Changes in patient-reported outcomes (PROs) and tumor markers (TMs) to predict treatment response and survival in patients with metastatic gastrointestinal (GI) cancer.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 154-154
Author(s):  
Joy X. Jarnagin ◽  
Islam Baiev ◽  
Emily E. Van Seventer ◽  
Yojan Shah ◽  
Amirkasra Mojtahed ◽  
...  

154 Background: PROs assessing quality of life (QOL) and symptoms at a single timepoint frequently correlate with clinical outcomes in patients with cancer, yet efforts to understand how longitudinal changes in PROs can predict for treatment outcomes are lacking. In practice, oncologists often use changes in serum TMs (CEA and CA19-9) to monitor patients with GI cancer, and thus we sought to examine associations of 1-month changes in PROs and TMs with treatment response and survival outcomes among patients with advanced GI cancer. Methods: We prospectively enrolled patients with metastatic GI cancer prior to initiating chemotherapy at Massachusetts General Hospital from 5/2019-12/2020. At baseline (start of treatment) and 1-month later, we collected PROs (QOL [Functional Assessment of Cancer Therapy General {FACT-G}], physical symptoms [Edmonton Symptom Assessment System {ESAS}], and psychological symptoms [Patient Health Questionnaire-4 {PHQ-4}]) and TMs. We used regression models to examine associations of 1-month changes in PROs and TMs with treatment response (clinical benefit [defined as decreased or stable tumor burden] or progressive disease at the time of first scan) and survival outcomes (progression-free survival [PFS] and overall survival [OS]), adjusted for baseline values of each respective variable. Results: We enrolled 159 of 191 patients approached (83.2% enrollment); 134 had 1-month follow-up data (median age = 64 years [range: 28 to 84 years], 64.2% male, 46.3% pancreaticobiliary cancer). For treatment response, 63.4% had clinical benefit and 36.6% had progressive disease at the time of first scan (mean time to first scan = 2.01 months). Changes in PROs (ESAS-Total: OR = 0.97, p = 0.022; ESAS-Physical: OR = 0.96, p = 0.027; PHQ-4 depression: OR = 0.67, p = 0.014; FACT-G: OR = 1.07, p = 0.001), but not TMs (CEA: OR = 1.00, p = 0.836 and CA19-9: OR = 1.00, p = 0.796), were associated with clinical benefit at the time of first scan. Changes in ESAS-Total (HR = 1.03, p = 0.004), ESAS-Physical (HR = 1.03, p = 0.021), PHQ-4 depression (HR = 1.22, p = 0.042), FACT-G (HR = 0.97, p = 0.003), and CEA (HR = 1.00, p = 0.001) were predictors of PFS. Changes in ESAS-Total (HR = 1.03, p = 0.006) and ESAS-Physical (HR = 1.04, p = 0.015) were predictors of OS, but 1-month changes in TMs (CEA: HR = 1.00, p = 0.377 and CA19-9: HR = 1.00, p = 0.367) did not significantly predict for OS. Conclusions: We found that 1-month changes in PROs can predict for treatment response and survival outcomes in patients with advanced GI cancers. Notably, 1-month changes in CEA only correlated with PFS, while changes in CA19-9 did not significantly predict treatment response or survival outcomes. These findings highlight the potential for early changes in PROs to predict treatment outcomes while underscoring the need to monitor and address PROs in patients with advanced cancer. Clinical trial information: NCT04776837.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6560-6560
Author(s):  
Joy X. Jarnagin ◽  
Aparna Raj Parikh ◽  
Emily E. Van Seventer ◽  
Yojan Shah ◽  
Islam Baiev ◽  
...  

