Machine-Learning and Stochastic Tumor Growth Models for Predicting Outcomes in Patients With Advanced Non–Small-Cell Lung Cancer

2019 ◽  
pp. 1-11 ◽  
Author(s):  
Kien Wei Siah ◽  
Sean Khozin ◽  
Chi Heem Wong ◽  
Andrew W. Lo
Keyword(s):  
Machine Learning ◽  
Lung Cancer ◽  
Clinical Trials ◽  
Operating Characteristic ◽  
Advanced Nsclc ◽  
Characteristic Curve ◽  
Small Cell ◽  
Small Cell Lung ◽  
Out Of Sample ◽  
Operating Characteristic Curve

PURPOSE The prediction of clinical outcomes for patients with cancer is central to precision medicine and the design of clinical trials. We developed and validated machine-learning models for three important clinical end points in patients with advanced non–small-cell lung cancer (NSCLC)—objective response (OR), progression-free survival (PFS), and overall survival (OS)—using routinely collected patient and disease variables. METHODS We aggregated patient-level data from 17 randomized clinical trials recently submitted to the US Food and Drug Administration evaluating molecularly targeted therapy and immunotherapy in patients with advanced NSCLC. To our knowledge, this is one of the largest studies of NSCLC to consider biomarker and inhibitor therapy as candidate predictive variables. We developed a stochastic tumor growth model to predict tumor response and explored the performance of a range of machine-learning algorithms and survival models. Models were evaluated on out-of-sample data using the standard area under the receiver operating characteristic curve and concordance index (C-index) performance metrics. RESULTS Our models achieved promising out-of-sample predictive performances of 0.79 area under the receiver operating characteristic curve (95% CI, 0.77 to 0.81), 0.67 C-index (95% CI, 0.66 to 0.69), and 0.73 C-index (95% CI, 0.72 to 0.74) for OR, PFS, and OS, respectively. The calibration plots for PFS and OS suggested good agreement between actual and predicted survival probabilities. In addition, the Kaplan-Meier survival curves showed that the difference in survival between the low- and high-risk groups was significant (log-rank test P < .001) for both PFS and OS. CONCLUSION Biomarker status was the strongest predictor of OR, PFS, and OS in patients with advanced NSCLC treated with immune checkpoint inhibitors and targeted therapies. However, single biomarkers have limited predictive value, especially for programmed death-ligand 1 immunotherapy. To advance beyond the results achieved in this study, more comprehensive data on composite multiomic signatures is required.

Systemic immune–inflammation index changes predict outcome in stage III non-small-cell lung cancer patients treated with concurrent chemoradiotherapy

2021 ◽  
Author(s):  
Taosheng Huang ◽  
Huanqian Zhang ◽  
Yunzheng Zhao ◽  
Yanping Li ◽  
Guofeng Wang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Operating Characteristic ◽  
Concurrent Chemoradiotherapy ◽  
Characteristic Curve ◽  
Small Cell ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Operating Characteristic Curve ◽  
Stage Iii Nsclc ◽  
Nsclc Patients

Background: Although the systemic immune–inflammation index (SII) has been used to predict recurrence and survival in non-small-cell lung cancer (NSCLC) patients, the prognostic significance of change in SII (ΔSII) is unclear for stage III NSCLC patients treated with concurrent chemoradiotherapy (CCRT). In the present study we aimed to explore the association between ΔSII and the clinical outcomes of 142 patients with stage III NSCLC treated with CCRT. Methods: A total of 142 patients were included in this retrospective study. The SII values were calculated based on laboratory data regarding platelet, neutrophil and lymphocyte counts, and ΔSII was calculated using data acquired before and approximately 2 weeks after CCRT. The receiver operating characteristic curve was used to determine the optimal cut-off value for the peripheral blood inflammation index. Kaplan–Meier analysis and Cox proportional regression were used to analyze the prognostic value of ΔSII for overall survival (OS) and progression-free survival (PFS). Results: The area under the receiver operating characteristic curve for ΔSII (0.708) was larger than those for pre-CCRT SII (0.578) and post-CCRT SII (0.610). The optimal cut-off point for ΔSII was defined as 43. OS and PFS were better in patients with low ΔSII and in multivariate analysis, the ΔSII was an independent predictor of OS and PFS (p = 0.006 and p = 0.017, respectively). Conclusions: ΔSII is related to progression and death in patients with stage III NSCLC. The ΔSII can provide a detailed prognostic prediction for stage III NSCLC.

scholarly journals Are clinical trial eligibility criteria an accurate reflection of a real-world population of advanced non-small-cell lung cancer patients?

