Cooperative Oncology Group Performance Scale Research Articles

Addressing disparities in health outcomes for patients with advanced pancreatic cancer and limited English proficiency.

There are significant challenges and a lack of data related to culturally and linguistically diverse (CALD) cancer patients. We compared patient characteristics, treatment patterns, and outcomes of patients with advanced pancreatic cancer that required an interpreter. Registry data was extracted for advanced pancreatic cancer patients from a single health institution with a comprehensive Transcultural and Language Service (TALS). Demographic and clinicopathologic characteristics were compared. Kaplan-Meier survival estimates with log-rank testing, and univariate and multivariable regression analysis were performed to compare the group with limited English proficiency (LEP) to theEnglish proficient (EP)group. Of 155 patients, 32.9% (n=51) required the TALS. TheLEP group had a higher mean age (71.2vs. 76.8 years; p=0.005) and received less chemotherapy (42.3%vs. 31.4%, p=0.220). Univariate analysis revealed a shorter median overall survival (OS) in the LEP group (3.6vs. 5.0 months), with a hazard ratio [HR] of 1.51 (95% confidence interval [CI]: 1.03-2.21, p=0.033). Upon multivariable analysis, adjusting for Eastern Cooperative Oncology Group (ECOG) performance scale, the number of sites of metastatic disease and chemotherapy use, the strength of association between LEP and OS reduced marginally (HR 1.42, 95% CI: 0.93-2.16), and was no longer statistically significant (p=0.103). In patients with advanced pancreatic cancer utilizing a comprehensive TALS, there was a trend to poorer survival with limited English proficiency, although this association was not statistically significant. An ongoing research commitment to the CALD experience is necessary to build a granular understanding of this population and ensure equitable outcomes.

Effects of palliative intrathecal analgesia on patients with refractory cancer bone pain.

This study examined the effects of intrathecal analgesia (ITA) using an extracorporeal pump with a subcutaneous port system in cancer patients with bone metastasis. Among the patients who died of cancer with bone metastasis at the palliative care unit of our institution, 11 who received ITA were selected. Changes in pain, opioid doses, the palliative prognostic index (PPI), and Eastern Cooperative Oncology Group Performance Scale after ITA were assessed. Pain, opioid doses, and PPI decreased after ITA (P = 0.002, 0.002, and 0.017). ITA for cancer patients with increased PPI due to refractory cancer bone pain decreased pain, opioid doses, and PPI.(100 words).

DDEL-02. CLINICAL BENEFIT OF BEVACIZUMAB AND IRINOTECAN (BEV+IRI) IN PATIENTS WITH RELAPSED/REFRACTORY GLIOBLASTOMA (R/RGBM) AND ITS POTENTIAL PREDICTORS

Abstract BACKGROUND/AIM: Bevacizumab-containing chemotherapy constitutes an important salvage treatment for recurrent/refractory glioblastoma(r/rGBM). Patients and methods: We retrospectively collected the data of r/rGBM patients treated with the combination of bevacizumab and irinotecan (BEV+IRI) as their salvage treatment from July 2013 and December 2021 in Konkuk Medical Center of Korea. Patients with available results from molecular diagnostic tests were eligible, and markers of interest were examined including the presence of MGMT methylation, IDH1/2 mutation, or 1p/19q co-deletion. Efficacy of BEV+IRI and its potential biomarker was explored. RESULTS: Among 21 patients, 38.1% demonstrated European Cooperative Oncology Group-Performance scale (ECOG-PS) ≥3. The majority (71.4%) received BEV+IRI as their second-line chemotherapies, and the median dose was 5 (range=1-25). Objective response rate (ORR) was 33.3% and disease-control rate (DCR) was 85.7%. Irrespective of objective response, early clinical response was achieved in 14(66.7%) patients. During the median follow-up of 16.4 months for survivors, median progression-free survival (PFS) and overall survival (OS) were 3.6 and 6.8 months, respectively. ECOG PS≥3 and TP53 loss were independent predictors of an unfavorable OS, while prompt clinical improvement could predict favorable OS. Any molecular aberration was associated with OS or PFS in the study. CONCLUSION: Salvage BEV+IRI treatment in r/rGBM conferred comparable clinical benefit. ECOG PS ≥3, TP53 loss, and lack of prompt clinical improvement after the treatment were significantly associated with an unfavorable OS.

