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 ◽  
...  

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]

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 395-395 ◽  
Author(s):  
Ravi Bharat Parikh ◽  
Matt D. Galsky ◽  
Bishal Gyawali ◽  
Fauzia Riaz ◽  
Tara Laura Kaufmann ◽  
...  

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]


2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 41-41
Author(s):  
Yuurin Kondo ◽  
Maria Michiko Nakajima ◽  
Go Nakajima ◽  
Kazuhiko Hayashi

41 Background: Currently, palliative chemotherapy (PC) near the end of life is frequently discussed. It is important to know when it is appropriate to end PC to maintain the best quality of life. The criteria for discontinuation of anti-cancer therapy are often “exacerbation of patient’s condition,” “problems with toxicity,” or “patient refusal.” However, there is no clear agreement regarding when to end PC. Ending treatment is one of the most difficult decisions for oncologists. The purpose of this study was to determine clear reasons for the discontinuation of PC and to gain an understanding of the current situation regarding explanation of prognosis in clinical practice. Methods: This retrospective study included 144 patients with incurable cancer who had received PC and died between January 2014 and November 2016. We examined the reasons for discontinuation of PC and whether patients had completed end-of-life discussions, including a discussion of life expectancy, when their PC was terminated. Results: Causes of discontinuation of PC were as follows: 8.3% patient’s desire, progressive disease (PD) in 48.5%, poor performance status (PS) in 20.1%, and toxicity in 17.4%. In patients who chose to end anticancer therapy voluntarily, all patients received a clear explanation of their prognosis, including life expectancy. Among 67 patients with PD, 45 (67.1%) received information regarding their prognosis; 17 of 29 patients (58.6%) with poor PS received similar information. Among patients who ended PC due to toxicity, only 8 of 25 patients (32%) completed end-of-life discussions, including a discussion of life expectancy. In addition, death within 1 month from the discontinuation of PC occurred in 0 cases where treatment was discontinued due to patient’s desire, 10 cases (15%) due to PD, 10 cases (34.4%) due to PS, and 7 cases (28%) due to toxicity. Conclusions: This study shows that patients who discontinued treatment due to poor PS or toxicity had a shorter interval between the final PC and death. Moreover, it indicated that the details of the end-of-life discussion might be influenced by the reason for discontinuation of PC, including or excluding a discussion of life expectancy.


2020 ◽  
Vol 13 ◽  
pp. 175628482097491
Author(s):  
Hasan Rehman ◽  
Jeffrey Chi ◽  
Nausheen Hakim ◽  
Shreya Prasad Goyal ◽  
Coral Olazagasti ◽  
...  

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.


2019 ◽  
Vol 37 (3) ◽  
pp. 179-184 ◽  
Author(s):  
Chad Glisch ◽  
Yuya Hagiwara ◽  
Stephanie Gilbertson-White ◽  
Yubo Gao ◽  
Laurel Lyckholm

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.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12024-12024 ◽  
Author(s):  
Harpreet Singh ◽  
Yutao Gong ◽  
Pourab Roy ◽  
Bellinda King-Kallimanis ◽  
Vishal Bhatnagar ◽  
...  

