Frequency and distribution of gastrointestinal oncology patient-reported symptomatic adverse events (SAEs) at a comprehensive cancer center.

Authors

null

Nadine Jackson McCleary

Dana-Farber Cancer Institute, Boston, MA

Nadine Jackson McCleary , Ellana Haakenstad , Jessica Cleveland , Sunyi Zhang , Michael J. Hassett , Deborah Schrag

Organizations

Dana-Farber Cancer Institute, Boston, MA

Research Funding

Other
Dana-Farber Cancer Institute funding.

Background: In clinical trials, the systematic collection of patient (pt) reported outcomes has been shown to improve quality of life & overall survival. To develop predictive care models for symptom management, we explored the frequency & distribution of SAEs reported by pts who reported electronic patient reported outcomes (ePRO) prior to outpatient visits to the Gastrointestinal Cancer Center (GCC) at Dana Farber Cancer Institute (DFCI). Methods: ePRO is a modified NCI Patient Reported Outcomes – Common Terminology Criteria for Adverse Events instrument distributed weekly to GCC pts with a medical/surgical/radiation oncology encounter. Responses are available to the care team in the electronic health record. ePRO consists of presence/frequency/severity/interference of 15 core SAEs (fatigue, insomnia, general pain, decreased appetite, nausea, vomiting, constipation, diarrhea, shortness of breath, numbness and tingling, rash, concentration, fever, anxiety, sadness). Responses are scored 0 to 3 (with 2 and 3 indicating moderate and severe SAEs, respectively). We examined the frequency & distribution of grade 2 and 3 SAEs in ePRO responders by age, gender, race/ethnicity. All pts had gastrointestinal cancer and an outpatient visit for treatment, symptom management, follow-up care. Results: From 9/1/2018 to 8/31/2020, 1912 unique pts responded (response rate 23%). Most respondents were age 50-69 years (58% compared to 15% age <50, 27% age ≥70; range 18-95), male (53%), white (75%). Grade 3 SAE frequencies were pain (12%), fatigue (11%), anxiety/constipation/insomnia/decreased appetite (5%), sadness/numbness and tingling/diarrhea (3%), concentration/shortness of breath (2%), nausea/rash (1%), fever/vomiting (0%). Across pts, fatigue, general pain, insomnia, anxiety were the most common grade 2 and 3 SAEs. Shortness of breath, vomiting, rash, fever were least common (Table). Conclusions: In GCC pts responding to ePRO, the most frequent SAEs were pain, fatigue, insomnia, anxiety. Shortness of breath, nausea, vomiting, diarrhea were less often severe. Pts <50 were more likely to report severe anxiety but there were no other major differences based on age, sex, race/ethnicity. Ongoing efforts will increase pt/provider engagement and develop predictive models & symptom management interventions from ePRO responses.

Percent with grade 2 or 3 severe SAE, displaying highest & lowest frequency.

General painFatigueInsomniaAnxietyShortness of breathVomitingRashFever
Age< 5035.833.622.230.95.35.41.91.3
50-7032.434.721.118.47.55.01.30.9
70+29.738.521.718.411.83.23.40.9
SexFemale32.335.521.624.46.94.11.71.0
Male32.235.721.316.79.65.02.10.9
Race/
Ethnicity
Black40.230.716.515.38.17.30.01.6
Latinx36.436.427.39.10.00.00.00.0
Other37.036.024.417.39.95.01.72.0
White32.238.622.522.57.63.81.90.9

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Abstract Details

Meeting

2021 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session: Other GI Cancer

Track

Other GI Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 39, 2021 (suppl 3; abstr 463)

DOI

10.1200/JCO.2021.39.3_suppl.463

Abstract #

463

Poster Bd #

Online Only

Abstract Disclosures

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