scholarly journals Atezolizumab in a CoHort of pretreated, advanced, non-small cell lung cancer patients with rare HistologiCal SubtypEs (CHANCE trial)

2020 ◽  
Vol 12 ◽  
pp. 175883592091598
Author(s):  
Francesco Gelsomino ◽  
Giuseppe Lamberti ◽  
Marcello Tiseo ◽  
Danilo Rocco ◽  
Giulia Pasello ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Unmet Need ◽  
Sarcomatoid Carcinoma ◽  
The United States ◽  
Small Cell ◽  
European Medicines Agency ◽  
Small Cell Lung ◽  
Nsclc Patients

Background: Although immunotherapy with immune-checkpoint inhibitors (ICIs) has profoundly changed the therapeutic scenario in the treatment of advanced non-small cell lung cancer (NSCLC), trials of ICIs only enrolled NSCLC patients with common histology. Atezolizumab was approved by the United States Food and Drug Administration (US FDA) in October 2016 and by the European Medicines Agency (EMA) in September 2017 for the treatment of patients with metastatic NSCLC whose disease progressed during or following platinum-containing chemotherapy, regardless of PD-L1 expression. Methods: We designed a single-arm, multicenter, two-stage phase II study and plan to enroll 43 patients. The primary objective of the study is to evaluate the antitumor activity of atezolizumab in advanced NSCLC patients with rare histology subtypes. Patients with prior atezolizumab or ICI treatment and with untreated, symptomatic, or progressing brain metastases will be excluded. The primary endpoint is disease control rate. Secondary objectives are toxicity and safety, overall response rate, progression-free survival, overall survival, and time to progression. Diagnosis of NSCLC with rare histology will be confirmed by central pathology revision, and will include: colloid carcinoma, fetal adenocarcinoma, non-endocrine large cell carcinoma, sarcomatoid carcinoma, salivary gland-type tumor, lymphoepithelioma-like carcinoma, and NUT-nuclear protein in testis carcinoma. Archival tumor tissue is required for correlative studies of PD-L1 expression on tumor cells and tumor infiltrating lymphocytes. Conclusions: Therapeutic options in NSCLC with rare histology subtypes, to be assessed in specifically designed trials, are an unmet need. This trial will help elucidate the role of atezolizumab as a viable option in this setting.

scholarly journals Dabrafenib in combination with trametinib in the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer: clinical evidence and experience

2018 ◽  
Vol 12 ◽  
pp. 175346661876761 ◽  
Author(s):  
Arjun Khunger ◽  
Monica Khunger ◽  
Vamsidhar Velcheti
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Braf V600e Mutation ◽  
Mitogen Activated Protein Kinase ◽  
Braf V600e ◽  
European Medicines Agency ◽  
Small Cell Lung ◽  
Nsclc Patients

Mutations in the BRAF oncogene are found in 2–4% of all non-small cell lung cancer (NSCLC) patients. The most common activating mutation present within the BRAF oncogene is associated with valine substitution for glutamate at position 600 (V600E) within the BRAF kinase. BRAF-targeted therapies are effective in patients with melanoma and NSCLC harboring BRAF V600E mutation. In both melanoma and NSCLC, dual inhibition of both BRAF and the downstream mitogen-activated protein kinase (MEK) improves response rates compared with BRAF inhibition alone. BRAF-MEK combination therapy (dabrafenib plus trametinib) demonstrated tolerability and efficacy in a recent phase II clinical trial and was approved by the European Medicines Agency and United States Food and Drug Administration for patients with stage IV NSCLC harboring BRAF V600E mutation. Here, in this review, we outline the preclinical and clinical data for BRAF and MEK inhibitor combination treatment for NSCLC patients with BRAF V600E mutation.

Is survival improving in stage IV non-small cell lung cancer?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6577-6577
Author(s):  
A. E. Birnbaum ◽  
T. Ng ◽  
B. O'Connor ◽  
A. Plette ◽  
D. Berz
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Stage Iv ◽  
The United States ◽  
Small Cell ◽  
Small Cell Lung ◽  
Metastatic Nsclc ◽  
Time Period ◽  
Nsclc Patients

6577 Background: Non small cell lung cancer (NSCLC) represents the number one cause of cancer mortality in the United States. Over several decades clinical research has focused on the development of new, more active chemotherapeutic drugs to improve survival. Over the time period from 1994 to 2003 six drugs have been approved for the treatment of metastatic NSCLC. We are presenting a population based analysis of the survival in patients with metastatic NSCLC in the US from 1981–1990, 1991–1997 and 1998–2003. We also provide a pharmaco-economic view of this observation. Methods: We analyzed the SEER (Surveillance, Epidemiology, and End Results) program database for cancer specific survival rates in stage IV NSCLC patients who were diagnosed between 1980 and 2003 in the SEER catchment geographic areas. The primary exposure of interest was the year of diagnosis. Results: We identified 52,086 eligible patients in total. 8,950, 21,111 and 18,712 patients were diagnosed 1981 to1990, 1991 to 1997 and 1998 to 2003 respectively. The cox proportional hazard ratios were 0.97 (95% CI 0.94–0.99) and 0.85 (0.83–0.88) for the time periods 1991 to 1997 and 1998 to 2003, respectively, using the time period from 1981 to1990 as reference. This subtle increase in survival was strictly paralleled by increasing costs for the medical care of this patient population. Conclusions: The survival of stage IV NSCLC patients seems to be mildly improving, what is paralleled by increasing cost for the care of those patients. [Table: see text] No significant financial relationships to disclose.

Costs of care associated with non-small-cell lung cancer in a commercially insured cohort.

