Real-world treatment of metastatic hormone-sensitive prostate cancer in the USA, Europe and Asia.

Aim: To characterize real-world patients with metastatic hormone-sensitive prostate cancer (mHSPC) and treating physicians and evaluate treatment trends and baseline concordance versus guidelines internationally. Materials & methods: Retrospective, cross-sectional data from the Ipsos Global Oncology Monitor database 2018-2020 were used for descriptive analysis of mHSPC patients, treating physicians and treatment utilization. Results: Among the 6198 mHSPC patients from five countries, the most common treatment was either androgen deprivation therapy (ADT) monotherapy or first-generation androgen receptor inhibitor + ADT. Second-generation androgen receptor inhibitor use was only initiating but increasing over the study period. Conclusion: Despite contemporaneous guidelines recommending treatment intensification of ADT in combination with novel antihormonals or docetaxel, 76.1% of reported mHSPC patients received non-guideline-concordant care.

Prostate cancer is the second most common cancer among men worldwide and a leading cause of cancer-related death globally. Metastatic hormone-sensitive prostate cancer (mHSPC) refers to the stage of prostate cancer where it has spread to other parts of the body ('metastatic') but still responds to hormonal therapy ('hormone-sensitive'), such as androgen deprivation therapy (ADT). Treatment guidelines around the world for men with mHSPC have changed over time, but there remains a lack of understanding of how well guidelines are followed in real-world practice. Consequently, this study analyzes real-world data from five countries between 2018 and 2020 to understand treatment patterns, baseline concordance versus guidelines and potential drivers of treatment trends. The study found prevalent use of ADT monotherapy and older antihormonal agents, and only marginal but increasing use of novel antihormonals in real-world practice. These practices deviate from guidelines from the study period, which generally recommended ADT combination with either newer antihormonal agents or docetaxel for patients with mHSPC. Overall, the proportion of the 6198 patients treated with non­guideline-concordant therapies was 76.1%. Since guideline-recommended care is associated with better outcomes, this baselining finding highlights the need for appropriate treatment selection and intensification for mHSPC patients.

[Short-term Effect of Venetoclax Combined with Azacitidine and "7+3" Regimen in the Treatment of Newly Diagnosed Elder Patients with Acute Myeloid Leukemia].

OBJECTIVE: To compare the short-term effect and adverse reaction of venetoclax (VEN) combined with azacitidine (AZA) versus "7+3" regimen in newly diagnosed elder patients with acute myeloid leukemia (AML). METHODS: From January 2021 to January 2022, the clinical data of seventy-nine newly diagnosed elder patients with AML at the Second Hospital of Shanxi Medical University and the Shanxi Bethune Hospital were retrospectively analyzed, including VEN+AZA group (41 cases) and "7+3" group (38 cases). The propensity score matching(PSM) method was used to balance confounding factors， then response， overall survival(OS), progressionfree survival(PFS) and adverse reactions between the two groups were compared. RESULTS: The ORR of VEN+AZA group and "7+3" group was 68% and 84%, respectively, and the CRc was 64% and 72%, respectively, the differents were not statistically significant (P >0.05). In the VEN+AZA group, there were 5 non-remission (NR) patients, 4 with chromosome 7 abnormality (7q-/-7), and 1 with ETV6 gene mutation. Median followed-up time between the two groups was 8 months and 12 months, respectively, and the 6-months OS was 84% vs 92% (P =0.389), while 6-months PFS was 84% vs 92% (P =0.258). The main hematological adverse reactions in two groups were stage Ⅲ-Ⅳ myelosuppression, and the incidence rate was not statistically different(P >0.05). The median time of neutrophil recovery in two groups was 27(11-70) d, 25(14-61) d （P =0.161）, and platelet recovery was 27(11-75) d, 25(16-50) d （P =0.270）, respectively. The infection rate of VEN+AZA group was lower than that of "7+3" group (56% vs 88%, P =0.012）. The rate of lung infections of two groups was 36% and 64%, respectively, the difference was statistically significant (P =0.048). CONCLUSION: The short-term effect of VEN+AZA group and "7+3" regimens in eldrly AML patients are similar， but the VEN+AZA regimen had a lower incidence of infection. The presence of chromosome 7 abnormality（7q-/-7） may be a poor prognostic factor for elderly AML patients treated with VEN+AZA.

Total neoadjuvant therapy improves survival of patients with borderline resectable pancreatic cancer with arterial involvement.

