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Objective: To analyze the survival and prognosis of Hodgkin lymphoma (HL) patients receiving standard first-line therapy. Methods: Data of clinical characteristics and treatment outcomes of patients with HL diagnosed in Cancer Hospital Chinese Academy of Medical Sciences (CHCAMS) from January 1st, 2000 to December 31st, 2018 who received standard first-line treatment were retrospectively analyzed and compared with that of HL patients who received treatment in the Surveillance, Epidemiology and End Results (SEER) database in the United States during the same period. Factors associated with freedom from progression (FFP) of patients in CHCAMS were analyzed. Treatment and survival data of patients with relapsed/refractory HL (r/rHL) who had failed the standard first-line treatment during the corresponding period in CHCAMS were collected to analyze the outcomes of salvage therapy. Results: A total of 764 HL patients in CHCAMS were included in this study. The median age was 30 years (range, 14-83 years), with 424 males and 340 females. By February 26th, 2022, the patients were followed-up for a median time of 111 months(range, 0.3-262.0 months). Lymphoma-specific survival (LSS) rate and overall survival (OS) rate at 10 years for HL patients in CHCAMS was 91.7% (95% CI : 89.5%-93.9%) and 87.1% (95% CI : 84.5%-89.8%), respectively. LSS and OS rate at 10 years for HL patients from SEER database was 86.8% (95% CI : 86.3%-87.2%) and 79.0% (95% CI : 78.5%-79.5%), respectively. The unadjusted LSS and OS rate for patients in CHCAMS were higher than those for patients from SEER database (both P <0.001). No significant difference was observed in LSS and OS rate (both P >0.05) between the two groups after adjustment. European Organization for Research and Treatment of Cancer staging system (early-stage unfavorable: HR =2.35, 95% CI : 1.13-4.89, P =0.023; advanced stage: HR =5.44, 95% CI : 2.62-11.30, P <0.001) and serum β2 microglobulin ( HR =1.67, 95% CI : 1.08-2.58, P =0.021) were influencing factors of FFP for patients in CHCAMS. The complete remission rate, median progression-free survival (PFS), 5-year PFS rate and 5-year OS rate for the 116 patients with r/rHL was 37.9% (95% CI : 29.6%-47.0%), 15.0 months (95% CI : 9.9-20.1 months), 29.9% (95% CI : 20.9%-38.9%) and 62.9% (95% CI : 54.1%-71.7%), respectively. Conclusions: The outcomes of HL patients receiving standard first-line treatment are excellent. However, the therapeutic effect of HL patients who incurrs disease progression or relapse after standard first-line treatment is not satisfying.

Objective: To investigate the postoperative prognostic factors of non-metastatic colorectal cancer (non-mCRC), and construct a prognostic prediction model. Methods: A total of 846 patients with colorectal cancer who were admitted to the Cancer Hospital, Chinese Academy of Medical Sciences from July 1, 2014 to December 31, 2016 were included in the study. There were 314 patients in the metastatic colorectal cancer (mCRC) group and 532 patients in the non-mCRC group. The data of clinical characteristics, preoperative blood routine and common serum tumor markers for CRC tests were collected retrospectively. The disease-free survival time (DFS) data of patients in non-mCRC group were obtained by follow-up. Univariate and multivariate Cox regression analyses were used to clarify the independent risk factors of DFS, and then these factors were included to construct a nomogram prediction model. The concordance index (C index), receiver operating characteristic curve (ROC) and calibration curve were used to evaluate the performance of the model. Results: Platelet/lymphocyte ratio (PLR), neutrophil/lymphocyte ratio (NLR), carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9) and carbohydrate antigen 242 (CA242) in the mCRC group were higher than those of the non-mCRC group, while the lymphocyte/monocyte ratio (LMR) was lower than that of the non-mCRC group ( P <0.05). ROC analysis showed that the area under curve (AUC) of CEA, CA19-9, CA242, NLR, LMR and PLR for the diagnosis of mCRC were 0.775, 0.716, 0.712, 0.607, 0.591 and 0.556, respectively. Multivariate Cox regression analysis demonstrated that age, perineural invasion, pN stage and preoperative CA242 level were independent risk factors for DFS of non-mCRC patients ( P <0.05). Based on this, a nomogram prediction model predicting 3 years of DFS for non-mCRC patients was constructed, its C index and AUC for non-CRC prognostic prediction were 0.710 and 0.733, respectively, higher than 0.696 and 0.701 of AJCC 7th edition TNM staging system. The calibration curve of nomogram showed that the predicted DFS rate was consistent with the actual DFS rate. Conclusions: Age, perineural invasion, pN stage and preoperative CA242 level are independent risk factors for 3-year DFS of non-mCRC patients. The nomogram prediction model constructed based on these four indictors has a good predictive performance and may provide prognosis evaluation reference for the patients with non-mCRC.

