Clinical Effect of Tislelizumab Combined with Chemotherapy in the Treatment of Stage IIIb-IV Non-Small Cell Lung Cancer

Objective:To analyze the therapeutic effect of tislelizumab combined with chemotherapy in patients with stage IIIb-IV non-small cell lung cancer(NSCLC).Methods:A total of 50 patients with stage IIIb-IV NSCLC admitted between January 2022 and January 2024 were randomly divided into two groups using a random number table.The observation group included 25 cases treated with tislelizumab combined with chemotherapy,while the reference group included 25 cases treated with conventional chemotherapy.The clinical control rate,adverse reaction rate,tumor markers,immune function indicators,and quality of life scores were compared between the two groups.Results:The observation group had a higher clinical control rate and a lower adverse reaction rate compared to the reference group(P<0.05).Before treatment,there were no significant differences in tumor markers,immune function indicators,and quality of life scores between the two groups(P>0.05).Three months after treatment,the tumor marker levels in the observation group were lower than those in the reference group.Except for CD8^(+),all immune function indicators in the observation group were higher than those in the reference group,and the quality-of-life scores in the observation group were higher than those in the reference group(P<0.05).Conclusion:Implementing tislelizumab combined with chemotherapy in patients with stage IIIb-IV NSCLC can improve the clinical control rate,reduce the adverse reaction rate,lower tumor marker levels,protect immune function,and improve quality of life.

Prognostic Impact of Histopathologic Response after Neoadjuvant Chemotherapy in Stage Ⅲ_A Non-small Cell Lung Cancer

Objective： To investigate prognostic impact of histopathologic response induced by neoadjuvant chemotherapy in patients with stage ⅢA non-small cell lung cancer （NSCLC）. Methods： Forty patients with stage ⅢA NSCLC underwent two cycles of neoadjuvant chemotherapy with mitomycin, vindosine, and cisplatin followed by surgery. Histopathologic response in resection of the tumor was examined after surgery. Tumor regression was classified as grade Ⅳ, grade Ⅲ, grade Ⅱ, and grade Ⅰ according to the extent of tumor necrosis and the extent of the vital tumor tissues. The tumor regression grading was correlated with the survival time of the patients. Results： After two cycles of chemotherapy, 19 （47.5%） of 40 patients had objective response （2 complete and 17 partial response）. In 40 resected tumor specimens, 2 （5%） were classified as regression grade Ⅳ, 16 （40%） as regression grade Ⅲ, 18 （45%） as regression gradeⅡ, and 4 （10%） as regression grade Ⅰ. The rate of complete surgical resection was significantly higher in patients with tumor regression grade Ⅲ-Ⅳ （〈10% vital tumor tissue）（P〈0.05）. The median survival time in patients classified as having tumor regression grade Ⅲ-Ⅳ was significantly longer than that in patients who had regression grade Ⅰ-Ⅱ （P〈0.05）. The 3-year survival rate in patients with regression grade Ⅲ-Ⅳ was markedly higher than that in patients who had regression grade Ⅰ-Ⅱ （P〈0.05）. Conclusion： The extent of tumor regression induced by neoadjuvant chemotherapy is a critical issue for successful therapeutic approach in patients with stage ⅢA NSCLC. In resected specimens of tumors after chemotherapy, the presence of marked tumor regression （regression grade Ⅲ-Ⅳ） is predictive for superior survival time.

The prognostic value of radiomics based on ^(18)F-FDG PET/CT imaging in advanced non-small cell lung cancer

