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TMR Cancer 2019年第2期2卷 170-180页

作者： Liu Pu Wei-Hao Chen Kun-Ji Wu Ji-Huan Lin Cheng-Lu Li Shu-Lian Chen Lu-Xi Cao Shi-Qi Wang Shu-Jun Lin Yi-Min Zhang Ming-Min Zhu Traditional Chinese Medical College Jinan University 601 Huangpu West Avenue Guangzhou 510632 China College of Stomatology Jinan University 601 Huangpu West Avenue Guangzhou 510632 China

Objective: To evaluate the immunoregulation of KangAi (KA) injection combined with chemo-treatment (chemo) for non-small cell lung cancer (NSCLC). Methods: We systematically searched the literature of PubMed, EMBASE, CENTRAL, MEDLINE, CNKI, Wanfang, and VIP databases for all Randomized controlled trials (published from the earliest possible year to January 2019, no language restrictions) comparing KA injection combined with chemo and chemo alone in patients with NSCLC. Our main endpoints were immune function, clinical efficiency, KPS score and adverse events. The Cochrane Risk of Bias tool was applied for quality assessment. Results: 11 studies involving 1060 participants were included. The immune function (MD=3.18, 95% CI: 0.98-4.00, P<0.00001), clinical response rate (RR=1.28, 95%CI: 1.17-1.40, P<0.00001), KPS score (RR=1.86, 95%CI: 1.35-2.57, P=0.0002), and adverse events (RR=0.57, 95%CI: 0.50-0.65, P<0.00001) in the group of KA injection plus Chemo were vastly different from those in Chemo alone. Conclusion: KA injection combined with Chemo in the treatment of NSCLC improved the immune function, clinical efficiency and safety compared to Chemo alone. However, because many of the methodologies included in randomized controlled trials are of poor quality, more rigorous design and large randomized controlled trials are needed to test this benefit.

关键词： non-small cell lung cancer KangAi injection Immunoregulation

Resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer

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Science Foundation in China 2019年第1期27卷 72-80页

作者：周清魏雪武高欣何韵婷杨潇蓉 Guangdong Lung Cancer Institute Guangdong General Hospital and Guangdong Academy of Medical Sciences School of Medicine South China University of TechnologyGuangzhou Higher Education Mega Center Second School of Clinical Medicine Southern Medical University

Treatment with epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKIs) prolongs the overall survival of patients with EGFR-mutated advanced non-small-cell lung cancer(NSCLC). EGFR-TKIs including first-generation(e.g., gefitinib and erlotinib), second-generation(e.g., afatinib and dacomitinib) and third-generation(e.g., osimertinib) drugs are effective for the treatment of EGFR-mutated NSCLC. However, almost all patients exhibit drug failure related to resistance including primary and acquired resistance. Several mechanisms involved in primary and acquired resistance to EGFR-TKIs have been reported recently. Primary resistance to EGFR-TKIs involves point mutations in exon 18, deletions or insertions in exon 19, insertions, duplications and point mutations in exon 20 and a point mutation in exon 21 of the EGFR gene. Acquired resistance to EGFR-TKIs can be characterized into two groups: resistance to first-and second-generation EGFR-TKIs, and resistance to third-generation EGFR-TKIs. The third-generation EGFR-TKI resistance group presents a complex model including EGFR C797 S mutations, erb-b2 receptor tyrosine kinase 2 gene(ERBB2) amplification, BRAF V600 E mutations, ROS1 fusion, and MNNG HOS transforming gene(c-Met) amplification. Personalized diagnosis and monitoring as well as the development of next generation drugs are desperately needed for better survival outcomes in EGFR mutant NSCLC patients. In this article, we review these mechanisms and discuss the latest therapeutic strategies to overcome resistance to EGFR-TKIs.

