The FOCCUS study: a prospective evaluation of the frequency, severity and treatable causes of gastrointestinal symptoms during and after chemotherapy View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-07-16

AUTHORS

H. Jervoise N. Andreyev, Amyn Lalji, Kabir Mohammed, Ann C. G. Muls, David Watkins, Sheela Rao, Naureen Starling, Ian Chau, Sarah Cruse, Ville Pitkaaho, Jennifer Matthews, Laura Caley, Victoria Pittordou, Carolyn Adams, Linda Wedlake

ABSTRACT

BackgroundThe underlying mechanisms of chemotherapy-induced gastrointestinal (GI) symptoms are poorly researched. This study characterised the nature, frequency, severity and treatable causes for GI symptoms prospectively in patients undergoing chemotherapy for GI malignancy.MethodsPatients receiving chemotherapy for a GI malignancy were assessed pre-chemotherapy, then monthly for 1 year using the Gastrointestinal Symptom Rating Scale, a validated patient-reported outcome measure. Patients with new, troublesome GI symptoms were offered investigations to diagnose the cause(s). Their oncologist was alerted when investigations were abnormal.ResultsA total of 241 patients, 60% male, median age 63 years (range 30–88), were enrolled; 122 patients were withdrawn, 93%, because of progressive disease or death. During the study, > 20% patients reported chronic faecal incontinence and > 10% reported moderate or severe problems with taste, dysphagia, belching, heartburn, early satiety, appetite, nausea, abdominal cramps, peri-rectal pain, rectal flatulence, borborygmi, urgency of defecation or tenesmus. Thirty percent reported continuing passage of hard stools and 30% on-going diarrhoea. Moderate or severe fatigue affected 40% participants at its peak and persisted in 15% at 1 year. Toxicity dictated change in chemotherapy for 13–29% patients/month. Common Terminology Criteria for Adverse Events underestimated gastrointestinal morbidity. Pre-chemotherapy screening identified previously undiagnosed pathology: exocrine pancreatic insufficiency (9%), vitamin B12 deficiency (12%) and thyroid dysfunction (20%). Patients often refused investigations to diagnose their chemotherapy-induced symptoms; however, for every three investigations performed, one treatable cause was diagnosed: particularly small intestinal bacterial overgrowth (54%), bile acid malabsorption (43%), previously not described after chemotherapy, and unsuspected urinary tract infection (17%).ConclusionsPatients undergoing chemotherapy for GI malignancy commonly have difficult GI symptoms requiring active management which does not occur routinely. The underlying causes for these symptoms are often treatable or curable. Randomised trials are urgently needed to show whether timely investigation and treatment of symptoms improve quality of life and survival.Trial registrationClinicalTrials.gov Identifier: NCT02121626 More... »

PAGES

1443-1453

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00520-020-05610-x

DOI

http://dx.doi.org/10.1007/s00520-020-05610-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1129416017

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32676853


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23 schema:description BackgroundThe underlying mechanisms of chemotherapy-induced gastrointestinal (GI) symptoms are poorly researched. This study characterised the nature, frequency, severity and treatable causes for GI symptoms prospectively in patients undergoing chemotherapy for GI malignancy.MethodsPatients receiving chemotherapy for a GI malignancy were assessed pre-chemotherapy, then monthly for 1 year using the Gastrointestinal Symptom Rating Scale, a validated patient-reported outcome measure. Patients with new, troublesome GI symptoms were offered investigations to diagnose the cause(s). Their oncologist was alerted when investigations were abnormal.ResultsA total of 241 patients, 60% male, median age 63 years (range 30–88), were enrolled; 122 patients were withdrawn, 93%, because of progressive disease or death. During the study, > 20% patients reported chronic faecal incontinence and > 10% reported moderate or severe problems with taste, dysphagia, belching, heartburn, early satiety, appetite, nausea, abdominal cramps, peri-rectal pain, rectal flatulence, borborygmi, urgency of defecation or tenesmus. Thirty percent reported continuing passage of hard stools and 30% on-going diarrhoea. Moderate or severe fatigue affected 40% participants at its peak and persisted in 15% at 1 year. Toxicity dictated change in chemotherapy for 13–29% patients/month. Common Terminology Criteria for Adverse Events underestimated gastrointestinal morbidity. Pre-chemotherapy screening identified previously undiagnosed pathology: exocrine pancreatic insufficiency (9%), vitamin B12 deficiency (12%) and thyroid dysfunction (20%). Patients often refused investigations to diagnose their chemotherapy-induced symptoms; however, for every three investigations performed, one treatable cause was diagnosed: particularly small intestinal bacterial overgrowth (54%), bile acid malabsorption (43%), previously not described after chemotherapy, and unsuspected urinary tract infection (17%).ConclusionsPatients undergoing chemotherapy for GI malignancy commonly have difficult GI symptoms requiring active management which does not occur routinely. The underlying causes for these symptoms are often treatable or curable. Randomised trials are urgently needed to show whether timely investigation and treatment of symptoms improve quality of life and survival.Trial registrationClinicalTrials.gov Identifier: NCT02121626
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29 schema:keywords B12 deficiency
30 Common Terminology Criteria
31 ConclusionsPatients
32 GI malignancies
33 GI symptoms
34 Gastrointestinal Symptom Rating Scale
35 MethodsPatients
36 Rating Scale
37 ResultsA total
38 Symptom Rating Scale
39 Terminology Criteria
40 abdominal cramps
41 acid malabsorption
42 active management
43 adverse events
44 age 63
45 appetite
46 bacterial overgrowth
47 belching
48 bile acid malabsorption
49 borborygmi
50 cause
51 changes
52 chemotherapy
53 chemotherapy-induced symptoms
54 chronic fecal incontinence
55 cramps
56 criteria
57 death
58 defecation
59 deficiency
60 diarrhea
61 disease
62 dysfunction
63 dysphagia
64 early satiety
65 evaluation
66 events
67 fatigue
68 fecal incontinence
69 flatulence
70 frequency
71 gastrointestinal morbidity
72 gastrointestinal symptoms
73 hard stools
74 heartburn
75 identifiers
76 incontinence
77 infection
78 insufficiency
79 intestinal bacterial overgrowth
80 investigation
81 life
82 malabsorption
83 males
84 malignancy
85 management
86 measures
87 mechanism
88 median age 63
89 months
90 morbidity
91 nature
92 nausea
93 oncologists
94 outcome measures
95 overgrowth
96 pain
97 pancreatic insufficiency
98 participants
99 passage
100 pathology
101 patient-reported outcome measures
102 patient/month
103 patients
104 peak
105 percent
106 problem
107 progressive disease
108 prospective evaluation
109 quality
110 quality of life
111 rectal flatulence
112 satiety
113 scale
114 screening
115 severe fatigue
116 severe problems
117 severity
118 small intestinal bacterial overgrowth
119 stool
120 study
121 survival
122 symptoms
123 taste
124 tenesmus
125 thyroid dysfunction
126 timely investigation
127 total
128 toxicity
129 tract infections
130 treatable cause
131 treatment
132 treatment of symptoms
133 trials
134 troublesome GI symptoms
135 undiagnosed pathology
136 unsuspected urinary tract infection
137 urgency
138 urgency of defecation
139 urinary tract infection
140 vitamin B12 deficiency
141 years
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