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Background: The combination of PD-1/PD-L1 inhibitor and chemotherapy has been clinically confirmed to be beneficial as the first-line treatment of patients with advanced NSCLC. This study aimed to assess the effect of nivolumab + docetaxel versus nivolumab monotherapy in patients with NSCLC after the failure of platinum doublet chemotherapy. Materials and methods: The efficacy and toxicity of nivolumab + docetaxel combination therapy versus nivolumab monotherapy were compared in this retrospective study. Primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and toxicity. Results: Between November 2017 and December 2019, 77 patients were included in this study, with 58 patients in the nivolumab group and 19 in the nivolumab + docetaxel group. The median follow-up was 18 months, and the PFS was 8 months for patients receiving nivolumab + docetaxel and 2 months for those receiving nivolumab alone (p = 0.001), respectively. Nivolumab + docetaxel showed superior OS compared with nivolumab, with the median OS unreached versus 7 months (p = 0.011). Among patients without EGFR/ALK variation, compared to nivolumab monotherapy, nivolumab + docetaxel showed better PFS (p = 0.04) and OS (p = 0.05). There was no significant difference in grade 3–4 adverse events (AEs) between the two groups (p = 0.253). Conclusions: The combination of nivolumab and docetaxel demonstrated a meaningful improvement in progression-free survival and overall survival compared to nivolumab monotherapy, in patients with NSCLC after the failure of platinum doublet chemotherapy, irrespective of EGFR/ALK variation status. [ABSTRACT FROM AUTHOR]

Objective: Pembrolizumab and bevacizumab both have antitumor activity. According to NCCN updated guideline the benefit of pembrolizumab or bevacizumab as a first line in management of advanced nonsmall cell lung cancer (NSCLC) is documented in randomized controlled studies. The study aimed to evaluate the response and complications of patients with advanced NSCLC treated with pembrolizumab or bevacizumab plus chemotherapy. Methods: This study was a retrospective cohort study of patients with advanced nonsquamous NSCLC who received cisplatin with pemetrexed combined with pembrolizumab (A group) or bevacizumab (B group) from 07/02/2018 to 07/03/2021 at Peking University Cancer Hospital. Progression-free survival (PFS) was the primary outcome. The secondary outcomes included overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), and adverse events (AEs). Results: This study included 66 patients, 34 in A group and 32 in B group. There were no differences in median PFS (7.6 vs 9.9 months, P =.601). There were no differences in median OS (23.1 vs 24.2 months, P =.782). There were no differences in ORR (57.6 % vs 41.9 %, P =.211) and DCR (93.9 % vs 100.0 %, P =.164) between 2 groups. The occurrence of AEs was similar. No new safety signals were observed. Grade 3 to 4 treatment-related AEs occurred in 17 (50.0 %) patients of A group and in 12 (37.5 %) of B group (P >.05). Conclusion: The addition of pembrolizumab or bevacizumab to pemetrexed plus cisplatin was well tolerated and resulted in a clinically meaningful treatment benefit in advanced nonsquamous NSCLC. When pembrolizumab is not suitable, bevacizumab plus chemotherapy may be an option. [ABSTRACT FROM AUTHOR]

Background: Small cell lung cancer (SCLC) is characterized by aggressive spread and poor prognosis, but has limited treatment options. Results of prognostic factors from randomized trials on treatment arrangement are conflicting and large‐scale real‐world analysis is lacking. Methods: Patients diagnosed SCLC between 2008 and 2018 in Peking University Cancer Hospital were included in this study. Kaplan–Meier methods were adopted, and univariate analysis and multivariate Cox regression models were constructed to analyze prognostic factors. Results: Among 1045 patients who presented to our center, 988 eligible patients were identified. Median overall survival (OS) was 16.0 months for the whole group, 24.0 months and 11.0 months for limited stage small cell lung cancer (LS‐SCLC) and extensive stage small cell lung cancer (ES‐SCLC), separately. Limited‐stage, good performance status (PS) (ECOG 0–1), response to primary systemic treatment, and patients who received initiative irradiation and three or more lines of chemotherapy were predicted to have better OS in the whole group. Only response to first‐line systemic therapy and prophylactic cranial irradiation (PCI) were independent prognostic factors of survival in LS‐SCLC; while good PS (ECOG 0–1), without liver, bone, or subcutaneous metastases, response to first‐line therapy, initial local irradiation, and three or more lines of systemic therapy predicted a favorable prognosis in ES‐SCLC. Conclusions: The present study retrieved from large real–world data suggested that response to primary systemic therapy and aggressive radiotherapy are independent prognostic factors for SCLC. PCI and initiative irradiation for original or metastatic sites improved the OS in LS‐SCLC and ES‐SCLC, respectively. [ABSTRACT FROM AUTHOR]