关键词： Epidermal growth factor receptor tyrosine kinase inhibitors non-small cell lung cancer Primary resistance Acquired resistance

Safety and Efficacy of Racotumomab-Alum Vaccine as Second-Line Therapy for Advanced non-small Cell Lung Cancer

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International Journal of Clinical Medicine 2014年第14期5卷 844-850页

作者： Eduardo Santiesteban Leslie Perez Sailyn Alfonso Elia Neninger Soraida Acosta Yoana Flores Maurenis Hernandez Carmen Viada Robin García Meylán Cepeda Daymys Estevez Yoisbel Moreno Amparo Macías Celestino Hernández Robau Hospital Villa Clara Cuba Center of Molecular Immunology Havana Cuba Hermanos Ameijeiras Hospital Havana Cuba José Ramón López Tabranes Hospital Matanzas Cuba National Institute of Oncology and Radiobiology Havana Cuba Saturnino Lora Hospital Santiago de Cuba Cuba

Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The aim of this study was to evaluate safety and efficacy of racotumomab-alum in advanced NSCLC patients with progressive disease. This expanded access program included 86 histologically confirmed NSCLC patients, 18 years or older age, with advanced disease and without therapeutic option, with ECOG performance status ≤3, adequate organ functions and signed informed consent. The primary endpoint was overall survival and toxicity was measure assessed treatment-related toxicity according CTCAEv3. The study was approved by ethical review boards of participant institutions. Racotumomab-alum treatment consisted in 5 biweekly intradermal doses (1 mg/mL) during the induction phase of treatment (2 months). The maintenance phase consisted in monthly re-immunizations until unacceptable toxicity or PS worsening. The median overall survival time of all patients treated with racotumomab-alum was 8.96 months. The survival rates at 12 and 24 months were 42.8% and 28.0%, respectively. Patients that completed the induction phase of treatment (five doses or more) reached a median OS of 12.1 months. The most common adverse events were injection site reaction, bone pain, cough and asthenia. Racotumomab-alum cancer vaccine could be considered an effective and safe treatment option as second-line therapy for advanced NSCLC. Further clinical studies should be conducted to confirm this result.

关键词： non-small Cell Lung Cancer Cancer Vaccine Second-Line Treatment

Association of Polymorphic Variants of VEGFand KDRGenes with Development and Metastasing of non-small Cell Lung Cancer

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Journal of Cancer Therapy 2018年第9期9卷 714-728页

作者： А. N. Shchayuk E. V. Krupnova M. N. Shapetska A. P. Mikhalenka N. V. Chebotareva A. V. Kilchevsky Institute of Genetics and Cytology National Academy of Sciences of Belarus Minsk Republic of Belarus Belarusian State Medical University Minsk Republic of Belarus

Vascular endothelial growth factor (VEGF) is one of the most important and specific factors affecting angiogenesis in tumor development. VEGFR2 is a receptor encoded by the KDR gene. VEGF and VEGFR2 transmit a signal to intracellular tyrosine kinase cascades. Polymorphic variants of the VEGF and KDR genes significantly influence the expression levels of the endothelial growth factor and its receptor, which leads to a change in the activation of angiogenesis in oncopathological processes. In this study, the relationship between the polymorphic variants rs2010963, rs699947 and rs3025039 of the VEGF gene and rs1870377 and rs2071559 of the KDR gene was analyzed with the development of a specific histological type of non-small cell lung cancer and its clinical and morphological characteristics. It was established that the development of squamous cell carcinoma is associated with -634CC genotype of the VEGF gene and the genotypes containing -2578A allele of the VEGF gene reduce the likelihood of this cancer type development. The development of adenocarcinoma is associated with +936CC VEGF/1719TT KDR and +936CT VEGF/1719TT KDR combinations. In women with non-small cell lung cancer, -634GC genotype of the VEGF gene is associated with a greater degree of the primary lesion spread. Genotype -2578СС of the VEGF gene is associated with a higher degree of the primary tumor spread in the general group of patients and with regional metastases in women. Haplotypes -634G/-2578C/+936C are risky for the occurrence of metastases in regional lymph nodes in women.

关键词： non-small Cell Lung Cancer Angiogenesis Vascular Endothelial Growth Factor VEGF Gene Polymorphism KDR Gene Polymorphism

Analysis of prognostic factors for overall survival in patients with advanced non-small cell lung cancer treated with second line chemotherapy

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Advances in Lung Cancer 2013年第3期2卷 55-61页

作者： Milan Rancic Lidija Ristic Marina Cekic Tatjana Pejcic Department for Pulmonary Oncology Clinic for Lung Diseases Clinical Center Nis Nis Serbia

