Patient-reported outcomes (PROs) in older adults with gastrointestinal (GI) cancer undergoing surgery.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24032-e24032
Author(s):  
Helen Perry Knight ◽  
Carolyn L. Qian ◽  
Emilia R. Kaslow-Zieve ◽  
Chinenye C. Azoba ◽  
Cristina R. Ferrone ◽  
...  
Keyword(s):  
Older Adults ◽  
Physical Function ◽  
Surgical Outcomes ◽  
Psychological Symptom ◽  
Symptom Burden ◽  
Assessment System ◽  
Self Report ◽  
Depression Symptoms ◽  
Gi Cancer ◽  
Patient Reported

e24032 Background: Older adults with GI cancer often experience poor surgical outcomes, yet little is known about their PROs, such as physical function, quality of life (QOL), and physical and psychological symptom burden. Methods: As part of a randomized trial of perioperative geriatric care, we prospectively enrolled older adults with GI cancer planning to undergo surgical resection. We asked patients preoperatively to self-report their physical function (ability to perform activities of daily living [ADLs] and instrumental ADLs [IADLs], higher scores indicate better functioning), QOL (EORTC QLQ-C30, higher scores indicate better QOL), symptom burden (Edmonton Symptom Assessment System [ESAS], higher scores indicate more severe symptoms, scores > 3 considered moderate/severe [mod/sev]), and depression symptoms (Geriatric Depression Scale [GDS], higher scores indicate more severe symptoms, scores > 4 represent a positive screen for depression). We used regression models to identify patient characteristics associated with these PROs. We also explored relationships among PROs and surgical outcomes (receiving planned surgery, postoperative readmissions, and survival). Results: We enrolled 160 of 221 (72.4%) patients approached. A minority of patients were independent in all ADLs (5.2%) and IADLs (47.7%). Patients reported an average of 2.56 mod/sev ESAS symptoms, and 27.7% screened positive for depression, with 53.1% reporting at least one comorbidity. The number of comorbidities was significantly associated with impaired ADLs (B = -0.63, P < .01) and lower QOL (EORTC: B = -2.74, P = .03). For surgical outcomes, patients with better physical function were more likely to receive their planned surgery (ADLs: OR = 1.21, P = .02; IADLS: OR = 1.30, P = .03). Higher QOL correlated with greater odds of receiving planned surgery (EORTC: OR = 1.03, P = .06), but this did not reach statistical significance. A higher number of mod/sev ESAS symptoms was associated with greater postoperative readmission risk within 90 days of surgery (HR = 1.13, P = .03). Better physical function was associated with better postoperative survival (ADLs: HR = 0.87, P = .02; IADLs: HR = 0.73, P < .01), and higher depression scores correlated with worse survival (GDS: HR = 1.13, P = .02). Conclusions: Older adults with GI cancer often have baseline functional limitations and a high physical and psychological symptom burden, all of which are associated with worse surgical outcomes. Future work should study whether addressing preoperative PROs could improve older patients’ surgical outcomes. Clinical trial information: NCT02810652 .

Patient-reported outcomes (PROs) in older adults with gastrointestinal (GI) cancer undergoing surgery.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 159-159
Author(s):  
Helen Perry Knight ◽  
Zhi Ven Fong ◽  
Carolyn L. Qian ◽  
Emilia Kaslow-Zieve ◽  
Chinenye C. Azoba ◽  
...  
Keyword(s):  
Older Adults ◽  
Postoperative Complications ◽  
Physical Function ◽  
Clinical Outcomes ◽  
Surgical Outcomes ◽  
Lower Risk ◽  
Symptom Burden ◽  
Depression Symptoms ◽  
Gi Cancer ◽  
Patient Reported