1998 ◽  
Vol 16 (4) ◽  
pp. 1420-1424 ◽  
Author(s):  
B E Hillner ◽  
M K McDonald ◽  
C E Desch ◽  
T J Smith ◽  
L T Penberthy ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Survival Rates ◽  
The United States ◽  
Small Cell ◽  
Small Cell Lung ◽  
Nsclc Patients ◽  
Hospital Days ◽  
Incident Cases

PURPOSE To examine the cost of incident cases of non-small-cell lung cancer (NSCLC) in a commercially insured cohort. METHODS Claims from Virginia Blue Cross and Blue Shield (BCBS) beneficiaries with lung cancer from 1989 to 1991 were merged with records from the Virginia Cancer Registry (VCR). Data from the VCR identified incident cases, stage, and type of cancer at diagnosis. Costs for all medical care included insurance payment, copayments, and deductibles for 2 years after diagnosis or until death. RESULTS Three hundred forty-nine incident NSCLC patients were evaluated. The mean 2-year cost for each patient after diagnosis or until death was $47,941 (95% confidence interval, $43,758 to $52,124). Total average costs and hospital days were significantly lower for local disease ($37,514, 21.2 days), but were similar for regional ($52,797, 30.0 days) and distant ($49,382, 33.0 days) disease. Hospital days accounted for 48% and hospital-based claims for 70% of costs. Initial treatments, which included radiation, unadjusted for stage, had the lowest survival rates and the highest costs, and were associated with the most hospital days. Initial stage, race, gender, and age were not predictors of total 2-year costs. The independent predictors of total 2-year costs were type of treatment: any radiation therapy, any surgery, or any chemotherapy (all, P < .001). Inpatient hospital days was only a modest predictor of costs after adjusting for type of treatment. Patients who survived less than 1 year spent 30.5 days in hospital and had an average cost of $47,280. CONCLUSION The direct health care costs of younger NSCLC patients care are substantial. These results should serve as a benchmark for future comparisons as the United States market shifts to managed care.

scholarly journals Construction and Validation of a Nomogram for Non-small Cell Lung Cancer Patients with Liver Metastases: A Population-Based Analysis

2021 ◽  
Author(s):  
Ruhan Zhao ◽  
Yunnan Dai ◽  
Xinyang Li ◽  
Cuimin Zhu
Keyword(s):  
Lung Cancer ◽  
Prognostic Factors ◽  
Liver Metastases ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
The United States ◽  
Small Cell ◽  
Small Cell Lung ◽  
Cox Regression Analysis ◽  
Nsclc Patients

Abstract Background: Lung cancer is one of the most common malignancies in the United States, and the common metastatic sites in advanced non-small cell lung cancer (NSCLC) are bone, brain, adrenal gland, and liver, respectively, among which patients with liver metastases have the worst prognosis.Methods: We retrospectively analyzed 1963 patients diagnosed with NSCLC combined with liver metastases between 2010 and 2015. Independent prognostic factors for patients with liver metastases from NSCLC were identified by univariate and multivariate Cox regression analysis. Based on this, we developed a nomogram model via R software and evaluated the performance and clinical utility of the model by calibration curve, receiver operating characteristic curves, and decision curve analysis (DCA).Result: The independent prognostic factors for NSCLC patients with liver metastases included age, race, gender, grade, T stage, N stage, brain metastases, bone metastases, surgery, chemotherapy, and tumor size. The area under the curve predicting OS at 6, 9, and 12 months was 0.793, 0.787, and 0.784 in the training cohort, and 0.767, 0.771, and 0.773 in the validation cohort, respectively. Calibration curves of the nomogram showed high agreement between the outcomes predicted by the nomogram and the actual observed outcomes, and the DCA further demonstrated the value of the clinical application of the nomogram.Conclusion: By analyzing the Surveillance, Epidemiology, and End Results database, we established and verified a prognostic nomogram for NSCLC patients with liver metastases, to personalize the prognosis of patients. At the same time, the prognostic nomogram has a satisfactory accuracy and the results are a guide for the development of patient treatment plans.

scholarly journals Biomarkers and Gene Signatures to Predict Durable Response to Pembrolizumab in Non-Small Cell Lung Cancer

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3828
Author(s):  
Anello Marcello Poma ◽  
Rossella Bruno ◽  
Iacopo Pietrini ◽  
Greta Alì ◽  
Giulia Pasquini ◽  
...  
Keyword(s):  
Lung Cancer ◽  
T Cells ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Immune Cell ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Durable Response ◽  
Nsclc Patients

Pembrolizumab has been approved as first-line treatment for advanced Non-small cell lung cancer (NSCLC) patients with tumors expressing PD-L1 and in the absence of other targetable alterations. However, not all patients that meet these criteria have a durable benefit. In this monocentric study, we aimed at refining the selection of patients based on the expression of immune genes. Forty-six consecutive advanced NSCLC patients treated with pembrolizumab in first-line setting were enrolled. The expression levels of 770 genes involved in the regulation of the immune system was analysed by the nanoString system. PD-L1 expression was evaluated by immunohistochemistry. Patients with durable clinical benefit had a greater infiltration of cytotoxic cells, exhausted CD8, B-cells, CD45, T-cells, CD8 T-cells and NK cells. Immune cell scores such as CD8 T-cell and NK cell were good predictors of durable response with an AUC of 0.82. Among the immune cell markers, XCL1/2 showed the better performance in predicting durable benefit to pembrolizumab, with an AUC of 0.85. Additionally, CD8A, CD8B and EOMES showed a high specificity (>0.86) in identifying patients with a good response to treatment. In the same series, PD-L1 expression levels had an AUC of 0.61. The characterization of tumor microenvironment, even with the use of single markers, can improve patients’ selection for pembrolizumab treatment.

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