A phase II study of erlotinib monotherpay in patients with previously treated advanced non-small cell lung cancer (NSCLC) without EGFR gene mutation who have never/light smoking history: NEJ006/TCOG0903.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7561-7561 ◽  
Author(s):  
Yoshiki Ishii ◽  
Makoto Maemondo ◽  
Koichi Okudera ◽  
Kei Takamura ◽  
Yoshiki Demura ◽  
...  
Keyword(s):  
Disease Control ◽  
Gene Mutation ◽  
Response Rate ◽  
Disease Control Rate ◽  
Phase Iii ◽  
Smoking History ◽  
Egfr Gene ◽  
Grade 3 ◽  
Nsclc Patients ◽  
Egfr Gene Mutation

7561 Background: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have demonstrated good response in NSCLC harboring EGFR gene mutation. However, survival benefit from erlotinib was observed also in NSCLC patients with wild type (wt) EGFR gene in subsets of several phase III trials. Additionally, smoking status could be a predictive factor of erlotinib efficacy, This study aimed to evaluate the efficacy of erlotinib in Japanese NSCLC patients with wt-EGFR and find a biomarker that predicts the efficacy of erlotinib other than EGFR gene mutation. Methods: The primary endpoint was an objective response rate. Secondary endpoints included disease control rate, overall survival, and safety. Advanced NSCLC patients without EGFR gene mutation who had received one to three prior chemotherapy regimens and who had never smoked or light smoked (Brinkman Index: less than200) were eligible in this study. EGFR gene status was evaluated by the PNA-LNA PCR clamp method. Erlotinib was administered daily (150mg/day) until disease progression or unacceptable toxicities. Results: Forty seven patients were enrolled between March 2010 and November 2011. One patient was excluded for evaluation because having mutation of EGFR. Efficacy and safety were evaluated among 46 patients. Best responses were PR 7 (15.2%), SD 12 (26.1%), PD 26 (46.4%), NE 1 (2.2%). Response rate and disease control rate were 15.2% (95%CI: 4.9-25.5%) and 41.3 % (95%CI 27.1-55.5%) respectively. Grade 3 or 4 adverse events were anorexia (4), skin rash (2), neutropenia (1), leukopenia (1), anemia (2), elevation of AST/ALT (1), rectal ulcer (1), and cerebral infarction (1).Two patients suffered grade 3 interstitial lung disease. Conclusions: This is the first report to evaluate Erlotinib efficacy in selected NSCLC who do not possess EGFR gene mutation. Erlotinib showed significant anti-tumor activity in pretreated never or light smoked Japanese NSCLC patients without EGFR gene mutation. The results of biomakr analysis will be presented at the meeting.

Randomized multicenter phase III trial of oxaliplatin plus raltitrexed compared to oxaliplatin plus fluorouracil and leucovorin treatment in recurrent and metastatic colorectal cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4102-4102
Author(s):  
J. Wang ◽  
J. Li ◽  
S. Qin ◽  
T. Liu ◽  
Z. Ye ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Median Number ◽  
Disease Control Rate ◽  
Phase Iii ◽  
Progression Of Disease ◽  
Grade 3 ◽  
Number Of Cycles ◽  
Ecog Ps