Aim: This study aimed to evaluate the prognostic impact of total neoadjuvant therapy (TNT) for borderline resectable pancreatic cancer with arterial involvement (BR-A) pancreatic cancer. Methods: We analyzed 81 patients initially diagnosed as BR-A who received initial treatments between 2007 and 2021. Among them, 18 patients who received upfront surgery were classified as the UFS group, while 30 patients who were treated with neoadjuvant chemoradiotherapy were classified as the NACRT group. Furthermore, 33 patients who planned to receive a combination treatment of over 6 months of systemic chemotherapies followed by chemoradiotherapy before surgery were classified as the TNT group. Results: There were no significant differences in the patients' backgrounds between the three groups at the time of initial treatment. The resection rates of the UFS, NACRT, and TNT groups were 89%, 77%, and 67%, respectively. NACRT had no impact on the prognosis compared to upfront surgery. In sharp contrast, the TNT group had a significantly better prognosis compared to the other groups, especially after pancreatic resection. Multivariate analysis demonstrated that TNT and resection were independent prognostic factors for the patients of BR-A. Conclusion: TNT can be a promising therapeutic strategy for patients with BR-A.

Late toxicity comparison of alkylating-based maintenance regimen with cyclophosphamide (VAC) vs ifosfamide (VAI) in Ewing sarcoma survivors treated in the randomized clinical trial Euro-EWING99-R1 in France.

In Euro-EWING99-R1 randomized trial, cyclophosphamide was shown to be noninferior to ifosfamide in the consolidation of standard-risk Ewing sarcoma (SR-EWS) after a common induction with VIDE (vincristine-ifosfamide-doxorubicin-etoposide). We present the results of the late effects analysis of VAC (vincristine-dactinomycin-cyclophoshamide) vs VAI (vincristine-dactinomycin-ifosfamide) conducted in Euro-EWING99-R1 French cohort. Of 267 French randomized patients, 204 were alive and free-of-relapse at 5-years including 172 with available long-term follow-up data concerning cardiac, renal and/or gonadal functions (sex-ratio M/F = 1.3, median age at diagnosis = 14 years): 84 randomized in VAC (median cumulative doses: cyclophosphamide = 9.7 g/m2 , ifosfamide = 59.4 g/m2 ) and 88 in VAI (ifosfamide = 97.1 g/m2 ). With a median follow-up of 10 years (range = 5-17), five late relapses and five second malignancies were recorded. The 10-year event-free survival among 5-year free-of-relapse survivors was similar between VAC and VAI (93% vs 95%, P = .63). We estimated the 10-year cumulative probabilities of cardiac and kidney toxicities at 4.4% (95% confidence interval [95% CI] = 1.1%-7.6%) and 34.8% (95% CI = 26.8%-42.0%), respectively. Cardiac toxicity cumulative probability was similar in both arms, whereas kidney toxicity was higher in VAI (at 10 years, 43.0% vs 25.7%, P = .02), resulting from significant difference in glomerular toxicity (31.1% vs 13.1%, P < .01). At 10 years, gonadal toxicity was observed in 27% and 28% of pubertal men and women, respectively, without significant difference between VAC and VAI. Kidney and gonadal toxicities represent major issues in Euro-EWING99-R1, with significantly higher risk of kidney toxicities with VAI, without significant gonadal toxicity reduction. These results support the need to limit cumulative doses of both alkylating agents and to use mixed regimen as in VIDE-VAC or VDC/IE (vincristine-doxorubicin-cyclophoshamide/ifosfamide-etoposide).

Cost-effectiveness analysis of long-acting versus short-acting recombinant human granulocyte stimulating factor in the treatment of III° and IV° bone marrow suppression after chemotherapy / 中国基层医药

Objective:To investigate the cost-effectiveness of long-acting versus short-acting recombinant human granulocyte stimulating factor in the treatment of III° and IV° bone marrow suppression after chemotherapy. Methods:The data of patients who presented with III and IV° bone marrow suppression after chemotherapy and received treatment with recombinant human granulocyte stimulating factor from January 2018 to December 2019 were collected. These patients were divided into the short-acting recombinant human granulocyte stimulating factor group (rhG-CSF group) and the long-acting recombinant human granulocyte stimulating factor group (PEG-rhG-CSF group) group. Clinical efficacy, the incidence of adverse reactions, and cost-effectiveness were compared between the two groups.Results:There were 88 patients, aged (63.97 ± 11.64) years, in the rhG-CSF group. There were 80 patients, aged (63.26 ± 9.09) years in the PEG-rhG-CSF group. There was no significant difference in baseline data between the two groups ( P > 0.05). Total response rate was 72.72% (64/88) in the rhG-CSF group and 78.75% (63/80) in the PEG-rhG-CSF group ( χ2 = 0.82, P = 0.360). The incidence of related adverse reactions was 7.95% (7/88) and 7.5% (6/80) in the rhG-CSF and PEG-rhG-CSF groups respectively ( χ2 = 0.01, P = 0.910). The average cost was (124.88 ± 113.07) yuan and (3 159.04 ± 505.05) yuan in the rhG-CSF and PEG-rhG-CSF groups respectively ( t = 51.68, P < 0.01). The cost-effectiveness ratio was 1.55 and 40.11 in the rhG-CSF and PEG-rhG-CSF groups respectively. Taking the rhG-CSF group as a reference, the incremental cost-effectiveness ratio in the PEG-rhG-CSF group was 505.13. Conclusion:Long-acting and short-acting recombinant human granulocyte stimulating factors have similar curative effects and related adverse reactions in the treatment of III° and IV°bone marrow suppression after chemotherapy. The cost-effectiveness ratio of the rhG-CSF group is lower than that of the PEG-rhG-CSF group. Appropriate treatment schemes for increasing white blood cell levels should be selected based on the individual situation of the patient.