2018 ◽  
Vol 25 (4) ◽  
Author(s):  
K. Al-Baimani ◽  
H. Jonker ◽  
T. Zhang ◽  
G.D. Goss ◽  
S.A. Laurie ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eligibility Criteria ◽  
Ecog Ps

Background Advanced non-small-cell lung cancer (nsclc) represents a major health issue globally. Systemic treatment decisions are informed by clinical trials, which, over years, have improved the survival of patients with advanced nsclc. The applicability of clinical trial results to the broad lung cancer population is unclear because strict eligibility criteria in trials generally select for optimal patients.Methods We performed a retrospective chart review of all consecutive patients with advanced nsclc seen in outpatient consultation at our academic institution between September 2009 and September 2012, collecting data about patient demographics and cancer characteristics, treatment, and survival from hospital and pharmacy records. Two sets of arbitrary trial eligibility criteria were applied to the cohort. Scenario A stipulated Eastern Cooperative Oncology Group performance status (ecog ps) 0–1, no brain metastasis, creatinine less than 120 μmol/L, and no second malignancy. Less-strict scenario B stipulated ecog ps 0–2 and creatinine less than 120 μmol/L. We then used the two scenarios to analyze treatment and survival of patients by trial eligibility status.Results The 528 included patients had a median age of 67 years, with 55% being men and 58% having adenocarcinoma. Of those 528 patients, 291 received at least 1 line of palliative systemic therapy. Using the scenario A eligibility criteria, 73% were trial-ineligible. However, 46% of “ineligible” patients actually received therapy and experienced survival similar to that of the “eligible” treated patients (10.2 months vs. 11.6 months, p = 0.10). Using the scenario B criteria, only 35% were ineligible, but again, the survival of treated patients was similar in the ineligible and eligible groups (10.1 months vs. 10.9 months, p = 0.57).Conclusions Current trial eligibility criteria are often strict and limit the enrolment of patients in clinical trials. Our results suggest that, depending on the chosen drug, its toxicities and tolerability, eligibility criteria could be carefully reviewed and relaxed.

Bioinformatics Model of Serum Biomarkers to Prognosticate the Response to Programmed Death-1/Ligand-1 Targeted Immunotherapy in Metastatic Non–Small Cell Lung Cancer

2019 ◽  
Vol 152 (Supplement_1) ◽  
pp. S137-S137
Author(s):  
Imad Tarhoni ◽  
Maneet Multani ◽  
Ibtihaj Fughhi ◽  
David Gerard ◽  
Mary Fidler ◽  
...  
Keyword(s):  
Machine Learning ◽  
Lung Cancer ◽  
Overall Survival ◽  
Small Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Response Pattern ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Small Cell Lung ◽  
R Packages

Abstract Introduction Immune-checkpoint inhibitors revolutionized the therapeutic paradigm for metastatic non–small cell lung cancer (NSCLC). The average response, however, still hovers at 20%, demonstrating the urgent need for biomarkers predictive of response. High-throughput laboratory technology promises to serve as an insightful and robust tool to recognize and select patterns of biomarkers in serum. We applied machine learning on serum immune-checkpoint biomarkers for prognostication of response to immunotherapy in advanced NSCLC. Method Pretreatment sera from 106 advanced NSCLC cases who failed frontline chemotherapy were evaluated for 16 soluble immune-checkpoint molecules using the Human Immuno-Oncology Checkpoint Protein Panel (MilliporeSigma). This panel constituted BTLA, CD27, CD28, TIM-3, HVEM, CD40, GITR, GITRL, LAG-3, TLR-2, PD-1, PD-L1, CTLA-4, CD80, CD86, and ICOS. Primary data points were collected and calculated via a Luminex FLEXMAP 3D system (xPONENT v4.0.3 Luminex Corp). The minimum follow-up after treatment was 12 months. Response patterns were categorized based on their overall survival (OS) as long-term responders (>12 months) or short-term responders (<12 months). Values were analyzed with the clinical outcomes using “Survminer” and “survival” R packages to determine the log-rank-based cutoff values associated with overall survival. Finally, machine learning methods were implemented using “caret” and “rpart” R packages to fit a classification model to predict the response pattern. The model was trained and tested on random fractions of the cohort. Results BTLA4, HVEM, CD40, GITRL, LAG-3, PD-1, CD80, and CD86 serum levels significantly correlated with OS (all P values ≤.02 and HR of 0.27, 0.5, 4.59, 0.17, 0.12, 0.48, 3.64, and 0.37, respectively). The algorithm composing PD-1, LAG-3, CD86, and CTLA4 predicted the response pattern with PPV of 81%, specificity of 87%, and accuracy of 75%. Conclusion The serum immune-checkpoint predictive model might assist in the tissue and gene-based profiling of immune-checkpoints to predict the benefit from immunotherapy.