Prognostic Value of 18F-Fluorodeoxyglucose Uptake of Bone Marrow on PET/CT in Patients with Limited Disease Small Cell Lung Cancer

Merve AYIK TURK1, Berna KOMURCUOGLU2, Ahmet YANARTAS3, Ozgur BATUM2, Yunus TURK4, Mehmet Ufuk YILMAZ5 1Izmir Bozyaka Training and Research Hospital, Department of Pulmonology, İzmir 2Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital, Department of Pulmonology, İzmir 3Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital, Department of Nuclear Medicine, İzmir 4Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital, Department of Thoracic Surgery, İzmir 5Medicana Health Groups, Department of Pulmonology, İzmir Keywords: Small cell lung cancer, Prognostic factors, Limited stage, Bone marrow FDG uptake Small cell lung cancer (SCLC) is a malignancy from the neuroendocrine tumor family, which has a poor prognosis and presents with metastases at the time of the diagnosis. The present study investigated the relationship between bone marrow fluorodeoxy-D-glucose (FDG) uptake and survival to evaluate prognosis in limited-stage SCLC. This single-center retrospective study examined a total of 220 patients diagnosed with limited-stage SCLC between January 2010 and June 2019. Bone marrow FDG uptake, serum inflammatory markers, and other factors used to determine the prognosis, as well as overall survival (OS) and progression-free survival (PFS), were recorded and retrospectively analyzed. Within physiological limits, bone marrow standardized uptake value (SUV) mean of > 1.95 was identified as a good prognostic factor for PFS (p= 0.03). The multivariate analysis of OS and PFS revealed that the Eastern Cooperative Oncology Group (ECOG) performance scale (p= 0.001) was a common independent prognostic factor. Stages of the disease, albumin levels and bone marrow-to-liver ratio (BLR) [one of the positron emission tomography/computed tomography (PET/CT) parameters] of < 0.8 were prognostic factors for OS. The bone marrow SUV mean was positively correlated with the primary tumor SUV max and SUV mean. The bone marrow SUV mean is a parameter that can be used to predict PFS in limited-stage SCLC. For OS, in turn, the BLR was identified as an independent factor.

The impact of renin-angiotensin-aldosterone system inhibitors on immune checkpoint inhibitor-associated adverse cardiovascular events.

2605 Background: Immune checkpoint inhibitors (ICIs) are associated with adverse cardiovascular events that impair patient outcomes. Previous observational studies showed that renin-angiotensin-aldosterone system inhibitors (RAASi) may mitigate the cardiotoxicity associated with chemotherapeutic agents. However, the effects of RAASi on ICI-associated adverse cardiovascular events are unknown. Methods: We conducted a 1:1 propensity score-matched cohort study involving ICI-treated patients at two tertiary referral centers in Taiwan. The propensity score matching model includes age, sex, hypertension, diabetes mellitus, chronic kidney disease, Eastern Cooperative Oncology Group (ECOG) Performance Scale, cancer stage, and cancer type. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of myocardial infarction (MI), ischemic stroke, peripheral arterial occlusive disease (PAOD), pulmonary embolism (PE), deep venous thrombosis (DVT), heart failure, pericardial disease, myocarditis, and cardiac arrhythmias. The secondary outcomes were arterial thrombotic events (MI, ischemic stroke, PAOD) and venous thrombotic events (PE and DVT). Results: We identified 684 patients eligible for inclusion, from which 164 patients who received RAASi were matched to patients who did not receive RAASi. Over a median follow-up of 9.1 months, the incidence rate of MACE for RAASi and non-RAASi recipients was 6.5 and 13.9 per 100 patient-years, respectively, resulting in an incidence rate ratio of 0.47 [95% CI: 0.21–1.00] (p = 0.038). In a multivariate Cox proportional hazard model adjusting for cancer therapy, RAASi recipients had an approximately 60% reduction in the risk for MACE (HR, 0.37 [95% CI: 0.16-0.86], p = 0.021). In the secondary analysis, RAASi were associated with a reduction in venous thrombotic events (HR, 0.11 [95% CI: 0.02-0.63], p = 0.013), but not for arterial thrombotic events (HR, 0.47 [95% CI: 0.06-3.38], p = 0.45). Conclusions: In patients receiving ICI therapy, the use of RAASi is associated with a decreased cardiovascular risk, particularly for venous thrombotic events. [Table: see text]

Predictors of the 6-min walk test in patients with ovarian cancer.

To identify the predictors of the 6-min walk test (6MWT) and investigate the relationship between 6MWT, performance status, functional mobility, fatigue, quality of life, neuropathy, physical activity level, and peripheral muscle strength in patients with ovarian cancer (OC). Twenty-four patients diagnosed with stage II-III ovarian cancer were included in the study. Patients were assessed using the following measurement methods: 6MWT for walking capacity, Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) for performance status, an armband physical activity monitor for physical activity level, Checklist Individual Strength (CIS) for fatigue, Functional Cancer Treatment Evaluation with Quality of Life-Extreme (FACT-O) for quality of life, Functional Evaluation of Cancer Treatment/Gynecological Oncology-Neurotoxicity (FACT/GOG-NTX) for neuropathy, a hand-held dynamometer for peripheral muscle strength, and 30-s chair-stand test for functional mobility. The mean 6MWT distance was 578.48 ± 115.33 meters. 6MWT distance correlated with ECOG-PS score (r = -0.438, p = 0.032), handgrip strength (r = 0.452, p= 0030), METs (r = 0.414, p= 0.044) 30s-CST (r= 0.417, p= 0.043), and neuropathy score (r = 0.417, p = 0.043) significantly. There was no relationship between 6MWT distance and other parameters (p> 0.05). Multiple linear regression analysis demonstrated that performance status was the sole predictor of 6MWT. The walking capacity seems to be associated with performance status, peripheral muscle strength, level of physical activity, functional mobility, and severity of neuropathy in patients with ovarian cancer. Evaluating these may help clinicians to understand factors behind the decreased walking capacity.