Aim: The aim of this study was to investigate prognostic factors for survival in patients with advanced NSCLC who receiving second-line chemotherapy. Methods: We retrospectively reviewed data of 116 patients with NSCLC receiving second-line treatments from October 2010 to December 2012 in Clinic for Lung Diseases of Clinical center Nis, Department for Pulmonary Oncology. Thirteen potential prognostic factors were chosen for analysis. Univariate analysis was conducted to identify prognostic factors associated with progression free survival and overall survival. Multivariate analysis included the prognostic significance factors in univariate analysis. Results: The univariate analysis for progression free survival (PFS) and overall survival (OS) was identified to have prognostic significance: performance status, smoking, weight loss, comorbidity, number of meta localization, first-line chemotherapy regimen and response to first-line chemotherapy. Nevertheless, multivariate Cox prortional hazard regression analysis showed that performance status (PFS: p = 0.000, OS: p = 0.000) weight loss ≥ 5% (PFS: p = 0.000, OS: p = 0.002), comorbidity (PFS: p = 0.001, OS: p = 0.012) and four places of meta localization (PFS: p = 0.021, OS: p = 0.021) were considered independent prognostic factors for both, progression free survival and overall survival. Conclusion: Performance status, weight loss ≥ 5%, comorbidity and higher number of meta localization were identified as prognostic factors for survival in advanced NSCLC patients receiving second-line chemotherapy treatment. These findings may help pretreatment prediction of survival and may facilitate in the future integration new agents into second-line treatment.

关键词： Carcinoma non-small Cell Lung Cancer Treatment Protocol Prognosis Survival

A phase I study with Satraplatin and simultaneous chest radiation for non-small cell lung cancer

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Advances in Lung Cancer 2012年第3期1卷 13-19页

作者： Puneeth Iyengar Joseph C. Hodges Randall Hughes Michael DiMaio Michael Petrone Soyong Yun Hak Choy Department of Radiation Oncology University of Texas Southwestern Dallas USA Department of Thoracic Medical Oncology University of Texas Southwestern Dallas USA Department of Thoracic Surgical Oncology University of Texas Southwestern Dallas USA Formerly of GPC Biotech Princeton USA

Introduction: Satraplatin has been given in combination therapy for lung cancer to utilize its radio-sensitizing properties. The optimal dose of satra-platin given concurrently with radiation therapy for locally advanced non-small cell lung cancer (NSC-LC) has not been defined. This phase I trial attempts to identify a maximally tolerated dose (MTD) and dose limiting toxicity (DLT) for Satraplatin given con-currently with radiation for locally advanced N-SCLC. Patients and Methods: 15 patients with histologically confirmed Stage IIIA/B NSCLC entered onto this study with four dose escalations (10 to 40 mg daily) of Satraplatin. Eligibility included patients with NSCLC and one of the following criteria: 1) previously untreated, inoperable disease and planned to receive radiation therapy to primary disease site;2) previously resected disease with mediastinal relapse;or 3) metastatic disease in no more than one distant site. Results: The most common toxicities reported were all grades of fatigue (n = 9), nausea (n = 9), constipation (n = 7), fever (n = 7), and vomiting (n = 6). No DLT at the 1st, 2nd, and 3rd dose levels was identified. At the 4th dose level, one patient developed grade III elevation of liver function tests (LFTs) and a second patient developed grade III diarrhea with fever requiring hospitalization. There were 8 partial responses out of 11 evaluable patients for response (RR 67%). Conclusion: Elevated LFTs and diarrhea appear to be the principal DLTs of concurrent daily oral Satraplatin and thoracic radiation in the outpatient setting. The MTD of concurrent Satraplatin with thoracic radiation therapy appears to be 40 mg daily.

关键词： non-small Cell Lung Cancer Chemoradiation Satraplatin Phase I Study Toxicity

Long-term survival of more than 3 years among patients with advanced non-small cell lung cancer treated with chemotherapy

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World Journal of Respirology 2013年第3期3卷 110-115页

作者： Rieko Kaira Kyoichi Kaira Takehito Shukuya Hirotsugu Kenmotsu Akira Ono Haruyasu Murakami Asuka Tsuya Yukiko Nakamura Tateaki Naito Masahiro Endo Nobuyuki Yamamoto Toshiaki Takahashi Division of Thoracic Oncology Shizuoka Cancer Center Sunto-gun Shizuoka 411-8777 Japan Division of Diagnostic Radiology Shizuoka Cancer Center Sunto-gun Shizuoka 411-8777 Japan