4102 Purpose: To compare oxaliplatin (L-OHP) plus raltitrexed (RTX) with L-OHP plus fluorouracil and leucovorin (LV/5FU) for patients (pts) with recurrent and metastatic colorectal cancer(CRC). Methods: Eligible pts had to have histologically proven recurrent or metastatic CRC,not having previously received oxaliplatin as palliative chemotherapy,ECOG PS = 2,age:18∼70,and adequate hematological,renal and hepatic function.After written informed consent,pts were randomized to L-OHP:130 mg/m2 d1 + RTX: 3 mg/m2 d1 (Arm A) or + LV: 200 mg/m2 + 5FU:375 mg/m2 d1–5 (Arm B). Results: Between Jan 2005 and July 2006, 216 pts were enrolled at 15 centers in China.112 pts (mean age: 55.0 (19∼70), M/F: 57/46, PS 0/1/2: 46/53/13) were randomly assigned to A and 102 (mean age: 54.2(22∼70), M/F: 54/46, PS 0/1/2: 44/59/9) to B. 203 pts were eligible for response evaluation (A:103, B:100).The median number of cycles was 4 (1∼6) in A and 3 (1∼6) in B (P=0.1431).The RR was 29.1% (CR:2, PR:28, SD:50 , PD:23) in A and 17.0% (CR:2, PR:15, SD:46 , PD:37) in B (P=0.0437).The disease-control rate was 77.7% in A and 63.0% in B (P=0.0237). After a median follow-up of 10 months (4–16.5),92 pts had had progression of disease (40 in A and 52 in B); 73 deaths had occurred (35 in A and 38 in B), median time to progression was not reached. Following-up is ongoing.The median QoL scores for the two arms were comparable. 214 were included in the safety analyses (A:112, B:102). There was a higher incidence of neutropenia (48.2% verse 29.4%, P=0.005) and transaminase increase (49.1% verse 35.3%, P=0.041) among A. Grade 3 or 4 neutropenia was much common in pts in A than those in B (20.5% verse 4.9% , P=0.001), but was complicated by fever in only 3.6% of cases (4 pts) in A and in 2.9% of cases (3 pts) in B. No pts were dead or infectious due to neutropenia. There were similar rates of grade 3 or 4 transaminase elevation in the two groups. Vomitting and anorexia were much commoner with B. Conclusions: The L-OHP+RTX seems beneficial in recurrent and metastatic CRC, demonstrating better response rate and higher disease control rate with acceptable tolerability, maintenance of QoL and convenient administration schedule. No significant financial relationships to disclose.

FOLFIRI plus ramucirumab versus paclitaxel plus ramucirumab as second-line therapy for patients with advanced or metastatic gastroesophageal adenocarcinoma with or without prior docetaxel: Results from the phase II RAMIRIS Study of the AIO.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4514-4514 ◽  
Author(s):  
Sylvie Lorenzen ◽  
Peter C. Thuss-Patience ◽  
Claudia Pauligk ◽  
Eray Goekkurt ◽  
Thomas Jens Ettrich ◽  
...  
Keyword(s):  
Disease Control ◽  
Phase Ii ◽  
Response Rate ◽  
Objective Response ◽  
Disease Control Rate ◽  
Phase Iii ◽  
Response Analysis ◽  
Second Line ◽  
Significant Difference ◽  
Gastroesophageal Adenocarcinoma

4514 Background: Ramucirumab (Ram) as monotherapy or plus paclitaxel is a proven second-line option for advanced gastroesophageal adenocarcinoma (GEA). More and more patients (pts) are pretreated with docetaxel in the perioperative or first-line setting. These pts may benefit more from another, non-cross resistant chemotherapy backbone regimen. This trial evaluates the addition of Ram to FOLFIRI as second line treatment. Methods: This is a multicenter, randomized, investigator initiated, phase II trial. Pts with GEA who have progressed after treatment with a fluoropyrimidine/platinum-containing regimen were randomized 2:1 to either FOLFIRI plus Ram every two weeks (Arm A) or paclitaxel (days 1, 8, 15 of a 28-day cycle) plus Ram every two weeks (Arm B). Major endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and toxicity. Results: 111 pts (median age 61 years, 65% of pts had prior docetaxel therapy) were enrolled and 110 analyzed within intention to treat population (ITT, Arm A, 72; Arm B, 38). In the ITT, there was no significant difference in median OS (A, 6.8 vs. B, 7.6 months, HR 0.94, p = 0.77) and median PFS (A, 4.6 vs. B, 3.6 months, HR 0.72, p = 0.12). For pts with prior docetaxel use (71/110), median PFS was A, 4.3 vs. B, 2.0 months, HR 0.49, p = 0.008 and median OS was A, 7.5 vs. B, 6.4 months, HR 0.71, p = 0.25. In 101 pts with tumor assessment and included in the response analysis, ORR and DCR was 23% and 65% in Arm A and 11% and 60% in Arm B, respectively. 67 pts assessable for response were pre-treated with docetaxel. In these pts, ORR was 24% in Arm A and 9% in Arm B. Disease control rate (DCR) was 67% and 41% for Arm A and B respectively. Both therapies were similarly tolerable, final safety results will be shown. Conclusions: The RAMIRIS trial demonstrated feasibility of the combination of FOLFIRI and Ram. With a response rate of 24% and a median PFS of 4.3 months, docetaxel pre-treated pts seemed to derive pronounced benefit from FOLFIRI-Ram, providing a rationale for a phase III trial, which is currently ongoing. Clinical trial information: NCT03081143 .