Coping strategy among the women with metastatic breast cancer attending a palliative care unit of a tertiary care hospital of Bangladesh.

Breast cancer is one of the leading cancers among the Bangladeshi women. Coping helps these patients to adjust with this life-changing disease. Each individual has unique and different coping mechanism. But we know a little regarding their coping strategies. This study aims to explore the different coping strategies adopted by the women with metastatic (stage IV) breast cancer attending the palliative care unit and their relationship with the common mental health issues like anxiety and depression. This cross-sectional study was conducted among 95 patients with metastatic (stage IV) breast cancer attending the Department of Palliative Medicine, Bangabandhu Sheikh Mujib Medical University, Bangladesh from April 2021 to September 2021. Data was collected by face-to-face interview using a structured questionnaire adapted from Hospital Depression and Anxiety Scale (HADS), Brief COPE inventory and Eastern Cooperative Oncology Group (ECOG) performance scale. Pearson correlation test was used to find the relationships between various domains of coping strategies and psychological variables. Correlation matrix was done to observe the internal correlation among different coping strategies. Kruskal-Wallis H test was done to find the relationship between different coping strategies and ECOG performance status. The mean age of the respondents was 48.9 ± 9.9 years. Most of them were married (94.7%), Muslim (92.6%) and homemakers (82.1%). Commonly used coping strategies by the patients were: acceptance (median 10; IQR 10), religion (median 9; IQR 8-10) and instrumental support (median 9; IQR 6-10). Significantly strong positive correlation was found between emotional and instrumental support (R = 0.7; p = 0.01), planning, acceptance and active coping (R = 0.7; p = 0.01); behavioral disengagement, self distraction and denial (R = 0.5; p = 0.01). Significantly fair negative correlation was observed between active coping and depression (R = -0.4, p <0.001). Patients with better performance status on ECOG scale (Grade 0-2) leaned more on the positive coping strategies like instrumental support, emotional support, positive reframing and venting. Different coping strategies, especially positive coping helps the patients to adapt with their disease over time. All women suffering from breast cancer should be routinely screened and assessed for psychological distress and ensure early intervention and management to promote a better quality of life.

Prediction of Radiotherapy Compliance in Elderly Cancer Patients Using an Internally Validated Decision Tree.

This study aims to analyze the relationship between the available variables and treatment compliance in elderly cancer patients treated with radiotherapy and to establish a decision tree model to guide caregivers in their decision-making process. For this purpose, 456 patients over 74 years of age who received radiotherapy between 2005 and 2017 were included in this retrospective analysis. The outcome of interest was radiotherapy compliance, determined by whether patients completed their scheduled radiotherapy treatment (compliance means they completed their treatment and noncompliance means they did not). A bootstrap (B = 400) technique was implemented to select the best tuning parameters to establish the decision tree. The developed decision tree uses patient status, the Charlson comorbidity index, the Eastern Cooperative Oncology Group Performance scale, age, sex, cancer type, health insurance status, radiotherapy aim, and fractionation type (conventional fractionation versus hypofractionation) to distinguish between compliant and noncompliant patients. The decision tree's mean area under the curve and 95% confidence interval was 0.71 (0.66-0.77). Although external validation is needed to determine the decision tree's clinical usefulness, its discriminating ability was moderate and it could serve as an aid for caregivers to select the optimal treatment for elderly cancer patients.

Clinical Benefit of Bevacizumab and Irinotecan (BEV+IRI) in Patients With Relapsed/Refractory Glioblastoma (r/rGBM) and its Potential Predictors.

Bevacizumab-containing chemotherapy constitutes an important salvage treatment for recurrent/refractory glioblastoma(r/rGBM). We retrospectively collected the data of r/rGBM patients treated with the combination of bevacizumab and irinotecan (BEV+IRI) as their salvage treatment from July 2013 and December 2021 in Konkuk Medical Center of Korea. Patients with available results from molecular diagnostic tests were eligible, and markers of interest were examined including the presence of MGMT methylation, IDH1/2 mutation, or 1p/19q co-deletion. Efficacy of BEV+IRI and its potential biomarker was explored. Among 21 patients, 38.1% demonstrated European Cooperative Oncology Group-Performance scale (ECOG-PS) ≥3. The majority (71.4%) received BEV+IRI as their second-line chemotherapies, and the median dose was 5 (range=1-25). Objective response rate (ORR) was 33.3% and disease-control rate (DCR) was 85.7%. Irrespective of objective response, early clinical response was achieved in 14(66.7%) patients. During the median follow-up of 16.4 months for survivors, median progression-free survival (PFS) and overall survival (OS) were 3.6 and 6.8 months, respectively. ECOG PS≥3 and TP53 loss were independent predictors of an unfavorable OS, while prompt clinical improvement could predict favorable OS. Any molecular aberration was associated with OS or PFS in the study. Salvage BEV+IRI treatment in r/rGBM conferred comparable clinical benefit. ECOG PS ≥3, TP53 loss, and lack of prompt clinical improvement after the treatment were significantly associated with an unfavorable OS.