Effects of timing of chemotherapy after breast cancer surgery on patient's immune function and quality of life / 中国基层医药

Objective:To investigate the effects of the timing of chemotherapy after breast cancer surgery on patient's immune function and quality of life.Methods:A total of 100 patients who underwent modified radical mastectomy for breast cancer from January 2017 to January 2019 in Jining No. 1 People's Hospital were included in this study. These patients were randomly divided into a control group and an early chemotherapy group ( n = 50/group). Patients in the control group underwent chemotherapy 4-6 weeks after surgery. Patients in the early chemotherapy group received chemotherapy 2 weeks after surgery. The chemotherapy regimens were the same in the two groups. The levels of CD 4+, CD 8+, CD 4+/CD 8+, immunoglobulin A (IgA), and immunoglobulin G (IgG) were measured before and after chemotherapy in each group. Chemotherapy-related reverse reactions and infections were recorded. The quality of life was evaluated in each group at the last follow-up. Results:Before chemotherapy, there were no significant differences in CD 4+, CD 8+, CD 4+/CD 8+, IgA, and IgG levels between the two groups (all P > 0.05). After chemotherapy, CD 4+ and CD 4+/CD 8+ levels in the early chemotherapy group were (51.76 ± 5.21)% and (2.00 ± 0.25), respectively, which were significantly higher than (48.21 ± 4.78)% and (1.70 ± 0.21) in the control group ( t = 3.55, 4.98, both P < 0.05). After chemotherapy, the CD 8+ level in the early chemotherapy group was (25.93±2.43)%, which was significantly lower than (28.29 ± 2.31)% in the control group ( t = 6.50, P < 0.05). Serum IgA and IgG levels in the early chemotherapy group were (3.24 ± 0.38) g/L and (9.27 ± 1.04) g/L, respectively, which were significantly higher than (2.75 ± 0.37) g/L and (8.43 ± 0.97) g/L in the control group ( t = 6.53, 4.18, both P < 0.05). During chemotherapy, there was no significant difference in the incidence of reverse reactions between the two groups (all P > 0.05). The incidence of infections was significantly lower in the early chemotherapy group than the control group ( P < 0.05). At the last follow-up, generic quality of life inventory-74 scores in the early chemotherapy group were significantly higher than those in the control group (all P < 0.05). Conclusion:Early chemotherapy can markedly reduce the effects of chemotherapy on the immune function of patients after breast cancer surgery, decrease the incidence of infections, and improve quality of life.

Construction of narrative nursing intervention program for patients with advanced lung cancer undergoing chemotherapy based on the theory of meaning in life / 中国实用护理杂志

Objective:To construct a narrative nursing intervention program for patients with advanced lung cancer undergoing chemotherapy based on the meaning in life theory, so as to alleviate the negative psychology of patients and improve the meaning in life of patients.Methods:Using a mixed research design, based on the literature study and qualitative interview, the first draft of narrative nursing intervention program for patients with advanced lung cancer undergoing chemotherapy was constructed based on the theory of meaning in life. From June to September 2021, the Delphi method was used to conduct 2 rounds experts consultations among 15 experts from 8 hospitals, and the items were revised according to the expert′s advice.Results:The experts positive coefficients of the 2 rounds consultations were 83.33% and 100.00%, the expert authority coefficient was 0.88, and the Kendall coefficients of importance were 0.183 and 0.215, and the operational Kendall coefficients were 0.234 and 0.363. Finally, a narrative nursing intervention program for lung cancer patients based on the theory of meaning in life was formed. It included four modules: narrative theme, narrative content, narrative interview outline and homework assignment/auxiliary measures. It was performed 7 times in each chemotherapy cycle.Conclusions:The construction process of narrative nursing intervention program for patients with advanced lung cancer undergoing chemotherapy based on the theory of meaning in life is rigorous, scientific and practical and can be used to guide clinical psychological nursing intervention for patients with advanced diseases and enrich the way to seek the meaning in life of patients

Investigation and analysis of appetite status in patients with lymphoma during chemotherapy / 白血病·淋巴瘤