EGFR gene mutation and epithelial to mensenchymal transition (EMT) markers in advanced NSCLC patients treated with erlotinib.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18117-e18117
Author(s):  
Mary J. Fidler ◽  
Manish J Dave ◽  
Sanjib Basu ◽  
Thomas A. Hensing ◽  
Mark Pool ◽  
...  
Keyword(s):  
Negative Predictive Value ◽  
Gene Mutation ◽  
Predictive Value ◽  
Egfr Mutation ◽  
Nuclear Staining ◽  
Mesenchymal Transition ◽  
Egfr Gene ◽  
Nsclc Patients ◽  
Emt Markers ◽  
Egfr Gene Mutation

e18117 Background: TTF-1 is a transcription factor involved in regulating epithelial to mesenchymal transition (EMT). Previous work in a clinically enriched non-small cell lung cancer (NSCLC) population suggested low probability of an EGFR activating gene mutation in the absence of TTF-1 positivity (Somaiah ASCO 2011). This study's goal was to validate the relationship of TTF-1 and other immunohistochemical (IHC) markers of EMT to the presence of an EGFR activating gene mutation in a diverse group of NSCLC patients treated with erlotinib. Methods: Patients receiving erlotinib at two midwest institutions were retrospectively analyzed by IHC for TTF-1 (Greater than 5% of tumor cells with moderate (2+) or strong (3+) nuclear staining considered positive) and for PTEN, Ecadherin,vimentin, beta catinin, and snail (frequency(0-4) times intensity(0-4)). Exon 19 and L858R mutations were detectedusing single-strand conformation polymorphism and sequence-specific polymerase chain reaction (PCR)).Fisher’s exact testand logistic regression wereused to correlate TTF-1(positive or negative) and the remaining EMT markers with the presence of EGFR mutation. Results: 216 patients were analyzed for EGFR activating gene mutations: 15% squamous, 80% smokers. EGFR mutation was found in 11.6% of cases. TTF-1 was present in 8% of squamous cell patients and 71% of adenocarcinoma patients. TTF-1 correlated with prolonged progression free survival (log rank p=.004). TTF-1 positivity was strongly correlated with the presence of mutation (p=.0006, negative predictive value=97.7%). Increasing Ecadherin and increasing PTEN expression by IHC correlated with the presence of EGFR gene mutation when measured on continuum (p=.006 and p=.04, respectively). Conclusions: Though retrospective, our work confirms the negative predictive value of TTF-1 for an EGFR activating gene mutation in a NSCLC cohort representative of a North American population.Though high PTEN and Ecadherin expression also correlated with EGFR mutation, TTF-1 positivity may be a more straight-forward marker that can select patients who should be screened for the mutation prior to initiation of first line therapy.

The value of Fn14, CD44v, and EGFR expression in lung adenocarcinoma patients with and without activating EGFR gene mutation.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20514-e20514
Author(s):  
Maciej Bryl ◽  
Katarzyna Bednarek-Rajewska ◽  
Przemysław Zalewski ◽  
Małgorzata Janicka-Jedyńska ◽  
Rodryg Ramlau ◽  
...  
Keyword(s):  
Lung Adenocarcinoma ◽  
Gene Mutation ◽  
Prognostic Value ◽  
Neoplastic Disease ◽  
Study Group ◽  
Secondary Resistance ◽  
Egfr Gene ◽  
Egfr Expression ◽  
Nsclc Patients ◽  
Egfr Gene Mutation