Objective:To investigate the prognostic value of radiomics features based on ^(18)F-FDG PET/CT imaging for advanced non-small cell lung cancer(NSCLC)treated with chemotherapy.Methods:A sample of 146 NSCLC patients stagedⅢor stageⅣwere included in this retrospective study who received ^(18)F-FDG PET/CT before treatment.All patients were treated with standardized chemotherapy after PET/CT examination and were divided into training group and validation group in an 8:2 ratio randomly.Radiomics features were extracted.In the training group,the minimum absolute contraction and selection operator(LASSO)algorithm and Cox risk proportional regression model were used to screen radiomics and clinical prognostic factors of progression-free survival(PFS).The radiomic model,clinical model and complex model were established respectively.The corresponding scores were calculated,then verified in the validation group.Results:The LASSO algorithm finally screened four radiomics features.ROC results showed that in the training group,the AUC of PFS predicted by the radiomics model was 0.746,and that in the verification group was 0.622.COX multivariate analysis finally included three clinical features related to PFS in NSCLC patients,namely pathological type,clinical stage and MTV30.The AUC for predicting PFS by clinical model,radiomics model and composite model were 0.746,0.753 and 0.716,respectively.The radiomics model had the highest diagnostic efficacy,and its sensitivity and specificity were 0.663 and 0.833,respectively.Delong test verified that there was no statistical difference in the predictive efficacy between the radiomics model and the composite model(Z=1.777,P=0.076)and the clinical imaging model(Z=0.323,P=0.747).Conclusion:The radiomics model based on PET/CT has a good predictive value for the prognosis of advanced NSCLC treated with chemotherapy,but it needs further validation before it can be widely used in clinical practice.

A radiomics prognostic scoring system for predicting progression-free survival in patients with stageⅣnon-small cell lung cancer treated with platinum-based chemotherapy

Objective:To develop and validate a radiomics prognostic scoring system(RPSS)for prediction of progressionfree survival(PFS)in patients with stageⅣnon-small cell lung cancer(NSCLC)treated with platinum-based chemotherapy.Methods:In this retrospective study,four independent cohorts of stageⅣNSCLC patients treated with platinum-based chemotherapy were included for model construction and validation(Discovery:n=159;Internal validation:n=156;External validation:n=81,Mutation validation:n=64).First,a total of 1,182 three-dimensional radiomics features were extracted from pre-treatment computed tomography(CT)images of each patient.Then,a radiomics signature was constructed using the least absolute shrinkage and selection operator method(LASSO)penalized Cox regression analysis.Finally,an individualized prognostic scoring system incorporating radiomics signature and clinicopathologic risk factors was proposed for PFS prediction.Results:The established radiomics signature consisting of 16 features showed good discrimination for classifying patients with high-risk and low-risk progression to chemotherapy in all cohorts(All P<0.05).On the multivariable analysis,independent factors for PFS were radiomics signature,performance status(PS),and N stage,which were all selected into construction of RPSS.The RPSS showed significant prognostic performance for predicting PFS in discovery[C-index:0.772,95%confidence interval(95%CI):0.765-0.779],internal validation(C-index:0.738,95%CI:0.730-0.746),external validation(C-index:0.750,95%CI:0.734-0.765),and mutation validation(Cindex:0.739,95%CI:0.720-0.758).Decision curve analysis revealed that RPSS significantly outperformed the clinicopathologic-based model in terms of clinical usefulness(All P<0.05).Conclusions:This study established a radiomics prognostic scoring system as RPSS that can be conveniently used to achieve individualized prediction of PFS probability for stageⅣNSCLC patients treated with platinumbased chemotherapy,which holds promise for guiding personalized pre-therapy of stageⅣNSCLC.

Clinical observation of Shenmai injection in the treatment for adverse reactions of chemotherapy on advanced non-small cell lung cancer

Objective: To observe the efficacy of Shenmai injection in the treatment for adverse reactions of chemotherapy on advanced non-small cell lung cancer (NSCLC). Methods: 45 NSCLC patients with stages IIIb-IV were randomly divided into two groups: the treatment group (treated by chemotherapy combined with Shenmai injection) and the control group (treated by chemotherapy only). The efficacy of the two groups was evaluated after 3 cycles of treatment. Results: There was no significant difference between the two groups in the recent curative effects (P > 0.05), while there were significant differences between them in Karnofsky score and weight (P < 0.05). The treatment group was better than the control group in preventing leucopenia and decreased hemoglobin, and significant differences were found between them (P < 0.05). The incidence of thrombocytopenia, nausea and vomiting, hepatic and renal dysfunction in the treatment group was lower than that in the control group, but no significant differences were found between them (P > 0.05). Conclusion: Shenmai injection would not influence the efficacy of chemotherapy on advanced NSCLC patients, while it could improve the quality of life, increase the body weight of patients, alleviate adverse reactions of chemotherapy as myelosuppression so as to improve the tolerance of organism to chemotherapy.