Objective:To investigate the appetite of patients with lymphoma during chemotherapy and its influencing factors.Methods:A total of 103 patients with lymphoma who underwent chemotherapy were sequentially selected in Fujian Medical University Union Hospital from December 2020 to August 2021. The questionnaire survey was carried out by using general information and Karnofsky score was performed. Appetite score was calculated according to Chinese version of the appetite symptom questionnaire for cancer patients. Multiple linear regression analysis was used to analyze the influencing factors of appetite status of lymphoma patients during chemotherapy, and Pearson correlation analysis was used to explore the relationship between Karnofsky score and appetite score of patients.Results:For patients with lymphoma during chemotherapy, Karnofsky score was (75±18) scores and the appetite score was (25.0±5.0) scores. Univariate analysis showed that age, body mass index (BMI), nausea and vomiting, oral mucosa rupture, gum infection, fever, throat infection were influencing factors of appetite score of patients (all P < 0.05). Multivariate analysis showed that patients ' age ( B = -1.118, β = -0.187, P = 0.016), BMI ( B = -2.047, β = -0.271, P = 0.001), nausea and vomiting ( B = -4.352, β = -0.411, P < 0.001) were the independent influencing factors of appetite score. Correlation analysis showed that the Karnofsky score was positively correlated with appetite score ( r = 0.361, P < 0.05). Conclusions:Special attention should be paid to the appetite of elder lymphoma patients with lower BMI during chemotherapy, and nausea and vomiting should be paid more attention; targeted measures of increasing the patients' appetite could improve their nutritional level and prognosis.

Progress of immunotherapy strategies for uveal melanoma / 肿瘤研究与临床

Uveal melanoma (UM) is the most common intraocular malignancy in adults. Recently, great progresses have been made in the diagnosis, treatment and prognosis of UM, however, nearly 50% of patients still develop liver metastases, which severely affects on the survival of UM patients. Whether UM patients will benefit from the immune checkpoint blockade similarly as the cutaneous melanoma (CM)? Whether the specific gene mutations targeting UM could improve the anti-tumor efficacy? Whether chimeric antigen receptor T cell or T cell receptor T cell immunotherapy is effective to UM patients with liver metastases? How about the combinational therapies in UM and the clinical effects? This review summarizes the anti-tumor research and novel treatment options of UM, analyzes the current achievements and problems.

Expressions of STMN1, BubR1, bcl-2 and Bad in patients with esophageal squamous cell carcinoma and their relationship with chemotherapy effect of paclitaxel-containing regimen / 肿瘤研究与临床

Objective:To investigate the correlation between the expression levels of STMN1, BubR1, bcl-2 and Bad and the chemotherapy effect of paclitaxel-containing regimen in patients with esophageal squamous cell carcinoma (ESCC).Methods:The clinical data of ESCC patients who received paclitaxel-containing chemotherapy at Fenyang Hospital Affiliated to Shanxi Medical University from September 2016 to June 2021 were retrospectively analyzed. Among them, 59 cases received maintenance chemotherapy and 27 cases received surgery after 3 courses of neoadjuvant chemotherapy. The expression levels of STMN1, BubR1, bcl-2 and Bad in tumor tissues before chemotherapy were detected by immunohistochemistry. The imaging efficacy after 3 courses of chemotherapy and pathological efficacy after neoadjuvant chemotherapy were evaluated. The imaging efficacy, pathological efficacy and progression-free survival (PFS) were compared between the high expression group and the low expression group of each protein.Results:The proportion of patients with stage Ⅳ (46.3%, 19/41), the proportion of patients with low differentiation (22%, 9/41) and the incidence of lymph node metastasis (95.1%, 39/41) in STMN1 high expression group were higher than those in STMN1 low expression group (17.8%, 8/45; 4.4%, 2/45; 64.4%, 29/45), and the differences were statistically significant (all P < 0.05). The proportion of patients with stage Ⅳ in Bad high expression group was lower than that in Bad low expression group, and the difference was statistically significant ( P < 0.05). In the evaluation of imaging efficacy, the chemotherapy sensitivity rates in STMN1 and BubR1 high expression groups (29.3%, 12/41; 37.9%, 22/58) were lower than those in STMN1 and BubR1 low expression groups (75.6%, 34/45; 85.7%, 24/28), and the chemotherapy sensitivity rate of patients in Bad high expression group (65.9%, 27/41) was higher than that in Bad low expression group (42.2%, 19/45), and the difference was statistically significant (all P < 0.05). There was no statistical correlation between bcl-2 expression and chemotherapy sensitivity rate ( P > 0.05). In the evaluation of pathological efficacy, the proportion of patients with tumor regression grade (TRG) score 0-1 after neoadjuvant therapy in STMN1 high expression group (27.3%, 3/11) was lower than that in STMN1 low expression group (75.0%, 12/16), and the difference was statistically significant ( P = 0.022). There were no statistical differences in the proportions of patients with TRG score 0-1 after neoadjuvant therapy between high and low expression groups of BubR1, bcl-2 and Bad (all P > 0.05). The PFS rate was 15.2% (9/59) for patients received maintenance chemotherapy, and the median PFS time was 6 months. Kaplan-Meier analysis showed that PFS in STMN1 low expression group was better than that in STMN1 low expression group ( χ2 = 12.90, P < 0.001). PFS in BubR1 low expression group was better than that in BubR1 high expression ( χ2 =12.04, P < 0.001). PFS in Bad high expression group was better than that in Bad low expression group ( χ2 =9.69, P = 0.004). There was no statistical difference in PFS between high and low bcl-2 expression groups ( χ2 =1.43, P = 0.320). Conclusions:ESCC patients with low expression of STMN1, low expression of BubR1 and high expression of Bad have better chemotherapy effect after receiving paclitaxel-containing regimen, but there is no correlation between bcl-2 expression and chemotherapy efficacy.