Objective: To investigate the relationship between plasma levels of complements before treatment and the clinicopathological feathers and prognoses of diffuse large B-cell lymphoma (DLBCL) patients treated with Rituximab (R)-CHOP or R-CHOP-like therapy. Methods: The clinicopathological data of 105 DLBCL patients treated in cancer Hospital of Chinese Academy of Medical Sciences from 2010 to 2016 were collected. The plasma samples from 105 DLBCL patients treated with R-CHOP or R-CHOP-like therapy and 80 healthy controls were used to detect 34 complement levels before treatment by utilizing antibody microarray. The relationship between plasma levels of complements and the clinicopathological feathers and prognosis of DLBCL patients were analyzed. Results: The signal values of C1QA and CR1L in patients with international prognostic index (IPI) scores of 3-5 were 1 261.43±138.9 and 2 214.69±98.58, respectively, higher than 950.79±80.19 and 984.67±121.79 in patients with IPI scores of 0~2 (both P <0.05). The levels of C1QA and CR1L in the non-complete response (CR) group were 1 165.43±98.56 and 2 263.13±145.63, respectively, higher than 914.70±100.77 and 1 821.34±84.68 in the CR group (both P <0.05). Cox regression analysis showed that elevated C1QA signal value was associated with poor progression-free survival (PFS) and poor overall survival (OS) (PFS: HR =2.063, 95% CI : 1.220-3.489, P =0.007; OS: HR =2.23, 95% CI: 1.036~4.798, P =0.040). After IPI correction by Cox multivariate model, the elevated C1QA signal value was still correlated with poor PFS ( HR =1.765, 95% CI 1.034~3.013, P =0.037). Conclusions: The baseline plasma levels of C1QA and CR1L are correlated with IPI scores and therapeutic effects of DLBCL patients treated with R-CHOP. The baseline plasma level of C1QA has a certain predictive value for the prognostic evaluation of DLBCL.

Liver cancer is one of the malignant tumors with the highest fatality rate in China and the 5-years survival rate is only 12.5%. Early detection to undertake early treatment can improve the survival rate of patients with liver cancer. Nowadays, the unsatisfactory performance of serum Alpha-fetoprotein (AFP) test, and the problems of insensitive to small lesions for ultrasound and exposure to nuclear radiation for CT, necessitate the urgency to explore novel diagnostic biomarkers of liver cancer. It has been demonstrated the presence of autoantibodies targeting tumor-associated antigens prior to clinic symptoms implied underlying early diagnostic value of malignancies. High specificity but low sensitivity of single autoantibodies such as the most reported anti-p53, anti-insulin like growth factor-Ⅱ mRNA binding protein, and anti-glucose regulated protein can be solved by combining different autoantibodies. However, the autoantibodies of different combinations vary in studies. Simultaneously, autoantibodies in combination with AFP facilitate further improving the detection rate of liver cancer. Nevertheless, the autoantibodies related to prognosis of liver cancer needs to be more studied in the near future.

Objective: To determine the risk profile of venous thromboembolism (VTE) and evaluate VTE prophylaxis implementation of the hospitalized cancer patients in the DissolVE 2 study. Methods: The data of hospitalized cancer patients in the DissolVE 2 study were analyzed. The risk distribution of VTE, preventive measures and in-hospital VTE events of hospitalized patients with tumors were described by percentage and 95% confident interval (CI). Results: A total of 1 535 cancer patients were included. According to the Padua score, 826 (53.8%) patients were at low risk of VTE, while 709 (46.2%) patients were at high VTE risk. VTE events occurred in 4 low-risk patients (0.5%; 95% CI: 0.1%, 1.2%) and 5 high-risk patients (0.7%; 95% CI: 0.2%, 1.6%). The overall incidence was 0.6% (9/1 535, 95% CI: 0.3%, 1.1%). Among patients with high VTE risk, 666 (93.9%) did not receive any VTE prophylaxis, and only 11 (1.6%) patients received appropriate VTE prophylaxis. Among patients who received VTE prevention, no VTE event was observed. Conclusions: Nearly half of the hospitalized cancer patients are at high risk of VTE, but most of them don't receive VTE prophylaxis. The results reflect the insufficient management of VTE risk for hospitalized cancer patients in China, and improvement of awareness and practice of VTE prophylaxis is urgently needed.

Hodgkin's lymphoma (HL) is a unique malignancy in which rare malignant Hodgkin and Reed-Sternberg (HRS) cells are scattered in the inflammatory cell rich microenvironment. This extensive but ineffective inflammatory cell infiltrate indicates that HRS cells have developed mechanisms to evade immune surveillance. The immune escape mechanisms of HL provide prognostic biomarkers and opportunities to develop new drugs. The immune evasion mechanisms in Hodgkin lymphoma include a reduction of human leukocyte antigen (HLA) to affect first signal which is essential for T cell activation; an upregulation of negative co-stimulatory molecules to inhibit T cell activation; resistance to apoptosis or killing by expressing some molecules on HRS cells membrane; an immunosuppressive network formed by HRS cells regulating the microenvironment immune cells. Immune escape mechanisms of HRS cells provide new targets for the development of new drug and the new drug development strategies include drugs on HRS cells and drugs on microenvironment.

Medical oncology is a subject characterized by drug therapy. Continuous research and development (R&D) of high-efficiency and low-toxic anti-cancer drugs is the premise of the development of medical oncology. Clinical trials play an indispensable role in the process from drug R&D to application, which determines the success or failure of a new drug. The clinical trials for anti-cancer investigational new drug (IND) in China began in 1960, and have developed rapidly since 2008. With the guidance and support of national policies, as well as involved by all aspects of the society, the R&D of anti-cancer drugs in China has changed from imitation to innovation. China innovative anti-cancer drugs have been widely recognized in the world, and more and more new domestic anti-cancer drugs have been used in clinical practice, bringing benefit to Chinese cancer patients. This article reviews the development of the clinical trials for anti-cancer IND in China from 1960 to 2020, and the main achievements having been made in the past 60 years. A thorough understanding of this history will help us keep in mind the mission and grasp the direction, as to make more achievements when implementing the strategy of "Healthy China" .

Diffuse large B-cell lymphoma (DLBCL) is a highly heterogeneous malignancy. A variety of indicators have been identified to predict the prognosis of DLBCL. However, with the emerging new drugs and new therapeutic options in recent years, the prognostic value of these risk prediction models becomes limited, failing to accurately guide treatment. The rapid development of high throughput technologies has led to dramatic improvement in understanding of the biology of DLBCL. The emergence of various new biomarkers contributes to further understanding the pathogenesis, treatment optimization and prognostic stratification of this disease. This review summarizes the prognostic biomarkers related to DLBCL, which mainly covers the hematological, genetic and tumor microenvironment factors, aiming to provide some theoretical basis for the precision treatment of DLBCL.

