Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl

Anthony, Lowell; Ervin, Claire; Lapuerta, Pablo; Kulke, Matthew H.; Kunz, Pamela L.; Bergsland, Emily K.; Hörsch, Dieter; Metz, David C.; Pasieka, Janice L.; Pavlakis, Nick; Pavel, Marianne; Caplin, Martyn; Öberg, Kjell; Evans, Emily; Yang, Qi; Jackson, Simon; Arnold, Karie; Law, Linda; DiBenedetti, Dana

doi:10.1016/j.clinthera.2017.09.013

Cited by 39 publications

(47 citation statements)

References 18 publications

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“…Carcinoid syndrome (CS) is known to cause significant clinical morbidity with substantial effects on quality of life . Patients with carcinoid syndrome diarrhea (CSD) require more medical care and have more hospitalizations and higher health care costs than their peers without CSD .…”

Section: Introductionmentioning

confidence: 99%

“…Patients with carcinoid syndrome diarrhea (CSD) require more medical care and have more hospitalizations and higher health care costs than their peers without CSD . The prevalence of pretreatment CS symptoms among patients enrolled in a recent phase III clinical trial was considerable, including bowel movement‐related issues (97%), flushing (86%), and abdominal pain (63%) . The majority of patients (80%) reported meaningful reductions in quality of life and work productivity (43%) .…”

Section: Introductionmentioning

confidence: 99%

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TELEPRO: Patient-Reported Carcinoid Syndrome Symptom Improvement Following Initiation of Telotristat Ethyl in the Real World

et al. 2019

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

TELEPRO: Patient-Reported Carcinoid Syndrome Symptom Improvement Following Initiation of Telotristat Ethyl in the Real World

et al. 2019

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“…Analyses of correlations between treatment groups or treatment response and treatment satisfaction can link clinical trial data directly to interview data. 3,4 …”

Section: Analyses Of Patient Interview Datamentioning

confidence: 99%

“…2,3,5,6 Such interviews are one way to highlight the meaningful changes patients experience during clinical trials, thus contextualizing and enriching clinical trial results. Further, interviews yield unique data to supplement clinical trial findings (e.g., regarding safety concerns or the benefits of treatment).…”

Section: Passage Of the Usmentioning

confidence: 99%

“…Based on our experiences, we have found that a sample size of 20 to 40 patient participants can yield adequate data. 3,5 If the interview is not a requisite part of the study, recruitment relies on both site and patient volunteers. Although the effort involved in recruiting participants and coordinating interviews is modest, some sites may have insufficient resources for these additional tasks.…”

Section: Sample Size and Population Considerationsmentioning

confidence: 99%

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Conducting Patient Interviews Within a Clinical Trial Setting

DiBenedetti¹,

Brown²,

Romano³

et al. 2018

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Opportunities to Improve Symptom Control with Somatostatin Congeners in GEP-NETs: A Review of Key Issues

Anthony

O’Dorisio

2021

The Oncologist

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Octreotide acetate (octreotide) is the most prescribed and most studied somatostatin congener, or analog, for gastroenteropancreatic neuroendocrine tumors (GEP‐NETs) and carcinoid syndrome, the latter of which may be characterized by debilitating diarrhea and flushing. Approved in the U.S. more than 30 years ago, octreotide is widely used to control the symptoms of carcinoid syndrome and has been shown to demonstrate antiproliferative activity. The two formulations available in the U.S. include a subcutaneous immediate‐release (IR) injection introduced in 1989 and a long‐acting repeatable (LAR) intramuscular injection approved in 1999. Lanreotide depot (lanreotide), a more recent somatostatin congener, has been available in the U.S. since 2014. Despite widespread use of octreotide LAR, several key challenges exist with the current depot‐based treatment paradigm. Studies indicate that LAR formulations are associated with continued unmet patient needs, owing in part to a loss of bioactivity over time that may necessitate progressive supplemental treatment with IR octreotide to adequately control symptoms. Clinicians should understand the key differences in the pharmacokinetic profiles of the LAR and IR formulations that may contribute to bioactivity loss and somatostatin receptor desensitization. In addition, there is a need to re‐evaluate the role of IR octreotide in combination with depot therapy to provide consistent bioavailability and better control of carcinoid syndrome symptoms. The purpose of this review is to explore all these issues and to re‐establish a rationale for the IR formulation, particularly with respect to novel use cases and its use during the COVID‐19 pandemic. Implications for Practice There is a need to re‐evaluate the role of immediate‐release octreotide in combination with depot therapy to provide consistent bioavailability and better control of carcinoid syndrome symptoms.

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Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl

Cited by 39 publications

References 18 publications

TELEPRO: Patient-Reported Carcinoid Syndrome Symptom Improvement Following Initiation of Telotristat Ethyl in the Real World

TELEPRO: Patient-Reported Carcinoid Syndrome Symptom Improvement Following Initiation of Telotristat Ethyl in the Real World

Conducting Patient Interviews Within a Clinical Trial Setting

Opportunities to Improve Symptom Control with Somatostatin Congeners in GEP-NETs: A Review of Key Issues

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