Circulating tumour cells and tumour biomarkers in functional midgut neuroendocrine tumours.

Meyer T, Caplin M, Khan MS, Toumpanakis C, Shetty S, Ramage JK, Houchard A, Higgs K, Shah T

Journal of neuroendocrinology7 Feb 2022Cited by 16 (Europe PMC)

PMID35132704PMCIDPMC9285714DOI10.1111/jne.13096PepBankPUB-35132704

Summary

CALM-NET was a phase IV exploratory study in the UK that aimed to evaluate if the presence of circulating tumour cells (CTCs) at baseline predicted symptomatic response in patients with midgut neuroendocrine tumours (NETs) treated with lanreotide autogel (LAN). Adults with functional, well/moderately differentiated (Ki-67 <20%) midgut NETs received LAN 120 mg/28 days for 1 year. CTCs were present in blood if enumeration was >0. Primary endpoint was the clinical value of baseline CTCs to predict symptomatic response (decrease in diarrhoea or flushing of ≥50% frequency, or ≥1 severity level). Other endpoints included progression-free survival (PFS) and correlations between plasma and urinary biomarkers (including 5-hydroxyindoleacetic acid [5-HIAA]). Fifty patients were enrolled; 40 completed the study. Baseline CTCs were present in 22 (45.8%) patients (missing baseline CTC status n = 2). Overall, 87.5% (95% confidence interval [CI]: 73.9; 94.5) of patients had a symptomatic response; a 5.9-fold higher odds of symptomatic response in patients without CTC versus patients with CTC at baseline was observed, although this was not statistically significant (odds ratio: 0.17 [95% CI: 0.02; 1.65], p = .126). One-year PFS rate was 66.4% (95% CI: 48.8; 79.2). Biomarker concentrations did not correlate to baseline CTC status. However, there was a strong correlation between plasma and urinary 5-HIAA (Spearman correlation coefficients ≥0.87 [p < .001], all time points). In conclusion, patients without CTC at baseline may be more likely to achieve a symptomatic response following LAN treatment than patients with CTC. Plasma 5-HIAA correlated with urinary 5-HIAA during LAN treatment. ClinicalTrials.gov identifier: NCT02075606.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

2 results from studies that gave the peptide. 2 results from people.

01HumanNon-randomized trialEfficacy outcome
In functional midgut NET patients receiving lanreotide, 87.5% (95% CI 73.9; 94.5) had a symptomatic response.
In plain wordsIn functional midgut NET patients receiving lanreotide, 87.5% had a symptomatic response.
Peptide
Lanreotide
Outcome
Not applicableSymptomatic response
Study
n: not reported in source
Outcome group
Patient-reported outcomes · Cancer
Studied dose
120 mg/28 days · 1 yearAs given in this study (human).
Measurements
Symptomatic response rate
87.5%
all patients receiving lanreotide
95% CI of symptomatic response rate
73.9 to 94.5%
all patients receiving lanreotide
Source sentences
Summary
Overall, 87.5% (95% confidence interval [CI]: 73.9; 94.5) of patients had a symptomatic response;
3 context sentences(design, population, supporting numbers)
Summary · context
CALM-NET was a phase IV exploratory study in the UK that aimed to evaluate if the presence of circulating tumour cells (CTCs) at baseline predicted symptomatic response in patients with midgut neuroendocrine tumours (NETs) treated with lanreotide autogel (LAN).
Summary · context
Adults with functional, well/moderately differentiated (Ki-67 <20%) midgut NETs received LAN 120 mg/28 days for 1 year.
Summary · context
Primary endpoint was the clinical value of baseline CTCs to predict symptomatic response (decrease in diarrhoea or flushing of ≥50% frequency, or ≥1 severity level).
Show in the study text Report a problemFND-3513270401
02HumanNon-randomized trialEfficacy outcome
In functional midgut NET patients receiving lanreotide, one-year PFS was 66.4% (95% CI 48.8; 79.2).
In plain wordsIn functional midgut NET patients receiving lanreotide, one-year survival without progression was 66.4%.
Peptide
Lanreotide
Outcome
Not applicableOne-year progression-free survival
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
120 mg/28 days · 1 yearAs given in this study (human).
Measurements
One-year PFS rate
66.4%
patients receiving lanreotide
95% CI of one-year PFS rate
48.8 to 79.2%
patients receiving lanreotide
Source sentences
Summary
One-year PFS rate was 66.4% (95% CI: 48.8; 79.2).
3 context sentences(design, population, supporting numbers)
Summary · context
CALM-NET was a phase IV exploratory study in the UK that aimed to evaluate if the presence of circulating tumour cells (CTCs) at baseline predicted symptomatic response in patients with midgut neuroendocrine tumours (NETs) treated with lanreotide autogel (LAN).
Summary · context
Adults with functional, well/moderately differentiated (Ki-67 <20%) midgut NETs received LAN 120 mg/28 days for 1 year.
Summary · context
Primary endpoint was the clinical value of baseline CTCs to predict symptomatic response (decrease in diarrhoea or flushing of ≥50% frequency, or ≥1 severity level).
Show in the study text Report a problemFND-3513270403

Studies that did not test the peptide alone1

In this study, Lanreotide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Lanreotide.

03HumanNot a test of Lanreotide aloneObservational studyEfficacy outcome
In lanreotide-treated midgut NETs, patients without baseline CTC had 5.9-fold higher response odds, without significance; reported OR was 0.17 (95% CI 0.02; 1.65), p = .126.
In plain wordsIn lanreotide-treated midgut NETs, response odds were higher without baseline circulating tumor cells than with them, without a significant difference.
Peptide
Lanreotide
Outcome
No significant changeSymptomatic response by baseline CTC status
Study
n: not reported in source
Comparator
patients with baseline circulating tumor cells
Analysis
Primary
Outcome group
Patient-reported outcomes · Cancer
Measurements
Fold higher odds of symptomatic response, without versus with baseline CTC
5.9 fold
lanreotide-treated patients
Odds ratio
0.17 ratio
with versus without baseline CTC
95% CI of odds ratio
0.02 to 1.65 ratio
with versus without baseline CTC
P value
0.126 p
odds ratio
Source sentences
Summary
a 5.9-fold higher odds of symptomatic response in patients without CTC versus patients with CTC at baseline was observed, although this was not statistically significant (odds ratio: 0.17 [95% CI: 0.02; 1.65], p = .126).
3 context sentences(design, population, supporting numbers)
Summary · context
CALM-NET was a phase IV exploratory study in the UK that aimed to evaluate if the presence of circulating tumour cells (CTCs) at baseline predicted symptomatic response in patients with midgut neuroendocrine tumours (NETs) treated with lanreotide autogel (LAN).
Summary · context
Adults with functional, well/moderately differentiated (Ki-67 <20%) midgut NETs received LAN 120 mg/28 days for 1 year.
Summary · context
Primary endpoint was the clinical value of baseline CTCs to predict symptomatic response (decrease in diarrhoea or flushing of ≥50% frequency, or ≥1 severity level).
In this study, Lanreotide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Lanreotide.
Show in the study text Report a problemFND-3513270402

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4Results postedNCT02075606

Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients

Ipsenn = 50May 2014 to Jun 2017

NeuroEndocrine Tumours

Trial page ClinicalTrials.govUpdated 7 Jun 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

Keywords

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