12024 Background: Patients with poor performance status are often excluded from clinical trials. The FDA has published several guidances on modernizing oncology clinical trial eligibility criteria to more accurately reflect the patient population. Many patients receiving novel oncology therapeutics are heavily pretreated, and often have comorbidities, organ dysfunction, and frailty syndromes. Little is known about the safety of novel therapeutics in patients with poor performance status. Methods: Data from six randomized trials (n=4465) leading to registration for several solid tumor and malignant hematologic cancers, including multiple therapeutic mechanisms of action, such as EGFR TKI’s, immune checkpoint inhibitors (ICI), and chemotherapy, were pooled. Cumulative incidence of Grade 3-5 adverse events and serious adverse events at Days 30, 90, and 180 were evaluated based on ECOG 0-2. Rates of treatment discontinuation by ECOG was also examined. Results: Cumulative incidence of toxicity events at days 30, 90, and 180 are shown in Table. Patient dropout rates due to death were 3.9%, 6.7%, and 10.9%; dropout rates due to disease progression were 66.5%, 66.6% and 56.9%; and dropout rates due to reasons other than progression or death were 29.7%, 26.7% and 32.1% for ECOG PS 0, 1 and 2, respectively. Conclusions: This FDA exploratory analysis of safety outcomes in registration trials based on ECOG suggests increasing rates of adverse events and rates of treatment discontinuation due to death with worsening performance status. Discontinuation rates due to disease progression and other reasons did not appear to be worse for ECOG 2 compared to 0-1. These findings were consistent across therapies (targeted therapy, ICI, chemotherapy). All trials in the analysis led to FDA approval, thus inclusion of patients with ECOG 2 did not adversely affect the trial outcome for this set of FDA approved agents. ECOG performance status eligibility criteria should be evaluated and modified on a frequent basis during drug development. Additional analysis of trials which enroll patients with ECOG 2 is needed. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23011-e23011
Author(s):  
Shuji Hiramoto ◽  
Tomoko Tamaki ◽  
Hori Tetsuo ◽  
Ayako Kikuchi ◽  
Akira Yoshioka ◽  
...  

e23011 Background: Prognosis of end-of-life characteristics, which are indicators of palliative care, especially in elderly cancer patients, remains unclear. Methods: We retrospectively analyzed 510 patients who died of advanced cancer at our hospital from August 2011 to August 2016. The patients were divided into two groups: elderly patients (over 80 years old, N = 140) and non-elderly patients (under 80 years old, N = 370). The number of patients (306 male and 204 female) with gastro-esophageal, biliary-pancreatic, colorectal, lung, breast, urological, gynecological, hepatocellular, and other cancers were 114, 98, 82, 84, 25, 36, 20 and 51, respectively. The primary endpoint of the study was to analyze the relationship of end-of-life symptoms, treatment, and chemotherapy with age. The secondary endpoint was to identify the prognostic factors in elderly patients with advanced cancer at the end-of-life. Results: ECOG Performance Status of 0.1 was recorded for 12 patients and 2-4 for 498 patients. The prevalence rate of cancer pain in elderly patients was 19.3%, which was significantly lower than that in non-elderly patients (31.4%). Fatigue in elderly patients was 27.9%, which was significantly lower than that in non-elderly patients (37.6%). Continuous deep sedation usage in elderly patients was 12.9%, which was significantly lower than that in non-elderly patients (28.9%). The mean opioid dose in elderly patients was 23.3mg/day, which was significantly lower than that that in non-elderly patients (43.8mg/day). The rate of more than one line of chemotherapy for elderly patients was 44.4%, which was lower than that for non-elderly patients (65.4%). The rate of use of more than one type of cytotoxic agent in the last regimen for elderly patients was 13.3%, which was lower than that for non-elderly patients (30.8%). Consciousness level was recognized as a significant prognostic factor (HR 1.714, p = 0.048) using multivariate analysis of prognosis in elderly patients at the end-of-life. Conclusions: End-of-life symptoms and the intensity of end-of-life treatment, including chemotherapy, were lesser in elderly patients as compared to non-elderly patients. Consciousness level was a significant prognostic factor in elderly patients at the end-of-life.


1993 ◽  
Vol 11 (3) ◽  
pp. 561-569 ◽  
Author(s):  
S A Grossman ◽  
D M Finkelstein ◽  
J C Ruckdeschel ◽  
D L Trump ◽  
T Moynihan ◽  
...  

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.


2021 ◽  
Vol 10 (02) ◽  
pp. 53-57
Author(s):  
Saurav Verma ◽  
Kaushal Kalra ◽  
Sameer Rastogi ◽  
Ekta Dhamija ◽  
Avinash Upadhyay ◽  
...  

