Efficacy and safety of paclitaxel liposome versus paclitaxel in combination with carboplatin in the first-line chemotherapy for ovarian cancer:a multicenter,open-label,non-inferiority,randomized controlled trial

Background:The paclitaxel liposome formulation,encapsulating paclitaxel within a phospholipid bilayer,ad-dresses the insolubility of traditional paclitaxel formulations,thereby reducing toxicity without compromising its antitumor efficacy.Methods:This multicenter,open-label,non-inferiority randomized controlled trial(ChiCTR2000038555)evalu-ates the efficacy and safety of paclitaxel liposome in comparison to the standard regimen of paclitaxel combined with carboplatin(PLC vs.PC)as first-line therapy in patients with epithelial ovarian cancer.Results:An analysis of median progression-free survival(PFS)revealed non-inferior outcomes between 263 pa-tients in the PLC group and 260 patients in the PC group(32.3 vs.29.9 months,hazard ratio[HR],0.89[95%CI,0.64−1.25]),using a non-inferior margin of 1.3.Although the overall incidence of treatment-related adverse events was comparable between groups,the PLC group experienced significantly fewer non-hematologic toxicities than those treated with the PC regimen.Conclusion:The findings affirm the non-inferiority of paclitaxel liposome compared to the combination of pa-clitaxel and carboplatin regarding therapeutic efficacy,with an enhanced safety profile marked by reduced non-hematologic toxicities.

Hormonal therapy might be a better choice as maintenance treatment than capecitabine after response to first-line capecitabine-based combination chemotherapy for patients with hormone receptor-positive and HER2-negative,metastatic breast cancer

Background:Both hormonal therapy(HT) and maintenance capecitabine monotherapy(MCT) have been shown to extend time to progression(TTP) in patients with metastatic breast cancer(MBC) after failure of taxanes and anthracycline?containing regimens.However,no clinical trials have directly compared the efficacy of MCT and HT after response to first?line capecitabine?based combination chemotherapy(FCCT) in patients with hormone receptor(HR)?positive and human epidermal growth factor receptor 2(HER2)?negative breast cancer.Methods:We retrospectively analyzed the charts of 138 HR?positive and HER2?negative MBC patients who were in non?progression status after FCCT and who were treated between 2003 and 2012 at the Cancer Institute and Hospital,Chinese Academy of Medical Sciences,in Beijing,China.The median number of first?line chemotherapy cycles was 6(range,4–8);combined agents included taxanes,vinorelbine,or gemcitabine.Of these 138 patients,79 received MCT,and 59 received HT.Single?agent capecitabine was administered at a dose of 1250 mg/m2 twice daily for 14 days,followed by a 7?day rest period,repeated every 3 weeks.Of the 59 patients who received HT,37 received aromatase inhibitors(AIs),8 received selective estrogen receptor modulators(SERMs),and 14 received goserelin plus either AIs or SERMs.We then compared the MCT group and HT group in terms of treatment efficacy.Results:With a median follow?up of 43 months,patients in the HT group had a much longer TTP than patients in the MCT group(13 vs.8 months,P ease?free surviv= 0.011).When TTP was adjusted for age,menopausal status,Karnofsky performance status score,disal,site of metastasis,number of metastatic sites,and response status after FCCT,extended TTP was still observed for patients in the HT group(hazard ratio:0.63;95% confidence interval:0.44–0.93;P = 0.020).We also observed a trend of overall survival advantage for patients in the HT group vs.patients in the MCT group,but the difference was not significant(43 vs.37 months,P tients in the MCT g= 0.400).In addition,patients in the HT group gen?erally tolerated the treatment well,whereas paroup experienced grades 3–4 adverse events,the most frequent of which were hand?foot syndrome(15.8%) and hematologic abnormalities(7.6%).Conclusion:For HR?positive and HER2?negative MBC patients,HT might be considered a treatment after response to FCCT but prior to MCT as a long?term administration.

Correlation between postoperative chemotherapy regimen and survival in patients with resectable gastric adenocarcinoma accompanied with vascular cancer thrombus