Continuous intravenous infusion of recombinant human endostatin using infusion pump plus chemotherapy in non-small cell lung cancer

BACKGROUND Lung cancer is one of the deadliest cancers in the world with the highest incidence and mortality rate among all cancers.Non-small cell lung cancer(NSCLC)accounts for approximately 80%of primary lung cancer.However,efficacy and safety of the current regimens for NSCLC is unsatisfactory.Therefore,there has been an increasing urgency for development of potential therapeutic therapies for NSCLC.AIM To investigate the therapeutic outcomes and safety of continuous intravenous infusion of recombinant human endostatin(Rh-endostain)using an infusion pump in retreated advanced NSCLC.METHODS Patients with retreated advanced NSCLC who were admitted to Zhejiang Provincial People's Hospital from October 2017 to April 2019 were recruited.These patients received continuous intravenous infusion of Rh-endostain using an infusion pump.Objective response rate(ORR),clinical benefit rate(CBR),median progression-free survival(mPFS),and incidences of adverse events(AEs)were analyzed after treatment.RESULTS A total of 45 patients with retreated advanced NSCLC were included,and all of them were evaluated.In these patients,ORR was 22.2%,CBR was 84.4%,and mPFS was 5.3 mo.The following AEs were observed,decreased hemoglobin(34 cases,75.6%),nausea/vomiting(32 cases,71.1%),elevated transaminase(24 cases,53.3%),leukopenia(16 cases,35.6%),thrombocytopenia(14 cases,31.1%),and constipation(1 case,3.4%).None of the patients had leukopenia,nausea/vomiting,and constipation of grade III and above.CONCLUSION The patients showed improved adherence to 5-d continuous intravenous infusion of Rh-endostain using an infusion pump.Favorable efficacy and safety of this treatment regimen were achieved in retreated advanced NSCLC.

Is there an optimal time to initiate adjuvant chemotherapy to predict benefit of survival in non-small cell lung cancer?

Objective: Adjuvant chemotherapy (AC) after curative resection is known to improve the survival of patients with non-small cell lung cancer (NSCLC); however, few studies have reported the correlation between the time to initiation of AC (TTAC) and survival in NSCLC patients. Methods: The clinical data of 925 NSCLC patients who received curative resection and post-operative AC at the Cancer Hospital of Chinese Academy of Medical Sciences between 2003 and 2013 were retrospectively analyzed. TTAC was measured from the date of surgery to the initiation of AC. Disease-free survival (DFS) was defined as the duration from surgery to the time of tumor recurrence or last follow-up evaluation. The optimal cut-off value of TTAC was determined by maximally selected log-rank statistics. The DFS curve was estimated using the Kaplan-Meier method, and the Cox proportional hazards regression model was used to identify risk factors independently associated with DFS. Propensity score matching (PSM) was performed for survival analysis using the match data. Results: The optimal discriminating cut-off value of TTAC was set at d 35 after curative resection based on which the patients were assigned into two groups: group A (<= 35 d) and group B (> 35 d). There was no significant difference in the DFS between the two groups (P=0.246), indicating that the TTAC is not an independent prognostic factor for DFS. A further comparison continued to show no significant difference in the DFS among 258 PSM pairs (P=0.283). Conclusions: There was no significant correlation between the TTAC and DFS in NSCLC patients. Studies with larger samples are needed to further verify this conclusion.