159 Background: Older adults with GI cancer often experience poor surgical outcomes, yet little is known about their PROs, such as physical function, quality of life (QOL), and physical and psychological symptom burden. Methods: As part of a randomized trial of perioperative geriatric care, we prospectively enrolled adults age ≥65 with GI cancer planning to undergo surgical resection. We asked patients preoperatively to self-report their physical function (activities of daily living [ADLs] and instrumental ADLs [IADLs]), QOL (EORTC QLQ-C30), symptom burden (Edmonton Symptom Assessment System [ESAS], scores > 3 considered moderate/severe [mod/sev]), depression symptoms (Geriatric Depression Scale [GDS], scores > 4 represent a positive screen for depression), and comorbidities. We used regression models to explore relationships among PROs and clinical outcomes (receiving planned surgery, postoperative complications [Clavien-Dindo], hospital readmissions within 90 days, and survival). Results: From 9/2016 - 4/2019, we enrolled 160 of 221 (72.4%) patients approached (median age: 72, range: 65-92). At baseline, most (53.1%) reported at least one comorbidity and required assistance with ADLs (94.8%) and IADLs (52.3%). Patients reported an average of 2.56 mod/sev ESAS symptoms, and 27.7% screened positive for depression. For surgical outcomes, 137 patients (85.6%) underwent planned surgery, and 99 (72.2%) of these had at least one postoperative complication. Greater independence with ADLs was associated with undergoing planned surgery (OR = 1.21, P = .02), lower risk of complications (OR = 0.81, P < .01), and improved survival (HR = 0.87, P = .02), but not readmissions. Greater independence with IADLs was associated with undergoing planned surgery (OR = 1.30, P = .03) and improved survival (HR = 0.73, P < .01), but not other outcomes. Higher baseline QOL was only associated with lower risk of postoperative complications (OR = 0.97, P = .04). Higher depression scores were only associated with worse survival (HR = 1.13, P = .02). Higher baseline symptom burden predicted for shorter time to readmission (HR = 1.13, p = .03). Patient-reported number of comorbidities was associated with shorter time to readmission (HR = 1.49, p = .03) and higher risk of complications (OR = 1.70, P = .03). Conclusions: Older adults with GI cancer often have baseline functional limitations and a high symptom burden, all of which are associated with worse clinical outcomes. Future work should study whether addressing preoperative PROs could improve older patients’ surgical outcomes. Clinical trial information: NCT02810652 .

Randomized trial of a perioperative geriatric intervention for older adults with cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12012-12012 ◽  
Author(s):  
Carolyn L. Qian ◽  
Helen P. Knight ◽  
Cristina R. Ferrone ◽  
Hiroko Kunitake ◽  
Carlos Fernandez-del Castillo ◽  
...  
Keyword(s):  
Older Adults ◽  
Usual Care ◽  
Randomized Trial ◽  
Assessment System ◽  
Depression Symptoms ◽  
Readmission Rates ◽  
End Point ◽  
Patient Reported ◽  
Geriatric Intervention ◽  
Gi Cancers

12012 Background: Older adults with gastrointestinal (GI) cancers undergoing surgery often experience poor outcomes, such as prolonged postoperative (post-op) length of stay (LOS), intensive care unit (ICU) use, and readmissions. Involvement of geriatricians in the care of older adults with cancer can improve outcomes. We conducted a randomized trial of a perioperative geriatric intervention in older adults with GI cancers undergoing surgery. Methods: We randomly assigned patients age ≥65 with GI cancers planning to undergo surgical resection to receive a perioperative geriatric intervention or usual care. Intervention patients met with a geriatrician preoperatively in the outpatient setting and post-op as an inpatient consultant. The geriatrician conducted a geriatric assessment and made recommendations to the surgical/oncology teams. The primary end point was post-op LOS. Secondary end points included post-op ICU use, readmission risk, and patient-reported symptom burden (Edmonton Symptom Assessment System [ESAS]) and depression symptoms (Geriatric Depression Scale). We conducted both intention-to-treat (ITT) and per protocol (PP) analyses. Results: From 9/13/16-4/30/19, we randomized 160 patients (72.4% enrollment rate; median age = 72 [65-92]). The ITT analyses included 137/160 patients who underwent surgery (usual care = 68/78, intervention = 69/82). The PP analyses included the 68 usual care patients and the 30/69 intervention patients who received both pre- and post-op intervention components. In ITT analyses, we found no significant differences between intervention and usual care in post-op LOS (7.2 v 8.2 days, P = .37), ICU use (23.3% v 32.4%, p = .23), and readmission rates within 90 days of surgery (21.7% v 25.0%, p = .65). Intervention patients reported lower depression symptoms (B = -1.39, P < .01) at post-op day 5 and fewer moderate/severe ESAS symptoms at post-op day 60 (B = -1.09, P = .02). In PP analyses, intervention patients had significantly shorter post-op LOS (5.9 v 8.2 days, P = .02) and lower rates of post-op ICU use (13.3% v 32.4%, p < .05), but readmission rates were not significantly different (16.7% v 25.0%, p = .36). Conclusions: Although this perioperative geriatric intervention did not have a significant impact on the primary end point in ITT analysis, we found encouraging results in several secondary outcomes and for the subgroup of patients who received the planned intervention. Future studies of this perioperative geriatric intervention should include efforts, such as telehealth visits, to ensure the intervention is delivered as planned. Clinical trial information: NCT02810652 .