Assessment of Comorbidities and Their Association with Outcomes in Adults with Acute Lymphoblastic Leukemia (ALL)Using Various Comorbidity-Based Scoring Systems

Background: Outcomes of adults with ALL has remained poor as compared to pediatric ALL. While biological characteristics of the disease can increase the risk of poor treatment responses and resistance, age and concurrent comorbidities limit patient's tolerability to aggressive therapies and predispose to treatment related adverse effects, ultimately affecting survival. Despite similar chronological age, patients vary widely with respect to comorbidities and other aspects of health such that routine performance assessment scales such as Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Scale (KPS) may not be accurate in assessing their fitness for therapy. Several measures such as Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI), Charlson Comorbidity Index (CCI), Cumulative Illness Rating Scale-Geriatric (CIRS-G) and Adult Comorbidity Evaluation-27 (ACE-27) have been reported in the literature to assess comorbidities in patients receiving intensive treatments, but their utility when it comes specifically to ALL patients is unknown, given the lack of studies assessing role comorbidities in ALL. Methods: We conducted a retrospective single center analysis of adults (age >=18) with ALL to assess the effect of comorbid conditions using available scales and determined their association with outcomes. Patients with a diagnosis of ALL (B/T-cell) who received first line therapy between 2009-2021 were included. Key exclusion criteria were patients with relapsed/refractory ALL and with incomplete follow-up. Comorbid conditions prior to first line therapy were calculated using four scales - HCT-CI, CCI, CIRS-G and ACE-27. Baseline demographic and disease characteristics, first line treatment, response, outcomes were collected using chart review. Descriptive statistics, logistic regression, Cox Proportional Hazards regression method was used for analysis. Concordance (C-statistic) and 95% confidence interval was reported for each model for comparison. A receiver operating characteristic (ROC) curve was also created for each outcome to compare the performance of base and comorbidity score models. Results: A total of 201 patients were included for analysis. Median age was 54(range 39-65), 53% were males, 82% were Caucasians, 8.5% Hispanics. 86% had B-ALL (32% were Philadelphia chromosome positive), 83% received intensive therapy. Median OS was 3.8 years (3.7-not reached) and Event free survival was 2.0(1.5,3.3) for the entire patient population. Patients were categorized in 0(22%), 1 (19%),2(13%) and 3+(46%) per HCT-CI, 0(32%), 1(23%),2(12%) and 3+(33%) per CCI. In CIRS-G scale patients were categorized in to 2 groups of <6 and >=6(51.5% vs 48.5%). In ACE-27 scale there were 4 categories (none(0),mild(1) moderate(2) and severe(3)) with 19%, 41%, 21% and 18% in each group consecutively. All four comorbidity scales were able to predict overall and event-free survival with statistical significance. Patients with HCT-CI category of <=1 had statistically significant OS and EFS advantage when compared to patients with a score of >=2 (Not reached vs 3.1-3.7 yrs for OS, 2.4-5.2 vs 1.4-1.6 yrs for EFS). Patients with CCI category 0 (not reached, 3.4) had better median OS and PFS than categories 1,2 (3.7 years OS, 1.8-3.1 yrs PFS) and 3+ (3.4, 1.4 yrs). CIRS-G category of <6 score had better median OS and PFS (not reached) than 6+ category (3.0 yrs). In ACE-27 scale, 0 and 1 categories had better OS and PFS (not reached and 3.4 yrs, not reached and 2.3 yrs vs 3.0-3.2 and 1.4 yrs) than moderate and severe (2,3) categories. Though all scales could predict OS and EFS, the overall survival model with CIRS-G scale had a significantly higher C-statistic compared to the base model than other scales. The HCT-CI and CIRS scores were each significant in their models for complete remission, but there were no significant differences between c-statistics among any of the CR models. None of the comorbidity scores were significant in predicting 90-day readmission or ED visit. Conclusions: Comorbidities as assessed by HCT-CI, CCI, ACE-27 or CIRS-G were significantly associated with survival in adults with ALL. Incorporation of these formal methods of comorbidity assessment in clinical practice is needed to assess ALL patients at baseline and tailor therapy accordingly. Prospective studies to validate and identify the optimal comorbidity determination scale in ALL is needed. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Depression, anxiety,and performance status among the women with metastatic breast cancer receiving palliative care in Bangladesh: A cross sectional study.

