Safety and clinical efficacy of programmed cell death 1 antibodies (PD-1 Ab) in patients with advanced non-small cell lung cancer (NSCLC).

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 260-260
Author(s):  
Doran Ksienski ◽  
Elaine Wai ◽  
Nicole Croteau ◽  
Mary Lesperance
Keyword(s):  
Clinical Trials ◽  
Advanced Nsclc ◽  
Smoking Status ◽  
Multivariable Analysis ◽  
Physician Education ◽  
Kaplan Meier ◽  
Comorbidity Index ◽  
Cox Proportional Hazard Regression ◽  
Ecog Ps ◽  
Nsclc Patients

260 Background: In advanced NSCLC, clinical trials have shown significant benefits to pembrolizumab (P) and nivolumab (N). At BC Cancer, clinicians utilize protocol based algorithms to manage immune related adverse events (irAE). The incidence of irAE and efficacy of PD-1 Ab in everyday practice might differ from clinical trials. Methods: Advanced NSCLC patients (pts) treated with N or P between 11/2015 to 10/2017 at BC Cancer were identified. Demographic, tumor, treatment details, and frequency and grade (Gr, CTCAE v4.0) of irAE, were abstracted. Kaplan-Meier curves of median overall survival (OS) from initiation of PD-1 Ab were generated. Multivariable analysis (MVA) with 6-week landmark analysis was performed with Cox proportional hazard regression models. Results: Characteristics of cohort (230 N- and 41 P- treated): median age 64y (range 39-82), non-squamous histology 75%, ECOG PS > 1 at start of PD-1 Ab 31%, brain metastases (mets) 13%, liver mets 12%, and median Charlson Comorbidity Index (CCI) score 6. One hundred sixteen pts experienced 169 separate irAE: Gr1(74), Gr2 (68), Gr3(13), Gr4(10), Gr 5(4). Pneumonitis (14.6% vs. 4.8%, p = 0.041) and arthralgias (12.2% vs. 3.5%, p = 0.044) were more common in P than N. Steroids were administered to 25.2% of N pts and 19.5% of P pts (p = 0.557). Median follow-up from initiation of PD-1 Ab was 8.1months (range 0.1-33.9); median OS (95% CI) for N was 9.2 months (7.75-12.4) and for P was 13.5 months (10.6-not reached). 6-week landmark MVA for whole cohort revealed that male sex (p = 0.051), CCI≥3 (p < 0.001), ECOG PS > 1 (p < 0.001), liver mets (p = 0.017) and development of irAE > Gr2 versus no irAE (p = 0.036) were associated with decreased OS. Age, smoking status, histology, brain mets, EGFR status, irAE Gr 1/2 versus no irAE, and type of PD-1 Ab were not significant. Conclusions: Severe irAE were rare; pneumonitis and arthralgias were more common in P- than N- treated patients. The association with CCI, ECOG PS, and liver mets with decreased OS are consistent with literature. Association of severe irAE with shorter OS might reflect the need for improved physician education in irAE treatment algorithms.

Impact of prior radiation on survival in metastatic lung cancer ECOG-ACRIN trials.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9051-9051
Author(s):  
Saad A. Khan ◽  
Maneka Puligandla ◽  
Suzanne Eleanor Dahlberg ◽  
Gregory A. Masters ◽  
Corey J. Langer ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Clinical Trials ◽  
Advanced Nsclc ◽  
Cox Model ◽  
Multivariable Analysis ◽  
Palliative Intent ◽  
Prior Surgery ◽  
Ecog Ps ◽  
The Impact

