Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors.
Details
Serval ID
serval:BIB_60EC983FCAF2
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors.
Journal
BMC cancer
Working group(s)
CLARINET Study Group
Contributor(s)
Raderer A.M., Raderer A.M., Borbath B.I., Ysebaert D., Sedláčková E., Vítek P., Grønbæk D.H., Adenis F.A., Buscail L., Cadiot G., Dominguez S., Ducreux M., Lombard-Bohas C., Mitry E., Ruszniewski P., Seitz J.F., Begum N., Harsch I., Pavel M., Schöfl C., Weber M., Wiedenmann B., Mallath M., Patil P., Sambasivaiah K., Saxena R., Bajetta E., Buonadonna A., Buzzoni R., Cannizzaro R., Colao A., De Angelis C., Tomassetti P., Ćwikła J., Kos-Kudła B., Salek S.T., Capdevila J., Soler G., Tabernero J.M., Ahlman H., Kjellman M., Aithal G., Anthoney A., Caplin M., Grossman A., Newell-Price J., Ramage J., Reed N., Rees A., Steward W., Wall L., Choti M., Phan A.T., Wolin E.M.
ISSN
1471-2407 (Electronic)
ISSN-L
1471-2407
Publication state
Published
Issued date
14/01/2019
Peer-reviewed
Oui
Volume
19
Number
1
Pages
66
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Publication Status: epublish
Abstract
Lanreotide depot/autogel antitumor activity in intestinal/pancreatic neuroendocrine tumors (NETs) was demonstrated in the phase-3 CLARINET study (NCT00353496), based on significantly prolonged progression-free survival (PFS) versus placebo.
During CLARINET, patients with metastatic intestinal/pancreatic NETs received lanreotide depot/autogel 120 mg or placebo every 4 weeks for 96 weeks. Imaging data (response evaluation criteria in solid tumors [RECIST] v1.0, centrally reviewed) were re-evaluated in this post hoc analysis of tumor growth rate (TGR) in NETs. TGR (%/month) was calculated from two imaging scans during relevant periods: pre-treatment (TGR <sub>0</sub> ); 12-24 weeks before randomization versus baseline; each treatment visit versus baseline (TGR <sub>Tx-0</sub> ); between consecutive treatment visits (TGR <sub>Tx-Tx</sub> ). To assess TGR as a measure of prognosis, PFS was compared for TGR <sub>0</sub> subgroups stratified by optimum TGR <sub>0</sub> cut-off; a multivariate analysis was conducted to identify prognostic factors for PFS.
TGR <sub>0</sub> revealed tumors growing during pre-treatment (median [interquartile range] TGR <sub>0</sub> : lanreotide 2.1%/month [0.2; 6.1]; placebo 2.7%/month [0.15; 6.8]), contrary to RECIST status. TGR was significantly reduced by 12 weeks with lanreotide versus placebo (difference in least-square mean TGR <sub>0-12</sub> of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits. TGR <sub>0</sub> > 4%/month had greater risk of progression/death than ≤4%/month (hazard ratio 4.1; [95% CI 2.5-6.5]; p < 0.001); multivariate analysis revealed lanreotide treatment, progression at baseline, TGR <sub>0</sub> , hepatic tumor load, and primary tumor type were independently associated with PFS.
TGR provides valuable information on tumor activity and prognosis in patients with metastatic intestinal/pancreatic NETs, and identifies early lanreotide depot/autogel antitumor activity.
Retrospective registration, 18 July 2006; EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496 .
During CLARINET, patients with metastatic intestinal/pancreatic NETs received lanreotide depot/autogel 120 mg or placebo every 4 weeks for 96 weeks. Imaging data (response evaluation criteria in solid tumors [RECIST] v1.0, centrally reviewed) were re-evaluated in this post hoc analysis of tumor growth rate (TGR) in NETs. TGR (%/month) was calculated from two imaging scans during relevant periods: pre-treatment (TGR <sub>0</sub> ); 12-24 weeks before randomization versus baseline; each treatment visit versus baseline (TGR <sub>Tx-0</sub> ); between consecutive treatment visits (TGR <sub>Tx-Tx</sub> ). To assess TGR as a measure of prognosis, PFS was compared for TGR <sub>0</sub> subgroups stratified by optimum TGR <sub>0</sub> cut-off; a multivariate analysis was conducted to identify prognostic factors for PFS.
TGR <sub>0</sub> revealed tumors growing during pre-treatment (median [interquartile range] TGR <sub>0</sub> : lanreotide 2.1%/month [0.2; 6.1]; placebo 2.7%/month [0.15; 6.8]), contrary to RECIST status. TGR was significantly reduced by 12 weeks with lanreotide versus placebo (difference in least-square mean TGR <sub>0-12</sub> of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits. TGR <sub>0</sub> > 4%/month had greater risk of progression/death than ≤4%/month (hazard ratio 4.1; [95% CI 2.5-6.5]; p < 0.001); multivariate analysis revealed lanreotide treatment, progression at baseline, TGR <sub>0</sub> , hepatic tumor load, and primary tumor type were independently associated with PFS.
TGR provides valuable information on tumor activity and prognosis in patients with metastatic intestinal/pancreatic NETs, and identifies early lanreotide depot/autogel antitumor activity.
Retrospective registration, 18 July 2006; EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496 .
Keywords
Disease Progression, Female, Humans, Intestinal Neoplasms/mortality, Intestinal Neoplasms/pathology, Male, Neoplasm Grading, Neoplasm Staging, Neuroendocrine Tumors/mortality, Neuroendocrine Tumors/pathology, Pancreatic Neoplasms/mortality, Pancreatic Neoplasms/pathology, Prognosis, Proportional Hazards Models, Tumor Burden, Lanreotide, Neuroendocrine tumor, Prognostic factor, RECIST, Tumor growth rate
Pubmed
Web of science
Open Access
Yes
Create date
06/02/2019 12:09
Last modification date
20/08/2019 15:18
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