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.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11523-11523
Author(s):  
Michael J Wagner ◽  
Matthew Ingham ◽  
Corrie Painter ◽  
Rashmi Chugh ◽  
Jonathan C. Trent ◽  
...  

11523 Background: Sarcoma pts often receive aggressive, highly immunosuppressive therapy and may be at high risk for severe COVID-19. Demographics, outcomes and risk factors for pts with sarcoma and COVID-19 are unknown. We aimed to describe the course of COVID-19 in sarcoma pts and to identify factors associated with adverse outcomes. Methods: The COVID-19 and Cancer Consortium (NCT04354701) is an international registry of pts with cancer and COVID-19. Adult pts (≥18 years old) with a diagnosis of sarcoma and laboratory confirmed SARS-CoV-2 were included from 50 participating institutions. Data including demographics, sarcoma diagnosis and treatment, and course of COVID-19 infection were analyzed. Primary outcome was the composite rate of hospitalization or death at 30 days from COVID-19 diagnosis. Secondary outcomes were 30 day all-cause mortality, rate of hospitalization, O2 need, and ICU admission. Descriptive statistics and univariate Fisher tests are reported. Results: From March 17, 2020 to February 6, 2021, N=204 pts were included. Median follow up was 42 days. Median age was 58 years (IQR 43-67). 97 (48%) were male. 30 (15%) had ECOG performance status ≥2. 104 (51%) received cancer treatment, including surgery or radiation, within 3 months of COVID-19 diagnosis. 153 (75%) had active cancer, of whom 34 (22%) had lung metastases. 100 (49%) pts met the composite primary endpoint; 96 (47%) were hospitalized and 18 (9%) died within 30 days from COVID-19 diagnosis. 64 (31%) required oxygen, and 16 (8%) required ICU admission. Primary endpoint rates were similar for pts who received cytotoxic chemotherapy (38/58, 66%) or targeted therapy (16/28, 57%). Pts with higher rates of the primary endpoint included patients ≥60 years old (59% vs 40%, OR 2.04, 95% CI 1.12-3.74, p=0.016), pts with ECOG PS ≥2 vs 0-1 (90% vs 41%, OR 12.2, 95% CI 3.44-66.8, p<0.001), pts receiving any systemic therapy within 3 months of COVID-19 diagnosis (62% vs 39%, OR 2.65, 95% CI 1.43-4.97, p=0.001), and pts with lung metastases (68% vs 42%, OR 2.77, 95% CI 1.19-6.79, p=0.013). Primary endpoint rates were similar across sarcoma subtypes (Table). Conclusions: This is the largest cohort study of pts with sarcoma and COVID-19 to date. Sarcoma pts have high rates of complications from COVID-19. Older patients, those with poor performance status, those recently receiving systemic cancer therapy, and those with lung metastases appear to have worse outcomes.[Table: see text]


Cancers ◽  
2018 ◽  
Vol 10 (7) ◽  
pp. 236 ◽  
Author(s):  
Juliet Carmichael ◽  
Daisy Wing-san Mak ◽  
Mary O’Brien

Until recently, chemotherapy has remained the mainstay of treatment for the majority of patients with advanced non-small cell lung cancer (NSCLC). Excellent responses have been observed with immune-checkpoint inhibitors, and targeted treatments for those tumours with actionable mutations, resulting in a paradigm shift in the treatment approach for these patients. Elderly patients and those with poor performance status (PS), such as Eastern Cooperative Oncology Group (ECOG) 2, have historically been excluded from clinical trials due to poor outcomes. There is therefore a lack of data to define the optimal treatment strategy for these patients. Due to improved tolerability of novel therapies, inclusion of these patients in clinical trials has increased, and sub-group analyses have identified many treatments demonstrating potential activity. Here, we summarise key recent advances in the treatment of NSCLC, specifically evaluating their efficacy and tolerability in these patient cohorts.


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