Objective: To investigate the efficacy and safety of programmed cell death protein-1 (PD-1) inhibitor combined with rituximab in the treatment of refractory or relapsed diffuse large B-cell lymphoma (rrDLBCL) patients. Methods: The efficacy and safety of rrDLBCL patients treated with PD-1 inhibitor combined with rituximab as salvage therapeutic regimen after initially treated with rituximab, cyclophosphamide, anthracycline, vincristine and prednisone (R-CHOP) regimen in Cancer Hospital, Chinese Academy of Medical Science & Peking Union Medical College from October 2018 to Janurary 2020 were retrospectively analyzed.Patient who received at least one dose of PD-1 inhibitor combined with rituximab treatment and obtained the efficacy and safety evaluation were included. Results: A total of 22 patients were enrolled in this study. The median age was 51.5 years and the median number of prior treatment regimen was 2. The median time to progression (TTP) for the initial R-CHOP treatment was 9.3 months and the median interval time of rituximab administrations between the previous and the research regimen was 5.5 months. Patients were classified as germinal center B cell (GCB) origin ( n =8), non-GCB origin ( n =9) and primary mediastinal large B cell lymphoma (PMBCL, n =5). Four patients were double-expression lymphoma, one patient were triple-hit lymphoma. Nine patients had PD-L1 immunohistochemical staining and the proportion of PD-L1 positive tumor cells were 1%-90% for eight patients and negative for one patient.The objective response rate (ORR) and complete response rate (CR) were 72.7% (16/22) and 13.6% (3/22), respectively. The median progression free survival (PFS) was 8.0 (95% CI: 7.0-14.5) months, and overall survival (OS) was not reached. For the 17 patients of non-specific DLBCL, the ORR was 64.7% (11/17), the estimated median PFS was 4.0 (95% CI: 0-8.8) months, the 1-year PFS and OS rates were 39.2% (95% CI: 19.4%-43.4%)and 81.3% (95% CI : 71.4%-91.1%), respectively. All of 5 PMBCL cases achieved ORR, among them, one case was CR and 4 cases were partial responase (PR), and their PFS were 16.4, 9.3, 8.3, 7.9and 3.0 months, respectively. One patient had National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 grade 3 hypophysitis and one patient had NCI CTCAE grade 3 interstitial pneumonia. Conclusion: For rrDLBCL patients who have underwent rituximab treatment previously, PD-1 inhibitor combined with rituximab regimen shows a promising efficacy and tolerability, which can be a potential treatment option.

Objective: To explore the safety and therapeutic effect of programmed death 1 (PD-1) antibody combined with chemotherapy as a neoadjuvant therapy for patients with stage Ⅱ to Ⅲ non-small cell lung cancer (NSCLC). Methods: Thirteen patients, who had been diagnosed as stage Ⅱ-Ⅲ NSCLC and received PD-1 inhibitor plus chemotherapy as a neoadjuvant treatment in National Cancer Center/Cancer Hospital were recruited. The patients received consecutive neoadjuvant chemotherapy for 21 days as a cycle and the therapeutic efficacy was evaluated after two cycles. Results: At the last time of follow-up on December 2, 2019, the objective response rate (ORR) and disease control rate (DCR) of these patients were 61.5% (95% CI 30.9%-92.1%) and 100%, respectively. The downregulation rate of disease stage was 61.5% (8/13). The resectable rate was 38.5% (5/13), among them, the major pathologic response (MPR) was 60.0% (3/5) and the complete pathologic response (CPR) was 20.0% (1/5). The neoadjuvant chemotherapy displayed a low incidence of adverse reaction. The main grade 3 to 4 toxicities were neutropenia (38.5%) and leukopenia (23.1%). There was no significant immune-related toxicity. The safety and tolerability of perioperative period of patients underwent resection were promising. Conclusions: Immunotherapy combined with chemotherapy as a neoadjuvant treatment is an effective, low-toxicity treatment manner, which has perioperative safety and high rate of MPR for patients with resectable NSCLC. It is a promising treatment option for patients with stage Ⅱ to Ⅲ NSCLC.

Objective: To investigate the principles of differential diagnosis of pulmonary infiltrates in cancer patients during the outbreak of novel coronavirus (2019-nCoV) by analyzing one case of lymphoma who presented pulmonary ground-glass opacities (GGO) after courses of chemotherapy. Methods: Baseline demographics and clinicopathological data of eligible patients were retrieved from medical records. Information of clinical manifestations, history of epidemiology, lab tests and chest CT scan images of visiting patients from February 13 to February 28 were collected. Literatures about pulmonary infiltrates in cancer patients were searched from databases including PUBMED, EMBASE and CNKI. Results: Among the 139 cancer patients who underwent chest CT scans before chemotherapy, pulmonary infiltrates were identified in eight patients (5.8%), five of whom were characterized with GGOs in lungs. 2019-nCoV nuclear acid testing was performed in three patients and the results were negative. One case was a 66-year-old man who was diagnosed with non-Hodgkin lymphoma and underwent CHOP chemotherapy regimen. His chest CT scan image displayed multiple GGOs in lungs and the complete blood count showed decreased lymphocytes. This patient denied any contact with confirmed/suspected cases of 2019-nCoV infection, fever or other respiratory symptoms. Considering the negative result of nuclear acid testing, this patient was presumptively diagnosed with viral pneumonia and an experiential anti-infection treatment had been prescribed for him. Conclusions: The 2019 novel coronavirus disease (COVID-19) complicates the clinical scenario of pulmonary infiltrates in cancer patients. The epidemic history, clinical manifestation, CT scan image and lab test should be taken into combined consideration. The 2019-nCoV nuclear acid testing might be applied in more selected patients. Active anti-infection treatment and surveillance of patient condition should be initiated if infectious disease is considered.

