Phase III prospective randomized comparison trial of depot octreotide plus interferon Alfa-2b versus depot octreotide plus bevacizumab in patients with advanced carcinoid tumors: SWOG S0518

James C. Yao, Cesar Moran, Katherine A. Guthrie, Shannon McDonough, Jonathan R. Strosberg, Matthew H. Kulke, Jennifer A. Chan, Noelle Loconte, Robert R. McWilliams, Edward M. Wolin, Edward M. Wolin, Bassam Mattar, Helen Chen, Charles D. Blanke, Howard S. Hochster

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Abstract

Purpose Treatment options for neuroendocrine tumors (NETs) remain limited. This trial assessed the progression-free survival (PFS) of bevacizumab or interferon alfa-2b (IFN-a-2b) added to octreotide among patients with advanced NETs. Patients and Methods Southwest Oncology Group (SWOG) S0518, a phase III study conducted in a US cooperative group system, enrolled patients with advanced grades 1 and 2 NETs with progressive disease or other poor prognostic features. Patients were randomly assigned to treatment with octreotide LAR 20 mg every 21 days with either bevacizumab 15 mg/kg every 21 days or 5 million units of IFN-a-2b three times per week. The primary end point was centrally assessed PFS. This trial is registered with ClinicalTrials.gov as NCT00569127. Results A total of 427 patients was enrolled, of whom 214 were allocated to bevacizumab and 213 to IFN-a-2b. The median PFS by central review was 16.6 months (95% CI, 12.9 to 19.6 months) in the bevacizumab arm and was 15.4 months (95% CI, 9.6 to 18.6 months) in the IFN arm (hazard ratio [HR], 0.93; 95% CI, 0.73 to 1.18; P = .55). By site review, the median PFS times were 15.4 months (95% CI, 12.6 to 17.2 months) for bevacizumab and 10.6 months (95% CI, 8.5 to 14.4 months) for interferon (HR, 0.90; 95% CI, 0.72 to 1.12; P = .33). Time to treatment failure was longer with bevacizumab than with IFN (HR, 0.72; 95% CI, 0.58 to 0.89; P = .003). Confirmed radiologic response rates were 12% (95% CI, 8% to 18%) for bevacizumab and 4% (95% CI, 2% to 8%) for IFN. Common adverse events with bevacizumab and octreotide included hypertension (32%), proteinuria (9%), and fatigue (7%); with IFN and octreotide, they included fatigue (27%), neutropenia (12%), and nausea (6%). Conclusion No significant differences in PFS were observed between the bevacizumab and IFN arms, which suggests that these agents have similar antitumor activity among patients with advanced NETs.

Original languageEnglish (US)
Pages (from-to)1695-1703
Number of pages9
JournalJournal of Clinical Oncology
Volume35
Issue number15
DOIs
StatePublished - May 20 2017
Externally publishedYes

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interferon alfa-2b
Octreotide
Carcinoid Tumor
Neuroendocrine Tumors
Disease-Free Survival
Fatigue
Bevacizumab

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase III prospective randomized comparison trial of depot octreotide plus interferon Alfa-2b versus depot octreotide plus bevacizumab in patients with advanced carcinoid tumors : SWOG S0518. / Yao, James C.; Moran, Cesar; Guthrie, Katherine A.; McDonough, Shannon; Strosberg, Jonathan R.; Kulke, Matthew H.; Chan, Jennifer A.; Loconte, Noelle; McWilliams, Robert R.; Wolin, Edward M.; Wolin, Edward M.; Mattar, Bassam; Chen, Helen; Blanke, Charles D.; Hochster, Howard S.

In: Journal of Clinical Oncology, Vol. 35, No. 15, 20.05.2017, p. 1695-1703.