Updates in Local-Regionally Advanced Non–Small Cell Lung Cancer

2019 ◽  
pp. 553-562 ◽  
Author(s):  
Anne S. Tsao ◽  
Shruti Jolly ◽  
Jay M. Lee
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Early Stage ◽  
Standard Of Care ◽  
Small Cell ◽  
Small Cell Lung

The landscape for therapy in local-regionally advanced non–small cell lung cancer (NSCLC) has shifted dramatically in the last year as a result of the PACIFIC trial, which demonstrated a significant survival benefit with the addition of 1 year of durvalumab after concurrent chemoradiation. This is a new standard of care for unresectable local-regionally advanced NSCLC and is the first trial to show that immunotherapy can increase survival in earlier-stage NSCLC. Several clinical trials are underway or in development to explore the role of adding immunotherapy to concurrent chemoradiation, followed by a year of immunotherapy or to even replace chemotherapy in this treatment paradigm. In resectable disease, adjuvant chemotherapy is still the standard of care for stage IB (tumors ≥ 4 cm) through stage III disease. However, new studies are investigating the role of adding immunotherapy to neoadjuvant chemotherapy or as adjuvant therapy for 1 year after resection. Molecular profiling for early-stage disease is not currently the standard of care, but several national clinical trials are studying the benefit of adding adjuvant-targeted therapies. This article will detail the current standard practices in early-stage and local-regionally advanced NSCLC and describe the evolving strategies that are under investigation that may further refine our current practice.

scholarly journals Two Complementarity Immunotherapeutics in Non-Small-Cell Lung Cancer Patients—Mechanism of Action and Future Concepts

Cancers ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 2836
Author(s):  
Kamila Wojas-Krawczyk ◽  
Paweł Krawczyk ◽  
Michał Gil ◽  
Maciej Strzemski
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Limited Effectiveness

Due to the limited effectiveness of immunotherapy used as first-line monotherapy in patients with non-small-cell lung cancer (NSCLC), the concepts of combining classical immunotherapy based on immune checkpoint antibodies with other treatment methods have been developed. Pembrolizumab and atezolizumab were registered in combination with chemotherapy for the treatment of metastatic NSCLC, while durvalumab found its application in consolidation therapy after successful chemoradiotherapy in patients with locally advanced NSCLC. Exceptionally attractive, due to their relatively low toxicity and high effectiveness, are treatment approaches in which a combination of two different immunotherapy methods is applied. This method is based on observations from clinical trials in which nivolumab and ipilimumab were used as first-line therapy for advanced NSCLC. It turned out that the dual blockade of immune checkpoints activated T lymphocytes in different compartments of the immune response, at the same time affecting the downregulation of immune suppressor cells (regulatory T cells). These experiments not only resulted in the registration of combination therapy with nivolumab and ipilimumab, but also initiated other clinical trials using immune checkpoint inhibitors (ICIs) in combination with other ICIs or activators of costimulatory molecules found on immune cells. There are also studies in which ICIs are associated with molecules that modify the tumour environment. This paper describes the mechanism of the synergistic effect of a combination of different immunotherapy methods in NSCLC patients.