e20514 Background: Lung cancer is considered the most common cause of death in the world. The prognosis for patients is poor and depends on the clinical stage and the histological type of cancer. There is a need to identify and develop new therapeutic targets that could improve the prognosis of NSCLC patients and may be responsible for development of resistance to TKI therapy. Increased expression of Fn14 or CD44v and EGFR was observed in many tumors and also correlated with the overall survival of NSCLC patients Methods: We analyzed the clinical data and the immunohistochemical expression of Fn14, CD44v and EGFR in tumor tissues from 61 patients with NSCLC divided in two groups according to the presence of activating EGFR gene mutation. The aim of the study was to evaluate the correlation between the expression of the studied molecules and the neoplastic disease course of NSCLC patients. Results: Increased expression of Fn14 was observed in study group (B) compared to expression of this molecule in the control group (K). There were no differences in the intensity of the reaction with anti CD44v and EGFR antibodies in both groups. OS was significantly longer in the study group. Histological grade of tumor correlated with the intensity of CD44v expression in both groups. There was no correlation between the OS and Fn14 expression in any group. Negative correlation was noted between the expression of CD44v and the OS in the study group and between EGFR expression and the OS in both groups. Conclusions: Our observations suggest that the expression of CD44v and EGFR may be useful clinical markers of prognostic value in lung adenocarcinoma patients regardless of the presence of activating mutation in EGFR gene. Simultaneous assessment of Cd44v and EGFR expression may grant a greater prognostic value than the assessment of each receptor separately. Increased expression of Fn14 receptor in patients with EGFR gene mutation may become a new target in therapy allowing to eliminate the problem of secondary resistance to treatment with TKI’s

scholarly journals Clinicopathologic Features and Molecular Biomarkers as Predictors of Epidermal Growth Factor Receptor Gene Mutation in Non-Small Cell Lung Cancer Patients

2021 ◽  
Vol 29 (1) ◽  
pp. 77-93
Author(s):  
Lanlan Liu ◽  
Xianzhi Xiong
Keyword(s):  
Lung Cancer ◽  
Gene Mutation ◽  
Growth Factor Receptor ◽  
Small Cell ◽  
Small Cell Lung ◽  
Mutation Status ◽  
Egfr Gene ◽  
Epidermal Growth ◽  
Nsclc Patients ◽  
Egfr Gene Mutation

Lung cancer ranks first in the incidence and mortality of cancer in the world, of which more than 80% are non-small cell lung cancer (NSCLC). The majority of NSCLC patients are in stage IIIB~IV when they are admitted to hospital and have no opportunity for surgery. Compared with traditional chemotherapy, specific targeted therapy has a higher selectivity and fewer adverse reactions, providing a new treatment direction for advanced NSCLC patients. Tyrosine kinase inhibitors of epidermal growth factor receptor (EGFR-TKIs) are the widely used targeted therapy for NSCLC patients. Their efficacy and prognosis are closely related to the mutation status of the EGFR gene. Clinically, detecting EGFR gene mutation is often limited by difficulty obtaining tissue specimens, limited detecting technology, and economic conditions, so it is of great clinical significance to find indicators to predict EGFR gene mutation status. Clinicopathological characteristics, tumor markers, liquid biopsy, and other predictors are less invasive, economical, and easier to obtain. They can be monitored in real-time, which is supposed to predict EGFR mutation status and provide guidance for the accurate, individualized diagnosis and therapy of NSCLC patients. This article reviewed the correlation between the clinical indicators and EGFR gene mutation status in NSCLC patients.

Differential effect of erlotinib on survival of patients with non-small cell lung cancer in terms of EGFR status: A meta-analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18024-e18024
Author(s):  
Nay Min Tun ◽  
Asha Nayak
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Gene Mutation ◽  
Differential Effect ◽  
Meta Analysis ◽  
Small Cell ◽  
Small Cell Lung ◽  
Egfr Gene ◽  
Nsclc Patients ◽  
Egfr Gene Mutation