BACKGROUND Patients with resectable gastric adenocarcinoma accompanied by vascular cancer thrombus(RGAVCT)have a poor prognosis,with a 5-year survival rate ranging from 18.42%-53.57%.These patients need a reasonable postoperative treatment plan to improve their prognosis.AIM To determine the most effective postoperative chemotherapy regimen for patients with RGAVCT.METHODS We retrospectively collected the clinicopathological data of 530 patients who un-derwent radical resection for gastric cancer between January 2017 and January 2022 and who were pathologically diagnosed with gastric adenocarcinoma with a choroidal cancer embolus.Fur-thermore,we identified the high-risk variables that can influence the prognosis of patients with RGAVCT by asse-ssing the clinical and pathological features of the patients who met the inclusion criteria.We also assessed the significance of survival outcomes using Mantel-Cox univariate and multivariate analyses.The subgroups of pa-tients with stages Ⅰ,Ⅱ,and Ⅲ disease who received single-,dual-,or triple-drug regimens following surgery were analyzed using SPSS 25.0 and the ggplot2 package in R 4.3.0.RESULTS In all,530 eligible individuals with RGAVCT were enrolled in this study.The median overall survival(OS)of patients with RGAVCT was 24 months,and the survival rates were 80.2%,62.5%,and 42.3%at 12,24,and 59 months,respectively.Preoperative complications,tumor size,T stage,and postoperative chemotherapy were identified as independent factors that influenced OS in patients with RGAVCT according to the Cox multivariate analysis model.A Kaplan-Meier analysis revealed that chemotherapy had no effect on OS of patients with stage Ⅰ or Ⅱ RGAVCT;however,chemotherapy did have an effect on OS of stage Ⅲ patients.Stage Ⅲ patients who were treated with chemotherapy consisting of dual-or triple-agent regimens had better survival than those treated with single-agent regimens,and no significant difference was observed in the survival of patients treated with chemo-therapy consisting of dual-or triple-agent regimens.CONCLUSION For patients with stage Ⅲ RGAVCT,a dual-agent regimen of postoperative chemotherapy should be recom-mended rather than a triple-agent treatment,as the latter is associated with increased frequency of adverse events.

Sequential chemotherapy and icotinib as first-line treatment for advanced epidermal growth factor receptor-mutated non-small cell lung cancer

BACKGROUND Icotinib could have potential effect and tolerability when used sequentially with chemotherapy for advanced epidermal growth factor receptor(EGFR)-mutated non-small cell lung cancer(NSCLC).AIM To evaluate the efficacy and safety of chemotherapy followed by icotinib maintenance therapy as first-line treatment for advanced EGFR-mutated NSCLC.METHODS This multicenter,open-label,pilot randomized controlled trial enrolled 68 EGFRmutated stage IIIB/IV NSCLC patients randomized 2:3 to the icotinib alone and chemotherapy+icotinib groups.RESULTS The median progression-free survival in the icotinib alone and chemotherapy+icotinib groups was 8.0 mo(95%CI:3.84-11.63)and 13.4 mo(95%CI:10.18-16.33),respectively(P=0.0249).No significant differences were found in the curative effect when considering different cycles of chemotherapy or chemotherapy regimen(all P>0.05).CONCLUSION A sequential combination of chemotherapy and EGFR-tyrosine kinase inhibitor is feasible for stage IV EGFR-mutated NSCLC patients.

Serum basic fibroblast growth factor and interleukin-1βpredict the effect of first-line chemotherapy in patients with advanced gastric cancer

BACKGROUND The incidence and mortality rates of gastric cancer in China are the second-highest in the world,and most patients with gastric cancer lose their chance of surgery by the time of their diagnosis.AIM To explore the predictive potential of serum basic fibroblast growth factor and interleukin-1βlevels for the effect of first-line chemotherapy in patients with advanced gastric cancer.METHODS From the gastric cancer patients admitted to our hospital from May 2019 to April 2023,84 patients were selected and randomly and equally assigned to the experimental or control group.The FLOT group received the FLOT chemotherapy regimen(composed of oxaliplatin+calcium folinate+fluorouracil+paclitaxel),while the SOX group received the SOX chemotherapy regimen(composed of oxaliplatin+tiga capsules).The clinical efficacy,tumor marker levels,adverse reactions,and survival rates of the two groups were compared 7 days after the end of the relevant treatments.RESULTS The target effective rate of the FLOT group was 54.76%,which was much higher than that of the SOX group(33.33%;P<0.05).After treatment,both the groups demonstrated lower levels of cancer antigen(CEA),carbohydrate antigen 199(CA199),and peptide tissue antigen(TPS).For several patients before treatment(P<0.05).Third and fourth grades.In terms of adverse reactions,the level of white blood cells in both the groups was lower.Moreover,the incidence of hand-foot skin reactions in these two study groups was lower(P<0.05),while those of peripheral neuritis,vomiting,diarrhea,and abnormal liver function were significant(P<0.05).No statistically significant difference was noted between the two groups(P<0.05).The 1-year survival rate was higher in the FLOT group(P<0.05).CONCLUSION The FLOT regimen was effective in reducing the serum CEA,CA199,and TPS levels as well as in improving the 1-year survival rate of patients with good tolerability,making it worthy of clinical promotion and application.

