Trends in checkpoint inhibitor therapy for advanced urothelial cell carcinoma (aUC) at the end of life: Insights from real-world practice.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 395-395 ◽  
Author(s):  
Ravi Bharat Parikh ◽  
Matt D. Galsky ◽  
Bishal Gyawali ◽  
Fauzia Riaz ◽  
Tara Laura Kaufmann ◽  
...  
Keyword(s):  
End Of Life ◽  
Real World ◽  
Systemic Therapy ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Poor Performance ◽  
Nonparametric Tests ◽  
Poor Performance Status ◽  
National Guidelines ◽  
Health Database

395 Background: National guidelines recommend against chemotherapy use at the end of life. Five CPIs are now approved for aUC. We hypothesized that oncologists may have a lower threshold to initiate CPI in patients (pts) at the end of life, particularly among pts with poor performance status (PS), because of the perceived favorable toxicity profile of CPI. Methods: We conducted a secular trend analysis using the Flatiron Health Database, a large real-world electronic medical record-derived dataset. We used nonparametric tests of trend (p values reported as ptrend) to evaluate quarterly proportions of pts initiating CPI, chemotherapy, or no systemic therapy within 30 and 60 days of death, among 2959 pts diagnosed with aUC from 2015 to 2017. Results: 1637 pts died during follow-up and were eligible for analysis. 278 (17.0%) and 488 (29.8%) pts initiated a new line of systemic therapy in the last 30 and 60 days of life, respectively. The quarterly proportion of CPI initiators within 60 days of death increased from 1.0% to 23% during the study period ( ptrend < 0.001), with corresponding decreases in chemotherapy initiation and no systemic therapy. After CPI approval in mid-2016, CPI initiation significantly increased among pts with Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 ( ptrend = 0.02) but did not significantly change among pts with PS 0-1. Initiation of any systemic therapy at the end of life doubled (17.4% to 34.8%) over the study period, driven largely by end-of-life CPI use. Compared to chemotherapy initiators, CPI initiators had slightly worse PS (table). Conclusions: In patients with aUC, there has been a dramatic rise in CPI initiation at the end of life particularly among pts with poor PS. Existing guidelines on systemic therapy initiation near the end of life should account for the increasing use of CPI. [Table: see text]

Utilizing Eastern Cooperative Oncology Group (ECOG) performance status scores to prevent harm with chemotherapy at the end of life.

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 146-146
Author(s):  
Eve Newhart ◽  
Beth Karlan ◽  
Rita Shane ◽  
Vipul Patel ◽  
Bradley T. Rosen ◽  
...  
Keyword(s):  
End Of Life ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Cancer Treatments ◽  
Ecog Performance Status ◽  
Number Of Patients ◽  
Inpatient Settings ◽  
Practice Methods

146 Background: According to ASCO’s “top five” list of non evidence-based cancer treatments and procedures, the use of chemotherapy in solid tumor patients with evidence of poor performance status is at the top of the list. The Dartmouth Atlas report revealed a significant overuse of chemotherapy at the end of life (EOL), and Cedars-Sinai was identified as an outlier with regards to this practice. Methods: Cedars-Sinai’s interdisciplinary cancer quality committee designed a new initiative to eliminate the ineffective administration of chemotherapy. Each patient’s ECOG score, entered by a nurse or physician, was used as an appropriateness screen by pharmacists before they released chemotherapy in both the outpatient and inpatient settings. If a patient did not qualify for chemotherapy based on an ECOG score of 3 or greater, the pharmacist contacted the prescribing oncologist to discuss the case. Ultimately the oncologist had the final say as to whether the patient received chemotherapy. Data was collected on ECOG scores, number of patients screened and identified as being at risk, oncologists’ responses to being notified, and whether chemotherapy was ultimately administered. Results: Available data collected on the % of orders with ECOG scores, since February of 2014 is shown in the Table. Conclusions: Data and conclusions regarding oncologists’ responses to being notified, and whether chemotherapy was ultimately administered, and harm thus prevented, is currently being compiled and will be presented at the conference. [Table: see text]

scholarly journals Attenuated regimen of biweekly gemcitabine/nab-paclitaxel in patients aged 65 years or older with advanced pancreatic cancer