e18024 Background: Erlotinib is a small-molecule tyrosine kinase inhibitor that inhibits the protein kinase activity of epidermal growth factor receptor (EGFR). The primary objective of this meta-analysis is to compare the response of patients with EGFR-positive versus EGFR-negative advanced non-small-cell lung cancer (NSCLC) to erlotinib in terms of overall survival (OS) and progression-free survival (PFS). Methods: A Medline search using the MeSH terms “erlotinib” and “lung” in the title field, filtered by ‘clinical trial’, yielded 108 articles. Clinical trials involving erlotinib with available survival data on EGFR-positive versus EGFR-negative NSCLC were searched for. The intervention effect estimate and standard error of each study was derived from the hazard ratio (HR) and p value. Generic inverse variance method was applied to compute the overall effect size and HR with 95% confidence interval (CI). Fixed or random effects model was used according to the level of between-study heterogeneity. Results: 3 studies including 504 patients were eligible for the analysis. All patients received erlotinib in a single arm. EGFR gene mutation was tested in 326 patients (35 mutation-positive, 188 wild-type, 103 indeterminate). EGFR gene amplification by fluorescent in-situ hybridization (FISH) was studied in 353 patients (100 positive), and EGFR protein expression by immunohistochemistry (IHC) in 368 patients (290 positive). Patients with EGFR gene mutation had significantly longer PFS (HR = 0.4, CI 0.25-0.64, p = 0.0001) but not OS (HR = 0.59, CI 0.18-1.95, p = 0.39). In contrast, EGFR FISH-positivity was associated with better PFS as well as OS (HR = 0.52, CI 0.39-0.71, p < 0.00001 and HR = 0.65, CI 0.47-0.88, p = 0.006, respectively). Conclusions: Results of EGFR gene amplification by FISH rather than EGFR gene mutation by PCR may be a better predictor of survival for advanced NSCLC patients receiving erlotinib. Subgroup analyses of erlotinib's differential effect on NSCLC patients with regard to their EGFR status (as measured by PCR, FISH or IHC) are further warranted in randomized controlled trials.

scholarly journals Miliary pattern on chest imaging as a presentation of EGFR-negative primary lung adenocarcinoma

2019 ◽  
Vol 12 (5) ◽  
pp. e228534 ◽  
Author(s):  
Seth A Hoffman ◽  
Scott Manski ◽  
Janaki Deepak
Keyword(s):  
Lung Adenocarcinoma ◽  
Gene Mutation ◽  
Lung Metastases ◽  
Case Reports ◽  
Growth Factor Receptor ◽  
Smoking History ◽  
Egfr Gene ◽  
Primary Lung Adenocarcinoma ◽  
Bilateral Lung ◽  
Egfr Gene Mutation

A 64-year-old African American man, with a history of prostate adenocarcinoma treated in 2009 and a greater than 50-pack-year tobacco smoking history, presented with 2–3 weeks of non-productive cough, frontal headache and generalised myalgias and arthralgias. CT was positive for diffuse, miliary opacities in bilateral lung fields. He was diagnosed with stage four lung adenocarcinoma, negative for epidermal growth factor receptor (EGFR) gene mutation. The patient was unable to tolerate therapy and passed away approximately 4 months after his diagnosis. Previous case reports and research have suggested an association between EGFR gene mutation and miliary patterned lung metastases in non-small cell lung cancer. This case suggests that the mechanism by which miliary patterned metastases occur is more complex than purely mutation of the EGFR gene. Further study may elucidate novel molecular targets for treatment, especially in patients with rapidly progressive disease such as the patient we describe.

scholarly journals Cisplatin and Irinotecan as First-Line Chemotherapy for Previously Untreated Metastatic Thymic Carcinoma: Updated Analysis

2022 ◽  
Vol 11 ◽  
Author(s):  
Akito Fukuda ◽  
Yusuke Okuma ◽  
Taiki Hakosaki ◽  
Kie Mirokuji ◽  
Makiko Yomota ◽  
...  
Keyword(s):  
Disease Control ◽  
Thymic Carcinoma ◽  
Response Rate ◽  
Group Performance ◽  
Disease Control Rate ◽  
Hematological Toxicity ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Grade 3 ◽  
Line Chemotherapy

Platinum-based chemotherapy is the de facto standard treatment for metastatic or unresectable thymic carcinoma. The optimal chemotherapy regimen has not yet been determined, including whether this should be combined with a second- or third-generation anti-cancer agent. We retrospectively evaluated the data of patients with metastatic or unresectable thymic carcinoma who were treated with a combination of cisplatin and irinotecan as first-line chemotherapy between 2002 and 2021 (trial registration UMIN000012175). The primary endpoint was response rate according to the RECIST criteria version 1.1. Secondary endpoints were disease control rate, progression-free survival (PFS), overall survival (OS), and toxicity (adverse events). Some patients analyzed in this study were also included in the previous trial, which was terminated early. For this analysis, we included 18 patients with a median age of 56 years and an Eastern Cooperative Oncology Group performance status of 0 or 1. All patients had clinical stage IVa or IVb thymic carcinoma according to the Masaoka-Koga staging system. The response rate was 44% and the disease control rate was 89%. The median PFS was 8.4 months (95% confidence interval (CI): 2.7–11.6 months) and the median OS was 45.6 months (95% CI: 15.7–69.1 months). Grade 3 or worse hematological toxicity was observed in 5 patients and grade 3 or worse non-hematological toxicity was observed in 3 patients. None of the patients developed febrile neutropenia, and no treatment-related deaths occurred. Thus, the combination of cisplatin and irinotecan as first-line chemotherapy for metastatic thymic carcinoma showed efficacy and acceptable toxicity.