Background: Programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitors are increasingly used in China, but no real-world data are available about the immune-related adverse events (irAEs). This real-world retrospective study aimed to assess the safety and effectiveness of PD-1/PD-L1 inhibitors in patients with non-small cell lung cancer (NSCLC) and to analyze the association between irAEs and effectiveness. Methods: This was a retrospective study of the clinical data of patients with NSCLC treated with PD-1/PD-L1 inhibitors from August 2016 to November 2019 at Beijing Cancer Hospital. The patients were divided into the irAE or non-irAE groups. Overall adverse events, the impact of irAE on tumor response, and the association of irAEs with effectiveness were evaluated. Results: One hundred and ninety-one patients were included, including 70 (36.6%) patients in the irAE group and 121 (63.4%) patients in the non-irAE group. AE, grades 3–5 AEs, and irAE occurred in 107 (56.0%), 24 (12.6%), and 70 (36.6%) of the patients, respectively. The objective response rate (ORR) and disease control rate (DCR) were higher in the irAE group compared with the non-irAE group (42.0% vs. 25.8%, P=0.038; 91.9% vs. 70.8%, P=0.002). Multivariable analyses identified that irAE were associated with progression-free survival (HR=0.62, 95%CI: 0.43–0.91; P=0.015), but not with overall survival (HR=0.76, 95%CI: 0.44–1.28; P=0.299). Conclusion: In NSCLC treated with PD-1/PD-L1 inhibitors, patients with irAEs showed improved effectiveness over patients without irAEs. Future studies of anti-PD-1/PD-L1 immunotherapy should explore this association and the underlying biological mechanisms of efficacy. [ABSTRACT FROM AUTHOR]

The purpose of this prospective phase II clinical trial was to investigate the efficacy and safety of anlotinib in patients with relapsed small cell lung cancer (SCLC). Forty‐five patients with relapsed SCLC were enrolled and treated with anlotinib (one cycle of 12 mg daily for 14 days, discontinued for 7 days, and repeated every 21 days) until disease progression or intolerance of treatment. The primary end point was progression‐free survival (PFS). Secondary end points were overall survival (OS), disease control rate (DCR), objective control rate (ORR) and toxicity. The median PFS was 4.1 months (95% confidence interval [CI] 2.4‐5.8) and the median OS was 6.1 months (95% CI 2.2‐10.0). The OS for the limited‐stage subgroup was significantly longer than that of the extensive‐stage subgroup (P =.02). The DCR was 67%, and the ORR was 11%. The most common adverse event was hypertension (13%), which was controlled well with antihypertensive drugs. In conclusion, anlotinib has likely efficacy in patients with relapsed SCLC, and the side effects can be well tolerated. A longer OS was observed in limited‐stage SCLC patients treated with anlotinib. What's new? Although untreated small cell lung cancer (SCLC) patients are usually sensitive to chemotherapy, they are prone to relapse. Anlotinib is a novel multi‐target small molecule tyrosine kinase inhibitor with both anti‐angiogenesis and anti‐tumor growth effects. While anlotinib became the first drug approved for third‐line and further‐line treatment of SCLC in China, few studies have focused on anlotinib treatment in relapsed SCLC. This one‐arm, prospective phase II clinical study reports a median progression‐free survival of 4.1 months (95% CI 2.4‐5.8) and median overall survival of 6.1 months (95% CI 2.2‐10.0) for anlotinib treatment in relapsed SCLC, with relatively mild side effects. [ABSTRACT FROM AUTHOR]