Real-world outcomes of toripalimab (JS001) in advanced non-small cell lung cancer: A multicenter retrospective study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21193-e21193
Author(s):  
Zhihua Ruan ◽  
Bo Zhu ◽  
Yi Na Wang ◽  
Baogang Liu ◽  
Mengxia Li ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Retrospective Study ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Antiangiogenic Agent ◽  
Small Cell Lung

e21193 Background: In the past 3 years, immunotherapy has revolutionized the treatment paradigm of advanced non–small cell lung cancer (NSCLC). Checkpoint inhibitors showed promising results in the treatment of patients with advanced NSCLC with improved outcomes in clinical trials, but results from clinical trials can be difficult to generalize to real-world patient populations. Herein, we disclose the data of efficacy profile of toripalimab, a novel humanized IgG-4 mAb against programmed cell death protein 1 (PD-1), for NSCLC in a real-world setting in China. Methods: This retrospective study leveraged electronic health record (EHR) data collected during routine patient care in 8 cancer centers in China. The cohort included patients with mNSCLC who had received toripalimab for metastatic disease (n = 166) with > 1 EHR-documented visit from January, 2019, to June, 2020. Patients (age ≥ 18yrs) with pathologically or histologically diagnosed advanced NSCLC receiving toripalimab treatment were enrolled in this retrospective, multicenter, real-world study. The endpoints included progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR) and duration of response (DOR). Results: Between January 2019 and June 2020, 166 patients from 8 centers were eligible. The median age was 60.6 years, 134(81.7%) male, 123(76.4%) diagnosed as stage IV lung cancer, 69(42.9%) squamous histology, 25 (21.9%) underwent prior surgery and 94 (57%) received prior chemotherapy. Toripalimab was administered as first, second, and further lines of therapy in 45(28.1%), 60(37.5%) and 55(34.4%) patients, respectively. Among them, 28(17.5%) patients received toripalimab as monotherapy. 22(13.8%) received in combination with antiangiogenic agent and 132(82.5%) in combination with chemotherapy. The 164 patients were eligible for efficacy evaluation. The ORR and DCR were 21.3% and 81.7% for all the evaluable patients. The median PFS was 15.0 months (95% CI 10.2 – NA). The median PFS of adenocarcinoma and squamous cell carcinoma were 15.4 months(95% CI 10.2-NA) and 13.4 months(95% CI 10.6-NA), respectively. The PFS in first line and further-line treatment were 15.4 months(95% CI 12.6-15.4) and 13.4 months(95% CI 7.0-NA). Stratified analysis revealed that the PFS of toripalimab monotherapy and combination treatment were 15.0 months(95% CI 12.6-15.0) and 15.4 months(95% CI 8-NA). The PFS were comparable between the patients received with or without anti-angiogenesis agents (11.5m vs 15.4m). Conclusions: Toripalimab monotherapy or in combination with chemotherapy and/or antiangiogenic agent in real world were effective in advanced NSCLC patients.

Venous Thromboembolism and Non-Small Cell Lung Cancer: A Pooled Analysis of National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) Trials.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3995-3995
Author(s):  
Lisa Hicks ◽  
Matthew Cheung ◽  
Baktiar Hasan ◽  
Keyue Ding ◽  
Lesley Seymour ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Adjuvant Chemotherapy ◽  
Advanced Nsclc ◽  
Randomized Study ◽  
Pooled Analysis ◽  
Small Cell ◽  
Prior History ◽  
Small Cell Lung ◽  
History Of

