Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion – NETs and endocrine tumours

3362 - Impact of lung metastasis on overall survival (OS) in the phase 3 SELECT study with lenvatinib (LEN) in patients (pts) with radioiodine refractory differentiated thyroid cancer (RR-DTC)

Date

30 Sep 2019

Session

Poster Discussion – NETs and endocrine tumours

Presenters

Makoto Tahara

Citation

Annals of Oncology (2019) 30 (suppl_5): v756-v759. 10.1093/annonc/mdz267

Authors

M. Tahara1, N. Kiyota2, A..O. Hoff3, C. Badiu4, T.K. Owonikoko5, C.E. Dutcus6, T. Suzuki7, M. Ren8, S. Misir6, L.J. Wirth9

Author affiliations

  • 1 Department Of Head And Neck Medical Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Department Of Medical Oncology And Hematology, Kobe University, 650-0017 - Kobe/JP
  • 3 Departamento De Endocrinologia, Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, 01246-000 - São Paulo/BR
  • 4 Department Of Thyroid Related Disorders, National Institute of Endocrinology, 11863 - Bucharest/RO
  • 5 Department Of Hematology And Medical Oncology, Emory University, 30322 - Atlanta/US
  • 6 Clinical Research, Eisai Inc, 07677 - Woodcliff Lake/US
  • 7 Japan And Asia Clinical Development Department, Oncology Business Group, Eisai Co., Ltd., 112-8088 - Tokyo/JP
  • 8 Biostatistics, Eisai Inc., 07677 - Woodcliff Lake/US
  • 9 Department Of Medicine, Massachusetts General Hospital Cancer Center, 02114 - Boston/US

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 3362

Background

In the randomized phase III SELECT study, LEN demonstrated a significant prolongation of progression-free survival compared with placebo (PBO) in pts with RR-DTC. There was no significant difference in overall survival (OS) between LEN and PBO arms which was likely due to > 80% of pts on the PBO arm crossing over to open-label LEN treatment. This exploratory post hoc analysis investigated the impact of measurable lung metastasis on OS from the SELECT study.

Methods

The hazard ratio (HR) for OS (data cutoff, September 1, 2016) and the 95% CIs were estimated using the Cox proportional hazards model. The influence of various baseline characteristics on OS was analyzed using a multivariate analysis based on a Cox proportional hazards model. Subgroup analysis of OS was conducted based on maximum size of measurable lung metastasis (≥ 1 cm per RECIST 1.1) at baseline.

Results

In the overall population (392 pts), median OS of LEN (261 pts) and PBO (131 pts, with 115 pts crossed over to LEN) arms, were 40.3 months (M) and 34.5 M, respectively (hazard ratio [HR] 0.87, 95% CI 0.66 –1.15, P = 0.3170). In 306 pts with lung metastasis of ≥ 1.0 cm, significant prolongation of OS was observed with LEN (199 pts) compared with PBO (107 pts, with 95 pts crossed over to LEN) (HR 0.63, 95% CI 0.47–0.85, P = 0.0025). This was maintained after adjustment for baseline characteristics in the multivariate model. Similar trends of OS prolongation by LEN were observed in pts with lung metastasis of ≥ 1.5 cm, ≥ 2.0 cm, and 1.0–2.0 cm (Table).Table:

1862PD Overall survival by size of measurable lung metastasis at baseline

Lung LesionNumber of PtsMedian OS (M)HR95% CIP Value
LENPBOLENPBO
≥1.0 cm19910744.733.10.630.47 – 0.850.0025
≥1.5 cm1508444.122.30.630.45 – 0.890.0082
≥2.0 cm945834.719.30.650.44 – 0.980.0383
1.0–2.0 cm1054949.238.60.630.40 – 0.990.0438
*

≥ 1 cm per RECIST 1.1

Conclusions

In pts with lung metastasis of ≥ 1.0 cm, LEN significantly prolonged OS compared to pts treated by PBO including those crossed over to LEN. This post-hoc analysis suggests that RR-DTC pts with lung metastasis could be candidates for targeted therapy.

Clinical trial identification

NCT01321554; Release date: December 30, 2016.

Editorial acknowledgement

Oxford PharmaGenesis, Newtown, PA, USA; Funded by Eisai Inc.

Legal entity responsible for the study

Eisai Inc. and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Funding

Eisai Inc. and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Disclosure

M. Tahara: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bayer; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (institution): Eisai; Honoraria (self): Merck Serono; Honoraria (self): Takeda; Advisory / Consultancy, Research grant / Funding (institution): Boehringer-Ingelheim; Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (institution): Ono Pharmaceutical; Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Merck Sharp & Dohme; Research grant / Funding (institution): NanoCarrier; Research grant / Funding (institution): Novartis. N. Kiyota: Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self): Merck Serono; Honoraria (self), Research grant / Funding (institution): Astra-Zeneca; Honoraria (self), Research grant / Funding (institution): Eisai; Honoraria (self), Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Chugai Pharmaceutical. A..O. Hoff: Research grant / Funding (institution): Eisai; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Astra-Zeneca; Research grant / Funding (institution): Exelixis; Advisory / Consultancy: Genzyme. T.K. Owonikoko: Advisory / Consultancy, Research grant / Funding (institution): Novartis, Celgene, Bayer; Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca/MedImmune, Abbvie; Advisory / Consultancy, Research grant / Funding (institution): G1 Therapeutics, Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (institution): Amgen, Loxo/Lilly; Research grant / Funding (institution): Astellas, Stemcentrx, Regeneron, Corvus Pharmaceuticals; Research grant / Funding (institution): United Therapeutics, Fujifilm, Pfizer; Research grant / Funding (institution): Aeglea Biotherapeutics, Incyte, Merck; Advisory / Consultancy: Sandoz, Eisai, Takeda, Seattle Genetics; Advisory / Consultancy: BerGenBio, PharmaMar, Boehringer Ingelheim; Advisory / Consultancy: EMD Serono, Xcovery; Advisory / Consultancy: Heron Pharmaceuticals, Armo BioSciences; Shareholder / Stockholder / Stock options: Cambium Oncology. C.E. Dutcus: Full / Part-time employment: Eisai Inc.. T. Suzuki: Full / Part-time employment: Eisai Co., Ltd. M. Ren: Full / Part-time employment: Eisai Inc.. S. Misir: Full / Part-time employment: Eisai Inc. L.J. Wirth: Advisory / Consultancy: Bayer; Advisory / Consultancy: Eisai; Advisory / Consultancy: Loxo; Advisory / Consultancy: Merck. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.