Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors

Clarisse Dromain; Marianne E. Pavel; Philippe Ruszniewski; Alison Langley; Christine Massien; Eric Baudin; Martyn E. Caplin; Austria M. Raderer; Belgium I. Borbath; D. Ysebaert; E. Sedláčková; P. Vítek; Denmark H. Grønbæk; France A. Adenis; L. Buscail; G. Cadiot; S. Dominguez; M. Ducreux; C. Lombard-Bohas; E. Mitry; P. Ruszniewski; J. F. Seitz; N. Begum; I. Harsch; M. Pavel; C. Schöfl; M. Weber; B. Wiedenmann; M. Mallath; P. Patil; K. Sambasivaiah; R. Saxena; E. Bajetta; A. Buonadonna; R. Buzzoni; R. Cannizzaro; A. Colao; C. De Angelis; P. Tomassetti; J. Ćwikła; B. Kos-Kudła; Slovakia T. Salek; J. Capdevila; G. Soler; J. M. Tabernero; H. Ahlman; M. Kjellman; G. Aithal; A. Anthoney; M. Caplin; A. Grossman; J. Newell-Price; J. Ramage; N. Reed; A. Rees; W. Steward; L. Wall; M. Choti; A. T. Phan; E. M. Wolin

doi:10.1186/s12885-018-5257-x

Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors

Clarisse Dromain, Marianne E. Pavel, Philippe Ruszniewski, Alison Langley, Christine Massien, Eric Baudin, Martyn E. Caplin, Austria M. Raderer, Belgium I. Borbath, D. Ysebaert, E. Sedláčková, P. Vítek, Denmark H. Grønbæk, France A. Adenis, L. Buscail, G. Cadiot, S. Dominguez, M. Ducreux, C. Lombard-Bohas, E. MitryP. Ruszniewski, J. F. Seitz, N. Begum, I. Harsch, M. Pavel, C. Schöfl, M. Weber, B. Wiedenmann, M. Mallath, P. Patil, K. Sambasivaiah, R. Saxena, E. Bajetta, A. Buonadonna, R. Buzzoni, R. Cannizzaro, A. Colao, C. De Angelis, P. Tomassetti, J. Ćwikła, B. Kos-Kudła, Slovakia T. Salek, J. Capdevila, G. Soler, J. M. Tabernero, H. Ahlman, M. Kjellman, G. Aithal, A. Anthoney, M. Caplin, A. Grossman, J. Newell-Price, J. Ramage, N. Reed, A. Rees, W. Steward, L. Wall, M. Choti, A. T. Phan, E. M. Wolin

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Résumé

Background: 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. Methods: 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 ₀ ); 12-24 weeks before randomization versus baseline; each treatment visit versus baseline (TGR _Tx-0 ); between consecutive treatment visits (TGR _Tx-Tx ). To assess TGR as a measure of prognosis, PFS was compared for TGR ₀ subgroups stratified by optimum TGR ₀ cut-off; a multivariate analysis was conducted to identify prognostic factors for PFS. Results: TGR ₀ revealed tumors growing during pre-treatment (median [interquartile range] TGR ₀ : 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 _0-12 of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits. TGR ₀ > 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 ₀ , hepatic tumor load, and primary tumor type were independently associated with PFS. Conclusions: TGR provides valuable information on tumor activity and prognosis in patients with metastatic intestinal/pancreatic NETs, and identifies early lanreotide depot/autogel antitumor activity. Trial registration: Retrospective registration, 18 July 2006; EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496.

langue originale	Anglais
Numéro d'article	66
journal	BMC Cancer
Volume	19
Numéro de publication	1
Les DOIs	https://doi.org/10.1186/s12885-018-5257-x
état	Publié - 14 janv. 2019

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10.1186/s12885-018-5257-x

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Dromain, C., Pavel, M. E., Ruszniewski, P., Langley, A., Massien, C., Baudin, E., Caplin, M. E., 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., ... Wolin, E. M. (2019). Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors. BMC Cancer, 19(1), Article 66. https://doi.org/10.1186/s12885-018-5257-x