Clinical study on gefitinib combined with γ-ray stereotactic radiotherapy for senile patients with adenocarcinoma of lung as the first-line regimen

Objective: The aim of our study was to evaluate the efficacy and safety of gefitinib combined with γ-ray stereo-tactic radiotherapy for senile patients with adenocarcinoma of lung as the first-line regimen. Methods: The 153 senile patients with adenocarcinoma of lung were divided into 4 groups according to the therapy method. Group A was the 35 patients treated with gefitinib combined with γ-ray stereotactic radiotherapy. Group B was the 45 patients treated with γ-ray stereotactic radio-therapy. Group C was the 42 patients treated with gefitinib. Group D was the 31 patients treated with best supportive therapy. The patients received gefitinib of 250 mg/d from the first day until disease progression or other reasons. The patients were treated with γ-ray stereotactic radiotherapy from the second day. Dose curve of this group of cases was 50%-80%. Encircled dose was 4.0-6.5 Gy per fraction and the range of total dose was 36-48 Gy. The total number of treatment was 8-12 and treated six times every week. Results: All the patients were examined by enhanced double helix CT at the second month. The tumor response rate (RR) of group A was 68.6% (24/35). Disease control rate (DCR) was 88.6% (31/35). The median survival time (MST) was 13.4 months (range 3-34 months ) and the progression-free survival (PFS) was 7.8 months. The overall 1-year survival rate was 40.0% (14/35). The main side effects included skin rash and diarrhea. The RR of group B was 51.1% (23/45). DCR was 71.1% (32/45). MST was 9.6 months (range, 3-18 months ) and PFS was 5.3 months. The overall 1-year survival rate was 15.6 % (7/45). The RR of group C was 40.5 % (17/42). DCR was 61.9% (26 /42). MST was 10.3 months (range, 3-26 months ) and PFS was 5.1 months. The overall 1-year survival rate was 35.7 % (15/42). The main side effects included skin rash and diarrhea. The MST of group D was 5.6 months (range, 2-11 months ) and PFS was 1.7 months. The overall 1-year survival rate was 0. The short-term therapeutic effects (RR) of group A was higher than group C (P = 0.014 < 0.05, χ2 = 6.053) but has no significant difference with group B (P = 0.116 > 0.05, χ2 = 2.477). The long-term therapeutic effects (overall 1-year survival rate) of group A was higher than group B (P = 0.014 < 0.05, χ2 = 6.077) but has no significant difference with group C (P = 0.642 > 0.05, χ2 = 0.216). Conclusion: Gefitinib combined with γ-ray stereotactic radiotherapy is feasible and effective for treatment in senile patients with adenocarcinoma of lung as the first-line regimen.

Efficacy of cetuximab combination with chemotherapy in non-small cell lung cancer first-line setting:the summary based on publications

Objective： The combination of cetuximab with standard chemotherapy was not widely studied though it was recommended by NCCN 2009 to apply in non-small cell lung cancer （NSCLC） first-line setting. The aim of this study was to summary the efficacy and safety profiles of all the NSCLC patients available in openly published papers treated with above mentioned regimens. Methods： The PubMed database was used to search all the papers on NSCLC associated with cetuximab treatment, and only the clinical trails applied cetuximab combined with doublets cytotoxic chemotherapy in first-line setting till to 30 November 2009 were collected. And the medians and their 95% CI of objective response rate （ORR）, progression free survival （PFS）, overall survival （OS）, and the common adverse events were calculated. Results： （1） Eight papers including 1032 patients were collected, and all cases were at advanced stage. （2） The ratio of male and female patients was 1.6, 50.1% patients were adenocarcinoma and 28.2% patients were squamous cell carcinoma （SCC）, 90.0% patients were PS = 0-1, and 78.2% patients were white ethnic. （3） The disease control rate （DCR）, ORR, PFS, and OS were 65.2% （95% CI： 60.7%-69.7%）, 33.2% （95% CI： 30.3%-36.1%）, 5.0 months （95% CI： 4.7-5.3） and 10.9 months （95% Cl： 9.6-12.2）, respectively. Conclusion： This is the first study to summarize the efficacy and safety profiles of cetuximab combined with chemotherapy in NSCLC first-line setting based on all available patients. The addition of cetuximab caused promising prognosis and acceptable side effects excepting higher incidence of neutropenia, and febrile neutropenia.

FOLFOXIRI vs FOLFIRINOX as first-line chemotherapy in patients with advanced pancreatic cancer: A population-based cohort study