Effect of EGFR-TKI retreatment following chemotherapy for advanced non-small cell lung cancer patients who underwent EGFR-TKI

Objective： Non-small cell lung cancer （NSCLC） patients with epidermal growth factor receptor （EGFR）-activating mutations have higher response rate and more prolonged survival following treatment with single-agent EGFR tyrosine kinase inhibitor （EGFR-TKI） compared with patients with wild-type EGFR. However, all patients treated with reversible inhibitors develop acquired resistance over time. The mechanisms of resistance are complicated. The lack of established therapeutic options for patients after a failed EGFR-TKI treatment poses a great challenge to physicians in managing this group of lung cancer patients. This study evaluates the influence of EGFR-TKI retreatment following chemotherapy after failure of initial EGFR-TKI within at least 6 months on NSCLC patients. Methods： ＇i-he data of 27 patients who experienced treatment failure from their initial use of EGFR-TKI within at least 6 months were analyzed. After chemotherapy, the patients were retreated with EGFR-TKI （gefitinib 250 mg qd or erlotinib 150 mg qd）, and the tumor progression was observed. The patients were assessed for adverse events and response to therapy. Targeted tumor lesions were assessed with CT scan. Results： Of the 27 patients who received EGFR-TKI retreatment~ 1 （3.7%） patient was observed in complete response （CR）, 8 （29.6%） patients in partial response （PR）, 14 （51.9%） patients in stable disease （SD）, and 4 （14.8%） patients in progressive disease （PD）. The disease control rate （DCR） was 85.2% （95% CI： 62%-94%）. The median progression-free survival （mPFS） was 6 months （95% CI： 1-29）. Of the 13 patients who received the same EGFR-TKI, 1 patient in CR, 3 patients in PR, 8 patients in SD, and 2 patients in PD were observed. The DCRwas 84.6%, and the mPFS was 5 months. Of the 14 patients who received another EGFR-TKI, no patient in CR~ 6 patients in PR, 6 patients in SD, and 2 patients in PD were observed. The DCRwas 85.7%, and the mPFS was 9.5 months. Significant difference was found between the two groups in PFS but not in response rate or D CR. Conclusion： Retreatment of EGFR-TKIs can be considered an option after failure of chemotherapy for patients who were previously controlled by EGFR-TKI treatment.

Docetaxel as salvage chemotherapy in patients with advanced non-small cell lung cancer after failure of cytotoxic agents and gefitinib treatment

Objective： We conducted a prospective phase II trial of single-agent salvage chemotherapy with docetaxel in patients with advanced non-small cell lung cancer （NSCLC） after failure of chemotherapy and gefitinib to assess the efficacy and toxicity of docetaxel in this setting. Methods： Patients with histologically confirmed NSCLC who were failure of chemotherapy and gefitinib were given docetaxel 75 mg/m^2 intravenously for 30 rain every 3 weeks until the toxicity was unacceptable or disease progressed. The response evaluation criteria in solid tumors （RECIST） guidelines were used for the evaluation of an- titumor activity. Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria version 2.0. Results： In total, 31 patients were enrolled in this phase II trial between February 2004 and December 2006, and 84 cycles （average 2.7 cycles） were given. We observed 4 partial responses （PRs） and 10 stable disease （SD） states in 31 eligible patients. The objective response rate was 12.9%, and the disease control rate was 45.2%. The median survival time （MST） was 10 months （95% CI, 5.05-15.08 months）. The 1-year survival rate was 40.6%. The most common toxicities were neutropenia, anemia, and peripheral neuropathy that occurred as follows： 45% of the patients experienced grade 3 or 4 neutropenia, 29% experienced grade 3 anemia, and 25.8% had grade 3 peripheral neuropathy. No patient terminated docetaxel chemotherapy due to toxicity. Conclusion： Docetaxel is beneficial as salvage chemotherapy in patients with advanced NSCLC after failure of cytotoxic agents and gefitinib.