Advanced breast cancer patients suffer from various psychological issues including depression and anxiety. This study aims to explore these psychological issues and their relationship with the performance status. This cross-sectional study was conducted among 95 patients with metastatic breast cancer attending the Department of Palliative Medicine, Bangabandhu Sheikh Mujib Medical University, Bangladesh from April 2021 to September 2021. Data was collected by face-to-face interview using a structured questionnaire along with Hospital Depression and Anxiety Scale. The performance status of the patients was determined by the Eastern Cooperative Oncology Group (ECOG) performance scale. The association between different variables were assessed by χ 2test and Fisher Exact test. Mean age of the respondents was 48.9 ± 9.9 years. Most of them were married (94.7%), muslim (92.6%) and homemakers (82.1%). More than half (52.6%) of the patients were evaluated having ECOG performance status grade II. Four out of ten (44.2%) patients had moderate to severely anxiety, and almost one-third (36.9%) patients were suffering from moderate to severe depression. The patients with high educational status were found to have less depression. In addition, patients faring better on ECOG performance scale (Grade 0 to I) had significantly (p < 0.05) less depression and anxiety. Depression and anxiety are one of the major psychological sufferings among the women with metastatic breast cancers. All women suffering from breast cancer should be routinely screened and assessed for phychological distress and ensure early intervention.

The impact of the Well-Dying Law in Korea: comparing clinical characteristics and ICU admissions.

Since Korea implemented the Well-Dying Law in 2018, intensive, and end-of-life care have greatly changed. This study sought to determine whether there were any changes in the clinical aspects or appropriateness of intensive care unit admissions before and after the law was implemented. We performed a single-center retrospective study for 3 months with patients admitted to a medical intensive care unit before and after the law was implemented. We studied a total of 178 patients, divided pre-legislative group (83 patients) and a post-legislative group (95 patients). There were no significant differences in baseline characteristics, including age, sex, educational level, religion, economic status, and the Eastern Cooperative Oncology Group performance scale at the time of admission to the intensive care unit. There were no changes in the proportion of patients with terminal comorbidities, including malignancy and chronic lung diseases, with the exception of a decrease in patients with liver cirrhosis (12.1% in pre vs. 3.2% in post-legislative group, P=0.040). There were no differences in the APACHE II score at the time of admission, or in prognosis, including in-unit mortality (33.7 vs. 33.6%, P=0.53), in-hospital mortality (38.6% vs. 42.1%, P=0.73), and length of stay in the intensive care unit (IQR, 4.0-11.0 vs. 3.0-11.0 days, P=0.493). Last, no differences were observed in the appropriateness of admission, which was assessed by two separate intensivists, before and after implementing the law (P=0.646, and P=0.315, respectively). After the Well-Dying Law was implemented, there was a significant decrease in the number of liver cirrhosis patients admitted to the intensive care unit. No changes in other clinical characteristics, prognosis, and the appropriateness of admission were evident with the implementation of the law.

Comparison of preoperative assessment tools in older patients undergoing cancer surgery: A prospective study

IntroductionSurgery in older adults with cancer is complex due to multiple age related confounding factors. There are many scoring systems available for preoperative risk stratifications of older patients. Currently very few prospective studies comparing the various commonly used scales are available. This is the first study which compares the established preoperative risk assessment tools of Eastern Cooperative Oncology Group Performance Scale (ECOG) and American Society of Anaesthesiologists Physical Status Scale (ASA) with frailty scores of Modified Frailty Index (MFI) and Clinical Frailty Scale (CFS). Material and MethodsThis is a prospective observational study of older patients with cancer who underwent oncosurgery in a tertiary cancer centre during the one-year study period. Patients were scored on the CFS, MFI, ASA and ECOG scales. All patients were followed up for 30 days immediately following surgery and their post operative complications were documented. Univariate and multivariate analyses were done and a p value of ≤0.05 was considered statistically significant. ResultsOf the 820 patients studied, 15.6% had prolonged hospital stay, 9.1% had 30-day morbidity, 0.7% had readmission, and mortality was 1.1%. High-risk scores on the ASA and CFS were significantly associated with prolonged postoperative stay, readmission, morbidity, and mortality (p < 0.05). High-risk scores on the ECOG was significantly associated with prolonged hospital stay (p = 0.027), 30-day morbidity (p = 0.003), and mortality (p = 0.001), but not with readmission. There was no significant association between MFI score and the postoperative variables studied (p > 0.05). On multivariate analysis, morbidity was significantly associated only with male gender (p = 0.015), higher cancer stage (p = 0.005), higher ASA score (p = 0.029), and prolonged hospital stay (p = 0.001). Mortality was significantly associated only with emergency surgery (p = 0.012) and prolonged hospital stay (p = 0.004), and prolonged hospital stay was significantly associated with advanced cancer stage (p = 0.001) and emergency surgery (p = 0.02). ConclusionsIn older patients undergoing cancer surgery, ASA and CFS are predictors of prolonged postoperative stay, morbidity, mortality, and readmission. A high-risk ECOG score is predictive of prolonged post operative stay, 30-day morbidity, and mortality, but not of readmission. Score on MFI is not a predictor of postoperative outcomes. Newer predictive tools which include cancer- specific factors are required for better management of these patients.

