Recommendations from Experts in the Management of Adverse Reactions to ALK Inhibitors (2021 Version) / 中国肺癌杂志

Anaplastic lymphoma kinase (ALK) fusion gene, as a tumor driver gene, was crucial for the occurrence and development of non-small cell lung cancer (NSCLC). Recently, targeted ALK fusion gene has become the main treatment method for ALK-positive NSCLC. The first and second generation ALK inhibitors (ALKi), such as crizotinib, ceritinib, alectinib and ensartinib have been approved in China. However, there was no guidance for the management of ALKi adverse reactions. Therefore, this "Recommendations from experts in the management of adverse reactions to ALK inhibitors (2021 version)" has been summarized, led by Lung Cancer Professional Committee of Sichuan Cancer Society and Sichuan Medical Quality Control Center for Tumor Diseases, to provide practical and feasible strategies for clinical ALKi management specification of adverse reactions.
.

Safety and Preliminary Efficacy of Ceritinib 450 mg with Food in Chinese ALK-positive Non-small Cell Lung Cancer / 中国肺癌杂志

BACKGROUND@#Anaplastic lymphoma kinase (ALK) rearrangement is a common driver gene of non-small cell lung cancer (NSCLC). Ceritinib is a second-generation ALK inhibitor, which can bring survival benefits to ALK-positive metastatic NSCLC. However, few studies focus on the safety and efficacy of ceritinib in China. Therefore, this study intends to investigate the safety and preliminary efficacy of ceritinib 450 mg with meals in Chinese patients with ALK-positive NSCLC through a real world study.@*METHODS@#From October 2018 to December 2019, patients with ALK-positive NSCLC from 8 medical centers in Sichuan province were recruited in this study. All of these participants received ceritinib 450 mg/d with food. The basic characteristics, adverse effects (AEs) and responses were collected and analyzed in order to evaluate the safety and efficacy of ceritinib.@*RESULTS@#A total of 109 patients were included in this study. Data cutoff was January 23, 2020. The median duration of treatment exposure was 5.87 mon (range: 0.4 mon-15.7 mon). Total AEs were reported in 98 (89.9%) of 109 patients and grade 3 or 4 AEs were reported in 22.9% of patients. Most common AEs (mainly grade 1 or 2) were diarrhea (60.6%), elevated alanine aminotransferase (ALT)(38.5%) and aspartate aminotransferase (AST)(37.6%). As of data cutoff, 45 patients discontinued ceritinib. The overall response rate (ORR) was 37.6% (95%CI: 28.5%-47.4%) and disease control rate (DCR) was 86.2% (95%CI: 78.3%-92.1%).@*CONCLUSIONS@#The treatment of ceritinib 450 mg with food for Chinese ALK-positive NSCLC patients had a good safety profile and favorable DCR in real-world setting. However, this conclusion needs to be further verified by large sample, prospective trials.

Her-2 gene and breast cancer targeted therapy / 国际肿瘤学杂志

In recent years,with the development of tumor molecular biology technology,molecular targeted therapy has become a study hotspot,which plays a significant role on breast cancer treatment strategy.Among them,the human epidermal growth factor receptor-2 (Her-2) has been proven as an effective molecular target.So molecular targeted therapy of breast cancer become another important treatment except chemotherapy and endocrine therapy.

Protective Effect of Coenzymes Complex Combined with Vitamin E on Liver and Kidney Injury Induced by Neonatal Hyperbilirubinemia / 天津医药

Objective To study the effect of coenzymes complex combined with vitamin E on liver and kidney inju-ry induced by neonatal hyperbilirubinemia. Methods One hundred and fifty full-term neonatals with hyperbilirubinemia were chosen as observation groups, who were divided into mild, moderate and severe groups according bilirubin. Forty five healthy full-term newborns in the same period, who are either healthy or with physiological jaundice, were selected as con-trol group. Serum total bilirubin, gamma-glutamyl transferase (γ-GGT) , Malondialdehyde (MDA) and Cys-C were measured within 24 hours of hospital admission.The observation groups were randomly divided into regular and combined treatment groups. Coenzymes complex combined with vitamin E were given in addition to regular method to combined group while reg-ular group only received regular methods.All above biochemical indexes were tested in the 7th day after medication admin-istration. Results Serum MDA were higher in all observation groups (mild, moderate and severe groups) than in control group (P＜0.05);but the levels ofγ-GGT and Cys-C increased in moderate and severe groups compared with control group (P＜0.05). There were positive correlations (P＜0.05) between levels of serum total bilirubin with MDA,γ-GGT and Cys-C. Positive linear correlation were found between MDA with γ-GGT and Cys-C(P＜0.01). After early intervention,γ-GGT, Cys-C and MDA declined with drop of bilirubin level. This is more prominent and faster in a in combined treatment group than regular group (P＜0.05).Conclusion In hyperbilirubinemia newborns, lipid peroxidation activated by bilirubin may lead to damages of liver and kidney. Coenzymes combined with vitamin E have protective effect to these damages.