6560 Background: PROs assessing quality of life (QOL) and symptoms at a single timepoint frequently correlate with clinical outcomes in patients with cancer, yet efforts to understand how longitudinal changes in PROs can predict for treatment outcomes are lacking. In practice, oncologists often use changes in serum TMs (CEA and CA19-9) to monitor patients with GI cancer, and thus we sought to examine associations of 1-month changes in PROs and TMs with treatment response and survival outcomes among patients with advanced GI cancer. Methods: We prospectively enrolled patients with metastatic GI cancer prior to initiating chemotherapy at Massachusetts General Hospital from 5/2019-12/2020. At baseline (start of treatment) and 1-month later, we collected PROs (QOL [Functional Assessment of Cancer Therapy General {FACT-G}], physical symptoms [Edmonton Symptom Assessment System {ESAS}], and psychological symptoms [Patient Health Questionnaire-4 {PHQ-4}]) and TMs. We used regression models to examine associations of 1-month changes in PROs and TMs with treatment response (clinical benefit [defined as decreased or stable tumor burden] or progressive disease at the time of first scan) and survival outcomes (progression-free survival [PFS] and overall survival [OS]), adjusted for baseline values of each respective variable. Results: We enrolled 159 of 191 patients approached (83.2% enrollment); 134 had 1-month follow-up data (median age = 64 years [range: 28 to 84 years], 64.2% male, 46.3% pancreaticobiliary cancer). For treatment response, 63.4% had clinical benefit and 36.6% had progressive disease at the time of first scan (mean time to first scan = 2.01 months). Changes in PROs (ESAS-Total: OR = 0.97, p = 0.022; ESAS-Physical: OR = 0.96, p = 0.027; PHQ-4 depression: OR = 0.67, p = 0.014; FACT-G: OR = 1.07, p = 0.001), but not TMs (CEA: OR = 1.00, p = 0.836 and CA19-9: OR = 1.00, p = 0.796), were associated with clinical benefit at the time of first scan. Changes in ESAS-Total (HR = 1.03, p = 0.004), ESAS-Physical (HR = 1.03, p = 0.021), PHQ-4 depression (HR = 1.22, p = 0.042), FACT-G (HR = 0.97, p = 0.003), and CEA (HR = 1.00, p = 0.001) were predictors of PFS. Changes in ESAS-Total (HR = 1.03, p = 0.006) and ESAS-Physical (HR = 1.04, p = 0.015) were predictors of OS, but 1-month changes in TMs (CEA: HR = 1.00, p = 0.377 and CA19-9: HR = 1.00, p = 0.367) did not significantly predict for OS. Conclusions: We found that 1-month changes in PROs can predict for treatment response and survival outcomes in patients with advanced GI cancers. Notably, 1-month changes in CEA only correlated with PFS, while changes in CA19-9 did not significantly predict treatment response or survival outcomes. These findings highlight the potential for early changes in PROs to predict treatment outcomes while underscoring the need to monitor and address PROs in patients with advanced cancer.


2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 186-186
Author(s):  
Aparna Raj Parikh ◽  
Emily E. Van Seventer ◽  
Madeleine Fish ◽  
Kathryn Fosbenner ◽  
Katie Kanter ◽  
...  

186 Background: PROs assessing quality of life (QOL) and physical symptoms often correlate with clinical outcomes in patients (pts) with cancer. Yet, data are lacking about the use of PROs to predict treatment response. We evaluated associations of baseline PROs with treatment response, healthcare use, and survival among pts with advanced gastrointestinal cancer. Methods: We prospectively enrolled pts with metastatic gastrointestinal cancer prior to initiating chemotherapy at Massachusetts General Hospital. At baseline (start of treatment), pts reported their QOL (Functional Assessment of Cancer Therapy General [FACT-G], subscales assess QOL across 4 domains: functional, physical, emotional, social well-being) and symptom burden (Edmonton Symptom Assessment System [ESAS]). Higher scores on FACT-G indicate better QOL, while higher scores on ESAS represent a greater symptom burden. We used regression models to examine associations of baseline PRO scores with treatment response (clinical benefit [CB] or progressive disease [PD] at the time of first scan based on clinical documentation), healthcare use (unplanned hospital admissions), and survival. Results: From 5/2019-3/2020, we enrolled 112 of 131 (85.5% enrollment) consecutive pts (median age = 62.8, 61.6% male, 45.5% pancreatobiliary cancer). For treatment response, 64.3% had CB and 35.7% had PD. Higher ESAS-physical (B = 1.04, p = .027) and lower FACT-G functional (B = 0.92, p = .038) scores at baseline were significant predictors of PD. On the specific ESAS items, pts who experienced PD were more likely to report moderate/severe poor well-being (57.9% vs 29.7%; p = .001), pain (44.7% vs 25.0%; p < .050), drowsiness (42.1% vs 20.3%; p = .024), and diarrhea (23.7% vs 4.7%; p = .008) at baseline. Lower FACT-G total (HR = 0.96, p = .003), FACT-G physical (HR = 0.89, p < .001), FACT-G functional (HR = 0.87, p < .001), and higher ESAS-physical (HR = 1.03, p = .028) scores at baseline were significantly associated with greater risk of hospital admission. Lower FACT-G total (HR = 0.96, p = .009), FACT-G emotional (HR = 0.87, p = .014), as well as higher ESAS-total (HR = 1.03, p = .018) and ESAS-physical (HR = 1.03, p = .040) scores at baseline were significantly associated with greater risk of death. Conclusions: We found that baseline PROs predict treatment response in pts with advanced cancer, namely physical symptoms and functional QOL, in addition to healthcare use and survival outcomes. These findings further support the use of PROs to predict important clinical outcomes, including the novel finding of treatment response.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 157-157
Author(s):  
Gillian Hurwitz ◽  
Zahra Ismail ◽  
Lesley Moody ◽  
Lisa Catherine Barbera