Adjuvant Chemotherapy of Gemcitabine plus Carboplatin versus Paclitaxel plus Carboplatin in Patients with Resected Non-Small Cell Lung Cancer

Background: This retrospective study was to evaluate the efficacy and toxicity of gemcitabine plus carboplatin (GC regimen) and paclitaxel plus carboplatin (PC regimen) combination chemotherapy administered as an adjuvant therapy after complete resection of non-small cell lung cancer. Methods: Forty-four patients (GC regimen, n = 29;PC regimen, n = 15) received gemcitabine at a dose of 1000 mg/m2 on days 1 and 8, and carboplatin with the target dose of area under the curve (AUC) of 4 on day 8 every 28 days and paclitaxel at a dose of 70 mg/m2 on days 1, 8 and 15, and carboplatin with the target dose of AUC of 5 on day 1 every 28 days. Results: A total of 130 cycles of the treatment were administered (averaged, 3.1 in GC arm and 2.7 cycles in PC arm). Forty-three patients (97.7%) completed the scheduled cycles. One patient (2.3%) was discontinued due to grade 4 pneumonia. The dose was reduced in 2 patients (4.5%) due to grade 4 thrombocytopenia. Grade 3/4 neutropenia was significantly observed in the PC group (GC: 12/29, 41.4%;PC: 11/15, 73.3%, p = 0.0443). The nonhematological toxicities were mild. Grade 1/2 alanine aminotransferase and aspartate aminotransferase in the GC group was significantly observed higher compared to those of the PC group (GC: 20/29, 69.0%;PC: 4/15, 26.7%, p = 0.0076). Grade 1/2 alopecia was significantly observed in the PC group (GC: 0/25, 0.0%;PC: 13/15, 86.7%, p 0.0001). There was no treatment-related death. The median survival time (MST) of the entire GC group was 784 days, the 3-year overall survival (OS) was 75.9%, and 3-year recurrence-free survival (RFS) was 65.5%. The MST of the entire PC group was 963 days, the 3-year OS was 80.0%, and the 3-year RFS was 60.0%. Conclusion: These results demonstrate that the GC and PC combination chemotherapies are efficacious and feasible regimens, which should be considered as one of the standard therapies for adjuvant therapy.

Outcomes of Quality of Life Regarding the Next-Generation Thoracoscopic Intrapleural Hyperthermic Chemotherapy of Non-Small Cell Lung Cancer with Dissemination

Background: We have developed a new next-generation intrapleural hyperthermic chemotherapy (IPHC) for non-small cell lung cancer with dissemination, which is a hybrid chemotherapy combined with oral S-1 medication plus conventional cisplatin-based IPHC. We now report the preliminary feasibility and outcome of quality of life (QOL) regarding this hybrid IPHC. Methods: The patient was a 76-year-old male with a 2-cm nodule in the left upper lobe. After partial resection by video-assisted thoracic surgery (VATS), which was diagnosed with advanced pulmonary adenocarcinoma with intrapleural dissemination. We initially performed two regimens of systemic chemotherapy, S-1 (day 1 - 21, 100 mg 2X/day) + CDDP (day 8, 60 mg/m2) and S-1 (day 1 - 14,100 mg 2X/day) + CBDCA (day 1, AUC 5). The regimen of next-generation IPHC is oral S-1 medication (day 1 - 21, 100 mg/day) + intrapleural hyperthermic perfusion of cisplatin (200 mg/m2) with VATS (day 8,43°C, 2 hours). Adverse outcomes, QOL, and pleural effusion were assessed in three regimens. To investigate the outcomes of the QOL, the European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30 and QLQ-LC13), the QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ACD), the Cancer Dyspnea Score (CDS), and the St. George’s Respiratory Questionnaire (SGRQ) were used. Results: During the IPHC treatment course, grade 3 neutropenia, anemia, and diarrhea were observed. The physical function after IPHC became worse compared to that before the IPHC. Fatigue during chemotherapy (CBDCA+S-1) was more pronounced than that during the IPHC. Nausea, vomiting, and diarrhea during the IPHC were prevalent than those of chemotherapy. The overall QOL after the IPHC was improved compared to that before the IPHC. Regarding before and after the IPHC, the physical function after the IPHC became worse compared to that before the IPHC, on the other hand, the global QOL before and after the IPHC had not dramatically changed. Pleural effusion was controlled after the IPHC for more than 1 year. Conclusion: The first case of a clinical trial of the next-generation IPHC showed grade 3 adverse events. However, it was an acceptable feasibility compared to the usual platinum doublet chemotherapy. The effectiveness of the IPHC allowed the patient to obtain a good control of the pleural effusion and preserved the patient’s QOL.