[Clinical characteristics and prognosis of seizures in 75 children with acute lymphoblastic leukemia].

OBJECTIVE: To investigate the clinical characteristics, treatment, and prognosis of seizures in children with acute lymphoblastic leukemia (ALL) during chemotherapy. METHODS: Children with ALL with seizures during chemotherapy admitted to the Department of Pediatrics, Peking University People's Hospital from January 2010 to March 2022 were retrospectively analyzed. Clinical data including the incidence of seizure, time at seizure onset, causes, management, and prognosis were collected retrospectively. RESULTS: A total of 932 children with ALL were admitted during the study period, of whom, 75 (8%) were complicated with seizures during the period of chemotherapy. There were 40 males and 35 females, with a median age of 7.5 (1-17) years, and 43 cases (57.3%) occurred within the first 2 months of chemotherapy. The underlying diseases were reversible posterior encephalopathy syndrome (n=15), cerebral hemorrhage (n=10, one of whom was complicated with venous sinus thrombosis), intrathecal or systemic methotrexate administration (n=11), brain abscess (n=7, fungal infection in 3 cases, and bacterial in 4), viral encephalitis (n=2), febrile seizure (n=7), hyponatremia (n=7), hypocalcemia (n=2), and unknown cause (n=14). Sixty-four children underwent neuroimaging examination after seizure occurrence, of whom 37 (57.8%) were abnormal. The electroencephalograhpy (EEG) was performed in 44 cases and was abnormal in 24 (54.4%). Fifty-five patients remained in long-term remission with regular chemotherapy, 8 patients received hematopoietic stem cell transplantation, 9 died and 3 lost to follow-up. Symptomatic epilepsy was diagnosed in 18 cases (24%), and was well controlled in 16 with over 1 year of seizure-free. Whereas 2 cases were refractory to anti-seizure medications. CONCLUSION: Seizures are relatively common in children with ALL, most commonly due to reversible posterior encephalopathy syndrome, methotrexate-related neurotoxicity, and cerebral hemorrhage. Seizures occurred within 2 months of chemotherapy in most cases. Neuroimaging and EEG should be performed as soon as possible after the first seizure onset to identify the etiology and to improve the treatment regimen. Some cases developed symptomatic epilepsy, with a satisfactory outcome of seizure remission mostly after concurrent antiseizure medication therapy.

Hepatic epithelioid hemangioendothelioma after thirteen years' follow-up: A case report and review of literature.

BACKGROUND: Hepatic epithelioid hemangioendothelioma (EHE) is a rare vascular endothelial cell tumor of the liver, consisting of epithelioid and histiocyte-like vascular endothelial cells in mucus or a fibrotic matrix. Immunohistochemistry is usually positive for vascular markers, such as factor VIII-related antigen, CD31, and CD34. Hepatic EHE can have a varied clinical course; treatment includes liver transplantation, liver resection, chemotherapy, and radiation therapy. CASE SUMMARY: A 46-year-old woman with abdominal discomfort and elevated serum carcinoembryonic antigen was found to have multiple low-density lesions in the liver and lung on computed tomography (CT) evaluation. An ultrasound-guided fine needle aspiration biopsy revealed a fibrous stroma with dendritic cells, containing intracellular vacuoles. Immunohistochemical staining found that the tumor cells were positive for CD34, CD31, and factor VIII-related antigen. The patient received four courses of combined chemotherapy and was followed-up for 13 years, at which time the patient was in stable condition without disease progression and a confined neoplasm, as evidenced by CT scans. CONCLUSION: The histology and immunohistochemical characteristics of hepatic EHE are well described. Chemotherapy may be effective in patients with extrahepatic lesions.

Risk factors for oral mucositis during chemotherapy treatmentfor solid tumors: a retrospective STROBE-guided study