Abstract Purpose: To determine the incidence of venous thromboembolism (VTE) in patients with early and advanced non-small cell lung cancer (NSCLC); to explore predictive factors for VTE occurrence during trials in these populations, and to investigate the effect of VTE on overall survival in patients with NSCLC. Patients and Methods: Data from three National Cancer Institute of Canada Clinical Trials Group trials were included in the analyses (n=1987). JBR.10 was a randomized study of post-resection adjuvant vinorelbine/cisplatin versus observation in stage IB/II NSCLC. BR.18 was a randomized study of paclitaxel/carboplatin ± the metalloproteinase inhibitor BMS-275291 in advanced NSCLC (1st line). BR.21 was a randomized study of erlotinib versus placebo in previously treated (2nd or 3rd line) NSCLC. The relationship between VTE, cancer treatment, concomitant medications, and baseline patient characteristics was explored with univariate and multivariate analysis. Cox regression analysis was performed to determine whether VTE was independently associated with survival. Each trial was analyzed separately; in addition a pooled analysis was performed with the advanced disease trials (BR.18 and BR.21). Results: The incidence of VTE was 0% in the observation arm of JBR.10 and ranged from 3% in the adjuvant chemotherapy arm of JBR.10 to 8% in BR.18. In JBR.10, VTE was independently associated with the administration of adjuvant chemotherapy (p=0.015), baseline obesity (p=.001), and low platelet count (p=.007). For patients with advanced NSCLC, VTE was significantly more common in patients receiving chemotherapy (BR.18) compared to patients receiving erlotinib or placebo (BR.21) (8% vs 2%, p< 0.0001). In BR.18, but not BR.21, VTE was associated with a prior history of VTE (p=0.001). When BR.18 and BR.21 were pooled, prior VTE remained significant. In BR.18 and BR.21, VTE was associated with shorter survival in multivariate analysis (HR=1.69, 95%CI 1.32–2.17, p<.0001); further analyses, including JBR.10, are planned to explore this finding. Conclusion: VTE is a frequent event in patients with advanced NSCLC and is associated with the administration of chemotherapy. Treatment with metalloproteinase or epidermal growth factor inhibitors does not appear to increase the risk of VTE. In early NSCLC, adjuvant chemotherapy, morbid obesity and a prior history of VTE are associated with increased risk. VTE is associated with shortened survival in patients with advanced NSCLC. Funding for this study was provided by the Canadian Cancer Society.

scholarly journals Pemetrexed versus Gefitinib as Second-line Treatment for Advanced Non-small Cell Lung Cancer: A Meta-analysis Based on Randomized Controlled Trials

Pteridines ◽  
2019 ◽  
Vol 30 (1) ◽  
pp. 171-176
Author(s):  
Huiyu Wang ◽  
Zunjing Zhang ◽  
Feng Liu ◽  
Miaoying Zhou ◽  
Handi Lv
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Small Cell Lung Cancer ◽  
Skin Rash ◽  
Advanced Nsclc ◽  
Meta Analysis ◽  
Small Cell ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung

Abstract Objective To investigate the clinical efficacy and toxicity of Pemetrexed versus Gefitinib as second-line treatment for advanced non-small cell lung cancer (NSCLC). Methods By systematically searching the electronic databases of Pubmed, CENTRAL, Cochrane, EMBASE, ASCO, and CBM, open published randomized clinical trials (RCTs) relevant to clinical efficacy and toxicity of Pemetrexed versus Gefitinib as second-line treatment of advanced NSCLC were included in the meta-analysis. Data of objective response rate (ORR) and drug related toxicity were extracted from the original publications and pooled by random or fixed effect method. Results Fourteen clinical trials related to Pemetrexed versus Gefitinib as second-line treatment for advanced NSCLC fulfilled the inclusion criteria and were included in the meta-analysis. The pooled results show that the ORR (RR=0.81, 95% CI:0.56–1.16, p=0.25) and DCR (RR=1.11, 95% CI:0.94–1.31, p=0.24) were not statistical different for Pemetrexed versus Gefitinib as second-line treatment of advanced NSCLC. However, the pooled data demonstrated the risk of developing skin rash (RR=0.10, 95% CI:0.03–0.30, p=0.00) and diarrhea (RR=0.31, 95% CI:0.15–0.67, p=0.003) in patients with Pemetrexed was significantly lower than that of Gefitinib through random effect model analysis, but the incidence of neutropenia in Pemetrexed group was significantly higher than that of Gefitinib with statistical difference (RR=7.62, 95% CI:3.71–15.66, p=0.00). Conclusion Pemetrexed was not inferior as second-line treatment for advanced NSCLC compared to Gefitinib for tumor response. However, Pemetrexed had higher incidence of neutropenia but lower risk of developing skin rash and diarrhea.

Phase II study of docetaxel and cisplatin in advanced non-small-cell lung cancer.

