scholarly journals A clinical variable‐based nomogram could predict the survival for advanced NSCLC patients receiving second‐line atezolizumab

2021 ◽  
Author(s):  
Xiaoling Shang ◽  
Jianxiang Shi ◽  
Xiaohui Wang ◽  
Chenglong Zhao ◽  
Haining Yu ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Clinical Variable ◽  
Second Line ◽  
Nsclc Patients

A phase II trial comparing pemetrexed with gefitinib as the second-line treatment of nonsquamous NSCLC patients with wild-type EGFR (CTONG0806).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8042-8042 ◽  
Author(s):  
Jinji Yang ◽  
Ying Cheng ◽  
Mingfang Zhao ◽  
Qing Zhou ◽  
Hong hong Yan ◽  
...  
Keyword(s):  
Egfr Mutation ◽  
Advanced Nsclc ◽  
Phase Ii Trial ◽  
Progression Free Survival ◽  
Line Treatment ◽  
Second Line ◽  
Wild Type ◽  
Free Survival ◽  
Line Setting ◽  
Nsclc Patients

8042 Background: Pemetrexed or gefitinib is one of the standard second-line treatments for advanced non-squamousNSCLC in East Asia. The CTONG 0806 a multi-center, randomized, controlled, open-label phase II trial was designed to explore the efficacy of pemetrexed versus gefitinib as the second-line treatment in advanced NSCLC patients without EGFR mutation. Methods: The patients with locally advanced or metastatic, non-squamous NSCLC previously treated with platinum-based chemotherapy and no EGFR mutation in exons 18-21 were enrolled. Patients were 1:1 randomized to receive either gefitinib 250 mg per oral every day (G arm) or pemetrexed 500 mg/m2 iv day 1 with vitamin B12 and folic acid supplement every 21 days (P arm) until disease progression, unacceptable toxicity, or discontinuation of treatment due to other reason. The primary endpoint was progression-free survival (PFS). The secondary endpoints were 4-month and 6-month progression-free survival rate, overall survival (OS), objective response rate (ORR), quality of life using the FACT-L questionnaire and safety, EGFR and K-ras mutation status were evaluated and correlated with outcomes. Results: From Feb. 2009 to Aug. 2012, 157 evaluable patients were randomized (81 cases in G arm and 76 in P arm). Baseline age, gender, and ECOG performance status were balanced between arms. The primary endpoint of PFS was met with 1.6 months for G arm versus 4.8 months for P arm, the HR is 0.51 (95% CI 0.36~0.73, P<0.001). Overall response rates were 14.7 % and 13.3 % (P=0.814) and DCR were 32.0% and 61.3% (P<0.001) for G arm and P arm, respectively. OS data were not yet mature. More skin rash and diarrhoea were seen in G arm, but more fatigue and ALT increased in P arm. CTCAE grade 3 or 4 of AEs was 12.3% in G arm and 32.9% in P arm (p=0.002). The further analyses of efficacy evaluated by IRR and biomarkers analysis will be presented on the ground. Conclusions: CTONG0806 is the first trial to show significant improvements in PFS and DCR with pemetrexed compared with gefitinib in second-line setting for advanced NSCLC with EGFR wild type. Patients with EGFR wild type did not benefit from EGFR TKI gefitinb in second-line setting. Clinical trial information: NCT00891579.

PD-1 inhibitor plus chemotherapy as 2nd/subsequent line therapy had similar clinical outcome with PD-1/PD-L1 inhibitor monotherapy in advanced NSCLC.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21600-e21600
Author(s):  
Xiaoyang Zhai ◽  
Yaru Tian ◽  
Weiwei Yan ◽  
Ning An ◽  
Hui Zhu
Keyword(s):  
Overall Survival ◽  
Advanced Nsclc ◽  
Progression Free Survival ◽  
Second Line ◽  
Monotherapy Group ◽  
Second Line Therapy ◽  
Free Survival ◽  
Chemotherapy Group ◽  
Line Therapy ◽  
Nsclc Patients

