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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 purpose of this study was to determine the presence of Clostridium difficile infection (CDI) and risk factors for infection in hospitalized patients with diarrhea in a cancer hospital in Beijing, China. A total of 277 patients with hospital-associated diarrhea (HAD) were studied of which 41 (15%) were positive for fecal C. difficile toxin A/B. For each CDI case identified, a control with HAD but negative C. difficile specimen was enrolled to look for CDI risk factors. Receipt of cancer chemotherapy occurred in 20 (49%) patients with CDI and 9 (22.0%) patients with non-CDI HAD (OR3.39, 95%CI 1.78-10.05). Median length of chemotherapy before HAD developed was 39 days for those with CDI and 22 days for patients with CDI-negative HAD (P = 0.0391). The study found that CDI is commonly seen in cancer patients in China with increasing risk for patients who receive chemotherapy., (Copyright © 2013. Published by Elsevier Ltd.)

Purpose: To better understand the differences of patient influx and types of trauma between front-line and referral hospitals after the Wenchuan earthquake, so as to improve the efficiency of injury management., Methods: A retrospective and comparative study was performed in Deyang People's Hospital (a front-line hospital) and West China Hospital (a secondary referral hospital)., Results: A total of 1,106 patients were admitted to the front-line hospital, and 1,775 to the secondary referral hospital. The patient flow peaked within 24 h after the quake, and decreased dramatically thereafter in the front-line hospital, while it peaked 2 days after the disaster in the referral one. Extremities were the most frequent location of all identified injuries (48.4% in the front-line hospital and 49.5% in the second-line hospital). Head and trunk injuries were more frequent in the front-line hospital than the referral hospital. Most of the deaths in the front-line hospital occurred within 24 h (6/8), whilst most in the referral hospital died more than 7 days (29/30) after the earthquake. While the total mortality in the front-line hospital was less than that in the referral hospital (0.7 vs 1.7%), the critical mortality in the former was higher (22.8 vs 9.4%)., Conclusions: There were dramatically different features in terms of quake-related patient influx and types of injury between the epicenter and less-affected hospitals.

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.