Objective: To investigate the clinical features, survival and prognostic factors of elder patients with diffuse large B-cell lymphoma (DLBCL). Methods: The clinical data of elder patients with diffuse large B-cell lymphoma enrolled in the Cancer Hospital of Chinese Academy of Medical Sciences from April 2006 to December 2012 were retrospectively collected. All the patients were divided into R-CHOP-like group and CHOP-like group according to the dosage regimen. And the differences in demographic characteristics, clinical features, survival time and prognostic factors were compared between these two groups. Results: A total of 158 patients were enrolled, of which 78 patients in the R-CHOP-like group and 80 patients in the CHOP-like group were eligible. There were no significant differences between two groups on age, gender, pathological staging, B symptoms, bulky mass, ECOG score, IPI score, pathological type, LDH level, β(2)-MG level, lymphocyte/monocyte ratio(LMR), neutrophils/lymphocyte ratio(NLR), platelet/lymphocyte ratio(PLR), Ki-67 index and bone marrow invasion. In the R-CHOP like group, the median progression-free survival (PFS) time was 10 months, and the median overall survival (OS) time was 30 months. The 1-year and 2-year PFS rates were 46.2% and 19.2%, respectively. The 1-, 2-, and 5-year OS rates were 79.5%, 59.0%, and 19.2%, respectively. In the CHOP-like group, the median PFS was 7 months, and the median OS was 15 months. The 1-year and 2-year PFS rates were 27.5% and 12.5% respectively. The 1-year, 2-year, and 5-year OS rates were 65.0%, 32.5% and 13.8%, respectively. The median PFS time and OS time in the R-CHOP group were significantly better than those in the CHOP group ( P <0.05 for both). A stratified analysis showed that the PFS time and OS time were superior in the R-CHOP-like group compared to the CHOP-like group among patients older than 70 years ( P <0.05 for both). In patients with stage Ⅲ-Ⅳ, the PFS time and OS time in the R-CHOP-like group were also superior to CHOP-like group ( P <0.05 for both). Univariate Cox regression analysis showed that IPI score, LDH value, β(2)-MG value, ECOG score, LMR, and PLR had an significant effect on prognosis ( P <0.05 for all). Multivariate Cox regression analysis showed that lymphocyte/monocyte ratio and platelet/lymphocyte ratio were independent prognostic factors for diffuse large B-cell lymphoma ( P <0.05 for both). Conclusions: The R-CHOP-like chemotherapy regimen is superior to the CHOP-like regimen in the first-line treatment of patients with diffuse large B-cell lymphoma. ECOG score, LMR and PLR may be independent prognostic factors for diffuse large B-cell lymphoma. ECOG score, LMR and PLR are independent prognostic factors.

Lung cancer is the most frequently diagnosed cancer and the most common cause of cancer mortality in China. Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancers. The mutation rate of epidermal growth factor receptor (EGFR) gene is relatively high, accounts for 32%~38% of all NSCLC. During the last decade, the application of EGFR specific tyrosine kinase inhibitors (TKI) significantly improved prognosis of NSCLC patients with sensitive EGFR mutations. Thus, the research and development of third generation EGFR-TKI have entered the period of rapid development. The fourth generation EGFR-TKI which targeting EGFR C797S has even begun clinical development in China. This review will discuss the clinical research and drug review of EGFR-TKI from the perspective of drug review.

Over the past decades, although the clinical efficacy of advanced head and neck squamous cell carcinoma (HNSCC) has been moderately improved by the combination of cetuximab and chemotherapy, no remarkable treatment has emerged. The prognosis of HNSCC is still unsatisfied. With the deeper exploration of tumor immunological therapy, immunocheckpoint inhibitors such as monoclonal antibodies targeting on programmed cell death protein 1 (PD-1)/ cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) have shown appreciable anti-tumor effect on cancers such as melanoma and non-small cell lung cancer. Some successful clinical studies on HNSCC have also been reported, which provide a new opportunity for the improvement of HNSCC prognosis.Here we systemically review the progress of checkpoint inhibitors and its combination therapy in HNSCC, some immunotherapy efficacy-related biomarkers are also discussed.

Objective: To investigate the feasibility of surgical treatment of port-site metastasis after laparoscopic radical resection of gastric cancer. Methods: The clinical and follow-up data of five patients with port-site metastases after laparoscopic radical resection of gastric cancer at Zhejiang Provincial People's Hospital between January 2014 and January 2018 were retrospectively analyzed. Results: Port-site metastases occurred within 6 months after gastrointestinal tumor resection in three patients, 10 months after the operation in one patient, and 30 months after the operation in one patient, respectively. Metastasis to the abdominal cavity or distant metastasis was excluded before the surgical treatment of the port-site metastases, and all patients recovered well after the operation. No incisional infection or hernia occurred. By December 2018, two patients died (they survived for 13 and 24 months, respectively) and three patients survived. The follow-up duration ranged from 7 to 19 months. Conclusions: Surgical resection of port-site metastases is not difficult due to their superficial location. Surgical treatment can improve the prognosis of patients without abdominal or distant metastasis/recurrence.