9051 Background: Up to 50% of advanced NSCLC patients receive radiation therapy at some point in their course. We sought to determine whether patients with prior radiation demonstrate altered outcomes on subsequent metastatic clinical trials. Methods: We reviewed 8 ECOG-ACRIN advanced non-small cell lung cancer studies conducted between 1993 and 2011 in which information was collected about receipt of prior radiation. Whether radiotherapy was given with curative or palliative intent, or to specific sites was not recorded. Median follow-up among all trials was 66 months. We used the log-rank, Wilcoxon and Fisher’s exact tests to compare patients, and Cox Model and Kaplan-Meier method to calculate survival. Results: 574/3041 (18.9%) patients had received prior radiation. These patients were more likely to be male (64% vs 58%), have squamous histology (20% vs 14%) and have had prior surgery (48% vs 33%) compared to those with no prior radiation. At registration, prior radiation patients were more likely to have an ECOG PS of 1 (66% vs 58%), while they were less likely to have a PS of 0 (24% vs 36%) or have a pleural effusion (23% vs 37%). Patients who received radiation were more likely to have been registered on to studies between 1993-1999 than 2000-2011 (69% vs 31%) (all p < 0.001). Median Overall Survival (OS) for patients with prior radiation was 7.6 months (range 7-8.3) vs 9.5 (9.1-9.8) for those without (p < 0.001). Median Progression Free Survival (PFS) for those with prior radiation was 3.5 months (3-3.9) vs 4.2 (4.1-4.4) for those without (p < 0.001). In multivariable analysis controlling for stage IIIB/IV, sex, PS, histology, and prior surgery, the impact of prior radiation on overall survival remained significant (p = 0.042, HR (95% CI) = 1.11 (1.00, 1.22)). Conclusions: Almost one-fifth of lung cancer patients on systemic therapy trials for advanced disease previously received radiation. They are more likely to be male, have squamous histology, have an ECOG PS of 1 and have had prior surgery. Prior radiation is significantly associated with inferior OS and PFS. For advanced NSCLC clinical trials, documentation of whether curative intent/palliative intent radiation was given and stratification by prior radiation exposure should be considered.

Pembrolizumab (Pem) for advanced non-small cell lung cancer (aNSCLC): Efficacy and safety in everyday clinical practice.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20506-e20506
Author(s):  
Doran Ksienski ◽  
Elaine S. Wai ◽  
Nicole Croteau ◽  
Ashley Freeman ◽  
Leathia Fiorino ◽  
...  
Keyword(s):  
Regression Models ◽  
Multivariable Analysis ◽  
Efficacy And Safety ◽  
Logistic Regression Models ◽  
Cox Proportional Hazard ◽  
Kaplan Meier ◽  
Grade 5 ◽  
Grade 3 ◽  
Cox Proportional Hazard Regression ◽  
Ecog Ps

e20506 Background: In clinical trials, Pem improves overall survival (OS) compared to chemotherapy in a subset of patients (pts) with aNSCLC. Immune related adverse events (irAE) have correlated with improved OS in some studies. We explored efficacy and safety of Pem in a provincial population. Methods: aNSCLC pts treated with Pem between 06/2015 and 08/2018 at BC Cancer were retrospectively identified. Kaplan-Meier curves of OS from initiation of Pem were plotted and multivariable analysis (MVA) was performed with Cox proportional hazard regression models. 3, 6, and 9 month landmark Kaplan-Meier analysis was performed and log-rank tests used to determine the association of irAE subtypes with OS. Multivariable logistic regression models for irAE within 3 months of Pem initiation were also fit. Results: Characteristics of the 190 pt cohort: median age 70y (41-91), ECOG PS 2/3 at start of Pem: 34.2%, squamous histology: 22.1%, EGFR mutation: 3.7%, brain (13.7%) or liver (8.9%) metastases, PD-L1 expression ≥ 50%: 92.6%, treatment line: 1st/ ≥2nd: 74.2%/25.8%. Median cycles delivered 7 (range 1-35). With median survival follow-up of 6.1 months (range 0.03-39.8 months) and 43% pts decreased, median OS of Pem in the 1st line and ≥2nd line settings were 24.3 months (95% CI, 9.7-not reached, NR) and 13.4 months (95% CI, 8.1-NR), respectively. Pts with ECOG PS 2/3 had lower OS vs. ECOG PS 0/1 (5.8 months vs. 16.7 months, log-rank p < 0.0001). On MVA, only ECOG PS (p < 0.001) was associated with OS. 66 pts (34.7% of cohort) experienced 89 irAE; most common irAE: dermatitis (20pts), hypothyroidism (13pts), and pneumonitis (10pts). 8.4% of cohort developed grade 3 or 4 irAE; no grade 5 irAE. The odds of a grade ≥ 3 irAE within 3 months was 6.3 fold higher if ECOG 2/3 vs. 0/1 (p = 0.05). A weak association between pneumonitis and decreased OS at 9 month landmark (p = 0.09) was seen; otherwise no association with irAE subtypes at 3, 6, and 9 month landmarks was observed. Conclusions: In the whole cohort, clinical efficacy and toxicity of Pem was consistent with registration trials. Pts with ECOG PS 2/3 had a significantly lower OS and higher odds of developing grade ≥ 3 irAE than those with good ECOG PS 0/1.