@article{ef0bf4c78f1f47a5a93cf8ca5e44a70a,

title = "Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors",

abstract = " Background: 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. Methods: 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 0 ); 12-24 weeks before randomization versus baseline; each treatment visit versus baseline (TGR Tx-0 ); between consecutive treatment visits (TGR Tx-Tx ). To assess TGR as a measure of prognosis, PFS was compared for TGR 0 subgroups stratified by optimum TGR 0 cut-off; a multivariate analysis was conducted to identify prognostic factors for PFS. Results: TGR 0 revealed tumors growing during pre-treatment (median [interquartile range] TGR 0 : 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 0-12 of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits. TGR 0 > 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 0 , hepatic tumor load, and primary tumor type were independently associated with PFS. Conclusions: TGR provides valuable information on tumor activity and prognosis in patients with metastatic intestinal/pancreatic NETs, and identifies early lanreotide depot/autogel antitumor activity. Trial registration: Retrospective registration, 18 July 2006; EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496.",

keywords = "Lanreotide, Neuroendocrine tumor, Prognostic factor, RECIST, Tumor growth rate",

author = "Clarisse Dromain and Pavel, {Marianne E.} and Philippe Ruszniewski and Alison Langley and Christine Massien and Eric Baudin and Caplin, {Martyn E.} and Raderer, {Austria M.} and Borbath, {Belgium I.} and D. Ysebaert and E. Sedl{\'a}{\v c}kov{\'a} and P. V{\'i}tek and Gr{\o}nb{\ae}k, {Denmark H.} and Adenis, {France A.} and L. Buscail and G. Cadiot and S. Dominguez and M. Ducreux and C. Lombard-Bohas and E. Mitry and P. Ruszniewski and Seitz, {J. F.} and N. Begum and I. Harsch and M. Pavel and C. Sch{\"o}fl and M. Weber and B. Wiedenmann and M. Mallath and P. Patil and K. Sambasivaiah and R. Saxena and E. Bajetta and A. Buonadonna and R. Buzzoni and R. Cannizzaro and A. Colao and {De Angelis}, C. and P. Tomassetti and J. {\'C}wik{\l}a and B. Kos-Kud{\l}a and Salek, {Slovakia T.} and J. Capdevila and G. Soler and Tabernero, {J. M.} and H. Ahlman and M. Kjellman and G. Aithal and A. Anthoney and M. Caplin and A. Grossman and J. Newell-Price and J. Ramage and N. Reed and A. Rees and W. Steward and L. Wall and M. Choti and Phan, {A. T.} and Wolin, {E. M.}",

note = "Publisher Copyright: {\textcopyright} 2019 The Author(s).",

year = "2019",

month = jan,

day = "14",

doi = "10.1186/s12885-018-5257-x",

language = "English",

volume = "19",

journal = "BMC Cancer",

issn = "1471-2407",

number = "1",

}

Dromain, C, Pavel, ME, Ruszniewski, P, Langley, A, Massien, C, Baudin, E, Caplin, ME, Raderer, AM, Borbath, BI, Ysebaert, D, Sedláčková, E, Vítek, P, Grønbæk, DH, Adenis, FA, Buscail, L, Cadiot, G, Dominguez, S, Ducreux, M, Lombard-Bohas, C, Mitry, E, Ruszniewski, P, Seitz, JF, 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, ST, Capdevila, J, Soler, G, Tabernero, JM, 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, AT & Wolin, EM 2019, 'Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors', BMC Cancer, VOL. 19, Numéro 1, 66. https://doi.org/10.1186/s12885-018-5257-x

TY - JOUR

T1 - Tumor growth rate as a metric of progression, response, and prognosis in pancreatic and intestinal neuroendocrine tumors

AU - Dromain, Clarisse

AU - Pavel, Marianne E.

AU - Ruszniewski, Philippe

AU - Langley, Alison

AU - Massien, Christine

AU - Baudin, Eric

AU - Caplin, Martyn E.

AU - Raderer, Austria M.

AU - Borbath, Belgium I.

AU - Ysebaert, D.

