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Impact of Previous Somatostatin Analogue Use on the Activity of Everolimus in Patients with Advanced Neuroendocrine Tumors : Analysis from the Phase III RADIANT-2 Trial

Anthony, Lowell B. (author)
Univ Kentucky, Markey Canc Ctr, Div Med Oncol, Lexington, KY 40536 USA.
Pavel, Marianne E. (author)
Charite, Campus Virchow Klinikum, D-13353 Berlin, Germany.
Hainsworth, John D. (author)
Sarah Cannon Res Inst, Nashville, TN USA.
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Kvols, Larry K. (author)
H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA.
Segal, Scott (author)
Novartis Pharmaceut, E Hanover, NJ USA.
Hoersch, Dieter (author)
Zentralklin Bad Berka GmbH, Klin Innere Med Gastroenterol & Endokrinol, Zentrum Neuroendokrine Tumore, Bad Berka, Germany.
Van Cutsem, Eric (author)
Univ Hosp Gasthuisberg, Leuven, Belgium.
Öberg, Kjell (author)
Uppsala universitet,Institutionen för medicinska vetenskaper
Yao, James C. (author)
Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA.
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Univ Kentucky, Markey Canc Ctr, Div Med Oncol, Lexington, KY 40536 USA Charite, Campus Virchow Klinikum, D-13353 Berlin, Germany. (creator_code:org_t)
2015-03-21
2015
English.
In: Neuroendocrinology. - : S. Karger AG. - 0028-3835 .- 1423-0194. ; 102:1-2, s. 18-25
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • Background/Aims: The phase III placebo-controlled RADI-ANT-2 trial investigated the efficacy of everolimus plus octreotide long-acting repeatable (LAR) in patients with advanced neuroendocrine tumors (NET) associated with carcinoid syndrome. Here we report a secondary analysis based on the previous somatostatin analogue (SSA) exposure status of patients enrolled in RADIANT-2. Methods: Patients were randomly assigned to receive oral everolimus 10 mg/day plus octreotide LAR 30 mg intramuscularly (i.m.) or to receive matching placebo plus octreotide LAR 30 mg i.m. every 28 days. SSA treatment before study enrollment was permitted. Patient characteristics and progression-free survival (PFS) were analyzed by treatment arm and previous SSA exposure status. Results: Of the 429 patients enrolled in RADI-ANT-2, 339 were previously exposed to SSA (95% received octreotide); 173 of 339 patients were in the everolimus plus octreotide LAR arm. All patients had a protocol-specified history of secretory symptoms, but analysis by type showed that more patients who previously received SSA therapy had a history of flushing symptoms (77%), diarrhea (86%), or both (63%) compared with SSA-naive patients (62, 62, and 24%, respectively). Patients who received everolimus plus octreotide LAR had longer median PFS regardless of previous SSA exposure (with: PFS 14.3 months, 95% confidence interval, CI, 12.0-20.1; without: 25.2 months, 95% CI, 12.0-not reached) compared with patients who received placebo plus octreotide LAR (with: 11.1 months, 95% CI, 8.4-14.6; without: 13.6 months, 95% CI, 8.2-22.7). Conclusion: Everolimus in combination with octreotide improves PFS in patients with advanced NET associated with carcinoid syndrome, regardless of previous SSA exposure.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Neurosciences (hsv//eng)

Keyword

Everolimus
Neuroendocrine tumors
Mammalian target of rapamycin
Octreotide long-acting repeatable
Progression-free survival
Somatostatin analogue

Publication and Content Type

ref (subject category)
art (subject category)

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