157 Background: Patients undergoing cancer treatment often experience physical and psychosocial symptoms that go undetected by clinicians, which highlights the need to incorporate patient-reported outcome measures (PROMs) in routine care. Systematic symptom screening for cancer patients using the Edmonton Symptom Assessment System (ESAS) is standard practice in Ontario. However, provider response to PROMs is essential to addressing symptom burden. To measure provider response, Regional Cancer Centre (RCC) Leads and Cancer Care Ontario developed a chart audit process. The objective was to determine whether the clinical team acknowledged, assessed and/or addressed symptoms identified by ESAS screening. Methods: RCCs received a chart audit tool with preset options and a data dictionary. Sites audited at least 140 charts for seven of the ESAS symptoms. Sites used a business intelligence tool to access patient charts based on sampling parameters. RCCs were required to audit charts of patients whose ESAS symptom scores were moderate to severe (4-10), with at least five charts in the moderate range (4-6). Results: 2,380 charts from 13 RCCs were audited based on ESAS scores from September to December 2016. Symptoms were most often acknowledged when the intensity was severe (69.9%), regardless of symptom type. Acknowledgement (71.5%), assessment (67.7%) and intervention (55.8%) were most often offered to patients reporting pain. Patients reporting depression and anxiety were the least likely to have the symptom acknowledged (44.5%, 45.0%, respectively) and be offered assessments (45.8%, 50.1%, respectively) and interventions (35.7%, 36.6%, respectively). Patients reporting moderate to severe depression and anxiety most commonly declined interventions (7.8%, 7.7%, respectively). Conclusions: These data show that providers disproportionately respond to physical symptoms, which may be easiest to treat due to clear management plans and referral pathways. To truly offer person-centred care, the emotional burden related to cancer must also be addressed, and providers must be trained to properly respond to psychosocial symptoms. Chart audits identify gaps in symptom management and areas for quality improvement.


2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 46-46
Author(s):  
David Wallace ◽  
Jina Zhang-Salomons ◽  
Christopher M. Booth ◽  
William J. Mackillop

46 Background: Randomized controlled trials (RCTs) have shown that palliative gemcitabine provides clinical benefit and prolongs survival in patients with advanced pancreatic cancer. The purpose of this study was to determine if the efficacy of palliative gemcitabine demonstrated in RCTs has translated into effectiveness in routine clinical practice in Ontario. Methods: This was a retrospective cohort study of all patients with exocrine cancer of the pancreas treated with first line, single agent, palliative gemcitabine at all 13 provincial cancer centres in Ontario between 2008 and 2011. These patients were identified by linking electronic records of treatment from all cancer centres and hospitals in Ontario to the Ontario Cancer Registry. Patient-reported well-being and symptoms were captured by the Edmonton Symptom Assessment System, which has been in routine use at these centres since 2008. The effectiveness of gemcitabine was measured in terms of clinical benefit at two months and overall survival. Patients were classified as having achieved clinical benefit if they had not discontinued gemcitabine and their self-reported well-being was stable or improved at two months. Results: The study population included 423 patients. Their median age was 65 and 50% were women. Fifty-seven percent had stage IV disease, 17% had stage III disease, and 10% had recurrence after earlier treatment for stage I or II disease. Patients included in this study were older than, but otherwise similar to, patients enrolled in four relevant RCTs that used gemcitabine in the experimental or control arm. At two months, 36.9% (95% CI 29.6-44.2%) of patients in this study achieved clinical benefit, which was within the range of 24% to 56% observed in patients in these trials. Median overall survival was 5.7 months (95% CI 4.7-6.1), which was within the range of 5.4 to 6.9 months reported in the trials. Conclusions: The efficacy of gemcitabine demonstrated in RCTs has translated into effectiveness in routine clinical practice in Ontario. The approach described above could readily be used to study the effectiveness of other palliative interventions.


