ESA-SRB-AOTA 2019

Influence of tumor size and Eastern Cooperative Oncology Group performance status (ECOG PS) at baseline on patient outcomes in lenvatinib-treated radioiodine-refractory differentiated thyroid cancer (RR-DTC) (#780)

Lori J. Wirth 1 , Sophie Leboulleux 2 , Naomi Kiyota 3 , Makoto Tahara 4 , Kei Muro 5 , Myung-Ju Ahn 6 , Yuichi Ando 7 , Matthew H. Taylor 8 , Shunji Takahashi 9 , Sung-Bae Kim 10 , Bruce Robinson 11 , Soamnauth Misir 12 , Corina E. Dutcus 12 , Ran Xie 12 , Prashant Joshi 13 , Brett G.M. Hughes 14 , Javier Aller 15 , Monika Krzyzanowska 16 , Jaume Capdevila 17
  1. Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA
  2. Department of Nuclear Medicine, Gustave Roussy, Villejuif, France
  3. Department of Medical Oncology and Hematology and Cancer Center, Kobe University Hospital, Kusunoki Cho, Chuo-ku, Japan
  4. Division of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan
  5. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
  6. Department of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
  7. Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan
  8. Oregon Health & Science University, Portland, Oregon, USA
  9. Department of Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan
  10. Asan Medical Center, University of Ulsan College of Mecine, Seoul, Republic of Korea
  11. Cancer Genetics Laboratory, Kolling Institute of Medical Research, Syndey, Australia
  12. Eisai Inc., Woodcliff Lake, New Jersey, USA
  13. Formerly of Eisai Inc., Woodcliff Lake, New Jersey, USA
  14. Cancer Care Services, The Royal Brisbane and Women's Hospital, University of Queensland, Queensland, Australia
  15. Department of Endocrinology, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain
  16. Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada
  17. Medical Oncology Department, University Hospital Vall d’Hebron, Barcelona, Spain

Background:

In SELECT, lenvatinib significantly improved progression-free survival (PFS) of patients with RR-DTC versus placebo (18.3 vs 3.6 months; hazard ratio [HR]: 0.21 [99% CI: 0.14, 0.31]; P<0.001). Here we examine the treatment of RR-DTC with lenvatinib in relation to tumor size (sum of all targeted lesions) and ECOG PS.

Methods:

In this post hoc analysis of SELECT with patients randomized to receive lenvatinib, Kaplan-Meier estimates of time to ECOG PS ≥2 were calculated for subgroups of patients according to baseline ECOG PS or tumor size. Objective response rate (ORR) and Kaplan-Meier estimates of overall survival (OS) and PFS according to ECOG PS (0 or 1) at baseline were calculated. Percentage change from baseline to postbaseline nadir in the sum of diameters of target lesions and percentage change over time according to ECOG PS at baseline (0 or 1) were assessed.

Results:

Patients with ECOG PS 0 or 1 at baseline had similar demographic and disease characteristics. ORR was 78.5% and 51.0% for patients with ECOG PS 0 and 1 at baseline, respectively (odds ratio [95% CI]: 3.508 [2.018, 6.097]). Mean maximum percent decrease in tumor size was greater in patients with baseline ECOG PS 0 (-46.13%) versus patients with ECOG PS 1 (-37.16%). For patients with ECOG PS 1 at baseline, time to ECOG PS ≥2 was numerically shorter with tumor size >60 mm versus tumor size ≤60 mm (HR [95% CI]: 1.450 [0.708, 2.967]). Additional results are summarized in the table.

Conclusions:

Among patients with RR-DTC, PFS, OS, ORR, and time to ECOG ≥2 were generally better for patients with lower ECOG PS or smaller tumor size at baseline. These results may indicate that it is beneficial to start lenvatinib in patients with RR-DTC early, before ECOG PS worsens and tumor size increases.

Clinical trial information: NCT01321554

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