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.

scholarly journals Clinicopathologic correlates of pembrolizumab efficacy in patients with advanced NSCLC and a PD-L1 expression of ≥ 50%

2020 ◽  
Author(s):  
Alessio Cortellini ◽  
Marcello Tiseo ◽  
Giuseppe L Banna ◽  
Federico Cappuzzo ◽  
Joachim GJV Aerts ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Bone Metastases ◽  
Recursive Partitioning ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Tobacco Exposure ◽  
Former Smokers ◽  
Never Smokers ◽  
Ecog Ps ◽  
Nsclc Patients

AbstractBackgroundSingle agent pembrolizumab represents the standard first line option for metastatic non-small-cell-lung-cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%.MethodsWe conducted a multicenter study aimed at evaluating the clinicopathologic correlates of pembrolizumab efficacy in patients with treatment-naïve NSCLC and a PD-L1 TPS ≥ 50%.Results1026 consecutive patients were included. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis.Conclusionspembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. We confirmed that the absence of tobacco exposure, and the presence of bone and liver metastasis are associated with worse clinical outcomes to pembrolizumab. Increasing levels of PD-L1 expression may help identifying a subset of patients who derive a greater benefit from pembrolizumab monotherapy.

Impact of rapid multigene assays with short turnaround time (TAT) on the development of precision medicine for non-small cell lung cancer (NSCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9094-9094
Author(s):  
Shingo Matsumoto ◽  
Takaya Ikeda ◽  
Kiyotaka Yoh ◽  
Akira Sugimoto ◽  
Terufumi Kato ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Precision Medicine ◽  
Targeted Therapies ◽  
Advanced Nsclc ◽  
Genetic Alterations ◽  
Braf V600e ◽  
Gene Testing ◽  
Genomic Screening ◽  
Nsclc Patients

9094 Background: A variety of oncogene drivers have been identified in NSCLC and molecularly-stratified precision medicine has led to improved survival in advanced NSCLC. Next-generation sequencing (NGS)-based testing is utilized to detect actionable gene alterations; however, the TAT of NGS is often too long to translate into clinical decision making. Thus, rapid multi-gene testing alternatives are needed. Methods: A lung cancer genomic screening project (LC-SCRUM-Asia) capturing clinical outcome was established in 2013 to identify patients with oncogene drivers and to support the development of novel targeted therapies. Since February 2013 to May 2019 (LC-SCRUM-Asia 1st-phase), single gene testing and/or a targeted NGS assay, Oncomine Comprehensive Assay (OCA), were used for the genomic screening. Since June 2019 to December 2020 (2nd-phase), a multi-gene PCR assay (Amoy 9-in-1 test) and a rapid NGS assay (Genexus/Oncomine Precision Assay [OPA]) were also implemented as rapid multi-gene testing. Results: A total of 10667 Japanese NSCLC patients, including 6826 in the 1st-phase and 3841 in the 2nd-phase, were enrolled in the LC-SCRUM-Asia. Success rate for OCA: 93%, for 9-in-1 test: 98%, for Genexus/OPA: 96%. Median TAT for OCA: 21 days, for 9-in-1 test: 3 days, for Genexus/OPA: 4 days. The frequencies of genetic alterations detected in the 1st-/2nd-phase were EGFR: 17/24%, KRAS: 15/16%, HER2 ex20ins: 4/3%, ALK fusions: 3/3%, RET fusions: 3/2%, ROS1 fusions: 3/2%, MET ex14skip: 2/2%, BRAF V600E: 1/1%, NRG1 fusions: 0/0.2% and NTRK3 fusions: 0.05/0.04%. Overall percent agreement of 9-in-1 test compared with OCA for EGFR/KRAS/HER2/BRAF/MET/ALK/ROS1/RET/NTRK3 alterations was 98%, and that of OPA compared with OCA was 95%. The rate of patients who received targeted therapies as 1st-line treatment was significantly elevated in the 2nd-phase compared with the 1st-phase (510/3841 [13%] vs. 567/6826 [8%], p < 0.001). Through the genomic screening, 1410 (37%) and 1269 (18%) candidate patients for clinical trials of KRAS, HER2, BRAF, MET, ALK, ROS1, RET or TRK-targeted drugs were identified in the 2nd-phase and in the 1st-phase, respectively. The rate of patients who were actually enrolled into the genotype-matched clinical trials were also significantly higher in the 2nd-phase than in the 1st-phase (222 [6%] vs. 186 [3%], p < 0.001). In 1st-line treatments for advanced NSCLC patients, the median progression-free survival was 8.5 months (95% CI, 7.7−9.4) in the 2nd-phase (n = 1839) versus 6.1 months (95% CI, 5.9−6.3) in the 1st-phase (n = 4262) (p < 0.001). Conclusions: Both the 9-in-1 test and Genexus/OPA had short TATs (3−4 days), high success rates (96−98%) and good concordance (95−98%) compared with another NGS assay (OCA). These rapid multi-gene assays highly contributed to enabling precision medicine and the development of targeted therapies for advanced NSCLC.