2020 ◽  
Vol 13 ◽  
pp. 175628482097491
Author(s):  
Hasan Rehman ◽  
Jeffrey Chi ◽  
Nausheen Hakim ◽  
Shreya Prasad Goyal ◽  
Coral Olazagasti ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Weekly Schedule ◽  
Dose Reductions

Background: Treatment with gemcitabine/nab-paclitaxel confers a survival benefit over gemcitabine monotherapy in patients with advanced pancreatic cancer (APC). However, such treatment can be associated with significant toxicities especially in older patients and carries practical disadvantages related to a weekly schedule along with financial cost. We retrospectively analyzed patients >65 years of age with APC who received a modified biweekly regimen of gemcitabine/nab-paclitaxel to evaluate efficacy and toxicity. Methods: Patients aged >65 years with chemo-naïve APC with Eastern Cooperative Oncology Group performance status ⩽2 were studied. Patients were treated with a modified regimen of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 every 2 weeks on days 1 and 15 of a 28-day cycle. Patients were evaluated for progression-free survival (PFS) and overall survival (OS) with analyses performed using the Kaplan–Meier method. Adverse events were recorded on the day of chemotherapy. Cancer antigen 19.9 was measured in every cycle and restaging scans were performed every two cycles. Results: A total of 73 patients (median age: 73 years; range: 66–93) were treated with biweekly gemcitabine/nab-paclitaxel as first-line treatment. The median OS and PFS were 9.1 months and 4.8 months, respectively. Around 66% of patients received growth-factor support based on American Society of Clinical Oncology guidelines and no patient developed neutropenic fever. The incidences of grade ⩾3 toxicity for neutropenia, anemia, thrombocytopenia, and neurotoxicity were 2%, 7%, 3%, and 5%, respectively. Dose reductions of gemcitabine/nab-paclitaxel were required in 10% and 4% patients, respectively. Conclusion: In patients older than >65 years of age with APC, a modified regimen of biweekly gemcitabine/nab-paclitaxel was found to be effective when compared with the historical control from the MPACT study. This regimen allowed for fewer dose reductions, reduced healthcare costs from additional appointments, travel-related cost, as well as a favorable side-effect profile while maintaining efficacy. Though retrospective in nature, this study underlines the need for further investigation, particularly in elderly patients with poor performance status, such as those with pancreatic cancer, and in order to combine with a third agent, such as a targeted treatment or immunotherapy.

Immune Checkpoint Inhibitor Use Near the End of Life Is Associated With Poor Performance Status, Lower Hospice Enrollment, and Dying in the Hospital

2019 ◽  
Vol 37 (3) ◽  
pp. 179-184 ◽  
Author(s):  
Chad Glisch ◽  
Yuya Hagiwara ◽  
Stephanie Gilbertson-White ◽  
Yubo Gao ◽  
Laurel Lyckholm
Keyword(s):  
End Of Life ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitor ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Inhibitor Treatment

Background: Immune checkpoint inhibitors have changed the landscape of cancer care by increasing progression-free and overall survival in some patients with cancer. We evaluated use and variables contributing to immune checkpoint inhibitor treatment near the end of life. Methods: We studied 157 patients who received immune checkpoint inhibitors and died between January 2015 and December 2018. All patients had a palliative care consult any time between starting an immune checkpoint inhibitor and death. Univariate and multivariate models were used to examine variables related to immune checkpoint inhibitor use near the end of life. Results: Among 157 patients studied, 42 (27%) received a dose of immune checkpoint inhibitor in the last 30 days of life. Those who received treatment in the last 30 days of life had lower hospice enrollment (19 [45%] vs 78 [69%], P = .007) and higher rates of dying in the hospital (23 [56%] vs 33 [29%], P = .002). The percentage of patients with Eastern Cooperative Oncology Group (ECOG) ≥3 at the time of last immune checkpoint inhibitor dose was higher in the group that received immune checkpoint inhibitor treatment in the last 30 days of life (11 [26%] vs 9 [8%], P = .003). Lack of traditional chemotherapy after immune checkpoint inhibitor, ECOG ≥3, and lack of hospice enrollment were independently associated with receiving immune checkpoint inhibitor in the last 30 days of life. Conclusion: Immune checkpoint inhibitor use in the last 30 days of life is common and associated with poor performance status, lower hospice enrollment, and dying in the hospital.