Research output: Contribution to journalArticle

Yao, JC, Moran, C, Guthrie, KA, McDonough, S, Strosberg, JR, Kulke, MH, Chan, JA, Loconte, N, McWilliams, RR, Wolin, EM, Wolin, EM, Mattar, B, Chen, H, Blanke, CD & Hochster, HS 2017, 'Phase III prospective randomized comparison trial of depot octreotide plus interferon Alfa-2b versus depot octreotide plus bevacizumab in patients with advanced carcinoid tumors: SWOG S0518', Journal of Clinical Oncology, vol. 35, no. 15, pp. 1695-1703. https://doi.org/10.1200/JCO.2016.70.4072
Yao, James C. ; Moran, Cesar ; Guthrie, Katherine A. ; McDonough, Shannon ; Strosberg, Jonathan R. ; Kulke, Matthew H. ; Chan, Jennifer A. ; Loconte, Noelle ; McWilliams, Robert R. ; Wolin, Edward M. ; Wolin, Edward M. ; Mattar, Bassam ; Chen, Helen ; Blanke, Charles D. ; Hochster, Howard S. / Phase III prospective randomized comparison trial of depot octreotide plus interferon Alfa-2b versus depot octreotide plus bevacizumab in patients with advanced carcinoid tumors : SWOG S0518. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 15. pp. 1695-1703.
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title = "Phase III prospective randomized comparison trial of depot octreotide plus interferon Alfa-2b versus depot octreotide plus bevacizumab in patients with advanced carcinoid tumors: SWOG S0518",
abstract = "Purpose Treatment options for neuroendocrine tumors (NETs) remain limited. This trial assessed the progression-free survival (PFS) of bevacizumab or interferon alfa-2b (IFN-a-2b) added to octreotide among patients with advanced NETs. Patients and Methods Southwest Oncology Group (SWOG) S0518, a phase III study conducted in a US cooperative group system, enrolled patients with advanced grades 1 and 2 NETs with progressive disease or other poor prognostic features. Patients were randomly assigned to treatment with octreotide LAR 20 mg every 21 days with either bevacizumab 15 mg/kg every 21 days or 5 million units of IFN-a-2b three times per week. The primary end point was centrally assessed PFS. This trial is registered with ClinicalTrials.gov as NCT00569127. Results A total of 427 patients was enrolled, of whom 214 were allocated to bevacizumab and 213 to IFN-a-2b. The median PFS by central review was 16.6 months (95{\%} CI, 12.9 to 19.6 months) in the bevacizumab arm and was 15.4 months (95{\%} CI, 9.6 to 18.6 months) in the IFN arm (hazard ratio [HR], 0.93; 95{\%} CI, 0.73 to 1.18; P = .55). By site review, the median PFS times were 15.4 months (95{\%} CI, 12.6 to 17.2 months) for bevacizumab and 10.6 months (95{\%} CI, 8.5 to 14.4 months) for interferon (HR, 0.90; 95{\%} CI, 0.72 to 1.12; P = .33). Time to treatment failure was longer with bevacizumab than with IFN (HR, 0.72; 95{\%} CI, 0.58 to 0.89; P = .003). Confirmed radiologic response rates were 12{\%} (95{\%} CI, 8{\%} to 18{\%}) for bevacizumab and 4{\%} (95{\%} CI, 2{\%} to 8{\%}) for IFN. Common adverse events with bevacizumab and octreotide included hypertension (32{\%}), proteinuria (9{\%}), and fatigue (7{\%}); with IFN and octreotide, they included fatigue (27{\%}), neutropenia (12{\%}), and nausea (6{\%}). Conclusion No significant differences in PFS were observed between the bevacizumab and IFN arms, which suggests that these agents have similar antitumor activity among patients with advanced NETs.",
author = "Yao, {James C.} and Cesar Moran and Guthrie, {Katherine A.} and Shannon McDonough and Strosberg, {Jonathan R.} and Kulke, {Matthew H.} and Chan, {Jennifer A.} and Noelle Loconte and McWilliams, {Robert R.} and Wolin, {Edward M.} and Wolin, {Edward M.} and Bassam Mattar and Helen Chen and Blanke, {Charles D.} and Hochster, {Howard S.}",
year = "2017",
month = "5",
day = "20",
doi = "10.1200/JCO.2016.70.4072",
language = "English (US)",
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TY - JOUR

T1 - Phase III prospective randomized comparison trial of depot octreotide plus interferon Alfa-2b versus depot octreotide plus bevacizumab in patients with advanced carcinoid tumors

T2 - SWOG S0518

AU - Yao, James C.

AU - Moran, Cesar

AU - Guthrie, Katherine A.

AU - McDonough, Shannon

AU - Strosberg, Jonathan R.

AU - Kulke, Matthew H.

AU - Chan, Jennifer A.

AU - Loconte, Noelle

AU - McWilliams, Robert R.

AU - Wolin, Edward M.