AIM: To evaluate the prognostic factors of long-term survival of more than 3 years in patients with advanced non-small cell lung cancer(NSCLC). METHODS: We retrospectively analyzed the records of 474 patients with advanced ⅢB/Ⅳ NSCLC who received chemotherapy as initial treatment between September 2002 and March 2007.RESULTS: The median survival time(MST) was 12.5 mo and the 3 year and 5 year survival rates were 14.6% and 5.3%, respectively. Long-term survival of more than 3 and 5 years was observed in 65 and 16 patients, respectively. The MST for the 65 patients was61.5 mo(range, 60.1-81.0 mo). In the 474 patients, a good performance status(PS), female sex, non-smoking status and adenocarcinoma histology were significantly associated with a favorable outcome. Furthermore, female sex, a good PS, non-smoking status and adenocarcinoma histology were significantly correlated with longterm survival of more than 3 years and most of these patients(89.2%, 58/65) received epidermal growth factor receptor-tyrosine kinase inhibitors as any line treatment. Survival analysis of long-term survivors showed that a PS of 0 was an independent prognostic factor for predicting favorable outcomes. CONCLUSION: Our results suggest that a good PS and adenocarcinoma histology play an important role in long-term survival of more than 3 years. A PS of 0 was an independent prognostic factor for predicting favorable outcomes in patients with advanced NSCLC who survived for more than 3 years.

关键词： non-small cell lung cancer Long-term survivor Chemotherapy Performance status Epidermal growth factor receptor-tyrosine kinase inhibitors

Clinical Biomarkers and Prognosis in Taiwan Residents Patients with non-small Cell Lung Cancer (NSCLC)

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Journal of Cancer Therapy 2012年第4期3卷 412-423页

作者： Yixia Li Yea-Jyh Chen Li-Jung Chang Michael Hendryx Juhua Luo Department of Community Medicine School of Medicine West Virginia University Morgantown USA Department of Nursing Tzu Chi College of Technology Hualien Taiwan School of Nursing West Virginia University Morgantown USA

Introduction: Lung cancer is the leading cause of cancer death worldwide with poor survival rates. However, the prognostic factors for survival of patients with lung cancer are not well-established. In this study, we examined the impact of routine laboratory biomarkers and traditional factors on survival of patients with non-small cell lung cancer (NSCLC). Method: Secondary data analysis was conducted from a retrospective study of 404 patients with newly diag-nosed lung cancer in 2005-2007 in Taiwan. There were eight routine laboratory biomarkers and eight traditional factors investigated in the analyses. Cox proportional hazards model was used to assess the hazard ratios for the association between risk factors and patient overall survival. The Kaplan-Meier method was used to compare survival curves for each prognostic indicator. Results: High WBC counts (HR = 1.798, 95%CI: 1.225 - 2.639), low Hgb level (HR = 1.437, 95%CI: 1.085 - 1.903), and low serum albumin level (HR = 2.049, 95%CI: 1.376 - 3.052) were significant laboratory prognostic biomarkers for poor NSCLC survival. Additionally we confirmed the traditional prognostic factors for poor overall survival among NSCLC patients, including older age, comorbidity conditions, advanced cancer stage, and non-surgical treatment. Conclusions: This study identified three available laboratory biomarkers, high WBC counts, low Hgb level, and low serum albumin level, to be significant prognostic factors for poorer overall survival in NSCLC patients. Further prognostic evaluation studies are warranted to compare different ethnic groups on the prognostic values of these clinical parameters in NSCLC survival outcomes. These identified prognostic biomarkers should be included in early risk screening of hospitalized lung cancer patient population.

关键词： Clinical Biomarkers non-small Cell Lung Cancer (NSCLC) Prognostic Factors

Promoter Methylation of the CADM1 and 4.1BGenes Occurs Independently of the EGFRor the KRAS2 Mutation in non-small Cell Lung Cancer

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Journal of Cancer Therapy 2015年第3期6卷 273-285页

作者： Hiroyuki Kogai Shinji Kikuchi Takashi Obana Yumi Tsuboi Tomoko Maruyama Mika Sakurai-Yageta Hisao Asamura Yae Kanai Yoshinori Murakami Division of Molecular Pathology Institute of Medical Science The University of Tokyo Tokyo Japan Division of Thoracic Surgery National Cancer Research Center Hospital Tokyo Japan Division of Pathology National Cancer Research Center Research Institute Tokyo Japan