Study on the Changes of Immune Factors in Different Stages of Non-Small Cell Lung Cancer Chemotherapy

Objective: To analyze various immune cytokines (NKG2D, IL-12, IL-15, IL-18, DC cells, TNF-a, IFN-r) and peripheral blood of patients with non-small cell lung cancer (NSCLC) at different times after chemotherapy. Changes in CD4+, CD8+, Th17 and IgG, IgM, and IgA levels. Methods: A total of 118 NSCLC patients who attended the Oncology Department of the Affiliated Hospital of Chengde Medical College from September 2018 to September 2021 were selected as the research objects, and the patients were analyzed at different time points (before chemotherapy, after the first chemotherapy, and after the second chemotherapy). The effects of NKG2D, IL-12, IL-15, IL-18, DC cells, TNF-A, IFN-r, CD4+, CD8+ Th17, IgG, IgM and IgA levels in peripheral blood at different time points (before chemotherapy, after the first chemotherapy and after the second chemotherapy) were analyzed. The changes of NKG2D, IL-12, IL-15, IL-18, DC cells, TNF-A, IFN-r and the levels of CD4+, CD8+ Th17, IgG, IgM and IgA in peripheral blood were compared at each time point. Results: NKG2D, IL-12, IL-15, IL-18, TNF-a, IFN-r gradually decreased before chemotherapy, one week after chemotherapy, and two weeks after chemotherapy, the difference was statistically significant, but DC cells were not significant Variety. CD4+ and CD8+ both increased significantly, and the levels of Th17, IgG, IgM, and IgA gradually decreased. Conclusion: In the course of chemotherapy, all immune factors except DC cells were significantly decreased compared with those before chemotherapy, and the decrease of immune factors except DC cells was positively correlated with the length of chemotherapy cycle. If additional immunotherapy is needed, it should be carried out in the early stage of chemotherapy.

Efficacy and safety of Kang’ai injection adjunct with TP chemotherapy for the treatment of non-small cell lung cancer: a systematic review and meta-analysis of randomized controlled trials

Background:Combination therapy with traditional Chinese medicine and chemotherapy was proposed as a therapeutic strategy for non-small cell lung cancer patients.Therefore,we performed a systematic review and metaanalysis of randomized controlled trials to assess effects of this combination therapy on non-small cell lung cancer.To evaluate the efficacy and safety of the Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy in the treatment of non-small cell lung cancer.Methods:A randomized controlled study of the Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy in the databases of China National Knowledge Infrastructure Database,WanFang Database,VIP Database,Sino-Med Database,PUBMED,EMBASE and Cochrane library was searched by computer.The literatures published from the database establishment to July 1,2020 were included in the search scope.After 2 evaluators independently evaluated and cross checked the quality of the study,Revman 5.3 was used to meta analyze the clinical effect of the Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy on patients with non-small cell lung cancer.Results:A total of 1,370 lung cancer patients were included in 20 RCTs.The results of meta-analysis showed that there were significant differences between the 2 groups in clinical efficacy(RR=1.32,95%CI(1.20,1.44)),quality of life(RR=1.44,95%CI(1.32,1.57)),immune function(MD=0.53,95%CI(0.23–0.83)),adverse reactions(RR=0.49,95%CI(0.41,0.58)).Conclusion:The Chinese patent medicine Kang’ai injection adjunct with TP chemotherapy is effective and safe in the treatment of non-small cell lung cancer,and has great prospects for further development.However,the quality of evidence was very low-to-moderate.Considering the poor quality of evidence,we are not very confident in the results.We look forward to more research and update results in the future and improve the evidence quality.

