Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors a subgroup analysis of the phase III RADIANT-3 trial

Catherine Lombard-Bohas, James C. Yao, Timothy Hobday, Eric Van Cutsem, Edward M. Wolin, Ashok Panneerselvam, Sotirios Stergiopoulos, Manisha H. Shah, Jaume Capdevila, Rodney Pommier

Research output: Contribution to journalArticle

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Abstract

Objective: The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3). Methods: Patients with advanced, progressive, low- or intermediate-grade pNETwere prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203). Results: Of the 410 patients, 204 (50%) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95% confidence interval, 0.25A-A0.48; P < 0.0001) (chemonaive: 11.4 vs 5.4 months; hazard ratio, 0.42; 95% confidence interval, 0.29A-A0.60; P < 0.0001). Stable disease was the best overall response in 73% of everolimus-treated patients (151/207). The most common drug-related adverse events included stomatitis (60-69%), rash (47-50%), and diarrhea (34%). Conclusions: As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.

Original languageEnglish (US)
Pages (from-to)181-189
Number of pages9
JournalPancreas
Volume44
Issue number2
StatePublished - 2015
Externally publishedYes

Fingerprint

Neuroendocrine Tumors
Drug Therapy
Confidence Intervals
Stomatitis
Everolimus
Exanthema
Drug-Related Side Effects and Adverse Reactions
Disease-Free Survival
Diarrhea
Therapeutics
Placebos
Safety

Keywords

  • Chemotherapy
  • Everolimus
  • First-line therapy
  • Mammalian target of rapamycin inhibition

ASJC Scopus subject areas

  • Hepatology
  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism
  • Medicine(all)

Cite this

Lombard-Bohas, C., Yao, J. C., Hobday, T., Van Cutsem, E., Wolin, E. M., Panneerselvam, A., ... Pommier, R. (2015). Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors a subgroup analysis of the phase III RADIANT-3 trial. Pancreas, 44(2), 181-189.

Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors a subgroup analysis of the phase III RADIANT-3 trial. / Lombard-Bohas, Catherine; Yao, James C.; Hobday, Timothy; Van Cutsem, Eric; Wolin, Edward M.; Panneerselvam, Ashok; Stergiopoulos, Sotirios; Shah, Manisha H.; Capdevila, Jaume; Pommier, Rodney.

In: Pancreas, Vol. 44, No. 2, 2015, p. 181-189.

Research output: Contribution to journalArticle

Lombard-Bohas, C, Yao, JC, Hobday, T, Van Cutsem, E, Wolin, EM, Panneerselvam, A, Stergiopoulos, S, Shah, MH, Capdevila, J & Pommier, R 2015, 'Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors a subgroup analysis of the phase III RADIANT-3 trial', Pancreas, vol. 44, no. 2, pp. 181-189.
Lombard-Bohas, Catherine ; Yao, James C. ; Hobday, Timothy ; Van Cutsem, Eric ; Wolin, Edward M. ; Panneerselvam, Ashok ; Stergiopoulos, Sotirios ; Shah, Manisha H. ; Capdevila, Jaume ; Pommier, Rodney. / Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors a subgroup analysis of the phase III RADIANT-3 trial. In: Pancreas. 2015 ; Vol. 44, No. 2. pp. 181-189.
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abstract = "Objective: The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3). Methods: Patients with advanced, progressive, low- or intermediate-grade pNETwere prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203). Results: Of the 410 patients, 204 (50{\%}) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95{\%} confidence interval, 0.25A-A0.48; P < 0.0001) (chemonaive: 11.4 vs 5.4 months; hazard ratio, 0.42; 95{\%} confidence interval, 0.29A-A0.60; P < 0.0001). Stable disease was the best overall response in 73{\%} of everolimus-treated patients (151/207). The most common drug-related adverse events included stomatitis (60-69{\%}), rash (47-50{\%}), and diarrhea (34{\%}). Conclusions: As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.",
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AU - Van Cutsem, Eric

AU - Wolin, Edward M.

AU - Panneerselvam, Ashok

AU - Stergiopoulos, Sotirios

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AU - Pommier, Rodney

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N2 - Objective: The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3). Methods: Patients with advanced, progressive, low- or intermediate-grade pNETwere prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203). Results: Of the 410 patients, 204 (50%) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95% confidence interval, 0.25A-A0.48; P < 0.0001) (chemonaive: 11.4 vs 5.4 months; hazard ratio, 0.42; 95% confidence interval, 0.29A-A0.60; P < 0.0001). Stable disease was the best overall response in 73% of everolimus-treated patients (151/207). The most common drug-related adverse events included stomatitis (60-69%), rash (47-50%), and diarrhea (34%). Conclusions: As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.

AB - Objective: The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3). Methods: Patients with advanced, progressive, low- or intermediate-grade pNETwere prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203). Results: Of the 410 patients, 204 (50%) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95% confidence interval, 0.25A-A0.48; P < 0.0001) (chemonaive: 11.4 vs 5.4 months; hazard ratio, 0.42; 95% confidence interval, 0.29A-A0.60; P < 0.0001). Stable disease was the best overall response in 73% of everolimus-treated patients (151/207). The most common drug-related adverse events included stomatitis (60-69%), rash (47-50%), and diarrhea (34%). Conclusions: As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.

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