BACKGROUND FOLFIRINOX regimen is the first-line reference chemotherapy(L1)in advanced pancreatic ductal adenocarcinoma(aPDAC).FOLFOXIRI,a schedule with a lower dose of irinotecan and no bolus 5-fluorouracil,has demonstrated efficacy and feasibility in colorectal cancer.AIM To investigate the potential clinical value of FOLFOXIRI in patients with aPDAC in routine clinical practice.METHODS Analyses were derived from all consecutive aPDAC patients treated in L1 between January 2011 and December 2017 in two French institutions,with either FOLFOXIRI(n=165)or FOLFIRINOX(n=124)regimens.FOLFOXIRI consisted of irinotecan(165 mg/m2),oxaliplatin(85 mg/m2),leucovorin(200 mg/m2)and 5-fluorouracil(3200 mg/m2 as a 48-h continuous infusion)every 2 wk.Ninety-six pairs of patients were selected through propensity score matching,and clinical outcomes of the two treatment regimens were compared.RESULTS Median overall survival was 11.1 mo in the FOLFOXIRI and 11.6 mo in the FOLFIRINOX cohorts,respectively.After propensity score matching,survival rates remained similar between the two regimens in terms of overall survival(hazard ratio=1.22;P=0.219)and progression-free survival(hazard ratio=1.27;P=0.120).The objective response rate was 37.1%in the FOLFOXIRI group vs 47.8%in the FOLFIRINOX group(P=0.187).Grade 3/4 toxicities occurred in 28.7%of patients in the FOLFOXIRI cohort vs 19.5%in the FOLFIRINOX cohort(P=0.079).FOLFOXIRI was associated with a higher incidence of grade 3/4 digestive adverse events.Hematopoietic growth factors were used after each chemotherapy cycle and the low hematological toxicity rates were below 5%with both regimens.CONCLUSION FOLFOXIRI is feasible in L1 in patients with aPDAC but does not confer any therapeutic benefit as compared with FOLFIRINOX.The low hematological toxicity rates strengthened the relevance of primary prophylaxis with hematopoietic growth factors.

Gefitinib combined with γ-ray stereotactic body radiation therapy has better efficacy than gefitinib alone for senile lung adenocarcinoma patients with EGFR mutations as first-line regimen

Objective： The senile lung adenocarcinoma patients harboring an activating epidermal growth factor receptor （EGFR） mutation shows good and rapid response to EGFR tyrosine kinase inhibitors （TKIs）. Whether gefitinib combined with y-ray stereotactic body radiation therapy has better efficacy than gefitinib alone for senile lung adenocarcinoma patients with EGFR mutations as first-line regimen is still under investigation. Methods： The 42 senile lung adenocarcinoma patients with EGFR mutations were divided into 2 groups according to the therapy method. Group A was the 22 patients treated with gefitinib combined with y-ray stereotactic body radiation therapy （SBRT）. Group B was the 20 patients treated with gefitinib alone. All of the patients received gefitinib of 250 mg/d from the first day until disease progression or other reasons. The patients of Group A were treated with y-ray stereotactic body radiation therapy from the second day. Radiation fields included the primary lesions and the integration of lymph nodes. Dose curve of this group was 50%-80%. Encircled dose was 4.0-6.5 Gy per fraction and the range of total dose was 40-52 Gy. We treated the patients 8-12 times and treated five times every week. Results： All the patients were examined by enhanced double helix CT at the second month. The tumor response rate （RR） of group A was 81.8% （18/22）. Disease control rate （DCR） was 90.9% （20/22）. The median overall survival （OS） was 24.2 months （range 8-58 months ） and the progression-free survival （PFS） was 18.6 months. The overall 1-year survival rate was 72.3% （16/22） and 2-year survival rate was 54.5% （12/22）. The main side effects included skin rash and diarrhea. The RR of group B was 50.0 % （10/20）. DCR was 75.0% （15/20）. OS was 17.4 months （range 6-32 months ） and PFS was 12.1 months. The overall 1-year survival rate was 60.0% （12/20） and 2-year survival rate was 40.0% （8/20）. The main side effects included skin rash and diarrhea. The group A who were treated with gefitinib combined with y-ray stereotactic body radiation therapy had a higher short term therapeutic effects （RR） and long term therapeutic effects （OS） than group B who were treated with gefitinib alone respectively （81.8% vs 50.0%, P = 0.029 〈 0.05, x2 = 4.773 and 24.2 vs 17.4, P = 0.024 〈 0.05, X2 = 5.098）. Conclu. sion： Gefitinib combined with y-ray stereotactic body radiation therapy has better efficacy than gefitinib alone for senile lung adenocarcinoma patients with EGFR mutations as first-line regimen. The side affects are acceptable.

Paclitaxel-etoposide-carboplatin/cisplatin versus etoposidecarboplatin/cisplatin as first-line treatment for combined small-cell lung cancer: a retrospective analysis of 62 cases