Effect of intensity modulated radiation therapy combined with paclitaxel+ endostar chemotherapy on serum malignant molecule levels in patients with locally advanced non-small cell lung cancer

Objective: To discuss the effect of intensity modulated radiation therapy combined with paclitaxel + endostar chemotherapy on serum malignant molecule levels in patients with locally advanced non-small cell lung cancer. Methods: Patients with locally advanced NSCLC who were treated in the hospital between February 2015 and January 2017 were collected and divided into control group (n=59) and research group (n=59) by random number table. Control group received the routine paclitaxel + endostar chemotherapy after the operation, and research group underwent intensity modulated radiation therapy combined with paclitaxel +endostar chemotherapy after the operation. The differences in serum levels of NSCLC-related tumor markers and angiogenesis indexes were compared between the two groups before and after treatment. Results: Before treatment, the differences in serum levels of NSCLC-related tumor markers and angiogenesis indexes were not statistically significant between the two groups. After treatment, serum TK1, CYFRA21-1, Pro-GRP, CEA, CA125 and SCC-Ag levels of research group were lower than those of control group;serum EGFR, COX-2, VEGF, HIF-1 and MMP-2 levels of research group were lower than those of control group. Conclusion:Postoperative intensity modulated radiation therapy combined with paclitaxel + endostar chemotherapy can effectively reduce the serum malignant molecule levels and optimize the illness in patients with local advanced NSCLC.

A pilot study of weekly docetaxel chemotherapy combined with regional hyperthermia for pretreated stage Ⅲ non-small cell lung cancer

Objective： To evaluate the feasibility and therapeutic effect of chemotherapy combined with regional radio frequency hyperthermia for pretreated locally advanced non-small cell lung cancer. Methods： 29 patients with stage Ⅲb non- small cell lung cancer were enrolled in present study, administered chemotherapy up to 4 cycles and radio frequency hyperthermia up to 32 times. The primary end points were grade 3, 4 hematological or non-hematological toxicities and progression free survival, the secondary end points were response rate, tumor control rate and overall survival. Method of Kaplan-Meier was used to do the survival analysis. Results： 21 patients completed whole treatment. The most common grade 3, 4 toxicity was neutropenia （24.1%）. Median progression free survival was 4 months （range 0-13 months）, one year progression free survival rate was 10.3%, Overall response rate was 25.9%, tumor control rate was 66.6%. Median overall survival was 11 months （range 2-18^＊ months）, one year overall survival rate was 44.8%. Conclusion： Treatment of chemotherapy in conjunction with regional hyperthermia was safe and well tolerant, and it showed an impressive tumor control rate and an acceptable one year progression free survival.

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.

Clinical analysis of preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced non-small cell lung cancer

Objective:The purpose of this study was to assess the curative effect and adverse reaction of preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced non-small cell lung cancer(NSCLC).Methods:This prospective randomized controlled trial included 115 patients with locally advanced NSCLC were randomly divided into experimental and control groups and were treated from January 2007 to January 2010.The experimental group of 63 cases was treated with two cycles of induction chemotherapy before operation,radical surgery had been performed about three weeks after completion of chemotherapy,followed by received two cycles of chemotherapy.And the control group(52 cases) was treated at first with radical surgery,then treated with four cycles of chemotherapy.Two groups of the cases received routine thoracic radiotherapy with a total dose of 45 Gy.One cycle of gemcitabine combined with cisplatin regimen included gemcitabine 1000 mg/m2 on day 1 and day 8 and cisplatin 25 mg/m2 on day 1,day 2 and day 3 by intravenous infusion,with 21 days as one cycle.The tumor recurrence was evaluated by chest CT and abdominal B-ultrasound.Efficacy and toxicity results were compared by two groups.Results:All patients were followed up for three months to two years.The surgical stage of the experimental group reduced,two-years disease-free survival and postoperative recovery in the experimental group were better than in the control group,the difference was statistical significant.Toxicity and side effect after chemotherapy were mainly bone marrow suppression and gastrointestinal reactions,other complications included thrombocytopenia,leukopenia,anemia,liver and kidney dysfunction were no significant difference in two groups.Conclusion:Preoperative induction chemotherapy with gemcitabine combined with cisplatin for locally advanced lung cancer can reduce the surgical staging and extend the postoperative disease-free survival.