Chemotherapy with or without irinotecan in patients with advanced or recurrent gastric cancer: a meta-analysis of randomized controlled trials / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Studies have shown that irinotecan can improve survival in patients with advanced or recurrent gastric cancer, but the overall benefit of irinotecan in the treatment of advanced or recurrent gastric cancer remains controversial. The aim of this study was to evaluate the benefits and risks of irinotecan for survival in patients with advanced or recurrent gastric cancer. Method We searched PubMed, EmBase, the Cochrane Central Register of Controlled Trials, reference lists of articles, and proceedings of major conferences for relevant clinical trials. We included randomized controlled trials that reported on the efficacy and safety of irinotecan in patients with advanced or recurrent gastric cancer. Outcomes were analyzed by survival rate, objective response rate (ORR), and toxicity. Furthermore, the analysis was further stratified by factors that could affect the treatment effects.</p><p><b>RESULTS</b>Eight trials recruiting 1 546 patients with advanced or recurrent gastric cancer were included in the analysis. Overall, irinotecan therapy was associated with a 6% improvement in survival rate, but this difference was not statistically significant (odds ratio (OR) 0.94; 95% confidence interval (95% CI) 0.70-1.27; P = 0.69). However, irinotecan therapy had more frequent ORR than irinotecan-free arm (OR 1.70; 95% CI 1.34-2.17; P < 0.001). Furthermore, irinotecan therapy was associated with a clinically and statistically significant increase in the risk for declined hemoglobin, hyponatremia, and diarrhea, but it also protected against thrombocytopenia risk when compared with irinotecan-free therapy.</p><p><b>CONCLUSIONS</b>There is no evidence to support the use of irinotecan therapy in patients with advanced or recurrent gastric cancer; however, given the significant advantage in ORR irinotecan therapy using combination regimens may be considered for further evaluation in subsets of patients who may benefit from this treatment.</p>

Transcatheter hepatic arterial chemoembolization in treatment of hepatocelluar carcinoma / 国际肿瘤学杂志

Operation is always thought to be the soul way to cure hepatocelluar carcinoma(HCC),but there are only 30% patients who have the opportunity to receive the operation.Transcatheter hepatic arterial cheomoembolization is the most extensive non-surgery approach to treat hepatocelluar carcinoma which also has a lot of shortcoming and limitation.It is common sense that enhancement of effectiveness of liver cancer therapy largely depends on the combined therapy.

Effect of position on ventilation function in neonates after weaning from mechanical ventilation / 中国小儿急救医学

Objective To evaluate the effects of supine and prone position on ventilation function in neonates in the initial six-hour period after weaning. Methods Sixty-four neonates weaned from mechanical ventilation and with normal body temperature hospitalized from Sep. 2004 to Apr. 2006 in our NICU were randomly divided into prone group and supine group. All of them were oxygen administrated through head net, oxygen flow rate was adjusted continously to keep SpO2 at normal level by monitoring SpO2 and RR. FiO2、RR were recorded at 15 minutes,1 h,2 h,3 h,4 h,5 h,6 h after weaning. Arterial blood gas was meas-ured at 1 h ,6 h after weaning and A-aDO2, RI, OI were calculated. Results (1) At 1～6 h after weaning the values of FiO2 in prone group were significantly lower than those in the supine group(P<0.01). (2) After weaning there was a decreasing tendency of RR in the prone group and the significant decrease was found at 4 h ,5 h ,6 h compared with supine group (P<0.01). (3) At 1h and 6h after weaning, the value of PaO2 and OI were significantly higher and the value of A-aDO2, RI were lower in the prone group than in the supine group(P<0.05,P<0.01). (4) At 6 h the PaCO2 in prone group were obviously higher than that in supine group (P<0.05). Conclusion At first 6h after weaning prone position can improve ventilation functions.

Oxaliplatin combined with vinorelbine in the treatment of patients with advanced non-small cell lung cancer / 中国肺癌杂志

<p><b>BACKGROUND</b>Vinorelbine (NVB) and oxaliplatin (OXA) have shown effective anticancer activity in a wide range of solid tumors. This study is to observe the efficacy and side effects of OXA in combination with NVB in the treatment of advanced non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>Fifty-nine patients with NSCLC were randomly treated by OXA+NVB or cisplatin (DDP)+NVB regimen, repeated every 3-4 weeks. They received at least 2 cycles of chemotherapy.</p><p><b>RESULTS</b>There were 29 patients treated with NO regimen, in which there was no complete response (CR) patient, 12 patients showed partial response (PR), and the response rate was 41.4%. There were 30 patients treated with NP regimen. One patient showed CR, 13 patients showed PR, and the response rate was 46.7%. There was no significant difference in response rate between the two groups (P > 0.05). The major toxicities, including leukopenia and phlebitis, were similar in the two groups. The incidences of gastrointestinal reaction and alopecia of NP regimen were more severe than those of NO regimen (P < 0.05), but neurotoxicity of NO regimen was more obvious than that of NP regimen (P < 0.05).</p><p><b>CONCLUSIONS</b>The efficacy of the two regimens are similar in the treatment of advanced NSCLC. The side effects such as leukopenia and phlebitis are similar in the two groups. However, there are significant differences in gastrointestinal reaction, alopecia and neurotoxicity between the two groups. All the toxicities are well tolerable.</p>