2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 833-833
Author(s):  
Aparna Raj Parikh ◽  
Madeleine Fish ◽  
Emily E. Van Seventer ◽  
Kathryn Fosbenner ◽  
Katie Kanter ◽  
...  

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.


2018 ◽  
Vol 25 (2) ◽  
pp. 176 ◽  
Author(s):  
K. Tran ◽  
S. Zomer ◽  
J. Chadder ◽  
C. Earle ◽  
S. Fung ◽  
...  

Patient-reported outcomes measures (proms) are an important component of the shift from disease-centred to person-centred care. In oncology, proms describe the effects of cancer and its treatment from the patient perspective and ideally enable patients to communicate to their providers the physical symptoms and psychosocial concerns that are most relevant to them. The Edmonton Symptom Assessment System–revised (esas-r) is a commonly used and validated tool in Canada to assess symptoms related to cancer. Here, we describe the extent to which patient reported outcome programs have been implemented in Canada and the severity of symptoms causing distress for patients with cancer.As of April 2017, 8 of 10 provinces had implemented the esas-r to assess patient-reported outcomes. Data capture methods, the proportion of cancer treatment sites that have implemented the esas-r, and the time and frequency of screening vary from province to province. From October 2016 to March 2017 in the 8 reporting provinces, 88.0% of cancer patients were screened for symptoms. Of patients who reported having symptoms, 44.3% reported depression, with 15.5% reporting moderate-to-high levels; 50.0% reported pain, with 18.6% reporting moderate-to-high levels; 56.2% reported anxiety, with 20.4% reporting moderate-to-high levels; and 75.1% reported fatigue, with 34.4% reporting moderate-to-high levels.There are some notable areas in which the implementation of proms could be improved in Canada. Findings point to a need to increase the number of cancer treatment sites that screen all patients for symptoms; to standardize when and how frequently patients are screened across the country; to screen patients for symptoms during all phases of their cancer journey, not just during treatment; and to assess whether giving cancer care providers real-time patient-reported outcomes data has led to appropriate interventions that reduce the symptom burden and improve patient outcomes. Continued measurement and reporting at the system level will allow for a better understanding of progress in proms activity over time and of the areas in which targeted quality improvement efforts could ensure that patient symptoms and concerns are being addressed.


2018 ◽  
Vol 105 (2) ◽  
pp. 144-150 ◽  
Author(s):  
Martina Ferrari ◽  
Carla I. Ripamonti ◽  
Nicholas J. Hulbert-Williams ◽  
Guido Miccinesi

Introduction: In oncology settings, less attention is given to patients’ unmet needs and to existential and emotional distress compared to physical symptoms. We aimed to evaluate correlations between unmet needs and emotional distress (self-reported anxiety and depression) in a consecutive cohort of cancer patients. The influence of sociodemographic and clinical factors was also considered. Methods: A total of 300 patients with cancer recruited from an outpatient Supportive Care Unit of a Comprehensive Cancer Centre completed the Need Evaluation Questionnaire and the Edmonton Symptom Assessment System (ESAS). Unmet needs covered 5 distinct domains (informational, care/assistance, relational, psychoemotional, and material). Results: After removal of missing data, we analyzed data from 258 patients. Need for better information on future health concerns (43%), for better services from the hospital (42%), and to speak with individuals in the same condition (32%) were the most frequently reported as unmet. Based on the ESAS, 27.2% and 17.5% of patients, respectively, had a score of anxiety or depression >3 and needed further examination for psychological distress. Female patients had significantly higher scores for anxiety ( p < 0.001) and depression ( p = 0.008) compared to male patients. Unmet needs were significantly correlated with both anxiety ( rs = 0.283) and depression ( rs = 0.284). Previous referral to a psychologist was significantly associated with depression scores ( p = 0.015). Results were confirmed by multiple regression analysis. Conclusions: Screening for unmet needs while also considering sociodemographic and clinical factors allows early identification of cancer patients with emotional distress. Doing so will enable optimal management of psychological patient-reported outcomes in oncology settings.


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 ◽  
...  

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 .


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