scholarly journals Survival analysis of 219 dogs with hyperadrenocorticism attending primary care practice in England

2019 ◽  
Vol 186 (11) ◽  
pp. 348-348 ◽  
Author(s):  
Imogen Schofield ◽  
David C Brodbelt ◽  
Anna R L Wilson ◽  
Stijn Niessen ◽  
David Church ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Care Practice ◽  
Multivariable Analysis ◽  
Care Practice ◽  
Electronic Patient Records ◽  
Kaplan Meier ◽  
All Cause Mortality ◽  
Cox Proportional Hazard Regression ◽  
Primary Care Practitioners ◽  
Primary Care Practices

BackgroundHyperadrenocorticism is an endocrine disease routinely encountered within primary care practice; however, few studies evaluating survival beyond diagnosis have studied this population.MethodsThis retrospective cohort study analysed the electronic patient records of 219 cases of hyperadrenocorticism from a sample of dogs attending primary care practices in England. Kaplan-Meier plots examined the cumulative survival and Cox proportional hazard regression modelling identified factors associated with the hazard of all-cause mortality.ResultsIn the analysis, 179/219 (81.7 per cent) hyperadrenocorticism cases died during the study period with a median survival time from first diagnosis of 510 days (95% CI 412 to 618 days). Trilostane was used in 94.1 per cent of cases and differentiation between pituitary-dependent and adrenal-dependent disease was made in 20.1 per cent of cases. In the multivariable analysis, dogs weighing greater than or equal to 15 kg (HR 1.51, 95% CI 1.06 to 2.15, P=0.023) and those diagnosed greater than or equal to 13 years of age (HR 3.74, 95% CI 2.29 to 6.09, P<0.001) had increased hazards of all-cause mortality. Dogs that had their initial trilostane dose increased had a favourable prognosis (HR 0.49, 95% CI 0.32 to 0.76, P=0.015).ConclusionThis study shows that survival from diagnosis of hyperadrenocorticism appears fair for many dogs and provides primary care practitioners with relatable benchmark prognostic figures.

Clinical outcomes of intermediate risk metastatic germ cell tumors (IRGCT): Results from a single-institution series.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 380-380
Author(s):  
Daniele Raggi ◽  
Salvatore Lo Vullo ◽  
Patrizia Giannatempo ◽  
Daniele Giardiello ◽  
Nicola Nicolai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Prognostic Factors ◽  
Cox Regression ◽  
Lung Metastases ◽  
Multivariable Analysis ◽  
Germ Cell Tumors ◽  
Time Frame ◽  
Logrank Test ◽  
First Line Therapy ◽  
Kaplan Meier