Abstract OT-31-01: A phase II study to evaluate the efficacy and safety of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer: PEMBRACA trial

Abstract Background Considering the high proportion of tumor-infiltrating lymphocytes (TILs) in BRCA-related breast cancer, we expect that PD-1 pathway is highly expressed and PD-1 antagonist pembrolizumab could provide clinical activity in this kind of tumor. Furthermore, BRCA-related breast cancers are known to be more sensitive to platinum-derived drugs. Thus the association between Pembrolizumab and Carboplatin in metastatic BRCA-related breast cancer seems to be active in this setting of patients. This study will evaluate the safety and the efficacy of Pembrolizumab associated with Carboplatin in BRCA mutated or with unknown mutations metastatic breast cancer patients. Study and Statistical DesignThis is a national multicenter two-stage single arm phase II study, enrolling BRCA mutated or with unknown mutations metastatic breast cancer patients. The sample size has been estimated by using the two-stage Simon’s design. In the first stage, 20 subjects will be enrolled. If, after first stage ≤11 responses (r1) will be observed, accrual will terminate and the experimental regimen will be rejected. Otherwise if 12 or more responses will be seen then the accrual will continue to the second stage of an additional 33 subjects (total, 53 subjects). At the second stage if 33 or less responses out of 53 subjects will be observed the treatment will be rejected. With the null hypothesis (p0) being equal 0.55 with a type I (alfa) error of 0.10 (10%) and a type II (beta) error of 0.20 (power=80%) and the alternative hypothesis (p1) is 0.70, (response rate 70%), we expect to reach an overall response rate (ORR) ≥ 70% by the combination of Pembrolizumab plus Carboplatin. We also expect to reach a median Time to Progression (TTP) and Overall Survival (OS) of five and fifteen months respectively. The Disease Control Rate (DCR) will be expected as ≥ 80% by the combination of Pembrolizumab plus Carboplatin Study TreatmentCarboplatin at area under the time-concentration curve 6 (AUC 6) intravenously once every 3 weeks in combination with Pembrolizumab 200 mg intravenously every 3 weeks will be administered for six courses and then only Pembrolizumab alone will continue until occurrence of unacceptable toxicities or disease progression. Eligibility CriteriaIn order to be eligible for participation in this trial, the subject, aged ≥ 18 years, must have metastatic confirmed breast cancer, with a disease progression by radiological techniques within 12 months prior to signing informed consent, and a documented mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious or with unknown significance. The subject must have measurable disease based on RECIST 1.1 and have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. Prior chemotherapy with anthracyclines and taxanes has to be administered in neoadjuvant or adjuvant setting. In case of luminal tumors hormonal treatments for advanced disease can be administered before. The life expectancy must be greater than 3 months and the subject must demonstrate adequate organ function by screening labs performed within 10 days of treatment initiation. Objectives and HypothesisThe primary end-point will be the ORR, evaluated according to RECIST criteria. Secondary objectives will be the TTP, the duration of response (DOR ), the DCR, and the OS. The safety of the combination will be evaluated according to the worst toxicity grade reported throughout the whole treatment period.The Exploratory Objective will be the evaluation of ORR, TTP, DOR, and DCR based on irRECIST. Biological parameters of CD8/TILs and PD-L1 will be considered in the metastatic biopsy. Target AccrualThe first subject was enrolled in January 2019 and recruitment is ongoing. Enrollment of the first 20 subjects is expected to complete in Q2 2021. Citation Format: Laura Cortesi, Marta Venturelli, Federica Caggia, Luigi Marcheselli, Annita Gozzi, Alberto Zambelli, Valentina Guarneri, Antonino Musolino, Elena Fiorio, Giancarlo Bisagni, Andrea Rocca, Valentina Arcangeli, Elisabetta De Matteis, Sergio Rizzo, Andrea Michelotti. A phase II study to evaluate the efficacy and safety of pembrolizumab plus carboplatin in BRCA-related metastatic breast cancer: PEMBRACA trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-31-01.

Impact of age on outcomes and symptoms in patients with advanced gastroesophageal cancer (GEC).