Systemic therapy use and outcomes after relapse from accelerated hemithoracic radiation and surgery for malignant pleural mesothelioma (MPM).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8559-8559
Author(s):  
Sara V. Soldera ◽  
John Kavanagh ◽  
Melania Pintilie ◽  
Ronald Feld ◽  
Natasha B. Leighl ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Performance Status ◽  
Poor Performance ◽  
Final Diagnosis ◽  
Rank Test ◽  
Poor Performance Status ◽  
Extrapleural Pneumonectomy ◽  
First Line ◽  
Poor Prognostic Factor ◽  
Surgical Specimen

8559 Background: The prognosis of patients (pts) with MPM remains poor. Accelerated hemithoracic radiation followed by extrapleural pneumonectomy and adjuvant chemotherapy in ypN2 disease (SMART) provides encouraging results. The ability to administer systemic therapy (Tx) and response rate (RR) after recurrence remains unclear. We therefore examined subsequent lines of Tx and outcomes following relapse after SMART. Methods: A retrospective analysis of pts diagnosed with recurrent MPM following SMART was conducted at a single institution. OS was determined from date of relapse to death and was estimated using the Kaplan-Meier method. Potential prognostic variables were tested utilizing the log-rank test. Results: Out of 86 pts undergoing SMART from 2008 to 2016, 53 (62%) developed recurrent disease of which 36% had pathological confirmation. Two cases with initial epithelial subtype on surgical specimen relapsed with different histology (sarcomatoid and small cell). In 48% of pts, relapse was unclear at first imaging (n = 42) and a median of 98 days (range 6-966) lapsed between first suspicion and final diagnosis. The median age at relapse was 66 years (range 45-79), 47% had a performance status (PS) ≥2 (n = 45) and 64% were of epithelial subtype. After a median follow up of 7.6 mo, the median OS was 5.2 mo. PS ≥2 was associated with worse OS (2.8 vs 10.7 mo, p < 0.001). Of 42 pts followed after relapse, 36% received any Tx (19% 1 line; 12% 2 lines; 5% ≥3 lines). Tx was omitted in 62% of pts due to poor PS (26/42). First line Tx consisted of platinum doublet in 93% of pts (n = 15). Of 13 pts with response evaluable disease, RR was 15% (0 CR, 15% PR). Of note, 0/13 pts had neoadjuvant Tx and 3/13 pts had adjuvant Tx (10, 13 and 38 mo lapsed between end of adjuvant Tx and start of Tx in the relapsed setting). 6/15 pts discontinued Tx due to toxicity, 5/15 due to progression and median number of cycles was 4. Conclusions: Pts with relapsed MPM following SMART have poor prognosis and low RR to first line Tx. Poor performance status at relapse is a poor prognostic factor. Earlier detection, novel diagnostic markers of relapse and consideration of maintenance strategies should be investigated in future studies.

scholarly journals Real world clinical outcomes of adjuvant sequential chemoradiation in patients with gallbladder carcinomas with poor performance status

2020 ◽  
Vol 38 (4) ◽  
pp. 262-269
Author(s):  
Rakesh Kapoor ◽  
Kannan Periasamy ◽  
Rajesh Gupta ◽  
Arun Yadav ◽  
Divya Khosla
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status

Impact of cytoreductive nephretomy on timing of systemic therapy in metastatic kidney cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 503-503
Author(s):  
Liam Connor Macleod ◽  
Atreya Dash ◽  
George Schade ◽  
Jonathan D. Harper ◽  
Daniel W. Lin ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Systemic Therapy ◽  
Performance Status ◽  
Postoperative Mortality ◽  
Poor Performance ◽  
Prognostic Models ◽  
Poor Performance Status ◽  
Surgical Morbidity ◽  
Factors Associated ◽  
Node Positive Disease