With the support of the national policies, the improvement of research ability and the development of economy and society, China clinical trials have developed rapidly. Many achievements are made in the clinical trials of new anti-cancer drugs during last several decades. Many innovative new drugs have come into the market and gained influence at home and abroad. Those drugs provide more treatment options for Chinese patients. This article reviews the results of new anti-tumor drug clinical trials, with special focus on the challenge and chance for the new anti-cancer drug clinical trials in China.

Objective: Adenosquamous carcinoma of lung is an uncommon subtype with more aggressive behavior and poor prognosis than adenocarcinoma and squamous cell carcinoma. This study was aimed to investigate the clinicopathological characteristics and prognostic factors of lung adenosquamous carcinoma. Methods: The pathological features and follow-up data of 133 patients were collected and the prognostic factors of these patients were retrospectively analyzed. Results: Among the 133 patients, 81 cases (60.9%) smoked. Among the 62 patients whose percentage of histological components were identified, 45 cases had >50% adenocarcinoma components, and 17 cases had >50% squamous cell carcinoma components. 55 patients had lymph node metastasis at the first visit. All patients accepted at least one test of tumor driven gene mutation, and the results showed that the mutation rate of EGFR was 50.8% (67/132), the mutation rate of K-ras was 8.6% (11/128), the ALK-positive rate was 4.2% (2/48). The gender, smoking status, and the proportion of pathological components were the main influence factors of EGFR mutation status. The median overall survival was 28 months, the rates of 1-year, 3-year, and 5-year survival were 72.9%, 23.3%, and 9.0%, respectively. EGFR tyrosine kinase inhibitors (TKIs) treatment was an independent risk factor for prognose of these patients ( P =0.024). Conclusions: Lung adenosquamous carcinoma is a rare subtype with high malignancy and poor prognosis. Early diagnosis and driven-mutation-based individualized therapy may improve the survival of patients with lung adenosquamous carcinoma.

Objective: To investigate the efficacy of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) on patients with lung adenosquamous carcinoma, and to analyze relative factors. Methods: From August 2007 to July 2017, 40 patients who were pathologically diagnosed as lung adenosquamous carcinoma in our hospital and received EGFR TKIs treatment were retrospectively analyzed. All patients underwent EGFR mutation detection, resulted in 11 wild type, 13 19Del, 13 21L858R mutations, and 3 uncommon EGFR mutations in 20 exon and 19/21 complex mutation. A higher frequency of EGFR mutation was found in non-smokers and patients with adenocarcinoma components over 50.0%. Results: Twenty-six (65.0%) patients had disease progression after EGFR TKIs treatment, with a median progression-free survival (PFS) of 5.5 months (95% CI 0.52-10.49 months). A total of 20 (50.0%) patients died with an median overall survival (OS) of 15 months (95% CI 11.03-18.97 months). Multivariate analysis showed that gender, age, smoking, histopathological subtypes, EGFR mutations, and brain metastasis had no influence on PFS (all P >0.05). Gender, age, smoking, histopathological subtypes, and the presence of brain metastasis during TKI treatment had no influence on OS ( P >0.05), while EGFR mutation is the only influencing factor of OS ( P <0.05) in the current study. Conclusions: EGFR TKIs had modest efficacy in lung adenosquamous carcinoma, especially in patients with EGFR mutation. Based on the pathological features, EGFR mutation and EGFR TKIs treatment should be introduced into the routine clinical practice to improve the survival of patients with lung adenosquamous carcinoma.

Objective: To analyze the clinical characteristics and prognosis of newly diagnosed localized head and neck rhabdomyosarcoma. Methods: Cases of newly diagnosed localized head and neck rhabdomyosarcoma between January 2006 and December 2016 were analyzed retrospectively. The clinical features of the patients were described. The Kaplan-Meier method was used to analyze the survival rate under different combined modality therapy and the survival rate with or without chemotherapy. The prognostic factors were analyzed by Cox model. Results: A total of 46 patients were included in this study. Among them, the median follow-up time was 77 months and the median relapse free survival time was 13 months. The relapse free survival time of 5 cases with inadequate local treatment and without combined chemotherapy was 5 months as control, and it was 7 months ( P =0.110) in 11 cases with adequate local treatment without combined chemotherapy. Then in 7 cases with inadequate local treatment combined with chemotherapy and 23 cases with adequate local treatment combined with chemotherapy, it was 13 months ( P =0.007) and 21 months ( P <0.001), respectively. The median relapse-free survival time of chemotherapy patients was significantly longer than that of those without chemotherapy (21 vs 6 months, P =0.018). The effect of combined modality therapy was evaluated according to the adequacy of local treatment and whether to receive systemic chemotherapy, and the combined modality therapy degree was the independent prognostic factor in Cox's proportional hazards regression model ( P =0.004). Conclusions: Rhabdomyosarcoma in head and neck is a highly malignant tumor with high relapse rate and easy metastasis. In patients with tolerable condition, systemic chemotherapy and adequate combined modality therapy are recommended to improve relapse-free survival.

Chimeric antigen receptor modified T cell (CAR T) cytotherapy is a modified technology of T cell immunotherapy. It has achieved encouraging breakthroughs in the treatment of hematological malignancies. Recent studies had shown that CAR T cells can also be used in the treatment of solid tumors. However, it's indispensable to understand its bottlenecks, including regulating CAR T cell expansion, survival time, metastasis, and prognosis in vivo, to establish a feasible and effective CART-based solid tumor therapy model. Therefore, we summarized the advances, challenges and possible solutions for CAR T therapy to treat solid tumors, and then prospected in the future clinical treatment.

