Surgery did not significantly increase the number of days alive and outside of the hospital (so-called good days) for patients with malignant bowel obstruction, but surgery did lead to improvements in symptoms, according to a comparative effectiveness trial.
Among 199 patients who were either randomized to surgery versus no surgery or chose to undergo surgery versus no surgery, there was an adjusted mean difference of 2.9 additional good days in the surgical group compared with the no-surgery group (95% CI -5.5 to 11.3, P=0.50), reported Robert S. Krouse, MD, of the University of Pennsylvania in Philadelphia, and colleagues.
During the initial hospital stay, six patients died, five due to cancer progression (two from each randomized group, and one from the patient-choice surgery group) and one due to malignant bowel obstruction treatment complications (from the patient-choice non-surgery group).
Of note, patients’ ability to eat at week 5 did not differ between the two treatment approaches.
Other secondary measures, however, suggested that surgery improved post-hospitalization malignant bowel obstruction-related symptoms, including nausea, vomiting, constipation, pain, and bloating.
“Evidence from this study could help in making difficult decisions regarding treatment for this population of patients,” Krouse and colleagues wrote in Lancet Gastroenterology & Hepatology. “We believe that surgically eligible patients, often deemed non-operative, should be offered an operation earlier in their hospital stay to improve gastrointestinal symptoms, although not to improve survival or to increase the number of days alive and out of the hospital in the first few months after admittance.”
“This could be practice-changing for many surgeons,” they added.
According to the authors, patients with malignant bowel obstruction typically have late-stage cancer and usually require palliative care to reduce symptoms and pain and improve quality of life. Surgery or non-surgical medical management, including somatostatin analogues, are the primary treatment options for these patients.
In a commentary accompanying the study, Jason W. Boland, MB, PhD, of Hull York Medical School at the University of Hull in England, and Elaine G. Boland, MD, PhD, of Hull University Teaching Hospitals in England, noted that the study showed a clear preference for non-surgical options among patients who had a choice.
“Because clinicians might have strong (often preconceived) views about the preferred treatment option for patients with malignant small bowel obstruction, even when the choice between surgery and non-surgery is equipoised, this study should also increase confidence in respecting the individual choice of patients, giving evidence to help inform patient-centred discussions,” they wrote.
“In this population, many people might not opt for surgery and there are pros and cons of the treatment options,” they concluded. “This study progresses our understanding of these issues, suggesting that survival is overall similar, and that surgery might help some symptoms but that there might be surgical morbidity. These outcomes might differentially be important to different patients, emphasizing the need for individualized management.”
In this pragmatic comparative effectiveness trial, 221 patients with intra-abdominal or retroperitoneal primary cancer and malignant bowel disease across 30 hospitals and cancer centers in the U.S., Mexico, Peru, and Colombia were enrolled from May 2015 to April 2020. Of these patients, 199 were evaluable (median age 60, 65% women).
Patients were randomly assigned 1:1 to surgery or no surgery. Those who declined consent for randomization were offered a prospective observational patient choice pathway for surgery or no surgery.
Among the 199 patients, those who were randomized to surgery (n=24) had a mean of 42.6 “good days” versus a mean of 43.9 good days in the randomized non-surgery group (n=25), while those in the patient choice surgery group (n=58) had a mean of 54.8 good days versus 52.7 in the patient choice non-surgery group (n=92).
Of 170 patients alive at week 5 who reported oral intake, all patients in the randomized groups reported being able to eat. In the patient choice groups, 83% of the surgical group and 85% of the non-surgical group reported being able to eat.
“The ability to consume food orally is of considerable importance for patients with a malignant bowel obstruction and should not be overlooked,” Krouse and colleagues noted.
Complications were more common among surgically treated patients compared with nonsurgically treated patients, with anemia being the most common grade 3-4 treatment-related complication, which occurred in three patients in the randomized group (all those who underwent surgery) and five patients in the patient choice group (four who underwent surgery and one who did not).
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Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.
Disclosures
This study was supported by grants from the Agency for Healthcare Research and Quality, the National Cancer Institute’s Division of Cancer Prevention, the National Cancer Institute Community Oncology Research Program Research Base, and the Behavioral Measurement and Interventions Shared Resource.
Krouse had no disclosures. Several co-authors reported multiple relationships with industry.
The editorialists had no disclosures.
Primary Source
Lancet Gastroenterology & Hepatology
Source Reference: Krouse RS, et al “Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial” Lancet Gastroenterol Hepatol 2023; DOI: 10.1016/S2468-1253(23)00191-7.
Secondary Source
Lancet Gastroenterology & Hepatology
Source Reference: Boland JW, Boland EG “Ensuring patients with malignant bowel obstruction are central in research and clinical decisions” Lancet Gastroenterol Hepatol 2023; DOI: 10.1016/S2468-1253(23)00203-0.
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