Clinical study of docetaxel-vinorelbine as second-line chemotherapy in advanced non-small cell lung cancer

Objective： To evaluate the efficacy and toxicity of docetaxel and vinorelbine as second-line chemotherapy in the treatment of advanced non-small cell lung cancer （NSCLC）. Methods： 48 histologically or cytologically confirmed NSCLC patients with progressive or recurrent disease after first-line treatment were treated with docetaxel and vinoretbine. The chemotherapy included vinorelbine （25 mg/m^2） on days 1,5 and docetaxel （60 mg/m^2） on day 1. The treatment was repeated every 3 weeks. Patients receiving at least two cycles were evaluated for efficacy and toxicity. Results： Of 48 patients, 1 patient achieved complete response and 16 achieved partial response. Overall response rate for all 48 patients was 35.4% （17/48）. Main hematologic toxicities included neutropenia （60.4%） and febrile neutropenia （29.2%） and non-hematologic toxicities were mild. Conclusion： The combination of docetaxel-vinorelbine as second-line chemotherapy is an effective regimen with manageable toxicity for the treatment of advanced NSCLC. Further studies may confirm these results.

Induction chemotherapy followed by weekly paclitaxel and carboplatin with concurrent radiotherapy in inoperable stage Ⅲ non-small cell lung cancers: results of a phase Ⅱ trial

Objective： several trials have suggested the superiority of concurrent chemoradiotherapy. It has been hypothesized that the addition of systemic dose sequential chemotherapy to concurrent chemoradiotherapy, as induction or as consolidation, might further improve survival rates. So we sought to evaluate the safety and efficacy of induction paclitaxel and carboplatin followed by weekly paclitaxel and carboplatin with concurrent radiotherapy in inoperable stage III non-small cell lung cancer （NSCLC）. Methods： Fifty-six patients with stage III inoperable NSCLC received induction chemotherapy with 2 cycles of paclitaxel 200 mg/m2 and carboplatin AUC-6 every 3 weeks then patients were assigned to concurrent chemoradiotherapy with paclitaxel 45 mg/m2 and carboplatin AUC-2 weekly along with concurrent radiotherapy at dose of 60 Gy （1.8 Gy/d x 5 d/week）. Results： Median age of the 56 eligible patients was 61 years, most of them were males （87.5%）. Squamous cell carcinoma was the most common pathological type （55.4%） and 85.7% had a performance status of 1. The majority of patients were presented with stage IIIB （62.5%）. Neutropenia was the most common toxicity during induction therapy （12.5% expressed grade 3） whereas esophagitis was the most common non hematologic adverse reaction during concurrent chemoradiotherapy （14.3% of grade 3）. The overall response rate was 71.6% with complete response in 19.6%. After median follow up of 20 months, the median survival time was 13 months （95% CI： 10.917-15.083） and 1 year overall survival rate was 53.6%. Conclusion： This regimen has demonstrated an acceptable toxicity profile and encouraging response to treatment. Evaluation of this regimen in larger number and a phase III trial are recommended.

Clinical study of interventional preoperative bronchial artery infusion chemotherapy combined with surgical resection for advanced non-small cell lung cancer

Objective： How to improve the postoperative 5-year survival rate for lung cancer and to give more patients a chance of surgery have become research hotspots. The aim of this research is to evaluate the clinical and pathohistological responses and effects of preoperative bronchial artery infusion （BAI） chemotherapy in patients with locally advanced （stage Ⅲ） non-small cell lung cancer （NSCLC）. Methods： A total of 92 patients with locally advanced NSCLC were randomly divided into two groups. BAI group received BAI chemotherapy for 2 cycles before surgical resection. Surgery group received operation only. The complete resection rate and clinical response were compared between the two groups. Results： In the BAI group, the clinical response rate and the pathohistological response rate were 68.3% and 51.3%, respectively. The complete resection rate in the BAI group was 89.7%, which was significantly higher than that in the surgery group （72.5%） （P 〈 0.05）. The 1- and 2-year survival rate was 100.0% and 80.6% in the BAI group, and 94.1% and 60.0% in the surgery group. Conclusion： BAI neoadjuvant chemotherapy is safe and effective, which has a good clinical and pathohistological response. It might increase the complete resection rate of the tumor and improve the long term survival rate of stage Ⅲ NSCLC patients.