Objective: Primary gastric diffuse large B-cell lymphoma (PG-DLBCL) is the most common non-Hodgkin lymphoma (NHL) of extranodal origin. Most patients with PG-DLBCL had localized disease (stage Ⅰ or Ⅱ) at presentation, and will achieve complete response (CR) after induction chemotherapy. However, there has been little consensus regarding whether optimal treatment is provided by chemotherapy alone or chemotherapy plus radiotherapy, nor the treatment outcome from the addition of rituximab in localized-stage PG-DLBCL. Methods: Patients with Stage ⅠE and ⅡE PG-DLBCL were retrospectively analyzed. Patients have not undergone surgery, have received at least 3 cycles of R-CHOP or CHOP-like chemotherapy as initial therapy, and achieved CR or partial response (PR) were enrolled. Results: A total of 91 patients were studied. The median age was 51 years, included 47 males and 44 females. Fifty-two patients were at Stage ⅠE and 39 at Stage ⅡE, 64 (70.3%) patients received R-CHOP-like regimens, and 27 (29.7%) received CHOP-like regimens, the median chemotherapy cycle was 6 (3-8). Among the 91 patients, 80 (87.9%) patients achieved CR from induction chemotherapy, 11(12.1%) was evaluated PR. Of CR patients, 48 patients (60%) underwent consolidating radiotherapy and 32 patients (40%) did not receive radiotherapy; all PR patients received salvage radiotherapy. CR patients with and without radiation therapy had 4-year progression-free survival (PFS) rates of 96.4% and 96.7%, respectively (χ(2) = 0.546, P =0.46); 7/11 (63.6%) PR patients achieved CR after radiotherapy, with a median follow-up of 41 months, they were all disease free. For patients treated with R-CHOP or CHOP-like regimens, the 4-year PFS was 93.2% and 89.7%, respectively (χ(2)=0.096, P =0.757). Conclusions: Consolidation radiotherapy failed to improve the outcome for early-stage PG-DLBCL, while for PR patients, salvage radiotherapy increased CR rate and improved survival. The addition of rituximab to CHOP did not improve the efficacy.

Objective: The clinical features and prognosis of diffuse large B-cell lymphoma (DLBCL) were analyzed to optimize the treatment. Methods: We retrospectively collected the clinical data of patients with advanced-stage DLBCL from January 2006 to December 2012 in National Cancer Center/Cancer Hospital. The demographic characteristics, clinical stage, histological diagnosis, treatment and prognostic characteristics of these patients were analyzed. Results: A total of 370 patients with median age of 55 years old were recruited in the study. The male-to-female ratio was 1.3∶1. Among the 361 patients who underwent therapy, 280 cases received chemotherapy alone, 65 cases received chemoradiotherapy, and 16 cases received chemotherapy combined with autologous hematopoietic stem cell transplantation (AHSCT). The median follow-up period was 89 months, the 5-year overall survival (OS) rate of the entire cohort was 42.9%. The 5-year OS rate of chemotherapy alone, chemoradiotherapy and chemotherapy combined with AHSCT were 36.8%, 58.5%, 87.5%, respectively. The 5-year OS rate were significantly different between chemoradiotherapy and chemotherapy alone ( P =0.001), and between chemotherapy combined with AHSCT and chemoradiotherapy ( P =0.040). Univariate analysis showed that the age, Eastern Cooperative Oncology Group performance status (ECOG PS) score, Ann Arbor stage, B symptom, bulky disease, number of extranodal sites, Ki-67 index, lactate dehydrogenase (LDH), β2-microglobulin (β2-MG), international prognostic index (IPI), therapeutic manner and chemotherapy combined with rituximab were significantly associated with the prognosis of advanced DLBCL patients (all P <0.05). Multivariate analysis demonstrated that the age >60 years, Ann Arbor stage IV, with B symptom, with bulky disease, ECOG PS≥1, Ki-67 index > 90%, CD5 expression, up-regulation of serum LDH and β2-MG, and chemotherapy without rituximab were related with the poor prognosis of patients with advanced-stage DLBCL (all P <0.05). Conclusions: Chemotherapy combined with rituximab can improve the outcome of patients with advanced-stage DLBCL. The age, stage, B symptom, bulky disease, ECOG PS score, Ki-67 index, CD5 expression, LDH, β2-MG and chemotherapy combined with rituximab are associated with the prognosis of these patients.

Objective: To explore the prognostic significance of inflammatory indicator, neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR), for advanced-stage diffuse large B-cell lymphoma (DLBCL). Methods: The data of advanced stage DLBCL cases was retrospectively collected, and all the patients were seen from January 2006 to December 2012 in National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences. The patients were divided into the low NLR group (≤5∶1) and the high NLR group (>5∶1); the low PLR group (≤300∶1) and the high PLR group (>300∶1). Kaplan-Meier method was used to compare the survival rates between groups, multivriate Cox proportional hazard regression analysis was performed to assess the independent prognostic significance of clinical and histopathological variables on events or OS. Results: A total of 361 patients were included in the study. Under a median follow-up of 89 months, the 5-year overall survival (OS) and progression-free survival (PFS) of the whole group were 42.9% and 31.3%, respectively. The 5-year OS rate and PFS rate were 48.2% and 35.1% in the low NLR group, which were 24.1% and 17.7% in the high NLR group, respectively. The 5-year OS rates and PFS rate were 45.4% and 33.2% in the low PLR group, which were 29.8% and 21.1% in the high PLR group (all P <0.05). Univariate analysis showed that NLR >5∶1, PLR >300∶1, age>60 year, ECOG PS>1 score, stage Ⅳ, B symptom, bulky disease, number of extranodal sites >1, Ki-67index >90%, LDH elevated and β2-MG elevated had significant influence on prognosis(all P <0.05). Multivariate analysis demonstrated that NLR, stage, B symptom, bulky disease, ECOG PS score, Ki-67 index and β2-MG were associated with poor prognosis in the advanced-stage DLBCL. Conclusions: NLR was simple and feasible biomarker for prognosis of advanced-stage DLBCL patients.