Unmet supportive care needs of older adults with advanced cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10040-10040 ◽  
Author(s):  
Brandon Temel ◽  
Margaret Ruddy ◽  
Emily Olson ◽  
Samantha M.C. Moran ◽  
Charn-Xin Fuh ◽  
...  
Keyword(s):  
Older Adults ◽  
Linear Regression ◽  
Supportive Care ◽  
Advanced Cancer ◽  
Psychological Symptom ◽  
Symptom Burden ◽  
Physical Symptoms ◽  
Supportive Care Needs ◽  
Care Needs ◽  
Gi Cancer

10040 Background: Cancer disproportionately affects older adults, yet research defining the supportive care needs of these patients is lacking. We sought to examine associations between geriatric impairments, quality of life (QOL), and physical and psychological symptom burden in older adults with newly diagnosed incurable gastrointestinal (GI) cancer. Methods: We prospectively enrolled patients age ≥70 within 8 weeks of diagnosis of incurable GI cancer at Massachusetts General Hospital from 10/2015-11/2016. We used surveys to assess geriatric impairments (Vulnerable Elders Survey-13 [range 0-10, scores ≥3 identify patients with impairments), QOL (EORTC QLQ-C30 [range 0-100, higher scores indicate better QOL]), physical symptoms (Edmonton Symptom Assessment System [range 0-10, higher scores indicate greater symptom burden]) and psychological symptoms (Geriatric Depression Scale, [range 0-15, higher scores indicate greater depression symptoms]). We used descriptive statistics to determine differences in patient characteristics by the presence or absence of geriatric impairments. We used linear regression adjusted for age, employment, cancer type, and comorbidity to examine associations between geriatric impairments, QOL, and physical and psychological symptom burden. Results: We enrolled 50 of 58 (86%) patients approached (mean age = 78.7; 52% with pancreatic cancer). Nearly half (46%) screened positive for geriatric impairments; these patients were older (81.7 vs 76.1, p < .01) and had more comorbid conditions (2.4 vs 1.2, p = .01). On linear regression, patients with geriatric impairments reported worse QOL across all domains (General QOL: B = -28.3, p < .01; Physical: B = -36.8, p < .01; Role: B = -36.8, p < .01; Emotional: B = -30.1, p < .01; Cognitive: B = -17.8, p = .03; Social: B = -39.7, p < .01), higher depression scores (B = 5.1, p < .01) and worse fatigue (B = 4.6, p < .01), drowsiness (B = 4.0, p < .01), appetite (B = 3.8, p < .01), and pain (B = 2.7, p = .02). Conclusions: Older adults with advanced cancer experience considerable unmet supportive care needs, particularly those with geriatric impairments. Future research is needed to assess older patients for geriatric impairments and address their unique palliative and supportive care needs.

scholarly journals Prescreening of Patient-reported Symptoms using the Edmonton Symptom Assessment System (ESAS) in Outpatient Palliative Cancer Care

2019 ◽  
Author(s):  
Garden Lee ◽  
Han Sang Kim ◽  
Si Won Lee ◽  
Eun Hwa Kim ◽  
Bori Lee ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cancer Care ◽  
Severe Symptom ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Assessment System ◽  
Advanced Cancer Patients ◽  
Edmonton Symptom Assessment System ◽  
Patient Reported

Abstract Background: Although early palliative care is associated with a better quality of life and improved outcomes in end-of-life cancer care, the criteria of palliative care referral are still elusive. Methods: We collected patient-reported symptoms using the Edmonton Symptom Assessment System (ESAS) at the baseline, first, and second follow-up visit. The ESAS evaluates ten symptoms: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, sleep disorder, appetite, and wellbeing. A total of 71 patients were evaluable, with a median age of 65 years, male (62%), and the Eastern Cooperative Oncology Group (ECOG) performance status distribution of 1/2/3 (28%/39%/33%), respectively. Results: Twenty (28%) patients had moderate/severe symptom burden with the mean ESAS ≥5. Interestingly, most of the patients with moderate/severe symptom burdens (ESAS ≥5) had globally elevated symptom expression. While the mean ESAS score was maintained in patients with mild symptom burden (ESAS<5; 2.7 at the baseline; 3.4 at the first follow-up; 3.0 at the second follow-up; P =0.117), there was significant symptom improvement in patients with moderate/severe symptom burden (ESAS≥5; 6.5 at the baseline; 4.5 at the first follow-up; 3.6 at the second follow-up; P <0.001). Conclusions: Advanced cancer patients with ESAS ≥5 may benefit from outpatient palliative cancer care. Prescreening of patient-reported symptoms using ESAS can be useful for identifying unmet palliative care needs in advanced cancer patients.

