Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors: An Analysis of 2 Phase II Trials

Pamela L. Kunz, Raymond Balise, Louis Fehrenbacher, Minggui Pan, Alan P. Venook, George A. Fisher, Margaret A. Tempero, Andrew H. Ko, W. M. Korn, Jimmy Hwang, Emily K. Bergsland

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Abstract

OBJECTIVES: This study aimed to determine the safety and effectiveness of bevacizumab (B) plus FOLFOX or CAPOX in advanced neuroendocrine tumors (NETs) by performing a combined analysis of 2 separate prospective phase II studies. METHODS: In the FOLFOX/B study, patients received chemotherapy without scheduled breaks in 3 cohorts: carcinoid, pancreatic NET, and poorly differentiated neuroendocrine carcinomas. In the CAPOX/B study, NET subtypes were pooled, and patients were treated with 4 cycles of CAPOX/B followed by optional maintenance therapy. Primary end points were radiographic response rate (RR) after 12 cycles (FOLFOX/B), progression-free survival (PFS) (CAPOX/B), and toxicity (both). RESULTS: Seventy-six patients (FOLFOX/B, n = 36; CAPOX/B, n = 40) were included. In FOLFOX/B, RR for carcinoid at 12 cycles 3/22 (13.6%), median PFS 19.3 months; RR for pancreatic NET at 12 cycles 4/12 (41.7%), median PFS 21 months; RR 1/2 (50%) in poorly differentiated neuroendocrine carcinoma; pooled RR 25% and median PFS 21 months (1-year PFS 68%). In CAPOX/B (pooled NET), RR 18% and median PFS 16.7 months (1-year PFS 65%). Predictable toxicity was observed. CONCLUSIONS: Neither study met its primary end point, but radiographic responses and prolonged disease stability in previously progressing patients suggest that selected patients with NET may benefit from oxaliplatin–fluoropyrimidine chemotherapy plus bevacizumab and that the combination may warrant further study.

Original languageEnglish (US)
JournalPancreas
DOIs
StateAccepted/In press - May 11 2016

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Neuroendocrine Tumors
Disease-Free Survival
Drug Therapy
Neuroendocrine Carcinoma
Carcinoid Tumor
Bevacizumab
Safety

ASJC Scopus subject areas

  • Hepatology
  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors : An Analysis of 2 Phase II Trials. / Kunz, Pamela L.; Balise, Raymond; Fehrenbacher, Louis; Pan, Minggui; Venook, Alan P.; Fisher, George A.; Tempero, Margaret A.; Ko, Andrew H.; Korn, W. M.; Hwang, Jimmy; Bergsland, Emily K.

In: Pancreas, 11.05.2016.

Research output: Contribution to journalArticle

Kunz, Pamela L. ; Balise, Raymond ; Fehrenbacher, Louis ; Pan, Minggui ; Venook, Alan P. ; Fisher, George A. ; Tempero, Margaret A. ; Ko, Andrew H. ; Korn, W. M. ; Hwang, Jimmy ; Bergsland, Emily K. / Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors : An Analysis of 2 Phase II Trials. In: Pancreas. 2016.
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title = "Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors: An Analysis of 2 Phase II Trials",
abstract = "OBJECTIVES: This study aimed to determine the safety and effectiveness of bevacizumab (B) plus FOLFOX or CAPOX in advanced neuroendocrine tumors (NETs) by performing a combined analysis of 2 separate prospective phase II studies. METHODS: In the FOLFOX/B study, patients received chemotherapy without scheduled breaks in 3 cohorts: carcinoid, pancreatic NET, and poorly differentiated neuroendocrine carcinomas. In the CAPOX/B study, NET subtypes were pooled, and patients were treated with 4 cycles of CAPOX/B followed by optional maintenance therapy. Primary end points were radiographic response rate (RR) after 12 cycles (FOLFOX/B), progression-free survival (PFS) (CAPOX/B), and toxicity (both). RESULTS: Seventy-six patients (FOLFOX/B, n = 36; CAPOX/B, n = 40) were included. In FOLFOX/B, RR for carcinoid at 12 cycles 3/22 (13.6{\%}), median PFS 19.3 months; RR for pancreatic NET at 12 cycles 4/12 (41.7{\%}), median PFS 21 months; RR 1/2 (50{\%}) in poorly differentiated neuroendocrine carcinoma; pooled RR 25{\%} and median PFS 21 months (1-year PFS 68{\%}). In CAPOX/B (pooled NET), RR 18{\%} and median PFS 16.7 months (1-year PFS 65{\%}). Predictable toxicity was observed. CONCLUSIONS: Neither study met its primary end point, but radiographic responses and prolonged disease stability in previously progressing patients suggest that selected patients with NET may benefit from oxaliplatin–fluoropyrimidine chemotherapy plus bevacizumab and that the combination may warrant further study.",
author = "Kunz, {Pamela L.} and Raymond Balise and Louis Fehrenbacher and Minggui Pan and Venook, {Alan P.} and Fisher, {George A.} and Tempero, {Margaret A.} and Ko, {Andrew H.} and Korn, {W. M.} and Jimmy Hwang and Bergsland, {Emily K.}",
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T1 - Oxaliplatin–Fluoropyrimidine Chemotherapy Plus Bevacizumab in Advanced Neuroendocrine Tumors