503 Background: High rates of disease control with systemic therapy (ST) in the post-cytokine era for metastatic renal cell carcinoma (mRCC) cause apprehension that cytoreductive nephrectomy (CN) may delay effective therapy. We therefore evaluated factors associated with early mortality and time to ST after CN. We hypothesized markers of poor performance status and morbid CN would be associated with postoperative mortality and therapeutic delays. Methods: The National Cancer Database was screened for adult mRCC cases having CN followed by ST, years 2006-2013. We classified a delay in systemic therapy as interval > 45 days (median time to ST in the cohort). Multivariable logistic regression was performed, identifying factors associated with perioperative mortality and delays to initiation of ST. Results: Of 10,913 patients with initial CN (45% of mRCC), 30- and 90-day mortality were 3% and 11%, respectively. 6,362 later received ST (87% targeted therapy, 13% immunotherapy), median start was 45 days post-operatively (IQR 9-72), with 73% receiving ST within 30 days of CN. Multivariable factors associated with 30-day mortality included, older age, (OR 2.3, 95% CI 1.5-3.5 for those >75 [referent < 55 years]), Charlson index >0 (OR 1.3, 95% CI 1.0-1.6), lack of insurance (OR 1.9, 95% CI 1.2-2.8 [referent private payer]), node-positive disease (OR 1.4 95% CI 1.1-1.7), length of stay > 90th percentile (> 10 days, OR 3.2, 95% CI 2.0-5.3), larger tumor size (T4 lesion OR 1.7, 95% CI 1.2-2.5 [referent T1]). Delayed ST was associated with travel burden > 50 miles (OR 1.2, 95% CI 1.0-1.4), concurrent metastasectomy (OR 1.3, 95% CI 1.2-1.5), and length of stay > 90th percentile (OR 1.5, 95% CI 1.1-2.3). Conclusions: These data suggest that markers of frailty, more progressive disease, and surgical morbidity may contribute to surgical-related deaths or hinder patients receiving potentially disease-controlling therapy when treated with initial CN in mRCC. Going forward, existing surgical prognostic models could incorporate risks of surgical-related mortality and delay to ST when considering CN.

Outcomes of urothelial carcinoma patients with central nervous system metastases.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 468-468
Author(s):  
Erik Andrews ◽  
Catherine Curran ◽  
Petros Grivas ◽  
Leonidas Nikolaos Diamantopoulos ◽  
Ravindran Kanesvaran ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Radiation Therapy ◽  
Urothelial Carcinoma ◽  
Systemic Therapy ◽  
Tumor Regression ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Best Response

468 Background: Urothelial carcinoma (UC) metastatic to the central nervous system (CNS) is extremely rare. Given the lack of systematic data regarding outcomes in UC metastatic to the CNS, we conducted a retrospective multicenter study to more broadly characterize outcomes. Methods: Patients (pts) diagnosed with metastatic UC to the CNS were identified from collaborating institutions. Data were collected for demographics, clinical and pathological variables. Descriptive statistics were reported to examine tumor regression, time to treatment discontinuation or failure (TTF), and overall survival (OS). Results: 39 pts with UC metastatic to the CNS were evaluable from 6 institutions. The ECOG-PS ranged from 0-4 (median 2), the median age was 67 (range 39-82), and 8 (20.5%) were female. The histology consisted of pure urothelial, mixed predominant urothelial, and mixed predominant non-urothelial in 26 (66.7%), 8 (20.5%), and 5 (12.8%) pts, respectively. The sites of CNS metastases (mets) were the brain, meninges, and a combination of CNS sites in 37 (95%), 1 (2.5%) and 1 (2.5%) pts, respectively. 33 (84.6%) pts received radiation therapy (RT) to their mets and 6 (15.4%) did not. Of 16 pts who received systemic therapy (ST), cisplatin-based chemotherapy, non-cisplatin based chemotherapy, and PD-1/L1 inhibitors were administered in 6 (37.5%), 5 (31.25%), and 5 (31.25%) pts, respectively. The overall median TTF and OS were 90 and 154 days (d). The median OS for pts who had ST compared to those who did not was 193.5 (n=12) versus 71 (n=17) d. The median OS for pts who had RT compared to those who did not was 92 (n=25) versus 15.5 (n=4) d. The median OS for pts who received neither ST nor RT, compared to pts receiving both, was 12 (range 7-19) versus 232 (n=11) d. Best response to systemic therapy PR, CR, SD and PD were seen in 2 (12.5%), 1 (6.25%), 1 (6.25%) and 12 (75%) pts, respectively. For the 5 pts who received RT only, best response PR and PD were seen in 2 (40%) and 3 (60%) pts, respectively. Conclusions: Pts with UC metastatic to the CNS present with a poor performance status and have outcomes that are dismal and appear worse than those with metastases to other organs. A combination of systemic and radiation therapy might achieve improved outcomes in selected pts.