Single arm trial (SAT) was widely used for new drug application (NDA) of novel anti-cancer drugs in recent years. The listing time was greatly shortened by SAT while comparing with randomized controlled trials (RCT). Thus, the companies intended to get NDA through SAT. To encourage innovation and accelerate the developments of anti-cancer agents, we summarize the background and key issues of SAT, discuss the conditions of accepting SAT for NDA, and systematically elaborate the design and principles of SAT in this review.

With the extensive application in clinical practice, biological medicine plays a significant role in both treatment and supportive care in oncology. With the expiration of original drug patents, biosimilars emerge. The biosimilars are defined as biological drugs that are be highly similar but not identical to the biological reference. Their development and evaluation procedure are different from those of small molecular chemical generics. Biosimilars are expected to reduce the health care costs worldwide. The booming developments of biosimilars, such as rituximab, trastuzumab and bevacizumab in medical oncology can optimize the clinical strategies, offer patients more treatment options and reduce the medical expenditure. In this article, we review the advances in the field of biosimilars, especially focus on the challenges and opportunities of biosimilars in clinical oncology.

Objective: To evaluate the clinical features and outcomes of HIV-negtive plasmablastic lymphoma (PBL). Methods: Nine patients with HIV-negtive PBL were diagnosed and treated between January 2006 and January 2016. The clinical and follow-up data were analyzed retrospectively. Results: The median age was 56 years (range 30-77 years) with a male-to-female ratio of 2∶1. Nobody had underlying diseases associated with immunosuppression. Primary extra nodal diseases were observed in 7 cases and only 1 patient had oral involvement. Two patients were in earlystage and 7 in advanced stage by the Ann Arbor stage system. Ki-67 index was 60%-90% in the 9 cases, and 80% or higher in 7 cases. Epstein-Barr virus-encoded RNA expression (EBER) was detected in 4 cases, and 2 of them were positive. Chemotherapy was documented in 9 patients, from which 8 received the cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP)-like regimens as the first-line chemotherapy and responses were observed in 5 (1 complete, 4 partial responses). Three elderly patients were treated with CHOP combined with thalidomide, and 2 of them achieved partial responses. One patient, failed three chemotherapy regimens, accepted thalidomide combined with etopside and achieved stable disease for 10 months. One patient with early stage had disease-free survival of 61.9 months after treatment. The other eight patients experienced recurrence or progression after the first-line chemotherapy, and 6 of them died of disease progression within 2 years after the diagnosis. Conclusion: The HIV-negative PBL patients in this study did not have an apparent association with immunosuppression. Primary extra nodal diseases were common, but only 1 patient had oral involvement. Most patients had advanced stage and poor prognosis. Effectiveness of thalidomide in the treatment of PBL deserves further investigation.

Objective: To explore the clinical characteristics and prognosis of CD20-positive classical Hodgkin lymphoma (CHL)., Methods: Data from CHL patients with CD20 immunohistochemical staining result who were treated in Cancer Hospital of Chinese Academy of Medical Sciences between September 2007 and March 2014 were reviewed. The relationship of CD20 expression in Reed-Sternberg(R-S)cells with CHL subtypes, clinical characteristics, and prognosis were analyzed. Fisher test was used to analyze the differences between groups and Kaplan-Meier for survival analysis., Results: A total of 263 patients were included in this study. Among the 263 patients, 74 (28.1%) were CD20-postitive. CD20-positive cases showed significantly higher proportions of Epstein-Barr virus (EBV) infection-related, mixed cellularity, and lymphocyte-rich CHL subtypes compared with CD20-negeative patients [52.8% (28/53) vs 19.0% (22/116), 37.9% (25/66) vs 31.6% (54/171), 22.7% (15/66) vs 3.5% (6/171), all P<0.05]. Univariate analysis identified EBV infection, age (≥ 40 years, especially ≥ 60 years), and Ⅲ-Ⅳ stage were correlated with reduced 3-year progression-free survival (PFS) and overall survival (OS) (PFS: 70.3 vs 87.7%, 79.2% vs 89.8%, 56.8% vs 91.5%, 70.4% vs 93.2%; OS: 81.0% vs 100%, 92.1% vs 99.4%, 75.4% vs 99.2%, 90.3% vs 100%; all P<0.05); and CD20-positive and not receiving local radiotherapy were associated with reduced PFS (79.7% vs 90.6%, 68.8% vs 90.6%, both P<0.05), not with OS (92.4% vs 98.3%, 94.0% vs 99.4%, both P>0.05). Patients positive in both CD20 expression and EBV-encoded small RNAs (EBER) showed low PFS., Conclusions: CD20 expression in R-S cells in CHL may be closed related with EBV infection. EBV infection is associated with unfavorable prognosis. The effect of CD20-postitive on prognosis may be mediated by the prognostic effect of EBV infection.