380 Background: IRGCT comprises a consistent category of metastatic patients (pts), and information on the recommended management of these pts should be updated. Usually they enter clinical trials for poor prognosis GCT. We aimed to address the heterogeneity of this category and to identify clinical prognostic factors for sub-stratification of pts. Methods: Data on consecutive pts with IRGCT and who received treatment at Fondazione INT Milano in the time-frame 02/1980-03/2014 were collected. Cox regression analyses were done evaluating potential prognostic factors for overall survival (OS, primary endpoint) to first-line therapy. Each factor was evaluated in a multivariable model. An exploratory OS comparison between outlier groups was undertaken with Kaplan Meier curves and logrank test. Results: Data on 181 pts were collected. Median age was 27 yrs (IQR 22-32), 10 pts had a retroperitoneal (RP) primary, 6 had pure seminoma. 72 (39.8%) had lung metastases and 54 (32.3%) bulky (i.e. ≥10cm) RP lymph-nodes (LN). Pts received cisplatin, bleomycin and etoposide (PEB, n=156) or vinblastine (PVB, n=23), 2 other treatments. Median follow up was 173 months (IQR: 87-237). Globally, 5-y PFS and OS were 66.8% (95%CI: 60.1-74.2) and 83.3% (77.8-89.2). However, 5-y OS for pts with AFP 5,000-10,000 IU/ml (N=19) was 61.8% (95%CI: 43.0-88.7) while it was 89.1% (95%CI: 81.2-97.7) for nonseminomas with elevated LDH only (N=57) and similar for elevated HCG only (N=22); overall p<0.001. Multivariable analysis for OS is shown in the table (c-index= 0.63). Distribution of variables over time: bulky RP LN and elevated LDH were more frequent in earlier series (p=0.003 and 0.011). Conclusions: The prognostic heterogeneity of IRGCT category is a matter of fact and should be addressed by clinical trials. Pts with highly elevated AFP have an OS similar to poor prognostic category, while those categorized by elevated HCG or LDH only are close to good risk ones. [Table: see text]

Potential risk factors of pneumonitis associated with consolidation pembrolizumab after chemoradiation in unresectable NSCLC patients.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 167-167
Author(s):  
Shahid Sattar Ahmed ◽  
Greg Andrew Durm ◽  
John Donatelli ◽  
Huan Yao ◽  
Yongmei Liu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Radiation Treatment ◽  
Smoking Status ◽  
Limited Data ◽  
Exact Test ◽  
Unresectable Stage ◽  
Related Risk ◽  
Potential Risk Factors ◽  
Ecog Ps ◽  
Nsclc Patients

167 Background: We have previously shown that consolidation pembrolizumab after chemoradiation is safe in a 93 patient-clinical trial of unresectable stage III NSCLC patients (Durm, ASCO 2016). However 15 patients (16%) developed grade ≥2 pneumonitis. There is limited data on risk factors for developing pneumonitis in this population. We conducted a retrospective review of these patients to identify potential clinical, biologic, radiographic and radiation treatment related risk factors for developing pneumonitis. Methods: We evaluated ECOG PS, age, gender, smoking status, stage, histology, chemo regimen, consolidation chemotherapy, TILs, PDL-1 status, PFTs, PET SUVs, grade of pre-existing ILD, COPD and Radiation dosimetry plans. Logistic regression and fisher’s-exact test were used for the odds ratio and p-values. Results: See Table. [1] [1] Age, histology, stage, chemo, PFTs, SUVs and PDL1 were not significant [2] n = sample size p = pneumonitis [3] Moderate/severe COPD was not seen in any patients with pneumonitis despite 94% of participants being smokers. Conclusions: This preliminary report highlights the utility of a multi-disciplinary approach to develop risk-stratification models for pneumonitis in an at-risk patient population. However larger prospective studies are needed to validate their meaningful use in the clinical setting.[Table: see text]

Evaluating the role of race in outcome of advanced non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitor (ICI): Our institutional experience.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9042-9042
Author(s):  
Bassel Nazha ◽  
Zhengjia Chen ◽  
Subir Goyal ◽  
Anne Engelhart ◽  
Jennifer Wilkinson Carlisle ◽  
...  
Keyword(s):  
Real World ◽  
Advanced Nsclc ◽  
Single Agent ◽  
Progression Free Survival ◽  
Minority Population ◽  
Duration Of Response ◽  
Diverse Patient Population ◽  
Institutional Experience ◽  
Ecog Ps ◽  
Nsclc Patients