193 Background: Although age is a non-modifiable risk factor for most cancers, alone it is not very helpful in deciding on the best treatment for patients. Insufficient data exist in the oldest old ( &gt; 75 years) compared to young-old (65-75 years) and to younger ( &lt; 65 years) patients with de novo metastatic GEC regarding which factors influence response and outcomes. Methods: We retrospectively assessed all patients with de novo metastatic GEC seen from 2006-2015 at the Princess Margaret Cancer Center in Toronto-Ontario, Canada. We used Kaplan-Meier plots and Cox proportional hazards analyses to examine factors associated with progression-free survival (PFS) and overall survival (OS). To examine patient-reported outcomes we used the Edmonton Symptom Assessment System (ESAS) in the first six months of therapy using cross-sectional and longitudinal analyses. Results: A total of 580 de novo metastatic GEC patients were seen between 2006 and 2015. Of these (14%) were oldest old, (31%) were young-old (age 65-75) and 54% were younger ( &lt; 65 years). Most patients (67-80%) were male. Median OS for the entire cohort was 9.1 mo. (95% confidence interval (CI) 8.0 – 10.1); the shortest OS was in the oldest old group at 4.5 mo. compared to 8.7 mo. in young-old and 9.8 mo. in younger group, p &lt; 0.001. PFS was also significantly different among the age groups (4.4 mo., 6.1 mo., and 6.5 mo., respectively), p = 0.0145. In a multivariate model predictors for OS were age (young-old group), number of metastasis, and Eastern Cooperative Oncology Group (ECOG) performance scale (PS). Similar predictors were found for PFS; however, age was not a significant factor. Of the 55 patients who provided ESAS data, 58% were &lt; 65 and 42% were age≥ 65. The most common symptoms at presentation were fatigue, appetite, and well-being. There were no differences by age group (all p &gt; 0.05). Conclusions: Patients age &gt; 75 have poorer OS compared to younger age groups but PFS does not differ, suggesting similar benefits with treatment in appropriately selected older adults with advanced GEC. Symptom profiles were similar with age. Further comprehensive care is needed for older patients with advanced GEC to improve their survival.

Extranodal non-Hodgkin’s lymphoma: A case series at a tertiary care hospital

To study and findings in a case series of Extra Nodal Non Hodgkin Lymphomas (EN NHL). 17 cases of primary, collected during a period of November 2019 to November 2020 (one year), wherein the clinical data included age, gender, site, clinical presentation and findings were collected and staining was done along with (IHC) using a panel of antibodies depending on the morphology.17 cases of primary taken. Majority of our patients were from higher age group, presenting in sixth decade, though the age range was wide between 5-92 years. Our study included 12 males and 5 females, with a male: female ratio of 2.4:1. We found masses and GIT as the most common site for. Weight loss followed by fever was the most common clinical presentation in our study presentation. Ann Arbor Staging was done in 16/17 cases where 35% (6/17) belonged to stage I, 35% (6/17) cases belonged to stage II, 17.6 (3/17) belonged to stage III and 1.5% (1/17) belonged to Eastern cooperative oncology group performance scale (ECOG) was also calculated and documented. This study highlights importance of diagnosing Non Hodgkin’s lymphomas as a separate entity since its clinical presentation, prognosis, staging and management differs from Nodal NonHodgkins lymphoma.

Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: A French nationwide cohort study (GCO-002 CACOVID-19).

BackgroundCancer patients are thought to have an increased risk of developing severe Coronavirus Disease 2019 (COVID-19) infection and of dying from the disease. In this work, predictive factors for COVID-19 severity and mortality in cancer patients were investigated.Patients and methodsIn this large nationwide retro-prospective cohort study, we collected data on patients with solid tumours and COVID-19 diagnosed between March 1 and 11th June 2020. The primary end-point was all-cause mortality and COVID-19 severity, defined as admission to an intensive care unit (ICU) and/or mechanical ventilation and/or death, was one of the secondary end-points.ResultsFrom April 4 to 11th June 2020, 1289 patients were analysed. The most frequent cancers were digestive and thoracic. Altogether, 424 (33%) patients had a severe form of COVID-19 and 370 (29%) patients died. In multivariate analysis, independent factors associated with death were male sex (odds ratio 1.73, 95%CI: 1.18–2.52), The Eastern Cooperative Oncology Group Performance Scale (ECOG PS) ≥ 2 (OR 3.23, 95%CI: 2.27–4.61), updated Charlson comorbidity index (OR 1.08, 95%CI: 1.01–1.16) and admission to ICU (OR 3.62, 95%CI 2.14–6.11). The same factors, age along with corticosteroids before COVID-19 diagnosis, and thoracic primary tumour site were independently associated with COVID-19 severity. None of the anticancer treatments administered within the previous 3 months had any effect on mortality or COVID-19 severity, except for cytotoxic chemotherapy in the subgroup of patients with detectable severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by reverse transcriptase polymerase chain reaction (RT-PCR), which was associated with a slight increase of the risk of death (OR 1.53; 95%CI: 1.00–2.34; p = 0.05). A total of 431 (39%) patients had their systemic anticancer treatment (such as chemotherapy, targeted or immune therapy) interrupted or stopped following diagnosis of COVID-19.ConclusionsMortality and COVID-19 severity in cancer patients are high and are associated with general characteristics of patients. We found no deleterious effects of recent anticancer treatments, except for cytotoxic chemotherapy in the RT-PCR-confirmed subgroup of patients. In almost 40% of patients, the systemic anticancer therapy was interrupted or stopped after COVID-19 diagnosis.