scholarly journals Implementing a Patient-Reported Outcome Measure for Hemodialysis Patients in Routine Clinical Care

2020 ◽  
Vol 15 (9) ◽  
pp. 1299-1309 ◽  
Author(s):  
Jenna M. Evans ◽  
Alysha Glazer ◽  
Rebecca Lum ◽  
Esti Heale ◽  
Marnie MacKinnon ◽  
...  
Keyword(s):  
Outcome Measure ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Patient Reported Outcome ◽  
Assessment System ◽  
Edmonton Symptom Assessment System ◽  
Patient Reported Outcome Measure ◽  
Symptom Screening ◽  
Patient Reported ◽  
Patient Provider Communication

Background and objectivesThe Edmonton Symptom Assessment System Revised: Renal is a patient-reported outcome measure used to assess physical and psychosocial symptom burden in patients treated with maintenance dialysis. Studies of patient-reported outcome measures suggest the need for deeper understanding of how to optimize their implementation and use. This study examines patient and provider perspectives of the implementation process and the influence of the Edmonton Symptom Assessment System Revised: Renal on symptom management, patient-provider communication, and interdisciplinary communication.Design, setting, participants, & measurements Eight in-facility hemodialysis programs in Ontario, Canada, assessed patients using the Edmonton Symptom Assessment System Revised: Renal every 4–6 weeks for 1 year. Screening and completion rates were tracked, and pre- and postimplementation surveys and midimplementation interviews were conducted with patients and providers. A chart audit was conducted 12 months postimplementation.ResultsIn total, 1459 patients completed the Edmonton Symptom Assessment System Revised: Renal; 58% of eligible patients completed the preimplementation survey (n=718), and 56% of patients who completed the Edmonton Symptom Assessment System Revised: Renal at least once completed the postimplementation survey (n=569). Provider survey response rates were 71% (n=514) and 54% (n=319), respectively. Nine patients/caregivers from three sites and 48 providers from all sites participated in interviews. A total of 1207 charts were audited. Seven of eight sites had mean screening rates over 80%, suggesting that routine use of the Edmonton Symptom Assessment System Revised: Renal in clinical practice is feasible. However, the multiple data sources painted an inconsistent picture of the value and effect of the Edmonton Symptom Assessment System Revised: Renal. The Edmonton Symptom Assessment System Revised: Renal standardized symptom screening processes across providers and sites; improved patient and provider symptom awareness, particularly for psychosocial symptoms; and empowered patients to raise issues with providers. Yet, there was little, if any, statistically significant improvement in the metrics used to assess symptom management, patient-provider communication, and interdisciplinary communication.ConclusionsThe Edmonton Symptom Assessment System Revised: Renal patient-reported outcome measure may be useful to standardize symptom screening, enhance awareness of psychosocial symptoms among patients and providers, and empower patients rather than to reduce symptom burden.

scholarly journals Anthropometric indices predict physical function and mobility in older Australians: the Australian Longitudinal Study of Ageing

2002 ◽  
Vol 5 (5) ◽  
pp. 655-662 ◽  
Author(s):  
Elaine Bannerman ◽  
Michelle D Miller ◽  
Lynne A Daniels ◽  
Lynne Cobiac ◽  
Lynne C Giles ◽  
...  
Keyword(s):  
Older Adults ◽  
Body Weight ◽  
Longitudinal Study ◽  
Waist Circumference ◽  
Physical Function ◽  
South Australia ◽  
Self Report ◽  
Mobility Limitations ◽  
Australian Longitudinal Study ◽  
Increased Risk

