Thyroid gland morphing into a flower, symbolizing hope in thyroid cancer treatment.

Lenvatinib and Thyroid Cancer: A New Hope for Refractory Cases

Jordan Keane in Health & Wellness August 2025 • 4 min read.

"Exploring the Impact of Lenvatinib on Differentiated Thyroid Cancer: A Cohort Study Analysis"

Thyroid cancer, particularly differentiated thyroid cancer (DTC), often begins with surgery, sometimes followed by radioactive iodine (RAI) therapy. This approach aims to eliminate any remaining thyroid tissue and address microscopic spread. However, when the cancer recurs or spreads and no longer responds to RAI therapy, treatment options become limited, casting a shadow over the patient's prognosis.

In recent years, the landscape has begun to shift. Global phase III trials have demonstrated that molecular-targeting agents, such as sorafenib and lenvatinib, can significantly improve progression-free survival (PFS) in patients with RAI-refractory DTC (RR-DTC). These advancements offer a beacon of hope for those who have exhausted other treatment avenues. Lenvatinib, in particular, works by selectively inhibiting multiple receptor tyrosine kinases, which are crucial for tumor angiogenesis and progression.

The approval of lenvatinib has marked a significant step forward. A pivotal phase III study comparing lenvatinib to a placebo in RR-DTC patients revealed that lenvatinib substantially improved median PFS (18.3 months versus 3.6 months) and overall response rate (64.8% versus 1.5%).

The Lenvatinib Study: Objectives and Design

Thyroid gland morphing into a flower, symbolizing hope in thyroid cancer treatment.

While initial results are promising, there's a need for more data on the long-term safety and efficacy of lenvatinib, especially within the Japanese population. A sub-analysis of Japanese patients in the phase III study indicated that dose reduction and therapy suspension due to adverse events (AEs) were more frequent compared to the overall patient population. To address these concerns, a prospective observational study was designed to gather comprehensive safety and efficacy data on lenvatinib in Japanese patients with curatively unresectable, RAI-refractory, and progressive DTC.

The study seeks to identify predictors of antitumor activity and survival, aiming to provide reference information for developing evidence-based DTC treatment guidelines. The primary endpoint is overall survival (OS), which will help determine whether achieving longer disease control with lenvatinib improves the prognosis. Clinical progressive disease is defined as disease progression with progressive symptoms, multiple disease progression, or life-threatening organ metastasis. Quality of life (QOL) will also be assessed, acknowledging the relatively long survival of DTC patients.

The key objectives of this observational study include:

Assessing the overall survival (OS) of patients treated with lenvatinib.
Evaluating progression-free survival (PFS) and time to treatment failure (TTF).
Analyzing the safety profile of lenvatinib in a real-world clinical setting.

The study protocol involves administering lenvatinib orally at a dose of 24 mg daily, with potential dose adjustments based on the patient's condition. Patients will undergo regular assessments, including hematology tests and biochemistry tests, to monitor adverse events and treatment response. Patient-reported outcomes, compliance, and symptoms will also be tracked to gain a holistic view of the patient experience. Antitumor activity will be evaluated at each study site, with progression assessed using clinical progressive disease criteria. Furthermore, a QOL survey will be conducted at baseline and during treatment to capture the impact of lenvatinib on patients' daily lives.

The Future of Lenvatinib in Thyroid Cancer Treatment

This study promises to offer valuable insights into the use of lenvatinib for treating differentiated thyroid cancer in Japan. By collecting comprehensive data on safety, efficacy, and patient-reported outcomes, researchers aim to refine treatment guidelines and optimize patient selection, dosages, and treatment duration. Ultimately, this collaborative effort seeks to improve the lives of individuals battling this challenging form of cancer, providing new hope and better outcomes for those in need.

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This article is based on research published under:

DOI-LINK: 10.1507/endocrj.ej18-0261, Alternate LINK

Title: Cohort Study Exploring The Effect Of Lenvatinib On Differentiated Thyroid Cancer

Subject: Endocrinology

Journal: Endocrine Journal

Publisher: Japan Endocrine Society

Authors: Makoto Tahara, Hiroshi Takami, Yasuhiro Ito, Kiminori Sugino, Shunji Takahashi, Hiroshi Takeyama, Hidemitsu Tsutsui, Hisato Hara, Ayako Mitsuma, Hiroyuki Yamashita, Takahiro Okamoto, Iwao Sugitani, Yasuo Ohashi, Tsuneo Imai

Published: 2018-01-01

Everything You Need To Know

Why is Lenvatinib considered a new hope for patients with differentiated thyroid cancer?

Lenvatinib is significant because it offers a treatment option for differentiated thyroid cancer (DTC) patients whose cancer is refractory to radioactive iodine (RAI) therapy. It works by inhibiting multiple receptor tyrosine kinases, which are crucial for tumor angiogenesis and progression, leading to improved progression-free survival (PFS).

What improvements were observed in the phase III study comparing Lenvatinib to a placebo?

In a pivotal phase III study, Lenvatinib demonstrated a substantial improvement in median progression-free survival (PFS) compared to a placebo in RAI-refractory DTC patients. The median PFS was 18.3 months for patients treated with lenvatinib, compared to only 3.6 months for those on the placebo. Additionally, the overall response rate was significantly higher with lenvatinib, at 64.8%, versus 1.5% with the placebo.

What are the key objectives and endpoints of the observational study of Lenvatinib in Japanese patients with differentiated thyroid cancer?

The primary endpoint of the observational study in Japanese patients is overall survival (OS). Secondary objectives include evaluating progression-free survival (PFS), time to treatment failure (TTF), and the safety profile of Lenvatinib. The study also aims to identify predictors of antitumor activity and survival to refine DTC treatment guidelines.

What does the treatment and monitoring protocol entail for patients participating in the Lenvatinib study?

The Lenvatinib study involves administering Lenvatinib orally at a dose of 24 mg daily, with potential dose adjustments based on the patient's condition and tolerance. Patients will undergo regular hematology and biochemistry tests to monitor adverse events and treatment response. Patient-reported outcomes, compliance, and symptoms will also be tracked. Antitumor activity is evaluated at each study site using clinical progressive disease criteria, and a QOL survey is conducted at baseline and during treatment.

How are the findings from the Lenvatinib study expected to influence the future treatment of differentiated thyroid cancer?

The findings from the Lenvatinib study are expected to offer valuable insights into the safety, efficacy, and patient-reported outcomes associated with Lenvatinib treatment for differentiated thyroid cancer (DTC) in the Japanese population. By identifying predictors of antitumor activity and survival, and by evaluating the impact of Lenvatinib on patients' quality of life, the research aims to refine treatment guidelines, optimize patient selection, dosages, and treatment duration. Ultimately, this effort seeks to improve the lives of individuals battling this challenging form of cancer, providing new hope and better outcomes.