B virus (HBV) infection status., Methods: Patients with advanced NSCLC and both chronic and/or resolved HBV infection who were treated with anti-PD-(L)1 monotherapy were retrospectively enrolled. The primary endpoint was the safety of PD-1/PD-L1 monotherapy, while the secondary endpoints included the survival outcomes., Results: Of the 62 eligible patients, 10 (16.1%) were hepatitis B surface antigen (HBsAg) positive [chronic hepatitis B (CHB) infection] and 52 (83.9%) were HBsAg negative and HBcAb positive [resolved hepatitis B (RHB) infection]; 42 (67.7%) patients had at least 1 treatment-related adverse event (AE), with 4 patients (6.5%) developing grade 3 AEs and 6 (9.7%) developing hepatic AEs. One CHB patient experienced HBV reactivation during anti-PD-1 immunotherapy due to the interruption of antiviral prophylaxis. The objective response rate and durable clinical benefit (DCB) rate were 17.7% and 29.0%, respectively. Median overall survival (OS) and progression-free survival (PFS) were 23.6 months [95% confidence interval (CI): 14.4-32.8] and 2.1 months (95% CI: 1.2-3.0), respectively. The DCB rate was significantly higher in the CHB group than in the RHB group (60% vs. 23.1%; P=0.048). Patients with CHB experienced a longer PFS (8.3 vs. 2.0 months; P=0.103) and OS (35.0 vs. 18.2 months, P=0.119) than did RHB patients., Conclusions: Anti-PD-(L)1 monotherapy was safe and effective in patients with NSCLC and HBV infection. This population should not be excluded from receiving immunotherapy in routine clinical practice or within clinical trials if HBV biomarkers are monitored and antiviral prophylaxis is properly used., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/tlcr-21-455). AR reports advisory board role for Astra Zeneca, MSD, and Novartis. RAS reports research grants from Astra-Zeneca, Boehringer Ingelheim, and advisory Board for Amgen, Astra-Zeneca, Bayer, BMS, Boehringer Ingelheim, Lilly, Merck, Novartis, Pfizer, Roche, Taiho, Takeda, Yuhan. EN received research funding from Roche, Pfizer, Merck-Serono, and Bristol Myers Squibb and received consultancy fees from Roche, BMS, MSD, Merck-Serono, Pfizer, Lilly, Amgen, Boehringer-Ingelheim, AstraZeneca, and Takeda. FP reports Consulting fees from MSD, Astrazeneca, Boehringer Ingheleim, Amgen and Pfizer. TM reports honorara for lecture and edcuational presentations as well as consultin fees from Astra Zeneca, Lilly, MSD, BMS. IJO received research funding from Roche and received consultancy fees from Roche, Ono, MSD, Pfizer, Boehringer-Ingelheim, AstraZeneca, Takeda. SW reports grant and personal fees from AstraZeneca and Boehringer Ingelheim, and personal fees from Chugai Pharma, Ono Pharmaceutical, Bristol-Myers, Eli Lilly, MSD, Taiho Pharmaceutical, Pfizer, Novartis and Daiichi Sankyo; outside the submitted work. The other authors have no conflicts of interest to declare., (2021 Translational Lung Cancer Research. All rights reserved.)

Background: Programmed death protein (ligand) 1 [PD-(L)1] inhibitors have provided new therapeutic options for advanced lung cancer. However, patients with hepatitis B virus (HBV) infection have been traditionally excluded from most registered trials of this form of treatment., Methods: We performed a retrospective analysis of patients with HBV and advanced lung cancer who received anti-PD-1 immunotherapy from September 2018 to May 2020 in our department. Treatment-related hepatotoxicity was evaluated and recorded. Overall response rate and progression free survival were also assessed in the patients using iRECIST., Results: Seventeen patients were evaluated in this analysis. Of these, six (35.3%) experienced hepatic transaminase elevation during immunotherapy. Three of these patients developed Grade 3 hepatic immune-related adverse events and received systemic corticosteroids, following which aminotransferase levels recovered to normal in all patients and no adverse events were observed in subsequent treatment. No patient experienced HBV reactivation or flare. One patient developed active pulmonary tuberculosis (TB). Other adverse events were mild, well tolerated and short term. The objective response rate (ORR) of the cohort was 62.5%, and the median progression-free survival (PFS) was 3 months., Conclusions: Lung cancer patients can be treated safely with anti-PD-1 inhibitors in the context of HBV infection. Close monitoring for hepatotoxicity and prophylactic antiviral therapy is advised. Further studies on the use of anti-PD-1 inhibitors in HBV-infected patients are needed., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tlcr-21-79). SKJ reports grants and personal fees from Merck & Co., outside the submitted work. SW reports personal fees from AstraZeneca, Chugai Pharma, Ono Pharmaceutical, Bristol-Myers, grants and personal fees from Boehringer Ingelheim, personal fees from Eli Lilly, personal fees from MSD, Taiho Pharmaceutical, Pfizer, Novartis, Daiichi Sankyo, outside the submitted work. The other authors have no conflicts of interest to declare., (2021 Translational Lung Cancer Research. All rights reserved.)