e21600 Background: PD-1/PD-L1 inhibitor monotherapy has been approved as second line therapy in advanced non-small-cell lung cancer (NSCLC). The study aims to compare clinical outcome of PD-1 inhibitor plus chemotherapy with PD-1/PD-L1 inhibitor monotherapy as 2nd/subsequent line therapy in advanced NSCLC. Methods: The clinical data of NSCLC patients who received PD-1/PD-L1 inhibitor as 2nd/subsequent line therapy were retrospectively collected in our study. According to the therapy modality, patients were assigned to PD-1/PD-L1 inhibitor monotherapy group and PD-1 inhibitor plus chemotherapy group. Disease control rates (DCRs), progression free survival (PFS) and overall survival (OS) were evaluated between the 2 groups. The prognostic role of derived neutrophils-to-lymphocyte ratio (dNLR) on the outcomes was also evaluated at the same time. Results: From April 2017 to October 2019, a total of 84 patients were enrolled in the current study. Twenty-six patients were allocated to the PD-1/PD-L1 inhibitor monotherapy group and fifty-eight patients were allocated to PD-1 inhibitor plus chemotherapy group. Chemotherapy regimens were detailed as follow: liposome paclitaxel (n = 15), nab-paclitaxel(n = 12), docetaxel(n = 9), pemetrexed(n = 6), and others(n = 16). Disease control rates (DCRs) and overall survival (OS) were not significantly different between the two groups. Progression free survival (PFS) in the PD-1/PD-L1 inhibitor monotherapy was longer(median PFS: NR vs 4.4 months, p = 0.02). Univariate and multivariate analyses suggested that derived neutrophils-to-lymphocyte ratio (dNLR) was independent prognostic factor of OS and gender was independent prognostic factor of PFS. In the second-line therapy subgroup of 38 patients, OS and PFS were not significantly different in the two groups. In the subgroup of 46 patients of over 2nd line, PD-1/PD-L1 inhibitor monotherapy group had longer PFS (median PFS: NR vs 4.0 months, p = 0.01).The incidence of any grade adverse events (AEs) was no significant difference in the two groups. One patient in the PD-1 inhibitor plus chemotherapy group died of immune-related pneumonitis. Conclusions: The addition of chemotherapy to PD-1 inhibitor as 2nd/subsequent line therapy had similar clinical outcomes compared with PD-1/PD-L1 inhibitor monotherapy of advanced NSCLC patients.

scholarly journals LKB1 mutations are not associated with the efficacy of first-line and second-line chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC): a post hoc analysis of the TAILOR trial

ESMO Open ◽  
2020 ◽  
Vol 5 (3) ◽  
pp. e000748
Author(s):  
Claudio Vernieri ◽  
Monica Ganzinelli ◽  
Eliana Rulli ◽  
Gabriella Farina ◽  
Anna Cecilia Bettini ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Cytotoxic Chemotherapy ◽  
Second Line ◽  
Small Cell Lung ◽  
First Line ◽  
Mutational Status ◽  
Platinum Based Chemotherapy ◽  
Nsclc Patients ◽  
The Impact ◽  
Chemotherapy Efficacy

PurposeIn patients with advanced lung adenocarcinoma, the impact of LKB1 mutations on cytotoxic chemotherapy efficacy remains poorly explored. Here, we aimed at investigating the potential impact of LKB1 mutational status on chemotherapy efficacy in advanced non-small-cell lung cancer (NSCLC) patients enrolled in the TArceva Italian Lung Optimisation tRial (TAILOR) trial.MethodsThe multicenter TAILOR trial randomised patients with EGFR-wild type (wt) advanced NSCLC progressing on/after previous platinum-based chemotherapy to receive docetaxel or erlotinib. Here, we evaluated the impact of LKB1 mutational status on progression-free survival (PFS) and overall survival (OS) in patients treated with second-line docetaxel/erlotinib or during prior platinum-based chemotherapy.ResultsOut of 222 patients randomised in the TAILOR trial, left-over tumour tissues were available for 188 patients, and 120 patients with evaluable LKB1 status were included. Of them, 17 (14.17%) patients had LKB1-mutated tumours, while 103 (85.83%) had LKB1-wt disease. During second-line treatment, PFS and OS were not statistically significantly different in patients with LKB1-mutated when compared with LKB1-wt NSCLC (adjusted HR (aHR)=1.29, 95% CI 0.75 to 2.21; p=0.364 and aHR=1.41, 95% CI 0.82 to 2.44; p=0.218, respectively). Similarly, we found no significant association between LKB1 mutations and patient PFS or OS during prior first-line platinum-based chemotherapy (aHR=1.04, 95% CI 0.55 to 1.97; p=0.910 and aHR=0.83, 95% CI 0.42 to 1.65; p=0.602, respectively).ConclusionAmong advanced NSCLC patients receiving two lines of systemic therapy, LKB1 mutations were not associated with PFS or OS during second-line docetaxel or prior first-line platinum-based chemotherapy. While larger prospective trials are needed to confirm our findings, cytotoxic chemotherapy remains the backbone of investigational combination strategies in this patient population.