9042 Background: Race-based differences in ICI efficacy for advanced NSCLC have not been studied due to under-representation of patients of minority background in pivotal trials. We systematically explored real-world differences in outcome in our diverse patient population. Methods: This is a retrospective review of clinical outcome of patients with advanced NSCLC treated with single-agent ICI between 2013 and July 2018 at the Winship Cancer Institute of Emory University. We performed univariate and multivariate analyses for overall survival (OS) and progression free survival (PFS) patients according to self-reported race and of OS according to gender and PD-L1 expression levels. Results: We analyzed clinical data from 90 eligible patients: Median age of 68.5 yrs, 51% male, White (W)/Black(B)/Asians(A) made up 62.3%/30.7%/5%; 36.5% had brain metastasis at the time of ICI initiation. The majority (85.9%) had ECOG PS ≤2; ICI was 1st line in 15 (16.9%), 2nd line in 59 (66.3%), 3rd line in 12 (13.5%) and nivolumab was the most commonly used agent (41.1%) followed by atezolizumab (32.2%) and pembrolizumab (26.7%). The median OS for the entire population was not reached (NR) (95%CI: 15.6, NR) while 12-month and 24-month OS rates were 63.8% (52.8%, 72.8%) and 53.1% (40.2%, 64.4%). The median OS, 12-month and 24-month OS rates for W and B respectively, were 23.6 months vs. NR; HR: 1.02 (95%CI: 0.51-2.04), p = 0.9571; 61.8% (47.7%, 73.2%) vs. 59.3% (38.6%, 75.0%) and 46.0% (27.9%, 62.4%) vs. 53.9% (32.8%, 70.9%). The overall response rate was 16.7%; 23.8% vs. 11% for B and W respectively. The median duration of response was comparable at 3.36 months vs. 2.94 months for W and B. The median PFS and 12-month PFS rate for W and B respectively were 5.5 (3.2, 14.8) vs. 3.0 (1.4, 10.7) months, p = 0.1350 and 40.0% (27.1%, 52.5%) vs. 29.6% (14.1%, 47.0%). Conclusions: Real-world analysis of our institutional experience showed no significant racial disparity in advanced NSCLC patients treated with ICI. Larger multi-institutional studies to include other US minority population would make our findings generalizable.

Impact of cachexia in advanced NSCLC patients treated with PD-1 inhibitor.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 44-44
Author(s):  
Hitomi Jo ◽  
Hidehito Horinouchi ◽  
Shigehiro Yagishita ◽  
Yuki Shinno ◽  
Yusuke Okuma ◽  
...  
Keyword(s):  
Body Weight ◽  
Confidence Interval ◽  
Advanced Nsclc ◽  
Smoking Status ◽  
Hazard Ratio ◽  
Disease Stage ◽  
Cancer Center ◽  
Study Cohort ◽  
Durable Response ◽  
Nsclc Patients

44 Background: Cancer cachexia is known to a multifactorial catabolic syndrome and is observed 15-40% in general cancer population with worse prognosis. A recent study suggested a shorter survival period in non-small cell lung cancer (NSCLC) patients with a higher pembrolizumab clearance associated with cachexia. We here conducted analyses for the clinical impact of cachexia in advanced NSCLC treated with pembrolizumab. Methods: We evaluated consecutive advanced NSCLC patients who received pembrolizumab between March 2017 and December 2018 at the National Cancer Center Hospital. Cachexia was defined as a body weight loss >5% over the past 6 months or >2% in patients with a BMI <20 kg/m2 at the start of treatment. Information on patient age, sex, performance status, histology, driver mutation status, smoking status, disease stage, treatment line, and PD-L1 tumor proportion score were recorded. The overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) were investigated according to the presence of cachexia. Univariate and multivariate analyses were performed. Results: A total of 157 NSCLC patients received pembrolizumab during the study period. Of these, 134 patients with information for body weight were included in the final analysis. Patients with cachexia accounted for 35% (47 out of 134) of this cohort. The ORR was 38% among the patients with cachexia and 35% among those without cachexia. The median PFS was significantly shorter for the patients with cachexia than for the patients without cachexia (median PFS, 4.2 months vs. 7.1 months; hazard ratio, 1.63; 95% confidence interval, 1.06 – 2.53; P = 0.02). The median OS was significantly shorter for the patients with cachexia (median OS, 8.6 months vs. NR; hazard ratio, 1.83; 95% confidence interval, 1.03-3.25; P = 0.04). The presence of cachexia was independently associated with a shorter PFS in a multivariate analysis. Conclusions: The presence of cachexia was significantly associated with a shorter PFS and OS in our study cohort. Screening for cachexia may help to identify patients who are more likely to achieve a durable response.

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