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Efficacy of everoli...
Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome : final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study
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- Pavel, M. E. (författare)
- Charite, Dept Hepatol & Gastroenterol, Campus Virchow Klinikum, D-13353 Berlin, Germany.
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- Baudin, E. (författare)
- Inst Gustave Roussy, Dept Nucl Med & Endocrine Oncol, Villejuif, France.
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- Öberg, Kjell, 1946- (författare)
- Uppsala universitet,Endokrin tumörbiologi
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- Hainsworth, J. D. (författare)
- Sarah Cannon Res Inst, Nashville, TN USA.
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- Voi, M. (författare)
- Novartis Pharmaceut, E Hanover, NJ USA.
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- Rouyrre, N. (författare)
- Novartis Int AG, Basel, Switzerland.
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- Peeters, M. (författare)
- Antwerp Univ Hosp, Dept Oncol, Edegem, Belgium.
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- Gross, D. J. (författare)
- Hadassah Hebrew Univ, Med Ctr, Neuroendocrine Tumor Unit, Jerusalem, Israel.
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- Yao, J. C. (författare)
- Univ Texas MD Anderson Canc Ctr, Dept Gastrointestinal Med Oncol, Div Canc Med, Houston, TX 77030 USA.
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Charite, Dept Hepatol & Gastroenterol, Campus Virchow Klinikum, D-13353 Berlin, Germany Inst Gustave Roussy, Dept Nucl Med & Endocrine Oncol, Villejuif, France. (creator_code:org_t)
- OXFORD UNIV PRESS, 2017
- 2017
- Engelska.
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Ingår i: Annals of Oncology. - : OXFORD UNIV PRESS. - 0923-7534 .- 1569-8041. ; 28:7, s. 1569-1575
- Relaterad länk:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Background: In the phase 3 RADIANT-2 study, everolimus plus octreotide long-acting repeatable (LAR) showed improvement of 5.1 months in median progression-free survival versus placebo plus octreotide LAR among patients with advanced neuroendocrine tumors associated with carcinoid syndrome. The progression-free survival P-value was marginally above the pre-specified threshold for statistical significance. Here, we report final overall survival (OS) and key safety update from RADIANT-2.Patients and methods: The RADIANT-2 trial compared everolimus (10 mg/day, orally; n = 216) versus placebo (n = 213), both in conjunction with octreotide LAR (30 mg, intramuscularly, every 28 days). Patients, unblinded at the time of progression or after end of double-blind core phase following primary analysis, were offered open-label everolimus with octreotide LAR (open-label phase). In the open-label phase, patients had similar safety and efficacy assessments as those in the core phase. For OS, hazard ratios (HRs) with 95% CIs using unadjusted Cox model and a Cox model adjusted for prespecified baseline covariates were calculated.Results: A total of 170 patients received open-label everolimus (143 crossed over from the placebo arm; 27 in the everolimus arm continued to receive the same treatment after unblinding). The median OS (95% CI) after 271 events was 29.2 months (23.8-35.9) for the everolimus arm and 35.2 months (30.0-44.7) for the placebo arm (HR, 1.17; 95% CI, 0.92-1.49). HR adjusted for baseline covariates was 1.08 (95% CI, 0.84-1.38). The most frequent drug-related grade 3 or 4 AEs reported during the open-label phase were diarrhea (5.3%), fatigue (4.7%), and stomatitis (4.1%). Deaths related to pulmonary or cardiac failure were observed more frequently in the everolimus arm.Conclusion: No significant difference in OS was observed for the everolimus plus octreotide LAR and placebo plus octreotide LAR arms of the RADIANT-2 study, even after adjusting for imbalances in the baseline covariates. Clinical Trial Number: NCT00412061, www.clinicaltrials.gov
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- everolimus
- neuroendocrine tumors
- carcinoid syndrome
- overall survival
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Pavel, M. E.
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Baudin, E.
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Öberg, Kjell, 19 ...
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Hainsworth, J. D ...
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Voi, M.
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Rouyrre, N.
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visa fler...
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Peeters, M.
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Gross, D. J.
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Yao, J. C.
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Uppsala universitet