Randomized prospective comparison of intraventricular methotrexate and thiotepa in patients with previously untreated neoplastic meningitis. Eastern Cooperative Oncology Group.

1993 ◽  
Vol 11 (3) ◽  
pp. 561-569 ◽  
Author(s):  
S A Grossman ◽  
D M Finkelstein ◽  
J C Ruckdeschel ◽  
D L Trump ◽  
T Moynihan ◽  
...  
Keyword(s):  
Systemic Disease ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Poor Performance ◽  
Neoplastic Meningitis ◽  
Intrathecal Methotrexate ◽  
Poor Performance Status ◽  
New Therapeutic Approaches ◽  
Prospective Comparison ◽  
Cranial Nerve Palsies

PURPOSE This prospective randomized cooperative group study was conducted in patients with neoplastic meningitis treated with intrathecal methotrexate or thiotepa to assess response rates and survival, prognostic factors, and the toxicity of these regimens. PATIENTS AND METHODS Fifty-nine adults with nonleukemic malignancies, performance status of 0 to 3, and positive CSF cytologies were assigned to receive intrathecal methotrexate (10 mg) or thiotepa (10 mg) twice weekly. Radiation, was administered to mass lesions and/or symptomatic sites and appropriate systemic therapy was given concomitantly. RESULTS Fifty-two patients were assessable. Most were female (79%), nonambulatory (77%), had been pretreated with radiation (52%) and chemotherapy (77%), and had evidence of systemic disease (65%). Most primary cancers were of the breast (48%), lung (23%), or lymphatics (19%). Treatment arms were well balanced, except that more patients randomized to methotrexate had breast cancer (61% v 33%) and were without evidence of systemic cancer (21% v 4%). No patient had important neurologic improvement with therapy, and 75% deteriorated neurologically within 8 weeks of initiating therapy. Survival ranged from 4 days to 110.5+ weeks. Median survival for patients receiving methotrexate was 15.9 weeks and 14.1 weeks for patients treated with thiotepa. Factors predictive of shorter survival included progressive systemic disease (P = .0005), poor performance status (P = .03), and significant cranial nerve palsies (P = .02). Although serious toxicities were similar, mucositis (P = .04) and neurologic complications (P = .008) were more common in patients who received methotrexate. CONCLUSION The efficacy and overall toxicities of intraventricular methotrexate and thiotepa seem similar and neither reverses fixed neurologic deficits. Early diagnosis and treatment and new therapeutic approaches are needed to improve the outcome for patients with neoplastic meningitis.

scholarly journals Trabectedin in Advanced Sarcomas—Experience at a Tertiary Care Center and Review of Literature

2021 ◽  
Vol 10 (02) ◽  
pp. 53-57
Author(s):  
Saurav Verma ◽  
Kaushal Kalra ◽  
Sameer Rastogi ◽  
Ekta Dhamija ◽  
Avinash Upadhyay ◽  
...  
Keyword(s):  
Group Performance ◽  
Care Center ◽  
Performance Status ◽  
Tertiary Care ◽  
Eastern Cooperative Oncology Group ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Median Number ◽  
Poor Performance Status