AU - Sedláčková, E.

AU - Vítek, P.

AU - Grønbæk, Denmark H.

AU - Adenis, France A.

AU - Buscail, L.

AU - Cadiot, G.

AU - Dominguez, S.

AU - Ducreux, M.

AU - Lombard-Bohas, C.

AU - Mitry, E.

AU - Ruszniewski, P.

AU - Seitz, J. F.

AU - Begum, N.

AU - Harsch, I.

AU - Pavel, M.

AU - Schöfl, C.

AU - Weber, M.

AU - Wiedenmann, B.

AU - Mallath, M.

AU - Patil, P.

AU - Sambasivaiah, K.

AU - Saxena, R.

AU - Bajetta, E.

AU - Buonadonna, A.

AU - Buzzoni, R.

AU - Cannizzaro, R.

AU - Colao, A.

AU - De Angelis, C.

AU - Tomassetti, P.

AU - Ćwikła, J.

AU - Kos-Kudła, B.

AU - Salek, Slovakia T.

AU - Capdevila, J.

AU - Soler, G.

AU - Tabernero, J. M.

AU - Ahlman, H.

AU - Kjellman, M.

AU - Aithal, G.

AU - Anthoney, A.

AU - Caplin, M.

AU - Grossman, A.

AU - Newell-Price, J.

AU - Ramage, J.

AU - Reed, N.

AU - Rees, A.

AU - Steward, W.

AU - Wall, L.

AU - Choti, M.

AU - Phan, A. T.

AU - Wolin, E. M.

PY - 2019/1/14

Y1 - 2019/1/14

N2 - Background: 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. Methods: 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 0 ); 12-24 weeks before randomization versus baseline; each treatment visit versus baseline (TGR Tx-0 ); between consecutive treatment visits (TGR Tx-Tx ). To assess TGR as a measure of prognosis, PFS was compared for TGR 0 subgroups stratified by optimum TGR 0 cut-off; a multivariate analysis was conducted to identify prognostic factors for PFS. Results: TGR 0 revealed tumors growing during pre-treatment (median [interquartile range] TGR 0 : 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 0-12 of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits. TGR 0 > 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 0 , hepatic tumor load, and primary tumor type were independently associated with PFS. Conclusions: TGR provides valuable information on tumor activity and prognosis in patients with metastatic intestinal/pancreatic NETs, and identifies early lanreotide depot/autogel antitumor activity. Trial registration: Retrospective registration, 18 July 2006; EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496.

AB - Background: 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. Methods: 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 0 ); 12-24 weeks before randomization versus baseline; each treatment visit versus baseline (TGR Tx-0 ); between consecutive treatment visits (TGR Tx-Tx ). To assess TGR as a measure of prognosis, PFS was compared for TGR 0 subgroups stratified by optimum TGR 0 cut-off; a multivariate analysis was conducted to identify prognostic factors for PFS. Results: TGR 0 revealed tumors growing during pre-treatment (median [interquartile range] TGR 0 : 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 0-12 of - 2.9 [- 5.1, - 0.8], p = 0.008), a difference that was maintained at most subsequent visits. TGR 0 > 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 0 , hepatic tumor load, and primary tumor type were independently associated with PFS. Conclusions: TGR provides valuable information on tumor activity and prognosis in patients with metastatic intestinal/pancreatic NETs, and identifies early lanreotide depot/autogel antitumor activity. Trial registration: Retrospective registration, 18 July 2006; EudraCT: 2005-004904-35; ClinicalTrials.gov: NCT00353496.

KW - Lanreotide

KW - Neuroendocrine tumor

KW - Prognostic factor

KW - RECIST

KW - Tumor growth rate

UR - http://www.scopus.com/inward/record.url?scp=85059955307&partnerID=8YFLogxK

U2 - 10.1186/s12885-018-5257-x

DO - 10.1186/s12885-018-5257-x

M3 - Article

C2 - 30642293

AN - SCOPUS:85059955307

SN - 1471-2407

VL - 19

JO - BMC Cancer

JF - BMC Cancer

IS - 1

M1 - 66

ER -