scholarly journals Combination Therapy With Anti-PD-1 or PD-1 Antibody Alone in Asian Pediatric Patients With Relapsed or Refractory Cancer

2021 ◽  
Vol 12 ◽  
Author(s):  
Yi Que ◽  
Juan Wang ◽  
Jia Zhu ◽  
Na Li ◽  
Junting Huang ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Disease Control ◽  
Pediatric Patients ◽  
Response Rate ◽  
Objective Response ◽  
Primary Objective ◽  
Disease Control Rate ◽  
Hematologic Toxicity ◽  
Retrospective Case ◽  
Grade 3

There is limited experience of PD-1 antibody combined with other therapies in children. We aimed to explore the antitumor activity and safety of PD-1 antibody monotherapy or combination with other regimens in relapsed or refractory pediatric cancer. This is a retrospective-case study conducted in two Chinese expert centers. The primary objective of this study was to describe the overall response rate (ORR) and disease control rate (DCR). Secondary objectives included characterizing toxicities. Of the 22 pediatric patients with cancer who received PD-1 inhibitors, the median follow-up for all patients after the commencement of PD-1 therapy with or without other regimens was 12.3 months (0 - 43 months). PD-1 antibody monotherapy demonstrated antitumor activity in a population of pediatric patients with Hodgkin lymphoma (HL), with an objective response rate (ORR) and disease control rate (DCR) of 83.3% (3CR and 2PR) and 100%, respectively. However, no objective response was observed in patients with melanoma or Burkitt lymphoma evaluated in this study. We reviewed responses for patients with chemotherapy, decitabine or everolimus combination therapies with PD-1 antibodies, and found that PD-1 antibody combined with decitabine showed potential efficacy in pediatric patients with advanced embryonal rhabdomyosarcoma and lymphoepitheliomatoid-like carcinoma. There were no severe treatment-related adverse events (TRAEs) directly attributed to PD-1 antibody monotherapy in Asian pediatric patients with lower incidence of hematologic toxicity and nonhematologic toxicity. The Grade ≥3 TRAEs were attributed to the combination chemotherapy.

scholarly journals Simple parameters to solve a complex issue: predicting response to checkpoint inhibitor therapy in lung cancer

2020 ◽  
pp. LMT44
Author(s):  
James Newman ◽  
Isabel Preeshagul ◽  
Nina Kohn ◽  
Craig Devoe ◽  
Nagashree Seetharamu
Keyword(s):  
Lung Cancer ◽  
Disease Control ◽  
Predictive Value ◽  
Checkpoint Inhibitor ◽  
Progression Free Survival ◽  
Disease Control Rate ◽  
Smoking History ◽  
Free Survival ◽  
Smoking Intensity ◽  
Nsclc Patients

Background: Noninvasive biomarkers predicting immune checkpoint inhibitor (ICI) response are urgently needed. We evaluated the predictive value of pretreatment neutrophil-to-lymphocyte ratio (NLR), smoking history, smoking intensity, BMI and programmed death ligand 1 (PD-L1) expression in non-small-cell lung cancer (NSCLC) patients treated with ICIs. Materials & methods: Single-center retrospective study included 137 patients from July 2015 to February 2018. Outcomes included 3-month disease control rate, progression-free survival, and overall survival. Predictive value of biomarkers was assessed independently and in a multivariable model. Results: NLR was associated with all outcomes. Smoking history was predictive of progression-free survival and smoking intensity was predictive of disease control rate. BMI and PD-L1 were not associated with any outcome. High BMI was associated with low NLR. Conclusion: Simple clinical biomarkers can predict response to ICIs. A score incorporating both clinical factors and established tissue/serum biomarkers may be useful in identifying NSCLC patients who would benefit from ICIs.

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