Objective: To investigate the optimal anticoagulation methods and monitoring strategy for Chinese patients undergoing heart valve replacement, which is potentially quite different from western populations., Methods: In this multicenter prospective cohort study, the anticoagulation and monitoring strategy data was acquired from 25 773 in-hospital patients in 35 medical centers and 20 519 patients in outpatient clinic in 11 medical centers from January 1st, 2011 to December 31th, 2015., Results: As for in-hospital patients, mean age of study population was (48.6±11.2) years old; main etiology of valve pathology was rheumatic (87.5%) origin among study cohort; 94.8% of study population received mechanical valve implantation; international normalized ratio (INR) monitoring (in all the study centers) and low-intensity anticoagulation strategy (31 hospitals chose target INR range of 1.5-2.5, and actual values of INR among 89.2% of 100 069 in-hospital monitoring samples were 1.5-2.5), with mean actual INR values of 1.84±0.53, and warfarin dosage of (2.82±0.93) mg/d were widely adopted among the study centers; strategies of in-hospital warfarin administration were similar in all the study centers; complication rates of low-intensity anticoagulation strategy were low in severe hemorrhage (0.02%), thrombosis (0.05%), and thromboembolism (0.05%) events, without anticoagulation-related death.As for 18 974 outpatient clinic patients, the follow-up rate was 92.47%, with a total of 30 012 patient-years (Pty). Anticoagulation-related morbidity and mortality rates were 0.67% and 0.15% Pty; major hemorrhage morbidity and mortality rates were 0.25% and 0.13% Pty; thromboembolism morbidity and mortality rates were 0.45% and 0.03% Pty.The mean dosage of warfarin daily dosage was (2.85±1.23) mg/d and INR value was 1.82±0.57.No significant regional difference in the intensity of anticoagulation therapy was noted during the study., Conclusions: INR can be used as a normalized indicator for intensity of anticoagulation therapy in China.The optimal anticoagulation intensity with INR range from 1.5 to 2.5 is safe and effective for Chinese patients with heart valve replacement, and there is no significant regional difference in the intensity of anticoagulation therapy.

The authors have studied the efficacy and safety of recombinant human granulocyte colony-stimulating factor (rhG-CSF, Granulocyte Injection) on leucopenia and neutropenia induced by chemotherapy with regimen CE (Carboplatin and Etoposide) in lung cancer patients in a randomized, matched and cross-over clinical trial. The total enrolled patients were twenty-two. They were randomized into A and B groups (11 patients in each group). Each patient received two cycles treatment. In group A chemotherapy and rhG-CSF were used in the first cycle and chemotherapy alone was used in the second cycle, while in group B chemotherapy alone was used in the first cycle and chemotherapy and rhG-CSF were used in the second cycle. The results showed that rhG-CSF significantly increased the number of white blood cell (WBC) and absolute neutrophil count (ANC) at the nadir, decreased incidence of leucopenia and neutropenia, and reduced the number of days with WBC < 4.0 x 10(9)/L, ANC < 2.5 x 10(9)/L as well as the number of days with WBC > 4.0 x 10(9)/L and ANC > 2.5 x 10(9)/L. rhG-CSF ensures the completion of chemotherapy and its side-effects were slight.

We have studied the efficacy and safety of recombinant human granulocyte-macrophate colony-stimulating factor (rhGM-CSF, leucomax) to treat leukopenia and neutropenia induced by chemotherapy with regimen CE (Carboplatin, Etoposide) and regimen CEA (Carboplatin, Etoposide, Adriamycin) on patients in a randomized comparative, cross-over clinical trial. Twenty-one patients enrolled were randomly divided into A(n = 8) and B group(n = 13). Each patient received two cycles of treatment. In group A, chemotherapy and rhGM-CSF were given in the first cycle and in the second cycle only chemotherapy was given. In group B, only chemotherapy was given in the first cycle and chemotherapy and rhGM-CSF were given in the second cycle. The results showed that rhGM-CSF significantly increased the total white cell count (WBC) and absolute neutrophil count (ANC) at nadir, decreased the incidence of leukopenia and neutropenia, and shortened the duration of leukopenia with WBC < 4.0 x 10(9)/L and ANC < 2.5 x 10(9)/L, and the number of days for recovery to WBC > 4.0 x 10(9)/L and ANC 2.5 x 10(9)/L. However, rhGM-CSF displayed little effect on platelets. The main side-effect of rhGM-CSF was fever (43%), as well as skin rashes and influenzalike symptoms.

The clinical usefulness of Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF, Filgrastim, GRAN) was evaluated in patients with leukopenia and neutropenia following chemotherapy for non-Hodgkin's lymphoma, lung cancer and breast cancer. During chemotherapy when patients' leukocyte count (WBC) fell below 4.0 x 10(9)/L.rhG-CSF(GRAN) at a dose of 75 micrograms/body.day was given subcutaneously 48 hours after the termination of chemotherapy. The results indicated that rhG-CSF(GRAN) could elevate nadirs of WBC and significantly shortened leukopenic period with WBC below 4.0 x 10(9)/L and expedited the recovery of WBC. rhG-CSF (GRAN)'s side effects were mild.

The causes of fever in 171 cases 10 days after 1527 cases of open heart surgery were analysed. The common noninfectious causes of fever were postpericardiotomy syndrome (35.8%) and drug fever (26.9%). The infectious causes of fever were respiratory system infection (18.1%), chest wall and incision infection (9.9%), infectious endocarditis (7.0%) and transfusion malaria (2.4%). In this paper, the diagnosis, prevention and treatment of common causes of fever after open heart surgery were discussed. The authors believed that etiologic diagnosis of fever and reasonable antibiotic use were key measures.

From January 1954 to December 1987, 42 cases with open thoracoabdominal injuries were surgically treated. The causes of trauma were gun shot in 11, stabbing in 28, and buffalo horn injury in 3 cases. 24 cases were complicated with shock and 29 cases had more than two thoracoabdominal organs injured. 3 patients died postoperatively, an operative mortality rate of 7.1%. The authors discussed the problems of nomenclature, diagnosis and treatment and emphasized that: (1) open wound with thoracic and abdominal cavities and diaphragm involved simultaneously should be called open thoraco-abdominal injury; (2) surgical treatment is often delayed if diagnosis depends solely on X-ray examination; (3) operative approach should be carefully selected according to circumstances.