Pancreatic exocrine insufficiency (PEI) in patients (pts) with well-differentiated neuroendocrine tumours (wd-NETs) treated with somatostatin analogues (SSAs): Incidence and impact on quality of life

Angela Lamarca; Lynne McCallum; Christina Nuttall; Jorge Barriuso; Melissa Frizziero; Rebecca Leon; Was Mansoor; Mairead Mcnamara; Richard Hubner; Juan Valle

Abstract

Background: Advanced wd-NET patients (pts) are commonly treated with SSAs. PEI may be under-estimated in trials due to difficulties in distinguishing carcinoid syndrome-related diarrhoea and PEI.

Methods: In this single-institution, prospective, observational study, sequential pts with advanced wd-NET were commenced on SSAs and followed for a minimum of 12 months (or until disease progression). Toxicity was prospectively assessed monthly. Faecal elastase testing (FE) (for diagnosis of PEI) and quality of life (QoL) questionnaires (QLQ-C30 and QLQ-GI.NET21) were performed 3-monthly.

Results: Of 52 pts recruited (Jan 15-Apr 16), 50 were eligible: median age 65.8 yrs; 58% male; ECOG performance status 0 (42%), 1 (46%) or 2 (12%); primary: small bowel (60%), pancreas (22%), lung (12%) and other (6%). Baseline median Ki-67 was 3.1% (range 0.7-25), serum 5HIAA: 195 nmol/L (95%CI 145-318) and chromogranin A (CgA): 327 ng/mL (95%CI 140-582). Most pts were metastatic (92%), non-functional (66%) and started SSA first-line (88%); depot SSA was octreotide in 60%, lanreotide in 40%. Forty-one pts (82%) started full-dose SSA (4-weekly octreotide 30mg or lanreotide 120mg); 96% achieved full dose; 3 pts required dose reduction due to toxicities. Grade (G) 1-2 toxicities were flatulence (50%), abdominal pain (32%), diarrhoea (30%), fatigue (20%), PEI (22%), nausea (16%), hyperglycaemia (6%), anorexia (4%) and constipation (2%). G 3-4 toxicities were few (G3 hyperglycaemia (n = 1) and G3 PEI (n = 1); no G4). Twelve pts (24%) developed SSA-related PEI (4 clinical diagnosis, 8 FE-confirmed) at a median of 2.9 mo (95%CI 1.7-8.6) after starting SSA; 11/12 (92%) pts received enzyme replacement. Questionnaires identified fatigue, insomnia and diarrhoea as the most important baseline symptoms; SSA therapy did not negatively-affect QoL. Estimated median progression-free survival (PFS) was 29.9 mo (95%CI 21.4-not reached). High baseline CgA was an independent factor for shorter PFS (HR 1.01 (95%CI 1.001-1.1); p-value 0.001) after adjustment for other factors (baseline 5HIAA, Ki-67).

Conclusions: SSA-induced PEI occurs in 1:4 pts; clinicians should actively identify and treat.

Original language	English
Publication status	Published - Sept 2017
Event	ESMO 2017 Congress - Madrid, Madrid, Spain Duration: 8 Sept 2017 → 12 Sept 2017

Conference

Conference	ESMO 2017 Congress
Country/Territory	Spain
City	Madrid
Period	8/09/17 → 12/09/17

Keywords

Pancreas exocrine insufficiency
WD-NETs
SSAs

Research Beacons, Institutes and Platforms

Manchester Cancer Research Centre

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

https://doi.org/10.1093/annonc/mdx368.022

Cite this

Lamarca, A., McCallum, L., Nuttall, C., Barriuso, J., Frizziero, M., Leon, R., Mansoor, W., Mcnamara, M., Hubner, R., & Valle, J. (2017). Pancreatic exocrine insufficiency (PEI) in patients (pts) with well-differentiated neuroendocrine tumours (wd-NETs) treated with somatostatin analogues (SSAs): Incidence and impact on quality of life. Abstract from ESMO 2017 Congress, Madrid, Spain. https://doi.org/10.1093/annonc/mdx368.022