Survival patterns by line of treatment of stage IIIb/v NSCLC patients from community U. S. oncology practice.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18097-e18097
Author(s):  
Shraddha Chaugule ◽  
Susan H Foltz Boklage ◽  
Charles Kreilick ◽  
Sean D Sullivan ◽  
Scott David Ramsey ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Advanced Nsclc ◽  
Stage Iii ◽  
Second Line ◽  
Second Line Therapy ◽  
Line Therapy ◽  
Third Line Therapy ◽  
Third Line ◽  
Nsclc Patients

e18097 Background: Lung cancer is the most common cause of cancer-related death in men and women worldwide. 80% of the lung cancer patients are diagnosed with NSCLC. Patients have varying survival results from multiple lines of treatment. The objective of this study was to evaluate in a real world context, treatment patterns with survival, and the impact of adding a third line of chemotherapy to a stage III/IV NSCLC population. Methods: The Georgia Cancer Specialist database (2005-2011) was used. Patients with stage III or IV primary NSCLC and treated with chemotherapy were followed from initial NSCLC diagnosis until death, study end or lost to follow-up. Patients were stratified into lines and type of protocol for treatments. Kaplan-Meier curves were used to compare the overall survival results between lines of therapy. Results: A total of 291 patients with advanced NSCLC were identified and included in the primary analysis. Of these, 40 patients received third line therapy. The most commonly used treatment regimens in third line were Pemetrexed with 11 patients (3.8%), Docetaxel with 10 patients (3.4%), Gemcitabine with 4 patients (1.4%), Vinorelbine with 3 patients (1%) Cisplatin/Gemcitabine/Bevacizumab with 2 patients (0.7%). No single treatment regimen was predominantly used in third line. No association of survival gain was seen in patients who received third line therapy over those who received second line therapy (Log-Rank test P=0.4926) Conclusions: In a large EMR physician practice based database of advanced NSCLC patients, we failed to find a difference in the median overall survival of patients who received third line therapy compared to those who received second line therapy. Limitations include a small sample size and no standardized timing of diagnosis and treatment. The lack of a standard of care in third line therapy necessitates the need of further randomized controlled clinical studies to establish a benefit for a particular combination.

scholarly journals Tumor burden as possible biomarker of outcome in advanced NSCLC patients treated with immunotherapy: a single center, retrospective, real-world analysis

2021 ◽  
Author(s):  
Edoardo Lenci ◽  
Giulia Marcantognini ◽  
Valeria Cognigni ◽  
Alessio Lupi ◽  
Silvia Rinaldi ◽  
...  
Keyword(s):  
Real World ◽  
Advanced Nsclc ◽  
Eastern Cooperative Oncology Group ◽  
Tumor Burden ◽  
Prognostic Impact ◽  
Second Line ◽  
Significant Difference ◽  
Metastatic Sites ◽  
Nsclc Patients ◽  
Sites Of Metastases

Aim: The role of tumor burden (TB) for patients with non-small cell lung cancer (NSCLC) receiving immunotherapy is still unknown. The aim of this analysis was to analyze the prognostic value of TB in a real-world sample of advanced NSCLC patients. Methods: Sixty-five consecutive patients with advanced NSCLC treated with immunotherapy as first or second line therapy were retrospectively analyzed between August 2015 and February 2018. TB was recorded at baseline considering sites and number of metastases, thoracic vs. extrathoracic disease, measurable disease (MD) vs. not-MD (NMD) and evaluating dimensional aspects as maximum lesion diameter (cut-off = 6.3 cm), sum of the 5 major lesions diameters (cut-off = 14.3 cm), and number of sites of metastases (cut-off > 4). All cut-offs were calculated by receiver operating characteristic curves. Median overall survival (OS) was estimated using Kaplan-Meier method. A Cox regression model was carried out for univariate and multivariate analyses. Results: Median age was 70 years and most patients (86.2%) had a good performance status (PS-Eastern Cooperative Oncology Group < 2). No significant difference in OS was noted between subgroups of patients according to TB. Bone metastases (BM) had a negative prognostic impact [median OS (mOS), 13.8 vs. 70.0 months, P = 0.0009; median progression free survival in the second line (mPFS2) 2.97 vs. 8.63 months; P = 0.0037]. Patients with NMD had a poorer prognosis (mOS, 15.9 months vs. not reached, P < 0.0001; mPFS2 3.8 vs. 12.2 months; P = 0.0199). Patients with disease limited to the thorax had a better prognosis compared to patients with involvement of extrathoracic sites (mOS, 70 vs. 17.3 months; P = 0.0136). Having more than 4 metastatic sites resulted as a negative prognostic factor (mOS, 15.9 vs. 25.2 months; P = 0.0106). At multivariate analysis, BM, NMD, extrathoracic disease and number of sites of metastases > 4 were negative prognostic factors (P < 0.0001). Conclusions: This study underlines the negative prognostic impact of specific metastatic sites, presence of NMD and extrathoracic disease in advanced NSCLC patients treated with immunotherapy. However, TB does not appear to affect the outcome of these patients.