Objective: To compare the efficacy and adverse effects of paclitaxel-etoposide-carboplatin/cisplatin(TEP/TCE) regimen with those of etoposide-carboplatin/cisplatin(EP/CE) regimen as first-line treatment for combined small-cell lung cancer(CSCLC).Methods: A retrospective study was conducted on 62 CSCLC patients who were treated at Tianjin Medical University Cancer Institute and Hospital from July 2000 to April 2013 and administered with TEP/TCE regimen(n=19) or EP/CE regimen(n=43) as first-line CSCLC treatment. All patients received more than two cycles of chemotherapy, and the response was evaluated every two cycles. The primary endpoint was overall survival(OS), and the secondary endpoints were progression-free survival(PFS), objective response rate(ORR), disease control rate(DCR), and adverse effects. Results: ORR between the TEP/TCE and EP/CE groups showed a statistical difference(90% vs. 53%, P=0.033). Both groups failed to reach a statistical difference in DCR(100% vs. 86%, P=0.212). The median PFS and OS of the TEP/TCE group were slightly longer than those of the EP/CE group, although both groups failed to reach a statistical difference(10.5 vs. 8.9 months, P=0.484; 24.0 vs. 17.5 months, P=0.457). However, stratified analysis indicated that the PFS of patients with stages III and IV CSCLC showed marginally significant difference between the TEP/TCE and EP/CE groups(19.5 vs. 7.6 months; P=0.071). Both rates of grade IV bone marrow depression and termination of chemotherapy in the TEP/TCE group were significantly higher than those in the EP/CE group(26.3% vs. 7.0%, P=0.036; 31.6% vs. 14.7%, P=0.004). Conclusion: The TEP/TCE regimen may not be preferred for CSCLC, and this three-drug regimen requires further exploration and research. To date, the EP/CE regimen remains the standard treatment for CSCLC patients.

Randomized Trial Comparing Cyclophosphamide, Methotrexate, and 5-Fluorouracil (CMF) Regimen with Rotational CMFEV Regimen (E=Epirubicin, V=Vincristine) as Adjuvant Chemotherapy in Moderate Risk Operable Breast Carcinoma

Objectives: The CMFEV (cyclophosphamide, methotrexate, 5-fluorouracil, epirubicin, vincristine) regimen is an innovative schedule, designed by our Group, aimed at administering five partially or totally no cross-resistant cytotoxic agents in breast carcinoma. It was randomly compared to CMF (cyclophosphamide, methotrexate, 5-fluorouracil) as primary treatment in operable disease and demonstrated a short-term significant increase in clinical complete response rate and a long-term significant locoregional relapse-free survival in premenopausal patients. So, it seemed worth comparing this regimen with CMF as adjuvant chemotherapy in moderate risk operable breast carcinoma. Methods: Four hundred and eighty-nine patients with stage I or II moderate risk breast carcinoma were randomized to receive CMF or CMFEV regimen for 6 cycles after surgery. Main end points were overall survival (OS), invasive disease-free survival (IDFS) and recurrence-free interval (RFI), as estimated by Kaplan-Meier analyses and log-rank tests. Results: At a median observation time of 7.3 years (range 5.4 months-10.3 years), no significant differences in OS and IDFS were observed between the two arms. Deaths from breast carcinoma were more frequent with CMF (58.5%) than with CMFEV regimen (41.7%) as well as recurrences from breast carcinoma (58.8% with CMF and 41.2% with CMFEV). These differences were not statistically significant. Conclusion: CMFEV appears more effective than CMF in preventing recurrences from primary disease in patients with moderate risk stage I-II breast carcinoma. The lack of statistical significance of the observed differences was probably due to the limited number of patients enrolled which rendered the study underpowdered.

Efficacy of chemotherapy containing bevacizumab in patients with metastatic colorectal cancer according to programmed cell death ligand 1

BACKGROUND Bevacizumab,an anti-vascular endothelial growth factor(VEGF)monoclonal antibody,inhibits angiogenesis and reduces tumor growth.Serum VEGF-C,lactate dehydrogenase,and inflammatory markers have been reported as predictive markers related to bevacizumab treatment.Programmed cell death ligand 1(PD-L1)could act upon VEGF receptor 2 to induce cancer cell angiogenesis and metastasis.AIM To investigate the efficacy of bevacizumab-containing chemotherapy in patients with metastatic colorectal cancer(CRC)according to the expression of PD-L1.METHODS This analysis included CRC patients who received bevacizumab plus FOLFOX or FOLFIRI as first-line therapy between June 24,2014 and February 28,2022,at Samsung Medical Center(Seoul,South Korea).Analysis of patient data included evaluation of PD-L1 expression by the combined positive score(CPS).We analyzed the efficacy of bevacizumab according to PD-L1 expression status in patients with CRC.RESULTS A total of 124 patients was included in this analysis.Almost all patients were treated with bevacizumab plus FOLFIRI or FOLFOX as the first-line chemotherapy.While 77%of patients received FOLFOX,23%received FOLFIRI as backbone first-line chemotherapy.The numbers of patients with a PD-L1 CPS of 1 or more,5 or more,or 10 or more were 105(85%),64(52%),and 32(26%),respectively.The results showed no significant difference in progression-free survival(PFS)and overall survival(OS)with bevacizumab treatment between patients with PDL1 CPS less than 1 and those with PD-L1 CPS of 1 or more(PD-L1<1%vs PD-L1≥1%;PFS:P=0.93,OS:P=0.33),between patients with PD-L1 CPS less than 5 and of 5 or more(PD-L1<5%vs PD-L1≥5%;PFS:P=0.409,OS:P=0.746),and between patients with PD-L1 CPS less than 10 and of 10 or more(PD-L1<10%vs PD-L1≥10%;PFS:P=0.529,OS:P=0.568).CONCLUSION Chemotherapy containing bevacizumab can be considered as first-line therapy in metastatic CRC irrespective of PD-L1 expression.