AbstractObjective:To evaluate, in terms of function and mobility, the predictive value of commonly adopted anthropometric ‘definitions’ used in the nutritional assessment of older adults, in a cohort of older Australians.Design:Prospective cohort study – Australian Longitudinal Study of Ageing (ALSA).Setting:Adelaide, South Australia (1992–1994).Subjects:Data were analysed from 1272 non-institutionalised (685 males, 587 females) older adults ≥70 years old in South Australia. Seven ‘definitions’ commonly used in the anthropometric assessment of both under- and overnutrition (including four using body mass index (BMI), waist-to-hip ratio, waist circumference and percentage weight change) were evaluated at baseline, for their ability to predict functional and mobility limitation assessed (by self-report questionnaire) at two years follow-up. All questionnaires were administered and anthropometry performed by trained investigators. The associations between the definitions and decline in mobility and physical function were evaluated over two years using multiple logistic regression.Results:A BMI >85th percentile or >30 kgm−2 or a waist circumference of >102 cm in males and >88 cm in females increased risk of functional and mobility limitations. Over two years, a loss of 10% body weight significantly increased the risk of functional and mobility limitations.Conclusion:Maintaining weight within older adults, irrespective of initial body weight, may be important in preventing functional and mobility limitations. Excessive weight is associated with an increased risk of limitation in function and mobility, both key components of health-related quality of life.

Impact of baseline symptom burden as assessed by patient-reported outcomes (PROs) on overall survival (OS) of patients with metastatic cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12020-12020
Author(s):  
Atul Batra ◽  
Colleen Ann Cuthbert ◽  
Andrew Harper ◽  
Lin Yang ◽  
Devon J. Boyne ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Cancer ◽  
Metastatic Breast ◽  
Symptom Burden ◽  
Assessment System ◽  
Clinical Practices ◽  
Cox Regression Analysis ◽  
Symptom Intensity ◽  
Patient Reported ◽  
Symptom Scores

12020 Background: Patients with metastatic cancer experience variable symptom burden, but serial symptom assessments using PROs may be challenging to implement in routine clinical practices. We aimed to determine if a single measurement of symptom burden at the time of metastatic diagnosis is associated with survival. Methods: We examined prospectively collected baseline PROs of patients newly diagnosed with metastatic breast, lung, colorectal, or prostate cancer using the revised Edmonton Symptom Assessment System (ESASr) questionnaire from a large province (Alberta, Canada) between 2016 and 2019. The ESASr was categorized into physical (PH), psychosocial (PS), and total symptom (TS) domains whereby scores were classified as mild (0-3), moderate (4-6), or severe (7-10). Multivariable Cox proportional hazards models were constructed to evaluate the effect of baseline symptom scores on OS. Results: We identified 1,315 patients, of whom 57% were men and median age was 66 (IQR, 27-93) years. There were 180, 601, 240, and 294 patients with breast, lung, colorectal, and prostate cancer, respectively. Approximately one-quarter of all patients reported moderate to severe PH, PS, and TS scores, with lung cancer patients experiencing the highest symptom intensity across all domains ( P<0.0001). While age did not affect symptom scores, women were more likely to report severe PH, PS, and TS scores as compared to men ( P=0.02, 0.002, and 0.007, respectively). On multivariable Cox regression analysis, older age (HR 1.02, 95% CI, 1.02-1.03, P<0.0001) and female sex (HR 1.67, 95% CI, 1.39-1.99, P<0.0001) were predictive of worse OS as were severe baseline PH and TS scores (see Table) . However, baseline PS scores were not related to OS. Conclusions: A single assessment of baseline symptom burden using the ESASr in patients with metastatic cancer has significant prognostic value. This may represent a feasible first step toward routine collection of PROs in real-world settings where serial symptom measurements can be challenging to implement. [Table: see text]

Patient-Reported Symptom Burden as a Predictor of Emergency Department Use and Unplanned Hospitalization in Head and Neck Cancer: A Longitudinal Population-Based Study

2021 ◽  
pp. JCO.20.01845
Author(s):  
Christopher W. Noel ◽  
Rinku Sutradhar ◽  
Haoyu Zhao ◽  
Victoria Delibasic ◽  
David Forner ◽  
...  
Keyword(s):  
Emergency Department ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Symptom Burden ◽  
Population Based ◽  
Assessment System ◽  
Emergency Department Use ◽  
Population Based Study ◽  
Patient Reported