Background: This study retrospectively analyzed the risk factors for transchemotherapy oral mucositis (OM).Material and Methods: Before each chemotherapy cycle, patients were routinely evaluated for the presence/severity of OM based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 scale for adverse effectsand graded as follows: However, specific conditions such as mucositis are graded on a five-point scale: 0, absenceof mucositis, grade 1 (Asymptomatic or mild), 2 (Presence of pain and moderate ulceration, without interferencewith food intake), 3 (severe pain with interference with food intake) or 4 (Life-threatening with the need for urgentintervention). Information from 2 years of evaluations was collected and patient medical records were reviewed toobtain data on chemotherapy cycle, sex, age, body mass index, body surface area, primary tumor, chemotherapyprotocol, and history of head and neck radiotherapy. The X² test and multinomial logistic regression were used forstatistical analysis (SPSS 20.0, p<0.05).Results: Among 19,000 total evaluations of 3,529 patients during 5.32±4.7 chemotherapy cycles (CT) the prevalence of OM was 6.3% (n=1,195). Chemotherapy duration (p<0.001), female sex (p=0.001), adjuvant intention(p=0.008) and the use of carboplatin (p=0.001), cisplatin (p=0.029), docetaxel (p<0.001) and bevacizumab(p=0.026) independently increased the risk of mucositis. In head and neck tumors, 2018 year (p=0.017), chemotherapy duration (p=0.018), BMI>30 (p=0.008), radiotherapy (p=0.037) and use of carboplatin (p=0.046) andcyclophosphamide (p=0.010) increased this prevalence.Conclusions: Cycles of chemotherapy, sex, cytotoxicity drugs, bevacizumab and head and neck radiotherapy increase the risk of OM in solid tumors. (AU)

[Comparison of the efficacy of IA and HAD induction regimens in the treatment of patients with newly diagnosed acute myeloid leukemia: a single-center study].

Objective: To compare the efficacy of two induction regimens, namely, idarubicin combined with cytarabine (IA) versus the combination of homoharringtonine, daunorubicin, and cytarabine (HAD) , in adult patients with newly diagnosed de novo acute myeloid leukemia (AML) . Methods: From May 2014 to November 2019, 199 patients diagnosed with AML receiving either the IA or HAD regimens were assessed for overall survival (OS) , relapse-free survival (RFS) , as well as the CR rate and the MRD negative rate after induction therapy. The differences in prognosis between the two induction therapy groups was assessed according to factors, including age, white blood cell (WBC) count, NPM1 mutation, FLT3-ITD mutation, 2017 ELN risk stratification, CR(1) transplantation, and the use of high-dose cytarabine during consolidation therapy, etc. Results: Among the 199 patients, there were 104 males and 95 females, with a median age of 37 (15-61) years. Ninety patients received the IA regimen, and 109 received the HAD regimen. Comparing the efficacy of the IA and HAD regimens, the CR rates after the first induction therapy were 71.1% and 63.3%, respectively (P=0.245) , and the MRD negative rates after the first induction therapy were 53.3% and 48.6%, respectively (P=0.509) . One patient in the IA group and two in the HAD group died within 60 days after induction. The two-year OS was 61.5% and 70.6%, respectively (P=0.835) , and the two-year RFS was 51.6% and 57.8%, respectively (P=0.291) . There were no statistically significant differences between the two groups. Multivariate analysis showed that the ELN risk stratification was an independent risk factor in both induction groups; CR(1) HSCT was an independent prognostic factor for OS and RFS in the IA patients and for RFS in the HAD patients but not for OS in the HAD patients. Age, WBC level, NPM1 mutation, and FLT3-ITD mutation had no independent prognostic significance. Conclusion: The IA and HAD regimens were both effective induction regimens for AML patients.

[Efficacy and safety of IAC regimen for relapse/refractory acute myeloid leukemia: a prospective randomized controlled study].

Objective: To evaluate the efficacy and toxicity profiles of idarubicin, cytarabine, and cyclophosphamide (IAC) in relapse/refractory acute myeloid leukemia (AML) . Methods: This study was a prospective, randomized controlled clinical trial with the registration number NCT02937662. The patients were randomly divided into two groups. The experimental group was treated with an IAC regimen, and the regimen of the control group was selected by doctors according to medication experience. After salvage chemotherapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) was conducted as far as possible according to the situation of the patients. We aimed to observe the efficacy, safety, and toxicity of the IAC regimen in relapse/refractory AML and to explore which is the better regimen. Results: Forty-two patients were enrolled in the clinical trial, with a median age of 36 years (IAC group, 22 cases and control groups, 20 cases) . ①The objective response rate was 71.4% in the IAC group and 40.0% in the control group (P=0.062) ; the complete remission (CR) rate was 66.7% in the IAC group and 40.0% in the control group (P=0.121) . The median follow-up time of surviving patients was 10.5 (range:1.7-32.8) months; the median overall survival (OS) was 14.1 (range: 0.6-49.1) months in the IAC group and 9.9 (range: 2.0-53.8) months in the control group (P=0.305) . The 1-year OS was 54.5% (95%CI 33.7%-75.3%) in the IAC group and 48.2% (95%CI 25.9%-70.5%) in the control group (P=0.305) , with no significant difference between these two regimens. ②The main hematologic adverse events (AEs) were anemia, thrombocytopenia, and neutropenia. The incidence of grade 3-4 hematologic AEs in the two groups was 100% (22/22) in the IAC group and 95% (19/20) in the control group. The median time of neutropenia after chemotherapy in the IAC group and control group was 20 (IQR: 8-30) and 14 (IQR: 5-50) days, respectively (P=0.023) . ③The CR rate of the early relapse (relapse within 12 months) group was 46.7% and that of the late relapse (relapse after 12 months) group was 72.7% (P=0.17) . The median OS time of early recurrence was 9.9 (range:1.7-53.8) months, and that of late recurrence patients was 19.3 (range: 0.6-40.8) months (P=0.420) , with no significant differences between the two groups. The 1-year OS rates were 45.3% (95%CI 27.2%-63.3%) and 66.7% (95%CI 40.0%-93.4%) , respectively (P=0.420) . Survival analysis showed that the 1-year OS rates of the hematopoietic stem cell transplantation group and non-hematopoietic stem cell transplantation group were 87.5% (95%CI 71.2%-100%) and 6.3% (95%CI 5.7%-18.3%) , respectively. The OS rate of the hematopoietic stem cell transplantation group was significantly higher than that of the non-hematopoietic stem cell transplantation group (P<0.001) . Conclusion: The IAC regimen is a well-tolerated and effective regimen in relapsed/refractory AML; this regimen had similar efficacy and safety with the regimen selected according to the doctor's experience for treating relapsed/refractory AML. For relapsed/refractory patients with AML, allogeneic hematopoietic stem cell transplantation should be attempted as soon as possible to achieve long-term survival.