AU - Wolin, Edward M.

AU - Mattar, Bassam

AU - Chen, Helen

AU - Blanke, Charles D.

AU - Hochster, Howard S.

PY - 2017/5/20

Y1 - 2017/5/20

N2 - Purpose Treatment options for neuroendocrine tumors (NETs) remain limited. This trial assessed the progression-free survival (PFS) of bevacizumab or interferon alfa-2b (IFN-a-2b) added to octreotide among patients with advanced NETs. Patients and Methods Southwest Oncology Group (SWOG) S0518, a phase III study conducted in a US cooperative group system, enrolled patients with advanced grades 1 and 2 NETs with progressive disease or other poor prognostic features. Patients were randomly assigned to treatment with octreotide LAR 20 mg every 21 days with either bevacizumab 15 mg/kg every 21 days or 5 million units of IFN-a-2b three times per week. The primary end point was centrally assessed PFS. This trial is registered with ClinicalTrials.gov as NCT00569127. Results A total of 427 patients was enrolled, of whom 214 were allocated to bevacizumab and 213 to IFN-a-2b. The median PFS by central review was 16.6 months (95% CI, 12.9 to 19.6 months) in the bevacizumab arm and was 15.4 months (95% CI, 9.6 to 18.6 months) in the IFN arm (hazard ratio [HR], 0.93; 95% CI, 0.73 to 1.18; P = .55). By site review, the median PFS times were 15.4 months (95% CI, 12.6 to 17.2 months) for bevacizumab and 10.6 months (95% CI, 8.5 to 14.4 months) for interferon (HR, 0.90; 95% CI, 0.72 to 1.12; P = .33). Time to treatment failure was longer with bevacizumab than with IFN (HR, 0.72; 95% CI, 0.58 to 0.89; P = .003). Confirmed radiologic response rates were 12% (95% CI, 8% to 18%) for bevacizumab and 4% (95% CI, 2% to 8%) for IFN. Common adverse events with bevacizumab and octreotide included hypertension (32%), proteinuria (9%), and fatigue (7%); with IFN and octreotide, they included fatigue (27%), neutropenia (12%), and nausea (6%). Conclusion No significant differences in PFS were observed between the bevacizumab and IFN arms, which suggests that these agents have similar antitumor activity among patients with advanced NETs.

AB - Purpose Treatment options for neuroendocrine tumors (NETs) remain limited. This trial assessed the progression-free survival (PFS) of bevacizumab or interferon alfa-2b (IFN-a-2b) added to octreotide among patients with advanced NETs. Patients and Methods Southwest Oncology Group (SWOG) S0518, a phase III study conducted in a US cooperative group system, enrolled patients with advanced grades 1 and 2 NETs with progressive disease or other poor prognostic features. Patients were randomly assigned to treatment with octreotide LAR 20 mg every 21 days with either bevacizumab 15 mg/kg every 21 days or 5 million units of IFN-a-2b three times per week. The primary end point was centrally assessed PFS. This trial is registered with ClinicalTrials.gov as NCT00569127. Results A total of 427 patients was enrolled, of whom 214 were allocated to bevacizumab and 213 to IFN-a-2b. The median PFS by central review was 16.6 months (95% CI, 12.9 to 19.6 months) in the bevacizumab arm and was 15.4 months (95% CI, 9.6 to 18.6 months) in the IFN arm (hazard ratio [HR], 0.93; 95% CI, 0.73 to 1.18; P = .55). By site review, the median PFS times were 15.4 months (95% CI, 12.6 to 17.2 months) for bevacizumab and 10.6 months (95% CI, 8.5 to 14.4 months) for interferon (HR, 0.90; 95% CI, 0.72 to 1.12; P = .33). Time to treatment failure was longer with bevacizumab than with IFN (HR, 0.72; 95% CI, 0.58 to 0.89; P = .003). Confirmed radiologic response rates were 12% (95% CI, 8% to 18%) for bevacizumab and 4% (95% CI, 2% to 8%) for IFN. Common adverse events with bevacizumab and octreotide included hypertension (32%), proteinuria (9%), and fatigue (7%); with IFN and octreotide, they included fatigue (27%), neutropenia (12%), and nausea (6%). Conclusion No significant differences in PFS were observed between the bevacizumab and IFN arms, which suggests that these agents have similar antitumor activity among patients with advanced NETs.

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