Background: The purpose of this study was to determine the effect of hepatitis B virus (HBV) infection on the clinicopathological features and survival outcomes of breast cancer (BC) patients., Methods: Patients diagnosed with BC at the Breast and Thyroid Center, Renmin Hospital, Wuhan University between January 2013 and December 2017 were included in the study. Among these patients, 100 (8.4%) were infected with HBV (case group), while 237 (19.9%) had never come into contact with HBV (control group). Chi-square tests for analyses of clinicopathological features, Kaplan-Meier survival analyses, the log-rank test for disease-free survival (DFS) between the case and control group, along with the factors correlated with prognosis, were evaluated using univariate and multivariate analyses., Results: The median follow-up of the patients in the case and control groups was 34.5 months. The clinicopathological features revealed that patients with HBV tended to have smaller tumors compared with the control group (case vs. control: 53.0% vs . 65.8%, P<0.05). In addition, more grade 3 tumors were observed in patients with HBV (case vs . control: 55.0% vs . 37.6%, P<0.01). The 3-year DFS was 94.3% in the case group and 89.4% in the control group patients (P=0.212). In multivariate analysis, nodal status [hazard ratio (HR) =5.033, P=0.003] and estrogen receptor (ER) status (HR =0.216, P=0.023) were both independent prognostic risk factors for DFS. However, HBV infection had no association with the DFS of BC., Conclusions: BC patients in central China have a higher incidence rate of HBV infection than the general population does. BC patients with chronic HBV infection tend to have an earlier tumor stage and higher histological grade, but there is no association with the DFS of BC., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tcr.2020.03.15). The authors have no conflicts of interest to declare., (2020 Translational Cancer Research. All rights reserved.)

Background: Except for hepatocellular carcinoma, chronic hepatitis B virus (HBV) infection has also been reported to be associated with increased morbidity and mortality of other cancers. However, the impact of chronic HBV infection on the prognosis of breast cancer (BC) remains unclear. Our study aimed to evaluate the prognostic value of HBV infection for BC in an endemic area of HBV in China., Methods: There was a total of 1,904 patients with early BC who underwent mastectomy or breast-conserving surgery enrolled in our study. HBV infection on overall survival (OS) and hepatic metastasis-free survival (HMFS) was the main research indicator for this study., Results: A total of 212 patients (11.1%) were identified with chronic HBV infection due to serum hepatitis B surface antigen (HBsAg) positive. HBsAg-positive patients had inferior OS (84.9% vs . 90.4%, P=0.005) and HMFS (92.5% vs . 97.1%, P=0.016) at 5 years than HBsAg-negative patients. Chronic HBV infection was an independent predictor of poor OS in patients with BC [multivariate analysis; hazard ratio (HR), 1.52; P=0.038], but not for HMFS. Subgroup analysis showed that chronic HBV infection was an unfavorable independent prognostic factor for OS in patients with stage II/III BC (HR, 1.59; P=0.025). The 5-year OS and HMFS rates of HBsAg-positive patients were 81.9% and 90.5% for patients with stage II/III BC, while those rates of HBsAg-negative patients were 88.5% and 96.3%, respectively. In stage I patients, there was no significant difference in 5-year OS (95.8% vs . 97.1%; P=0.629) and HMFS (100.0% vs . 99.0%; P=0.447)., Conclusions: In conclusion, chronic HBV infection predicts a worse prognosis in patients with stage II/III BC, but not stage I BC., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare., (2020 Annals of Translational Medicine. All rights reserved.)