[Dose-enhanced immunochemotherapy followed by first-line autologous peripheral blood stem cell transplantation for young patients with high-risk aggressive B-cell lymphoma: an efficacy and prognostic factor analysis].

Objective: This study aimed to determine the efficacy of dose-enhanced immunochemotherapy followed by autologous peripheral blood stem cell transplantation (ASCT) in young patients with newly diagnosed high-risk aggressive B-cell lymphoma. Methods: A retrospective study was conducted to examine the clinical and survival data of young patients with high-risk aggressive B-cell lymphoma who received dose-enhanced immunochemotherapy and ASCT as first-line treatment between January 2011 and December 2018 in Blood Diseases Hospital. Results: A total of 63 patients were included in the study. The median age range was 40 (14-63) years old. In terms of the induction therapy regimen, 52 cases received R-DA-EP (D) OCH, and the remaining 11 received R-HyperCVAD/R-MA. Sixteen (25.4% ) patients achieved partial response in the mid-term efficacy assessment, and ten of them were evaluated as complete response after transplantation. The median follow-up was 50 (8-112) months, and the 3-year progression-free survival (PFS) rate and overall survival (OS) rate were (83.9±4.7) % and (90.4±3.7) % , respectively. Univariate analysis demonstrated that age-adjusted international prognostic index ≥2 scores was a negative prognostic factor for OS (P=0.039) , and bone marrow involvement (BMI) was an adverse prognostic factor for OS (P<0.001) and PFS (P=0.001) . However, multivariate analysis confirmed that BMI was the only independent negative predictor of OS (P=0.016) and PFS (P=0.001) . Conclusions: The use of dose-enhanced immunochemotherapy in combination with ASCT as first-line therapy in the treatment of young, high-risk aggressive B-cell lymphoma results in good long-term outcomes, and BMI remains an adverse prognostic factor.

A Clinical Decision Support System for Increasing Compliance with Protocols in Chemotherapy of Children with Acute Lymphoblastic Leukemia.

Objective: In this survey, a protocol-based Chemotherapy Prescription Decision Support System (CPDSS) was designed and evaluated to reduce medication errors in the chemotherapy process of children with ALL. Methods: The CPDSS algorithm was extracted by the software development team based on the protocol used by doctors to treat children with ALL. The ASP.Net MVC and SQL Server 2016 programming languages were used to develop the system. A 3-step evaluation (technical, retrospective, and user satisfaction) was performed on CPDSS designed at 2 children's hospitals in Tehran. The data were analyzed using descriptive statistics. At the technical evaluation step, users provided recommendations included in the system. Results: In the retrospective CPDSS evaluation step, 1281 prescribed doses of the drugs related to 30 patients were entered into the system. CPDSS detected 735 cases of protocol deviations and 57 (95%, CI = 1.25-2.55) errors in prescribed chemotherapy for children with ALL. In the user satisfaction evaluation, the users approved two dimensions of the user interface and functionality of the system. Conclusions: With the provision of alerts, the CPDSS can help increase compliance with chemotherapy protocols and decrease the chemotherapy prescribing errors that can improve patient safety.

MUM1 Expression versus Hans Algorithm to Predict Prognosis in Indonesian Diffuse Large B-Cell Lymphoma Patients Receiving R-CHOP.