Abstract Background There is sparse literature on trabectedin in advanced soft-tissue sarcomas from developing world. It would be interesting to know about use and outcomes of trabectedin in Indian patients. Method In a retrospective study, consecutive patients treated with trabectedin from 2016 to 2019 were analyzed. Patients with L-sarcomas were treated at a dose of 1.5 mg/m2, while those with translocation-related sarcomas were treated at a dose of 1.2 mg/m2 as a 24-hour infusion through peripherally inserted central catheter line. From July 2019, infusions were administered through an ambulatory elastomeric pump, while before that patients were admitted for 24 hours. We used SPSS version 23.0 for statistical calculation. Result A total of 20 patients received trabectedin with a total of 116 infusions. The median age was 46 years (range: 22–73 years). The male (n = 11, 55%) and female patients were almost equal (n = 9, 45%). Thirteen patients (65%) had Eastern Cooperative Oncology Group Performance Status 1. Majority of the patients had leiomyosarcoma (n = 8, 40%); remaining comprised of liposarcoma (3, 15%), translocation-related sarcomas excluding myxoid liposarcoma (n = 8, 40%) and others (n = 1,5%). Most common site was extremity (n = 11, 55%) followed by retroperitoneal (n = 3, 15%), visceral (n = 3, 15%), and others (n = 3,15%). Median number of previous lines received was 2 (range: 0–4). Median number of trabectedin cycles received was 4 (range: 1–17). Best response assessed was stable disease (n = 10, 50%), progressive disease (n = 6, 30%), partial response (n = 1, 5%), and not assessed in 3 patients. After a median follow-up of 19 months, median progression-free survival was 4 months. Conclusion In this heavily treated population (composed of L-sarcomas and translocation-related sarcomas) with many patients with poor performance status, the outcome with trabectedin is in synchrony with literature. However, the need of 24-hour admission might deter quality of life. Elastomeric pump seems to be a reasonable alternative to admission and can be a breakthrough in administering trabectedin, especially in developing countries.

Effect of first-line pembrolizumab treatment in individuals with advanced non-small cell lung cancer and poor performance status.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18796-e18796
Author(s):  
Rajwanth Veluswamy ◽  
Jiayi Ji ◽  
Liangyuan Hu ◽  
Xiaoliang Wang ◽  
Cardinale B. Smith ◽  
...  
Keyword(s):  
Treatment Group ◽  
Real World ◽  
Advanced Nsclc ◽  
Performance Status ◽  
Poor Performance ◽  
Smoking History ◽  
Poor Performance Status ◽  
First Line ◽  
Inverse Probability ◽  
Ecog Ps

e18796 Background: There is limited evidence supporting the optimal use of immune checkpoint inhibitors (ICIs) in NSCLC patients with poor performance status (PS), as clinical trials exclude these patients. In this study, we use real-world oncology data to determine the impact of first line pembrolizumab vs. no treatment in high PD(L)-1 expressing cancers in individuals with advanced NSCLC and ECOG PS ≥2. Methods: We performed a retrospective cohort study of patients with advanced NSCLC with ECOG PS ≥2 between 09/01/2014 and 02/18/2020, using the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database. Patients were included if they were PD(L)-1 high (≥50%) and had clinical and treatment information recorded within 90 days of diagnosis. Real-world overall survival (rwOS) was defined as time from diagnosis to death (censored at last EHR activity). Median rwOS was estimated using weighted Kaplan-Meier methods. A marginal Cox structural model with inverse probability of treatment weighting was used to adjust for selection bias and estimate the effectiveness of pembrolizumab. The inverse probability weights were estimated using an ensemble machine learning technique, Super Learner, based on age, gender, race, practice type and smoking history. Adjusted hazard ratios (aHR) were estimated using weighted Cox proportional hazards models. Stratified analysis was conducted by ECOG PS (2 vs >2). Results: 217 (16%) individuals with advanced NSCLC and high PD(L)-1 expression received no treatment, compared to 546 (39%) individuals who received 1L pembrolizumab. The no-treatment group had a lower proportion of ECOG 2 compared to the pembrolizumab group (Table). Median rwOS in the no-treatment group was 2.4 months, compared to 7.1 months in the pembrolizumab group (p<0.001). In unadjusted survival analyses in the entire cohort and in cohorts stratified by ECOG status, treatment with pembrolizumab was associated with a significantly lower risk of death (hazard ratio [HR]: 0.38, 95% Confidence Interval [CI]: 0.31-0.45). In adjusted analyses, individuals treated with pembrolizumab had improved survival (HR: 0.40, 95% CI: 0.35-0.45). Conclusions: Our analysis of real-world clinical oncology data demonstrated that 1L treatment with pembrolizumab was associated with significantly improved rwOS among individuals with ECOG ≥ 2. [Table: see text]

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