PURPOSE: To determine the association between patient-reported symptom burden and subsequent emergency department use and unplanned hospitalization (ED/Hosp) in a head and neck cancer (HNC) patient population. METHODS: This was a population-based study of patients diagnosed with HNC who had completed at least one outpatient Edmonton Symptom Assessment System (ESAS) assessment between January 2007 and March 2018 in Ontario, Canada. Logistic regression models were used to determine the relationship between outpatient ESAS scores and subsequent 14-day ED/Hosp use. A generalized estimating equation approach with an exchangeable correlation structure was incorporated to account for patient-level clustering RESULTS: There were 11,761 patients identified, completing a total of 73,282 ESAS assessments and experiencing 5,203 ED/Hosp events. Six of the nine ESAS symptom scores were positively associated with ED/Hosp use, with pain, appetite, shortness of breath, and tiredness demonstrating the strongest associations. A global ESAS score was calculated by selecting the highest individual symptom score (h-ESAS). Among patients reporting a maximum h-ESAS score of 10, 15.1% had an ED/Hosp event within 14 days compared with 1.5% for those with the lowest possible score of zero. In adjusted analysis, the odds of ED/Hosp use increased with h-ESAS (1.23 per one-unit increase [95% CI, 1.22 to 1.25]). When treated as a categorical variable, patients with the maximum h-ESAS score of 10 had 9.23 (95% CI, 7.22 to 11.33) higher odds of ED/Hosp use, relative to the minimum score of zero. CONCLUSION: ESAS scores are strongly associated with subsequent ED/Hosp events in patients with HNC. Clinician education around how ESAS data might inform patient care may enhance symptom detection and management.

The role of circulating tumor DNA (ctDNA), tumor markers (TMs), and patient-reported outcomes (PROs) in predicting treatment response in patients with metastatic gastrointestinal (GI) cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 833-833
Author(s):  
Aparna Raj Parikh ◽  
Madeleine Fish ◽  
Emily E. Van Seventer ◽  
Kathryn Fosbenner ◽  
Katie Kanter ◽  
...  
Keyword(s):  
Treatment Response ◽  
Preliminary Analysis ◽  
Symptom Burden ◽  
Circulating Tumor Dna ◽  
Somatic Tissue ◽  
Gi Cancer ◽  
Patient Reported ◽  
Droplet Pcr ◽  
A Prospective Study ◽  
Tumor Types

833 Background: Changes in ctDNA and serum TMs (CEA and CA19-9) can serve as predictors of response to systemic therapy in GI cancer patients (pts). Similarly, PROs correlate with survival and treatment response. We present a preliminary analysis of ctDNA, TMs, and PROs in predicting treatment response. Methods: We are enrolling 200 pts in a prospective study with metastatic pancreatic (PDAC), colorectal (CRC), gastroesophageal (GE), and biliary cancers. We are collecting ctDNA, TMs (CEA for all tumor types; CA19-9 for PDAC, GE, biliary), and PROs (FACT-G for QOL [higher scores indicate better QOL]; ESAS-r and PRO-CTCAE for symptoms; and PHQ-4 [consists of GAD-2 and PHQ-2 for anxiety and depression]; higher ESAS-r, PRO-CTCAE, and PHQ-4 scores reflect greater symptom burden) at baseline and 4 weeks. ctDNA is benchmarked against somatic tissue alterations, and serially assessed by digital droplet PCR. We correlated median percent change from baseline to 4 weeks for ctDNA, TMs, and PROs with treatment response (clinical benefit [CB], progressive disease [PD]). Results: From April to August 2019, we have enrolled 38/45 (84.4%) eligible pts (median age = 64 years; 36.8% female). Among these 38 pts, tumor types are PDAC (36.8%), CRC (31.6%), GE (28.9%), and biliary (2.6%). 18/38 pts were evaluable for ctDNA. Change in ctDNA was -94.5% in pts with CB (n = 10) and -19.5% in pts with PD (n = 8; p = 0.025). No correlation was observed between CEA and treatment response (p = 0.367). Change in CA19-9 was -1.5% for pts with CB and +47% for pts with PD (p = 0.019). Changes in PRO-CTCAE (p = 0.345), GAD-2 (p = 0.697), and ESAS scores (p = 0.743) did not differ between pts with CB and PD. However, changes in PHQ-2 (CB 0% v. PD +22.5%; p < 0.001), PHQ-4 (CB -8.5% v. PD +5%; p = 0.015), and FACT-G (CB +30% v. PD +5%; p = 0.049) were significant. Conclusions: Preliminary analysis suggests that ctDNA and PROs demonstrate promising utility for early prediction of treatment response, with favorable performance relative to standard TMs. Further analyses of larger pt numbers in this ongoing study may clarify the use and integration of these measures to better predict pt outcomes.

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