Newly emerging standard chemotherapies for gastric cancer and clinical potential in elderly patients

With the increase in average life expectancy,the rate of occurrence of gastric cancer in elderly patients is also rising.While many clinical trials have been conducted to examine the effect of chemotherapy treatment on gastric cancer,age limits for eligible subjects have prevented the establishment of standards for chemotherapy in elderly patients with gastric cancer.As of March 2009,evidence-based standard chemotherapy regimens were established.In the Western world,debates centered on the ECF(Epirubicin/cisplatin/5FU) or DCF(Docetaxel/cisplatin/5-FU) regimens based on the phase □ randomized controlled trial at the Royal Marsden Hospital(RMH) or the V325 study,respectively.The JCOG9912 and SPIRITS trials emerged from Japan indicating attractive regimens that include S-1 for advanced gastric cancer patients.Using these active anticancer drugs,the trials that studied the eff icacy of adjuvant therapies or surgical approaches,such as the Int-116/MAGIC/ACTS-GC trials,have actually succeeded in demonstrating the benefits of adjuvant therapies in gastric cancer patients.For cases of gastric cancer in elderly patients,treatment policies should consider these studies while analyzing not only the therapeutic effects but also drug toxicity,individual general health conditions,and social factors to select treatments that emphasize quality of life.

Clinical study of FOLFOX4 regimen for patients of advanced hepatocellular carcinoma

Objective:The aim of our study was to observe the efficiency and toxicity of oxaliplatin (L-OHP) combined with CF/5-FU in patients with advanced primary hepatocellular carcinoma.Methods:Twenty patients with advanced primary hepatocellular carcinoma had recurrence/metastasis after multiple courses of TACE (cisplatin and epirubicin,etc.).All patients were treated with FOLFOX4 regimen of the combination of oxaliplatin and leucovorin and 5-fluorouracil.Treatment was repeated every 2 weeks until disease progression or unacceptable adverse effects occurred.The efficiency was evaluated according to RECIST criteria,and toxicities according to American National Cancer Institute Common Toxicity Criteria (NCI CTC),respectively.Results:Twenty patients were assessable for the objective efficiency and for toxicity.No patient achieved complete response (CR),4 patients were partial response (PR),8 patients were stable disease (SD),8 patients were disease progression (PD);Time to tumor progression (TTP) of the patients ranged from 1.5 to 4.8 months,median TTP was 2.2 months;Overall survival (OS) of the patients ranged from 3 to 10.2 months,median OS was 5 months.The 2 patients' serum AFP level decreasing.Sixteen patients relieved the symptoms obviously,stabilized or raised up Karnofsky Score.The toxicities were mainly grade I-II arrest of bone marrow (50%),mild neurotoxicity (30%) and mild reaction of gastrointestinal tract (40%).Conclusion:FOLFOX4 regimen is effective and safe for patients with advanced primary hepatocellular carcinoma.It can be worthy of further clinical investigation.

FOLFIRI regimen in metastatic pancreatic adenocarcinoma resistant to gemcitabine and platinum-salts