scholarly journals The Real-Life Efficacy And Safety of Osimertinib In Pretreated Advanced Non-Small Cell Lung Cancer Patients With T790M Mutation: A Turkish Oncology Group Study

2021 ◽  
Author(s):  
Mutlu Hizal ◽  
Burak Bilgin ◽  
Nail Paksoy ◽  
Özgür Açıkgöz ◽  
Ahmet Sezer ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Real Life ◽  
Line Treatment ◽  
Second Line ◽  
Efficacy And Safety ◽  
T790m Mutation ◽  
The Real ◽  
Third Line ◽  
Nsclc Patients ◽  
Egfr Tki

Abstract Introduction: Osimertinib, an irreversible third-generation EGFR-TKI, is the standard of care for second-line treatment of T790M-mutant advanced NSCLC patients whose progressed after first-line EGFR-TKI therapy. In this multicenter study, we aimed to determine the real-life efficacy and safety of Osimertinib in pretreated advanced NSCLC patients with T790M mutation.Materials and Methods: This retrospective trial included advanced T790M-mutant pretreated NSCLC patients who received Osimertinib from 24 different centers in Turkey. Primary endpoint was time-to-treatment discontinuation (TTD). Secondary endpoints were objective response rate (ORR), overall survival (OS), and safety.Results: Of 163 patients 68.7% had EGFR exon 19 deletion and 22.7% had exon 21 L858R mutation. Osimertinib was given as second-line treatment in 96 patients (58.9%) and third-line in 48 patients (29.4%). After median of 13 months disease follow-up, median TTD was 21.6 months with an 82.2% ORR. Estimated median OS was 32.1 months. Grade 3-4 adverse events were seen in 11.7% of the patients. Conclusion: Osimertinib is a highly effective option in second or third-line treatment of NSCLC patients with T790M mutation, with a favorable safety profile.

Prognostic and predictive value of hedgehog (Hh) signaling in advanced non-small cell lung cancer (NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e21070-e21070
Author(s):  
Rossana Berardi ◽  
Alfredo Santinelli ◽  
Azzurra Onofri ◽  
Miriam Caramanti ◽  
Agnese Savini ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Advanced Nsclc ◽  
Progression Free Survival ◽  
Second Line ◽  
Free Survival ◽  
Cell Growth And Differentiation ◽  
Hh Signaling ◽  
Negative Tumor ◽  
Nsclc Patients

e21070 Background: Advanced NSCLC still represents a medical challenge in cancer therapy. The Hh pathway is critical for cell growth and differentiation. The aim of our study is to evaluate the role of the Hh signaling pathway in determining the clinical outcome of NSCLC patients. Methods: The expressions of Hh-related molecules including Ptch1 and Gli1 (nuclear and cytoplasmic) were determined by immunohistochemistry in 35 histologic samples (biopsies and surgical specimens) of advanced NSCLC patients. All the neoplastic area presents in the slides was considered and both cytoplasmic and nuclear stainings were evaluated, according to the positive neoplastic cells. The intensity of the staining was considered and scored as 0 (absent), 1+ (low), 2+ (medium) and 3+ (high). Results: 18 adenocarcinomas and 17 squamous cell carcinomas were analysed. Positivity of Gli1-cytoplasmic expression and Gli1-nuclear expression were expressed in adenocarcinoma at a significantly higher level and more frequently than compared to squamous cell carcinoma (p<0.05), while Ptch1 did not differ significantly in the two histotypes. Overall survival was higher in Gli1 and Ptch1 negative tumor samples compared to the positive group (p=0.02). The 18 patients with adenocarcinoma received erlotinib as second line therapy and those presenting a lower Gli1 and Ptch1 expression experienced a significantly better progression free survival. Conclusions: These results suggest that the Hh pathway might play a major prognostic role in NSCLC with significant differences between the histotype. Furthermore it might predict the efficacy of erlotinib as second-line treatment in patients with advanced lung adenocarcinoma.

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