@conference{06eeb3b9dbd34ad88be1839a749e5a88,

title = "Pancreatic exocrine insufficiency (PEI) in patients (pts) with well-differentiated neuroendocrine tumours (wd-NETs) treated with somatostatin analogues (SSAs): Incidence and impact on quality of life",

abstract = "Background: Advanced wd-NET patients (pts) are commonly treated with SSAs. PEI may be under-estimated in trials due to difficulties in distinguishing carcinoid syndrome-related diarrhoea and PEI.Methods: In this single-institution, prospective, observational study, sequential pts with advanced wd-NET were commenced on SSAs and followed for a minimum of 12 months (or until disease progression). Toxicity was prospectively assessed monthly. Faecal elastase testing (FE) (for diagnosis of PEI) and quality of life (QoL) questionnaires (QLQ-C30 and QLQ-GI.NET21) were performed 3-monthly.Results: Of 52 pts recruited (Jan 15-Apr 16), 50 were eligible: median age 65.8 yrs; 58% male; ECOG performance status 0 (42%), 1 (46%) or 2 (12%); primary: small bowel (60%), pancreas (22%), lung (12%) and other (6%). Baseline median Ki-67 was 3.1% (range 0.7-25), serum 5HIAA: 195 nmol/L (95%CI 145-318) and chromogranin A (CgA): 327 ng/mL (95%CI 140-582). Most pts were metastatic (92%), non-functional (66%) and started SSA first-line (88%); depot SSA was octreotide in 60%, lanreotide in 40%. Forty-one pts (82%) started full-dose SSA (4-weekly octreotide 30mg or lanreotide 120mg); 96% achieved full dose; 3 pts required dose reduction due to toxicities. Grade (G) 1-2 toxicities were flatulence (50%), abdominal pain (32%), diarrhoea (30%), fatigue (20%), PEI (22%), nausea (16%), hyperglycaemia (6%), anorexia (4%) and constipation (2%). G 3-4 toxicities were few (G3 hyperglycaemia (n = 1) and G3 PEI (n = 1); no G4). Twelve pts (24%) developed SSA-related PEI (4 clinical diagnosis, 8 FE-confirmed) at a median of 2.9 mo (95%CI 1.7-8.6) after starting SSA; 11/12 (92%) pts received enzyme replacement. Questionnaires identified fatigue, insomnia and diarrhoea as the most important baseline symptoms; SSA therapy did not negatively-affect QoL. Estimated median progression-free survival (PFS) was 29.9 mo (95%CI 21.4-not reached). High baseline CgA was an independent factor for shorter PFS (HR 1.01 (95%CI 1.001-1.1); p-value 0.001) after adjustment for other factors (baseline 5HIAA, Ki-67).Conclusions: SSA-induced PEI occurs in 1:4 pts; clinicians should actively identify and treat.",

keywords = "Pancreas exocrine insufficiency, WD-NETs, SSAs",

author = "Angela Lamarca and Lynne McCallum and Christina Nuttall and Jorge Barriuso and Melissa Frizziero and Rebecca Leon and Was Mansoor and Mairead Mcnamara and Richard Hubner and Juan Valle",

year = "2017",

month = sep,

language = "English",

note = "ESMO 2017 Congress ; Conference date: 08-09-2017 Through 12-09-2017",

}

Lamarca, A, McCallum, L, Nuttall, C, Barriuso, J, Frizziero, M, Leon, R, Mansoor, W, Mcnamara, M, Hubner, R & Valle, J 2017, 'Pancreatic exocrine insufficiency (PEI) in patients (pts) with well-differentiated neuroendocrine tumours (wd-NETs) treated with somatostatin analogues (SSAs): Incidence and impact on quality of life', ESMO 2017 Congress, Madrid, Spain, 8/09/17 - 12/09/17. <https://doi.org/10.1093/annonc/mdx368.022 >

Pancreatic exocrine insufficiency (PEI) in patients (pts) with well-differentiated neuroendocrine tumours (wd-NETs) treated with somatostatin analogues (SSAs): Incidence and impact on quality of life. / Lamarca, Angela; McCallum, Lynne; Nuttall, Christina et al.
2017. Abstract from ESMO 2017 Congress, Madrid, Spain.

Research output: Contribution to conference › Abstract › peer-review

TY - CONF

T1 - Pancreatic exocrine insufficiency (PEI) in patients (pts) with well-differentiated neuroendocrine tumours (wd-NETs) treated with somatostatin analogues (SSAs)