Background: This real‐world study assessed the efficacy and toxicity of anlotinib as salvage treatment in Chinese patients with advanced non‐small cell lung cancer (NSCLC). Methods: The medical records of 81 patients with advanced NSCLC who had failed at least two lines of chemotherapy were retrospectively collected. All patients were administered anlotinib treatment until disease progression or intolerance as a result of adverse events. Survival curves were created using the Kaplan–Meier method. The log‐rank test was used for univariate analysis of progression‐free survival (PFS) between groups. Cox regression was used to estimate the statistically significant factors based on univariate analysis. Results: The median PFS was five months (95% confidence interval [CI] 3.5–6.5). The objective response rate (ORR) was 7% and the disease control rate (DCR) was 84%. The following subgroups of patients had longer PFS (P < 0.05): squamous cell carcinoma, no brain or liver metastases, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0–1, and no previous VEGF‐tyrosine kinase inhibitor treatment. The results of Cox regression indicated that an ECOG PS of 0–1 (hazard ratio 0.152, 95% CI 0.057–0.403; P = 0.00) and patients without brain metastases (hazard ratio 0.421, 95% CI 0.195–0.911; P = 0.028) had longer PFS following anlotinib treatment. Conclusion: Anlotinib, which is well tolerated, plays a significant role in the salvage treatment of advanced NSCLC. Patients with advanced NSCLC with an ECOG PS of 0–1 and no brain metastases achieved longer PFS following anlotinib salvage treatment. [ABSTRACT FROM AUTHOR]

Background: Thymoma and thymic carcinoma are rare thymic epithelial tumors. We investigated the efficacy of first‐line gemcitabine and cisplatin (GP) chemotherapy versus gemcitabine and cisplatin chemotherapy combined with the anti‐angiogenic drug endostar (GP + E) in advanced thymoma and thymic carcinoma. Methods: The records of 45 patients with invasive metastatic thymomas or thymic carcinomas treated with GP as first‐line therapy between August 2008 and July 2017 at the Department of Respiratory Medicine, Peking University Cancer Hospital and Institute were retrospectively reviewed. Results: Eighteen patients (75%) in the GP + E group achieved a partial response and six (25%) had stable disease. In GP only group, nine (42.8%) patients achieved a partial response, 11 (52.4%) had stable disease, and one (4.8%) had progressive disease. The GP + E group had a significantly higher overall response rate (75% vs. 42.9%; P = 0.028), and median progression‐free survival (PFS) and overall survival (OS) of 19 and 76 months, respectively. In the GP only group, median PFS and OS were 16 and 29 months, respectively. PFS and OS were not significantly different between the groups. Conclusions: GP has moderate efficacy and could represent a suitable first‐line therapy for thymic carcinoma and thymoma. Chemotherapy combined with endostar could improve the overall response rate, but did not prolong PFS or OS. [ABSTRACT FROM AUTHOR]

Aim: Patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC) who experienced progression with two or more lines chemotherapy have no treatment options that clearly confer a survival benefit. As a novel vascular endothelial growth factor receptor‐2 tyrosine kinase inhibitor, apatinib has a certain antitumor effect for various solid tumors. The present study evaluated the efficacy and safety of apatinib in advanced nonsquamous NSCLC as salvage treatment in Chinese real‐world practice. Methods: Twenty‐eight patients were enrolled in this observational study from October 2015 to May 2017. Progression‐free survival (PFS) and overall survival (OS) were graphed by Kaplan–Meier curve and intergroup comparisons were carried out by log‐rank test. Objective response rate (ORR), disease control rate (DCR) and adverse effects (AEs) were also evaluated. Results: Seven patients obtained partial response, and 18 obtained stable disease, representing an ORR of 26% and a DCR of 93%. Median PFS and OS were 3 (95% confidence interval [CI] 2.6–3.4) and 7.4 (95% CI 1.3–13.5) months, respectively. The efficacy analysis showed that Eastern Cooperative Oncology Group (ECOG) performance status 0–1 was correlated with prolonged OS and PFS (P < 0.05), and hypertension during apatinib treatment was correlated with prolonged OS (P < 0.05). Cox regression showed that ECOG performance status (P < 0.01) (RR = 0.231) (95% CI 0.083‐0.642) and hypertension during apatinib treatment (P = 0.05) were predictive indicators for apatinib treatment. Grade 3–4 AEs with incidences of 10% or greater were hypertension (21%), hand‐foot syndrome (14%) and proteinuria (11%) which could be relieved by dose reduction. Conclusion: In conclusion, apatinib has a certain therapeutic effect in patients with advanced nonsquamous NSCLC. ECOG performance status and hypertension during apatinib might be predictive indicators for treatment efficacy. [ABSTRACT FROM AUTHOR]