AIM: To evaluate the efficacy and safety of the FOLFIRI regimen in patients with metastatic pancreatic adenocarcinoma (PAC) after the failure of gemcitabine and platinum salts. METHODS: All consecutive patients with histologically confirmed, metastatic PAC and World Health Organiza-tion performance status (PS) ≤ 2 received FOLFIRI-1 [irinotecan 180 mg/m2 on day 1 and leucovorin 400 mg/m2 followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus, then 5-FU 2400 mg/m2 as a 46-h infusion, biweekly] or FOLFIRI-3 (irinotecan 100 mg/m2 on day 1 and leucovorin 400 mg/m2, then 5-FU 2400 mg/m2 as a 46-h infusion and irinotecan 100 mg/m2 repeated on day 3, biweekly) after failure of gemcitabine and platinum-based chemotherapies as a systematic policy in two institutions between January 2005 and May 2010. Tumor response, time to progression (TTP), overall survival rate (OS) and grade 3-4 toxicities were retrospectively studied. Subgroup analyses were performed to search for prognostic factors. RESULTS: Sixty-three patients (52.4% male, median age 59 years) were analyzed. Among them, 42.9% were PS 0, 38.1% were PS 1 and 19.0% were PS 2. Fifty one patients (81.0%) had liver metastases. Before the FOLFIRI regimen, patients had received 1 line (n = 19), 2 lines (n = 39) or 3 lines (n = 5) of chemotherapy. Median TTP obtained with the line before FOLFIRI was 3.9 mo (95% CI: 3.4-5.3 mo). A total of 480 cycles was completed (median: 6 cycles, range: 1-51 cycles). The main reason for discontinuing FOLFIRI was tumor progression (90.3%). Tumor control was achieved in 25 patients (39.7%) (partial response: n = 5, stable disease: n = 20) with FOLFIRI. Median TTP was 3.0 mo (95% CI: 2.1-3.9 mo) and median OS was 6.6 mo (95% CI: 5.3-8.1 mo). Dose adaptation was required in 36 patients (57.1%). Fifteen patients (23.8%) had grade 3-4 toxicities, mainly hematological (n = 11) or digestive (n = 4). Febrile neutropenia occurred in 3 patients. There was no toxic death. PS 2 was significantly associated with poor TTP [hazard ratio (HR): 16.036, P < 0.0001] and OS (HR: 4.003, P = 0.004). CONCLUSION: The FOLFIRI regimen had an acceptable toxicity and an interesting efficacy in our study, limited to patients in good condition (PS 0-1).

Analysis of Efficacy of DICE(Dexamethasone,Ifosfamide,Cisplatin and Etoposide)Regimen on Recurrent and Refractory Intermediate and High Grade Non-Hodgkin's Lymphoma

OBJECTIVE Thus far there is no standard salvage regimenfor patients with recurrent and refractory intermediate and highgrade non-Hodgkin's lymphoma (NHL). This study intends toinvestigate the therapeutic efficacy of the DICE (dexamethasone,isofosfamide, cisplatin and etoposide) regimen on the recurrentand refractory NHL, and to observe the related adverse effects.METHODS Clinical records of 22 patients with recurrent andrefractory NHL, who failed to achieve a remission from theCHOP [cyclophosphamide, hydroxydaunomycin/doxorubicin(adriamycin), oncovin, prednisone] regimen within 2 to 6 cyclesof treatment, were reviewed. DICE, as a salvage regimen with amedian course of treatment of 4 cycles (ranging from 2 to 7 cycles),was now used, and evaluation of the therapeutic efficacy andadverse effect of DICE was conducted in all the patients. Of the 22NHL cases, 8 were of T-cell origin and the other 14 B-cell origin.Salvage treatment was performed in the patients, with appraisal,prevention and treatment of the toxic reactions.RESULTS Following DICE treatment in the 22 patients, thetotal effective rate of the regimen was 63.6%, and the completeremission (CR) rate was 40.9%. The effective rates of DICE onthe T and B-cell sourced NHL were 75.0% and 57.1%, and the CRrate were 37.5%, 42.9%, respectively (P >0.05). An increase of thelactate dehydrogenase (LDH) level accompanied by a giant lumpwas the short-term effect on patients with recurrence (mean P <0.05) who were drug resistant. Myelosuppression, digestive systemreaction and alopecia were the commonly-seen complications inthe patients who received DICE regimen. All patients recoveredafter treatment, and no chemotherapy-related death occurred.CONCLUSION DICE regimen is effective in treating refractoryand recurrent NHL.

Combining of chemotherapy with targeted therapy for advanced biliary tract cancer:A systematic review and meta-analysis

BACKGROUND Targeted therapy(TT)has resulted in controversial efficacy as first-line treatment for biliary tract cancer(BTC).More efficacy comparisons are required to clarify the overall effects of chemotherapy(CT)combined with TT and CT alone on advanced BTC.AIM To conduct a meta-analysis of the available evidence on the efficacy of CT combined with TT for advanced BTC.METHODS The PubMed,EMBASE,ClinicalTrials,Scopus and Cochrane Library databases were systematically searched for relevant studies published from inception to August 2022.Only randomized clinical trials(RCTs)including comparisons between the combination of gemcitabine-based CT with TT and CT alone as firstline treatment for advanced BTC were eligible(PROSPERO-CRD42022313001).The odds ratios(ORs)for the objective response rate(ORR)and hazard ratios(HRs)for both progression-free survival(PFS)and overall survival(OS)were calculated and analyzed.Subgroup analyses based on different targeted agents,CT regimens and tumor locations were prespecified.RESULTS Nine RCTs with a total of 1361 individuals were included and analyzed.The overall analysis showed a significant improvement in ORR in patients treated with CT+TT compared to those treated with CT alone(OR=1.43,95%CI:1.11-1.86,P=0.007)but no difference in PFS or OS.Similar trends were observed in the subgroup treated with agents targeting epidermal growth factor receptor(OR=1.67,95%CI:1.17-2.37,P=0.004)but not in the subgroups treated with agents targeting vascular endothelial growth factor receptor or mesenchymal-epithelial transition factor.Notably,patients who received a CT regimen of gemcitabine+oxaliplatin in the CT+TT arm had both a higher ORR(OR=1.75,95%CI:1.20-2.56,P=0.004)and longer PFS(HR=0.83,95%CI:0.70-0.99,P=0.03)than those in the CT-only arm.Moreover,patients with cholangiocarcinoma treated with CT+TT had significantly increased ORR and PFS(ORR,OR=2.06,95%CI:1.27-3.35,PFS,HR=0.79,95%CI:0.66-0.94).CONCLUSION CT+TT is a potential first-line treatment for advanced BTC that leads to improved tumor control and survival outcomes,and highlighting the importance of CT regimens and tumor types in the application of TT.