T2 - ESMO 2017 Congress

AU - Lamarca, Angela

AU - McCallum, Lynne

AU - Nuttall, Christina

AU - Barriuso, Jorge

AU - Frizziero, Melissa

AU - Leon, Rebecca

AU - Mansoor, Was

AU - Mcnamara, Mairead

AU - Hubner, Richard

AU - Valle, Juan

PY - 2017/9

Y1 - 2017/9

N2 - Background: Advanced wd-NET patients (pts) are commonly treated with SSAs. PEI may be under-estimated in trials due to difficulties in distinguishing carcinoid syndrome-related diarrhoea and PEI.Methods: In this single-institution, prospective, observational study, sequential pts with advanced wd-NET were commenced on SSAs and followed for a minimum of 12 months (or until disease progression). Toxicity was prospectively assessed monthly. Faecal elastase testing (FE) (for diagnosis of PEI) and quality of life (QoL) questionnaires (QLQ-C30 and QLQ-GI.NET21) were performed 3-monthly.Results: Of 52 pts recruited (Jan 15-Apr 16), 50 were eligible: median age 65.8 yrs; 58% male; ECOG performance status 0 (42%), 1 (46%) or 2 (12%); primary: small bowel (60%), pancreas (22%), lung (12%) and other (6%). Baseline median Ki-67 was 3.1% (range 0.7-25), serum 5HIAA: 195 nmol/L (95%CI 145-318) and chromogranin A (CgA): 327 ng/mL (95%CI 140-582). Most pts were metastatic (92%), non-functional (66%) and started SSA first-line (88%); depot SSA was octreotide in 60%, lanreotide in 40%. Forty-one pts (82%) started full-dose SSA (4-weekly octreotide 30mg or lanreotide 120mg); 96% achieved full dose; 3 pts required dose reduction due to toxicities. Grade (G) 1-2 toxicities were flatulence (50%), abdominal pain (32%), diarrhoea (30%), fatigue (20%), PEI (22%), nausea (16%), hyperglycaemia (6%), anorexia (4%) and constipation (2%). G 3-4 toxicities were few (G3 hyperglycaemia (n = 1) and G3 PEI (n = 1); no G4). Twelve pts (24%) developed SSA-related PEI (4 clinical diagnosis, 8 FE-confirmed) at a median of 2.9 mo (95%CI 1.7-8.6) after starting SSA; 11/12 (92%) pts received enzyme replacement. Questionnaires identified fatigue, insomnia and diarrhoea as the most important baseline symptoms; SSA therapy did not negatively-affect QoL. Estimated median progression-free survival (PFS) was 29.9 mo (95%CI 21.4-not reached). High baseline CgA was an independent factor for shorter PFS (HR 1.01 (95%CI 1.001-1.1); p-value 0.001) after adjustment for other factors (baseline 5HIAA, Ki-67).Conclusions: SSA-induced PEI occurs in 1:4 pts; clinicians should actively identify and treat.

AB - Background: Advanced wd-NET patients (pts) are commonly treated with SSAs. PEI may be under-estimated in trials due to difficulties in distinguishing carcinoid syndrome-related diarrhoea and PEI.Methods: In this single-institution, prospective, observational study, sequential pts with advanced wd-NET were commenced on SSAs and followed for a minimum of 12 months (or until disease progression). Toxicity was prospectively assessed monthly. Faecal elastase testing (FE) (for diagnosis of PEI) and quality of life (QoL) questionnaires (QLQ-C30 and QLQ-GI.NET21) were performed 3-monthly.Results: Of 52 pts recruited (Jan 15-Apr 16), 50 were eligible: median age 65.8 yrs; 58% male; ECOG performance status 0 (42%), 1 (46%) or 2 (12%); primary: small bowel (60%), pancreas (22%), lung (12%) and other (6%). Baseline median Ki-67 was 3.1% (range 0.7-25), serum 5HIAA: 195 nmol/L (95%CI 145-318) and chromogranin A (CgA): 327 ng/mL (95%CI 140-582). Most pts were metastatic (92%), non-functional (66%) and started SSA first-line (88%); depot SSA was octreotide in 60%, lanreotide in 40%. Forty-one pts (82%) started full-dose SSA (4-weekly octreotide 30mg or lanreotide 120mg); 96% achieved full dose; 3 pts required dose reduction due to toxicities. Grade (G) 1-2 toxicities were flatulence (50%), abdominal pain (32%), diarrhoea (30%), fatigue (20%), PEI (22%), nausea (16%), hyperglycaemia (6%), anorexia (4%) and constipation (2%). G 3-4 toxicities were few (G3 hyperglycaemia (n = 1) and G3 PEI (n = 1); no G4). Twelve pts (24%) developed SSA-related PEI (4 clinical diagnosis, 8 FE-confirmed) at a median of 2.9 mo (95%CI 1.7-8.6) after starting SSA; 11/12 (92%) pts received enzyme replacement. Questionnaires identified fatigue, insomnia and diarrhoea as the most important baseline symptoms; SSA therapy did not negatively-affect QoL. Estimated median progression-free survival (PFS) was 29.9 mo (95%CI 21.4-not reached). High baseline CgA was an independent factor for shorter PFS (HR 1.01 (95%CI 1.001-1.1); p-value 0.001) after adjustment for other factors (baseline 5HIAA, Ki-67).Conclusions: SSA-induced PEI occurs in 1:4 pts; clinicians should actively identify and treat.

KW - Pancreas exocrine insufficiency

KW - WD-NETs

KW - SSAs

M3 - Abstract

Y2 - 8 September 2017 through 12 September 2017

ER -