Background: Treatment response in diffuse large B-cell lymphoma (DLBCL) is heterogenous. The Hans algorithm (using 30% cut-offs for CD10, BCL6, and MUM1 protein expression) has been the most favored method to categorize DLBCL into germinal center B-cell (GCB) and non-GCB subtypes in order to predict prognosis. However, the algorithm's ability to prognosticate is not always consistent. Methods: This retrospective cohort study was conducted on DLBCL patients receiving R-CHOP therapy at Dr. Cipto Mangunkusumo Hospital, Jakarta from 2014 to 2017. We aimed to compare the prognostic value of Hans algorithm as well as the protein levels of CD10, BCL6, MUM1, and Ki67 at different cut-offs. Ninety-two patients were classified based on Hans algorithm and various proteins at different cut-off values were analyzed with regard to event-free survival at 24 months using survival analysis. The cut-off values were then compared using receiver operating characteristic curves. Results: A significant survival difference was observed with MUM1 expression cut-off of 50% or more (log rank p = 0.035). CD10, BCL6, Ki67, and Hans algorithm showed AUCs below or near 0.5 (0.405, 0.436, 0.498, and 0.413, respectively), whereas MUM1 showed an AUC of 0.835, in predicting events within 24 months. MUM-1 cut-off of 70.5% yielded an optimal trade-off for sensitivity and specificity. Conclusion: MUM1 expression of 50% or more can help predict prognosis in DLBCL patients receiving R-CHOP therapy and can be considered as for use as a single marker to predict prognosis.

Effect of peri-operative chemotherapy regimen on survival in the treatment of locally advanced oesophago-gastric adenocarcinoma - A comparison of the FLOT and 'MAGIC' regimens.

BACKGROUND: Peri-operative chemotherapy improves survival in patients with locally advanced oesophago-gastric adenocarcinoma. Two regimens with proven survival benefits are epirubicin, cisplatin plus capecitabine or fluorouracil (Medical Research Council Adjuvant Gastric Infusional Chemotherapy, MAGIC) and fluorouracil plus leucovorin, oxaliplatin, and docetaxel (FLOT). This study aimed to compare the effect of these regimens on survival (primary aim) and pathological response, surgical complications, adverse events and chemotherapy completion rates. METHODS: Cohort study including 946 patients treated with FLOT (n = 257) or MAGIC (n = 689) who underwent surgical resection for oesophageal (n = 743) or gastric (n = 203) adenocarcinoma between 2002 and 2021 at St Thomas' Hospital or The Royal Marsden Hospital, London, UK. Survival analysis was performed using multivariable Cox regression, providing hazard ratios (HRs) with 95% confidence intervals (CIs) adjusted for age, sex, clinical T-stage, clinical N-stage, tumour grade and presence of signet ring cells. RESULTS: Patients treated with FLOT had better overall survival (HR = 0.69, 95% CI 0.50-0.94) and disease-free survival (HR = 0.75, 95% CI 0.58-0.98) than MAGIC. Patients treated with FLOT were more likely to have a complete pathological response (9.5% FLOT versus 5.5% MAGIC, p = 0.027) and were less likely to have a positive resection margin (19.1% FLOT versus 32.2% MAGIC, p < 0.001). The stratified analysis revealed similar results for oesophageal and gastric tumours. Rates of surgical complications, chemotherapy-associated adverse events and completion were similarly distributed between treatment groups. CONCLUSIONS: Patients with oesophageal or gastric adenocarcinoma treated with peri-operative FLOT had better survival and pathological response than those treated with peri-operative MAGIC. Rates of surgical complications, adverse events and chemotherapy completion were comparable.

[Efficacy of venetoclax combined azacitidine in newly diagnosed acute myeloid leukemia unfit for standard chemotherapy: a single center experience].

Objective: To investigate the effectiveness and safety of the VA regimen, which combines venetoclax with azacitidine in the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable candidates for conventional chemotherapy. Methods: In the Department of Hematology at the Second Hospital of Hebei Medical University, 66 AML patients who received venetoclax and azacitidine treatment from May 2020 to March 2022 were the subject of a retrospective study. The complete remission (CR) rate, cCR rate, ORR rate, MRD negative rate, the incidence of adverse events,1-year EFS, and OS were retrospectively analyzed. Patients subgroups with varying ages, ECOG scores, primary and secondary, risk stratifications, and gene mutation were compared for differences in efficacy and survival. Results: The median follow-up was 4.25 (0.9-19.9) months, and the median number of treatment courses was 2 (1-8) cycles. After the first cycle, the cCR rate was 78.8% , and the MRD negative rate was 51.9% . After prolonged treatment, the cCR rate was 81.8% and MRD negative rate was 66.7% . The median EFS and OS, respectively, were13.2 and 15.3 months. Secondary AML showed inferior efficacy and prognosis. IDH1/2 or NPM1 mutation groups had a significantly higher rate of CR than the control group (P<0.05) . The CR rate and MRD negative rate of patients with rebound thrombocytosis were significantly higher than those without rebound thrombocytosis (P<0.05) . Those who had epigenetic modification mutations (DNMT3, ASXL1, TET2) were more likely to benefit from ongoing therapy. The most common grade 3 and 4 adverse reactions were neutropenia, thrombocytopenia, and anemia. Conclusions: In real-world patients with newly diagnosed AML who are not candidates for standard chemotherapy, the VA regimen produces rapid deep remission. Primary AML patients, rebound thrombocytosis, IDH1/2, and NPM1 gene mutations are favorable factors for treatment benefit, and adverse reactions were tolerable.