Clinical observation of Fufangchangtai decoction combined with FOLFOX4 regimen for postoperative colorectal cancers

Objective:The aim of the study was to observe the therapeutic effect of FOLFOX4 regimen plus Fufangchangtai decoction on postoperative colorectal cancers.Methods:Thirty postoperative colorectal cancer patients were allocated into control and experiment groups respectively.Patients in experiment group were given Fufangchangtai decoction combined with FOLFOX4 regimen.Patients in control group were given FOLFOX4 regimen alone.Efficacy was evaluated after 2 periods of treatment.Results:The improvement rate of symptoms were 86.6% in experiment group compared to 53.3% in control group.KPS was stable in experiment group,and decreased in control group.QOL was increased in experiment group,and stable in control group after the treatment.For impact of immunity parameters,there were enhancements of CD3+ and CD4+ in experiment group,while they did not change in control group.In experiment group,WBC reduction was slighter than that of control group.The differences were not remarkable in PLT reduction,alimentary response,and toxicity of liver and kidney and nervous system.Conclusion:The clinical observation showed that Fufangchangtai decoction plus FOLFOX4 regimen could effectively enhance KPS,improve the symptoms,the quality of life and the immunity state,and down-regulate the side effects.In conclusion,Fufangchangtai decoction can decrease the toxicity so as to increase the treatment effect.

养阴清肺颗粒联合HRZE化疗方案治疗初治敏感肺结核的效果

目的探讨养阴清肺颗粒联合异烟肼+利福平+吡嗪酰胺+乙胺丁醇(HRZE)化疗方案治疗初治敏感肺结核的临床效果。方法回顾性收集2022年6月至2023年3月河南省胸科医院收治的95例初治敏感肺结核患者的临床资料,根据治疗方案分为对照组(47例,HRZE化疗方案治疗)和观察组(48例,HRZE化疗方案+养阴清肺颗粒治疗),均持续治疗6个月。比较两组疗效、肺功能指标(用力肺活量、呼气峰流速、第1秒用力呼气容积)、免疫功能指标,以及治疗期间不良反应发生情况。结果观察组总有效率高于对照组(P<0.05)。治疗6个月时,观察组肺功能指标、免疫功能指标均高于对照组(P<0.05)。两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论初治敏感肺结核患者采用HRZE化疗方案联合养阴清肺颗粒治疗效果显著,可改善患者免疫功能和肺功能,且不会增加不良反应。

地西他滨联合预激方案治疗首程标准诱导化疗未缓解初诊AML患者的效果观察

目的:探讨地西他滨联合预激方案治疗首程标准诱导化疗未缓解初诊急性髓系白血病(AML)患者的疗效及对调节性T淋巴细胞(Treg)相对含量的影响。方法:收集2013年3月-2019年3月陕西省人民医院收治的102例初诊经首程标准诱导化疗未缓解的AML患者(除急性早幼粒细胞白血病)的临床资料进行回顾性分析,根据治疗方案不同对患者进行分组,51例采用预激方案治疗为常规组,51例采用地西他滨联合预激方案治疗为联合组。比较两组疗效、毒副反应发生率、治疗前后生活质量核心量表(QLQ-C30)评分、T淋巴细胞亚群(CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)、Treg)及3年总生存率。结果:联合组治疗总有效率为80.39%,显著高于常规组的62.75%(P<0.05);治疗后联合组QLQ-C30评分为60.27±6.96,较常规组65.73±7.96低(P<0.001);两组毒副反应发生率比较,差异无统计学意义(P>0.05);治疗后联合组CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)水平较常规组高(均P<0.001),而Treg水平较常规组低(P<0.001);联合组3年总生存率为72.55%,高于常规组的52.94%(P<0.001)。结论:地西他滨联合预激方案治疗初诊首程标准诱导化疗未缓解AML患者效果显著,可通过调节Treg相对含量减少抗肿瘤免疫抑制,增强机体免疫功能,从而延长患者生存时间,提高生存质量,且未增加不良反应。