1998 ◽  
Vol 16 (5) ◽  
pp. 1948-1953 ◽  
Author(s):  
J Zalcberg ◽  
M Millward ◽  
J Bishop ◽  
M McKeage ◽  
A Zimet ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

PURPOSE Docetaxel (Taxotere, Rhone-Poulenc Rorer, Antony, France) and cisplatin are two of the most active single agents used in the treatment of non-small-cell lung cancer (NSCLC). A recently reported phase I study of the combination of docetaxel and cisplatin recommended a dose of 75 mg/m2 of both drugs every 3 weeks for subsequent phase II study. PATIENTS AND METHODS Eligible patients were aged 18 to 75 years with a World Health Organization (WHO) performance status < or = 2 and life expectancy > or = 12 weeks, with metastatic and/or locally advanced NSCLC proven histologically or cytologically. Patients were not permitted to have received prior chemotherapy, extensive radiotherapy, or any radiotherapy to the target lesion and must have had measurable disease. Concurrent treatment with colony-stimulating factors (CSFs) or prophylactic antibiotics was not permitted. Docetaxel (75 mg/m2) in 250 mL 5% dextrose was given intravenously (i.v.) over 1 hour immediately before cisplatin (75 mg/m2) in 500 mL normal saline given i.v. over 1 hour in 3-week cycles. Premedication included ondansetron, dexamethasone, promethazine, and standard hyperhydration with magnesium supplementation. RESULTS A total of 47 patients, two thirds of whom had metastatic disease, were entered onto this phase II study. The majority of patients were male (72%) and of good (WHO 0 to 1) performance status (85%). All 47 patients were assessable for toxicity and 36 were for response. Three patients were ineligible and eight (17%) discontinued treatment because of significant toxicity. In assessable patients, the overall objective response rate was 38.9% (95% confidence limits [CL], 23.1% to 56.5%), 36.1% had stable disease, and 25% progressive disease. On an intention-to-treat analysis, the objective response rate was 29.8%. Median survival was 9.6 months and estimated 1-year survival was 33%. Significant (grade 3/4) toxicities included nausea (26%), hypotension (15%), diarrhea (13%), and dyspnea mainly related to chest infection (13%). One patient experienced National Cancer Institute (NCI) grade 3 neurosensory toxicity after eight cycles. Grade 3/4 neutropenia was common and occurred in 87% of patients, but thrombocytopenia > or = grade 3 was rare (one patient). Significant (grade 3/4) abnormalities of magnesium levels were common (24%). Febrile neutropenia occurred in 13% of patients and neutropenic infection in 11%, contributing to two treatment-related deaths. No neutropenic enterocolitis or severe fluid retention was reported. CONCLUSION Compared with other active regimens used in this setting, the combination of docetaxel and cisplatin in advanced NSCLC is an active regimen with a similar toxicity profile to other combination regimens.

440 Activity and safety of camrelizumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced non-small-cell lung cancer

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A466-A466
Author(s):  
Guo Gui Sun ◽  
Jing Hao Jia ◽  
Peng Gao ◽  
Xue Min Yao ◽  
Ming Da Chen ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Small Cell ◽  
Large Sample Size ◽  
Small Cell Lung ◽  
Previously Treated ◽  
Line Chemotherapy

BackgroundEffective options are limited for patients with non–small-cell lung cancer (NSCLC) whose disease progresses after first-line chemotherapy. Camrelizumab is a potent anti-PD-1 monoclonal antibody and has shown promising activity in NSCLC. We assessed the activity and safety of camrelizumab for patients with previously treated, advanced NSCLC patients with negative oncogenic drivers.MethodsPatients who progressed during or following platinum-based doublet chemotherapy were enrolled. All patients received camrelizumab(200 mg)every 3 weeks or in combination with chemotherapy until loss of clinical benefit. The primary endpoint was objective response rate (ORR), other endpoints included disease control rate (DCR), progression-free survival (PFS) and safety.ResultsBetween Aug 5, 2019, and Jun 19, 2020, we enrolled 29 patients, 25 patients were available evaluated, ORR and DCR was 36% (9/25) and 92% (23/25), respectively. 25 of 29 patients were still receiving the treatment, the median PFS was not yet achieved. Compared with those without reactive cutaneous capillary endothelial proliferation (RCCEP), patients with RCCEP had higher ORR (60% vs. 28.6%). Treatment-related adverse events (AEs) occurred in 69.0% of patients (all Grade), and the most common were RCCEP (37.9%), pneumonitis (6.9%), and chest congestion (6.9%). Treatment-related grade 3 to 4 adverse events occurred in 10.3% of patients.ConclusionsIn patients with previously treated advanced NSCLC, camrelizumab demonstrated improved ORR and DCR, compared with historical data of the 2nd line chemotherapy, with a manageable safety profile. While patients with RCCEP derived greater benefit from camrelizumab. Further studies are needed in large sample size trials.

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