1924P - Efficacy and safety of lenvatinib in patients with chemotherapy-naive advanced or recurrent thymic carcinoma: A multicenter retrospective study

Background

Lenvatinib has been suggested to be effective and safe in patients with previously treated thymic carcinoma. However, there is little clinical data on lenvatinib use in patients with chemotherapy-naive thymic carcinoma.

Methods

We performed a retrospective, multicenter study of patients with advanced or recurrent thymic carcinoma who received lenvatinib between March 23, 2021, and October 31, 2022. This is the subgroup analysis of the efficacy and safety of first-line treatments.

Results

A total of 107 patients from 31 institutions across Japan were enrolled. Twenty received lenvatinib as the first-line treatment and their median age was 68 years (range, 39–81 years); 12 (60%) were males, 16 (80%) had a performance status of 0–1, and 16 (80%) had squamous cell carcinoma. The median observation period was 11.5 months (interquartile range, 9.8–17.3). Among these 20 patients, the objective response rate was 50% (95% confidence interval [CI]: 27.2–72.8). The disease control rate was 85% (95% CI: 62.1–96.8). The median progression-free survival was 10.8 months (95% CI: 5.6–not reached [NR]). The median overall survival was NR (95% CI: 12.0–NR). Treatment-related adverse events (AE) of any grade occurred in 19 patients (95%), the most common being proteinuria (80%), hypertension (70%), and fatigue or malaise (50%). Grade 3 or higher AE occurred in 11 patients (55%), the most common being proteinuria (45%) and increased aspartate or alanine aminotransferase levels (10% each). AE leading to dose interruption or reduction occurred in 16 patients (80%), the most common being proteinuria (45%) and decreased platelet count (15%). AE leading to treatment discontinuation occurred in five patients (25%), including proteinuria (20%) and bronchopulmonary hemorrhage (5%). No patient developed pneumonitis or died of AE.

Conclusions

These findings suggest that lenvatinib is a promising treatment option for chemotherapy-naive thymic carcinoma. No new safety signals were observed. Prospective investigations are required to confirm the efficacy and safety of the first-line treatment.

Clinical trial identification

UMIN000051645 Release date: July 19, 2023.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

D. Hazama: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, Eli Lilly, Ono pharmaceutical, Taiho pharmaceutical, Bristol Myers Squibb. K. Takagi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, Taiho pharmaceutical, Eisai. G. Saito: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, Ono pharmaceutical, Novartis, MSD, Pfizer, Daiichi Sankyo pharmaceutical, Taiho pharmaceutical. H. Ashinuma: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Chugai pharmaceutical, Boehringer Ingelheim, Bristol Myers Squibb, Ono pharmaceutical, Pfizer, Merck, Takeda pharmaceutical, Thermo Fisher Scientific K.K., Eli Lilly, Nippon Kayaku, Daiichi Sankyo pharmaceutical. T. Shukuya: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Chugai pharmaceutical, Boehringer Ingelheim, Eli Lilly, MSD, Ono pharmaceutical, Merck, Novartis, Takeda pharmaceutical, Pfizer, Daiichi Sankyo pharmaceutical, Taiho pharmaceutical, Bristol Myers Squibb, Eisai, Nippon Kayaku, Amgen; Financial Interests, Institutional, Local PI: AstraZeneca, Chugai pharmaceutical, MSD, Novartis; Financial Interests, Institutional, Research Funding: Chugai pharmaceutical, Boehringer Ingelheim. S. Sakata: Non-Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Chugai pharmaceutical, Takeda pharmaceutical. A. Mouri: Non-Financial Interests, Personal, Speaker’s Bureau: Chugai pharmaceutical, Eli Lilly, Ono pharmaceutical, Bristol Myers Squibb. H. Miwa: Financial Interests, Personal, Invited Speaker: Nippon Shinyaku. Y. Tamura: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, MSD, Ono pharmaceutical, Boehringer Ingelheim, Bristol Myers Squibb, Novartis. T. Tokito: Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, MSD, Ono pharmaceutical, Bristol Myers Squibb, Nippon Kayaku. Y. Tsukita: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca, Eli Lilly, MSD, Eisai, Chugai pharmaceutical, Taiho pharmaceutical, Daiichi Sankyo pharmaceutical, Bristol Myers Squibb, Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Chugai pharmaceutical, Eli Lilly. Y. Kogure: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai pharmaceutical, Eli Lilly, Ono pharmaceutical, Takeda pharmaceutical, Taiho pharmaceutical, MSD; Financial Interests, Institutional, Funding: MSD; Financial Interests, Institutional, Principal Investigator: MSD. T. Masuda: Financial Interests, Personal, Invited Speaker: Daiichi Sankyo pharmaceutical, Taiho pharmaceutical, Boehringer Ingelheim, Eli Lilly, Ono pharmaceutical, Chugai pharmaceutical, AstraZeneca, Otsuka pharmaceutical, Kyowa Kirin. H. Tanaka: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai pharmaceutical, Daiichi Sankyo pharmaceutical, Eisai, Eli Lilly, Hisamitsu pharmaceutical, Merck, MSD, Nippon Kayaku, Novartis, Ono pharmaceutical, Pfizer, Taiho pharmaceutical, Takeda pharmaceutical; Financial Interests, Institutional, Local PI: AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Chugai pharmaceutical, Daiichi Sankyo pharmaceutical, Eli Lilly, Janssen pharmaceutical, Merck, MSD, Ono pharmaceutical, Pfizer, Taiho pharmaceutical, Takeda pharmaceutical. S. Kubo: Financial Interests, Personal, Invited Speaker: Chugai pharmaceutical. T. Suzuki: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim; Non-Financial Interests, Personal and Institutional, Local PI: Boehringer Ingelheim, Merck, Taiho pharmaceutical. All other authors have declared no conflicts of interest.