Aim: The ALK inhibitor, crizotinib, has demonstrated effectiveness in patients with non-small-cell lung cancer harboring ALK rearrangements. As few studies of the clinical characteristics of Chinese patients with ALK rearrangements have been reported, we conduct this study to gain more understanding in such area among Chinese patients.Patients& Methods: We undertook a retrospective study of 288 non-small-cell lung cancer patients admitted to our institution over a period of 4.5 years.Results: Following testing, 14.9% of the patients (43/288) were found to be ALK fusion gene positive. Patient data including gender, age, smoking status, EGFR mutation status and medical imaging data were collected and analyzed.Conclusion: The findings suggested that patients with ALK rearrangements are more likely to be young, have EGFR wild-type, and more likely to exhibit mucus secretion, solid tumor growth, lymph node metastasis and pleural metastasis. [ABSTRACT FROM AUTHOR]

Background The programmed cell death-1/programmed cell death-1 ligand ( PD-1/ PD- L1) pathway plays a crucial role in tumor evasion. This study evaluated the association between circulating PD-L1 expression and clinical characteristics in patients with advanced non-small cell lung cancer ( NSCLC). Methods A total of 109 advanced NSCLC and 65 healthy patients from the Beijng Cancer Hospital were enrolled in the study. Circulating PD- L1 expression was tested by enzyme-linked immunosorbent assay. The associations between the level of PD- L1 expression and clinicopathologic features and prognosis were statistically analyzed. Results The expression of PD- L1 in advanced NSCLC patients was significantly upregulated compared with the healthy control ( P < 0.001). The expression of PD-L1 was significantly correlated with abdominal organ metastasis ( P = 0.004). A high PD- L1 expression had a worse prognosis than a low expression in patients (18.7 vs. 26.8 month, P < 0.001). Conclusions PD- L1 was elevated in advanced NSCLC patients and may play an important role in tumor immune evasion and patient prognosis. [ABSTRACT FROM AUTHOR]

Background The role of surgery in limited small cell lung cancer ( SCLC) is still controversial. To assess the role of surgery in SCLC we performed a retrospective analysis of survival in a group of limited stage patients, who were managed with trimodal therapy including surgery, or with chemotherapy and radiotherapy. Methods We performed a retrospective survival analysis in a series of 153 limited stage SCLC patients treated between 1995 and 2013. Kaplan- Meier survival analysis and Cox regression analysis were used to calculate the overall survival of the surgical and non-surgical groups. Results Median survival in all patients was 21.5 months. Median survival for surgical and non-surgical patients was 30.5 months and 16.9 months, respectively. The survival curves for the two arms are significantly different ( P < 0.01). In multivariate analysis, the benefit of surgical treatment and thoracic radiotherapy varied in a time-dependent fashion. Conclusions Our results suggest that surgery added to chemotherapy and radiotherapy may be associated with a therapeutic benefit in limited SCLC. [ABSTRACT FROM AUTHOR]

Objective: We investigated whether aprepitant, a neurokinin-1 antagonist, could decrease chemotherapy-induced nausea and vomiting (CINV) following cisplatin, when a conventional anti-emetic regimen had failed. Methods: This was a prospective study (April 2011-April 2012) of patients with lung cancer, treated with cisplatin at the Beijing Cancer Hospital, and initially receiving granisetron, dexamethasone, and metoclopramide as anti-emetics. If patients experienced vomiting of grade ≥2 and required rescue anti-emetic medications during the first cycle, oral aprepitant was added in subsequent cycles (day 1: 125 mg; days 2-3: 80 mg once daily). Acute (day 1) and delayed (days 2-5) nausea and vomiting, use of rescue medications, and occurrence of adverse reactions were monitored after the start of chemotherapy. Results: Twenty-five of 132 patients (18.9 %) were administered aprepitant for secondary prophylaxis against emesis during the second cycle of chemotherapy. The incidences of acute and delayed nausea were 52 and 100 % in the first cycle, but 8 and 72 % in the second cycle. The incidences of acute and delayed vomiting were 20 and 100 % in the first cycle, but 0 and 36 % in the second cycle. No patients required rescue medications or intravenous rehydration during the second cycle. Aprepitant was not associated with additional adverse events. Conclusions: In patients with lung cancer receiving cisplatin-based chemotherapy, the addition of aprepitant to a 5-HT antagonist, dexamethasone, and metoclopramide improves protection against CINV when the conventional anti-emetic regimen fails. [ABSTRACT FROM AUTHOR]