A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial

Figures & data

Figure 1 Response to treatment for (A) the C30-SS from baseline to week 12, (B) the diarrhea burden from baseline to week 12, and (C) the flushing burden from baseline to week 12.

Abbreviations: C30-SS, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ) C30 summary score; MCID, minimal clinically important difference.

Table 1 Overall Treatment Effect On The NET Function Responses, Classified As Responders Vs Non-Responders

Outcome	Lanreotide (n=59)		Placebo (n=56)		RR	95% CI	P^b
	n/N	%	n/N	%
C30 summary score	19/56	34	7/50	14	2.42	1.11–5.28	0.02
Diarrhea burden	21/59	36	7/56	13	2.85	1.31–6.17	0.005
Flushing burden	19/59	32	13/56	23	1.39	0.76–2.54	0.31
Composite score^a	34/59	58	21/55	39	1.48	0.99–2.21	0.06

Notes: ^aComposite score of diarrhea burden or flushing burden or C30 summary score. ^bFisher’s exact test. P values are nominal and do not represent Type-I protected hypothesis testing.

Abbreviations: CI, confidence interval; n, number of responders; N, total patients in group; NET, neuroendocrine tumor; RR, risk ratio.

Table 2 Association Of Percentage Of Days With Rescue Medication In The 16-Week Double-Blind Period And NET Function Responses

Outcome	OR	95% CI	P^b
C30 summary score	0.976	0.965–0.986	<0.001
Diarrhea burden	0.980	0.971–0.989	<0.001
Flushing burden	0.981	0.973–0.990	<0.001
Composite score^a	0.989	0.982–0.996	0.003

Notes: ^aComposite score of diarrhea burden and flushing burden and C30 summary score. ^bLogistic regression using odds ratios. P values are nominal and do not represent Type-I protected hypothesis testing.

Abbreviations: CI, confidence interval; NET, neuroendocrine tumor; OR, odds ratio.

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Where patient data can be anonymized, Ipsen will share all individual participant data that underlie the results reported in this article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available. Proposals should be submitted to [email protected] and will be assessed by a scientific review board. Data are available beginning 6 months and ending 5 years after publication; after this time, only raw data may be available.