CN43 Effect of self-care teaching module on radiation- induced acute side effects and clinical outcomes for head and neck cancer patients

The major concern of health care professionals regarding the value of teaching self-care for management of acute side effects of radiation therapy of head and neck cancer (HNC) patients is the improvement of their clinical outcomes. Aim: This quasi-experimental randomized controlled study design aimed to evaluate the effect of self-care teaching module on radiation-induced acute side effects and clinical outcomes in HNC patient. A random sample of (50) adult patients with HNC undergoing recent radiation therapy were selected. All subjects of the current study were meeting all inclusion criteria. Subjects were divided into two groups; each group consisted of 25 patients. Group I; control group did not receive self-care teaching module about acute side effect whereas the self-care teaching module was provided by the researcher to Group II. Three tools were utilized to collect data pertinent to the study. These tools were structured patient assessment interview questionnaire. Tool (II) included Modified Eastern Cooperative Oncology Group performance scale (ECOG). Tool (III) was Self-care questionnaire. There was improvement of mean scores regarding change of quality grade of functional ability of the study group II one and three months after receiving self-care teaching module with very high statistical significance difference. Also, the occurrence and severity of acute side effects was improved in the study group II compared to control group I. Self-care teaching module on radiation induced acute side effects had an effect on decreasing the occurrence, the severity and the distressing of these side effects in head and neck cancer patients.

AML-303: Systematic Review of Frailty Assessment Tools for Elderly Patients with Acute Myeloid Leukemia

Context Treating elderly AML patients (>65 years) with intensive remission-induction chemotherapy without proper frailty assessment results in poor survival. We hypothesize a lack of health status measurement tools specific for elderly AML patients that inform risk stratification and treatment decisions. Objective To determine the availability of frailty assessment tools for elderly AML patients. Methods We searched MEDLINE, EMBASE, PsycINFO and Cochrane CENTRAL databases from inception through March 5, 2020, for case-control, cohort, randomized controlled and validation studies. We used MeSH and free text terms for acute myeloid leukemia, frailty and the elderly. We included all languages and conference abstracts covered in the databases. Two reviewers independently screened references against inclusion/exclusion criteria and resolved differences through discussion. Results Out of 4115 retrieved references, 29 studies (3,526 patients) met eligibility criteria. We did not find any frailty assessment tools specific for elderly AML patients. Our search revealed 2 main categories of functional status measurement tools used in elderly AML patients. The first is disease-specific and used for functional status evaluation of cancer patients of any age. They included the Karnofsky performance scale (5 studies, 1,136 patients) and the Eastern Cooperative Oncology Group (ECOG) performance scale (6 studies, 458 patients). The second is age-specific and used for functional status assessment of elderly patients. These were Comprehensive Geriatric Assessment (CGA) tools (8 studies, 870 patients) including the Clinical Frailty Scale, instrumental activities of daily living functional score, Grip strength, and Timed Up and Go Test (TUGT). Both Karnofsky, ECOG performance scales, and most of the CGA tools were not significantly predictive of poor overall survival, except for a TUGT of more than 10 seconds [n = 96, HR 3.4 (95% CI 1.4 – 8.0), P = 0.005] and an abnormal CRP level [n = 96, HR 4.30 (95% CI 1.60 - 11.50), P = 0.003]. Conclusions Our systematic review demonstrates a lack of specific frailty assessment tools for elderly AML patients. There is a need to develop a novel, practical, time and cost-efficient health status measurement tool that will assess frailty in elderly AML patients to support hematologists in risk stratification and decision making.

Survival in patients with surgically treated spinal metastases.

Background:Despite the various treatment protocols available, survival evaluation is a fundamental criterion for the definition of surgical management; there are still many inconsistencies in the literature on this topic, especially in terms of the value of surgery and its morbidity in patients with very short survival.Objective:The objective was to analyze the association of clinical, oncological, and surgical factors in the survival of patients undergoing spinal surgery for spinal metastases (SM).Materials and Methods:A retrospective cohort of forty patients who were surgically treated at our institution for SM between 2010 and 2018 were included in the study. We applied the prognostic scales of Tomita and Tokuhashi in each patient and evaluated the systemic status using Karnofsky Performance Scale (KPS) and Eastern Cooperative Oncology Group Performance Scale. Survival rate in months was estimated using the Kaplan–Meier curve, with death considered as primary outcome and, for the evaluation of the association between the variables, the Chi-square test, Fisher’s exact test, or Fisher–Freeman–Halton test was applied for better survival. The level of statistical significance was considered as 5% (P ≤ 0.05).Results:The mean survival was 8.4 months. Patients with KPS <70 had a mean survival of 6.36 months, while those with KPS >70 had a mean survival of 14.48 months (P = 0.04). The mean survival of patients classified as ECOG 2 was 7.05 months (95% confidence interval [CI]: 3.4–10.7), and that of patients classified as ECOG 3 and 4 was 1.24 months (95% CI: 0.8–1.59). The mean survival rate among the patients with unresectable metastases in other organs was 6.3 months (95% CI: 3.9–8.9), while the survival rate of those who did not have metastases was 13.8 months (95% CI: 10.0–17.68; P = 0.022).Conclusion:Survival was associated with the preoperative functional status defined by the KPS and ECOG scales and with the presence of nonresectable visceral metastases.