T2 - An Analysis of 2 Phase II Trials

AU - Kunz, Pamela L.

AU - Balise, Raymond

AU - Fehrenbacher, Louis

AU - Pan, Minggui

AU - Venook, Alan P.

AU - Fisher, George A.

AU - Tempero, Margaret A.

AU - Ko, Andrew H.

AU - Korn, W. M.

AU - Hwang, Jimmy

AU - Bergsland, Emily K.

PY - 2016/5/11

Y1 - 2016/5/11

N2 - OBJECTIVES: This study aimed to determine the safety and effectiveness of bevacizumab (B) plus FOLFOX or CAPOX in advanced neuroendocrine tumors (NETs) by performing a combined analysis of 2 separate prospective phase II studies. METHODS: In the FOLFOX/B study, patients received chemotherapy without scheduled breaks in 3 cohorts: carcinoid, pancreatic NET, and poorly differentiated neuroendocrine carcinomas. In the CAPOX/B study, NET subtypes were pooled, and patients were treated with 4 cycles of CAPOX/B followed by optional maintenance therapy. Primary end points were radiographic response rate (RR) after 12 cycles (FOLFOX/B), progression-free survival (PFS) (CAPOX/B), and toxicity (both). RESULTS: Seventy-six patients (FOLFOX/B, n = 36; CAPOX/B, n = 40) were included. In FOLFOX/B, RR for carcinoid at 12 cycles 3/22 (13.6%), median PFS 19.3 months; RR for pancreatic NET at 12 cycles 4/12 (41.7%), median PFS 21 months; RR 1/2 (50%) in poorly differentiated neuroendocrine carcinoma; pooled RR 25% and median PFS 21 months (1-year PFS 68%). In CAPOX/B (pooled NET), RR 18% and median PFS 16.7 months (1-year PFS 65%). Predictable toxicity was observed. CONCLUSIONS: Neither study met its primary end point, but radiographic responses and prolonged disease stability in previously progressing patients suggest that selected patients with NET may benefit from oxaliplatin–fluoropyrimidine chemotherapy plus bevacizumab and that the combination may warrant further study.

AB - OBJECTIVES: This study aimed to determine the safety and effectiveness of bevacizumab (B) plus FOLFOX or CAPOX in advanced neuroendocrine tumors (NETs) by performing a combined analysis of 2 separate prospective phase II studies. METHODS: In the FOLFOX/B study, patients received chemotherapy without scheduled breaks in 3 cohorts: carcinoid, pancreatic NET, and poorly differentiated neuroendocrine carcinomas. In the CAPOX/B study, NET subtypes were pooled, and patients were treated with 4 cycles of CAPOX/B followed by optional maintenance therapy. Primary end points were radiographic response rate (RR) after 12 cycles (FOLFOX/B), progression-free survival (PFS) (CAPOX/B), and toxicity (both). RESULTS: Seventy-six patients (FOLFOX/B, n = 36; CAPOX/B, n = 40) were included. In FOLFOX/B, RR for carcinoid at 12 cycles 3/22 (13.6%), median PFS 19.3 months; RR for pancreatic NET at 12 cycles 4/12 (41.7%), median PFS 21 months; RR 1/2 (50%) in poorly differentiated neuroendocrine carcinoma; pooled RR 25% and median PFS 21 months (1-year PFS 68%). In CAPOX/B (pooled NET), RR 18% and median PFS 16.7 months (1-year PFS 65%). Predictable toxicity was observed. CONCLUSIONS: Neither study met its primary end point, but radiographic responses and prolonged disease stability in previously progressing patients suggest that selected patients with NET may benefit from oxaliplatin–fluoropyrimidine chemotherapy plus bevacizumab and that the combination may warrant further study.

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