Objective: Targeting mutated EGFR by EGFR-tyrosine kinase inhibitors (EGFR-TKI) is a potent approach to a subset of non-small cell lung cancer (NSCLC). However, the response to EGFR-TKI varies in individual cases even among tumors carrying the same?EGFR?mutation, suggesting the involvement of modifying factors. To characterize possible modifiers, we examined mutation state of the?EGFR?and the?KRAS?genes in Japanese NSCLC and compared them with the methylation state of lung tumor suppressors, the?CADM1 and?4.1B,?whose products have potentials to modify the functions of EGFR or KRAS. Materials and methods: A total of 103 Japanese NSCLC and 11 NSCLC cell lines were examined. Genomic DNA of exons 18–21 of the?EGFR?and exons 1 and 2 of the?KRAS?were amplified by polymerase chain reaction (PCR), followed by single-strand conformation polymorphism analysis and direct sequencing. Methylation status of gene promoters in NSCLC cells were examined by methylation-specific PCR. Results: Mutations of the?EGFR?and?KRAS?were detected mutually exclusively in 27 and 11 out of 103 NSCLC cases, respectively.?EGFR?mutations were observed exclusively in adenocarcinoma (27 of 69, 41%) and preferentially in tumors from female and non-smokers (p < 0.00001). Eight (30%) and 12 (44%) of 27 tumors carrying mutated?EGFR?and 4 (36%) and 8 (73%) of 11 tumors carrying mutated?KRAS?showed methylation of the?CADM1 and 4.1B, respectively.?EGFR-mutated tumors with methylation of either?CADM1 or 4.1B?showed more malignant features than those with unmethylated?CADM1 and 4.1B?(p < 0.05). Conclusion: Methylation state of the?CADM1 and?4.1B?are independent of the mutation status of the?EGFR?or?KRAS?but play roles in the malignant progression of NSCLC. Integration of epigenetic information would be useful for identifying possible modifiers to predict the response or recurrence of lung adenocarcinoma to the EGFR-TKI therapy.

关键词： non-small Cell Lung Cancer EGFR Mutation KRAS Mutation CADM1 Methylation 4.1B Methylation

Multicenter cooperative observational study of idiopathic pulmonary fibrosis with non-small cell lung cancer

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World Journal of Respirology 2016年第1期6卷 42-48页

作者： Noriyuki Ebi Shoji Tokunaga Kazunobu Itoh Isamu Okamoto Nobutaka Edakuni Shinji Fujii Kentaro Watanabe Shinichiro Hayashi Takashige Maeyama Yoichi Nakanishi Department of Respiratory Oncology Iizuka Hospital Department of Medical Informatics Kyushu University Hospital Division of Respiratory Medicine Shinbeppu Hospital Research Institute for Diseases of the Chest Graduate School of Medical SciencesKyushu University Division of Respirology Neurology and Rheumatology Department of Medicine Kurume University School of Medicine Division of Respiratory Disease Kumamoto Regional Medical Center Department of Respiratory Medicine Fukuoka University Hospital Department of Internal Medicine Faculty of MedicineSaga University

AIM: To research the natural course of idiopathic pulmonary fibrosis(IPF) with advanced non-small cell lung cancer(NSCLC) and the association between acuteMETHODS: From May 2007 through April 2011, 17 CT naive patients with IPF and advanced NSCLC were enrolled. Patients were classified into best supportive care(BSC) group or CT group based on the patient's preference. Patients in the CT group received carboplatin(CBDCA)(AUC 5-6) plus paclitaxel(PTX)(175-200 mg/m2) on day 1 of each 21-d cycle as first-line therapy.RESULTS: All patients but one chose the CT group. In the CT group, the objective response rate was 38%. The most frequent toxicity ≥ grade 3 was neutropenia(88%). Two patients(12.5%) developed AE-IPF. The median progression-free survival, the median survival time and the 1-year survival rate were 4.1 mo, 8.7 mo and 35%, respectively. Second-line CT-related AE and CT-unrelated AE occurred in 2 and 3 patients(1: BSC group; 2: CT group), respectively. Seven(41%) of all patients developed AE-IPF throughout the clinical course, and 6 of 7 patients with AE-IPF died within one month.CONCLUSION: The incidence of AE-IPF was higher among IPF patients with advanced NSCLC than among those without NSCLC. CBDCA plus PTX regimen was tolerable and effective. However, AE-IPF has a fatal toxicity with or without CT in IPF patients with advanced NSCLC.

关键词： non-small cell lung cancer Chemotherapy Idiopathic pulmonary fibrosis Acute exacerbation Best supportive care