Gland and Hormone Related Diseases

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Thyroid Diseases

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Thyroid Neoplasms

Thyroid Carcinoma, Anaplastic

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Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

Antineoplastic Agents

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Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive lenvatinib 24 milligrams (mg) (2 10-mg capsules and one 4-mg capsule) once daily by oral administration at approximately the same time each morning for up to approximately 24 months.

Lenvatinib 24 mg

The primary purpose of the study is to evaluate objective response rate (\[ORR\]: complete response \[CR\] and partial response \[PR\]) by investigator review in participants with anaplastic thyroid cancer (ATC) treated with lenvatinib.

A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)

An Open-Label, Single-Arm, Multicenter, Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)

Eisai IPD sharing statement: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target lesions. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameters of target lesions, taking as reference the Baseline sum diameters. Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response.

Twelve-week PFS rate was the percentage of participants in the analysis population who remain alive and progression-free at 12 weeks. PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first. The Kaplan-Meier estimated rate method was used to estimate 12-week PFS, along with the corresponding 95% confidence interval (CI). Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored.

Six-month OS rate was defined as the percentage of participants in the analysis population who are alive at 6 months. OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. The Kaplan-Meier estimated rate method was used to estimate six-month OS, along with the corresponding 95% CI. Participants with last known alive date as study terminated by sponsor were censored.

PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored.

OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. Median OS was estimated using the Kaplan-Meier method. Participants with last known alive date as study terminated by sponsor were censored.

Eisai Inc.

Participants received lenvatinib 24 mg (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The full analysis set included all participants who received at least one dose of lenvatinib.

The study was terminated since overall response rate was 3% (only 1 out of 33 participants had confirmed PR).

Eisai Medical Information

The evaluable analysis set included all participants with histological diagnosis of ATC that was confirmed by central pathology review and who received at least one dose of lenvatinib.

Objective Response Rate (ORR)

Progression-free Survival (PFS) Rate

Overall Survival (OS) Rate

Median PFS

Median OS

Participants received lenvatinib 24 milligram (mg) (two 10-mg capsules and one 4-mg capsule), orally, once daily in a 28-days treatment cycle up to disease progression, development of unacceptable toxicity, lost to follow up, withdrawal of consent, participant's choice, pregnancy, or study termination by sponsor (approximately 27 months).

Overall Study

Sorafenib

After the patient had diagnosed as anaplastic thyroid cancer, Nexavar was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.

operation for possible surgical treatment,with complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.

then External radiation therapy after surgery.

for Unresectable tumors ,After the patient had diagnosed as anaplastic thyroid cancer, Nexavar 400mg Bid was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.

Nexavar

If computed tomography (CT) evaluates for possible surgical treatment, complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.

operation

As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy

External radiation therapy

Undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. Most undifferentiated cancers lose the chance of surgery when they are first diagnosed. The current study, Nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. This study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery.

Undifferentiated thyroid cancer is the most malignant tumor of the thyroid gland, with a median survival of only 3 months. Most undifferentiated cancers lose the chance of surgery when they are first diagnosed. The current study, Nexavar, is used only for dedifferentiated thyroid cancer and has not been applied to undifferentiated cancer. This study attempted to apply it to preoperative treatment of undifferentiated cancer to see if it would shrink the tumor and give the patient an opportunity for surgery.

We chose patients with recurrent or inoperable anaplastic thyroid cancer and used NEXAVAR for 1 month of neoadjuvant therapy. If tumor lesions begin to resolve, they continue neoadjuvant therapy until the end of the second month. The total duration of preoperative treatment is two months.at the end of the second month, a CT scan was performed to assess whether surgery could be performed. If surgery is possible, NEXAVAR will continue to perform adjuvant radiotherapy after the surgery.

Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Prospective Study of Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer

Length of contact surface between tumor and common carotid artery

Percentage of patients in whom the actual dose of sorafenib equaled the planned dose

Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause

Overall tolerability of treatment as measured by rate of adverse events

Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after treatment with NEXAVAR

Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death

Adverse events was evaluated during received protocol therapy according to CTCAE 4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)	NCT02657369	Thyroid Carcino...	Lenvatinib 24 m...	18 Years - 99 Years	Eisai Inc.
Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer	NCT03565536	Thyroid Cancer,...	Nexavar operation External radiat...	18 Years -	Fujian Medical University
Nexavar for Neoadjuvant Treatment of Anaplastic Thyroid Cancer	NCT03565536	Thyroid Cancer,...	Nexavar operation External radiat...	18 Years -	Fujian Medical University

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