Abstract 3191
Background
The efficacy and safety of lenvatinib (LEN) are unknown in cases that were excluded in the phase III trial (REFLECT trial) of LEN, including those who experienced tyrosine kinase inhibitors (TKI) before LEN. In addition, no evidence has been established for early introduction of molecular targeted therapy in BCLC stage B patients. Therefore, we verified the efficacy and safety in the patients who did not meet the inclusion criteria of REFLECT trial and those who were BCLC Stage B.
Methods
A total of 203 patients received LEN from March 2018 to January 2019 at 21 sites in Japanese Red Cross Study Liver Group were registered. 128 cases out of REFLECT trial criteria and 74 cases of BCLC Stage B were retrospectively investigated. Tumors assessments in accordance with modified RECIST were done using dynamic CT and/or MRI.
Results
128 of 203 (63%) patients did not meet the inclusion criteria of the REFLECT trial. These cases included 69 receiving TKI therapy before LEN. The ORR and DCR in TKI naïve were 45% and 84%, respectively, and were 29% and 81% in TKI experienced (p = 0.072, p = 0.671). The OS between TKI naïve and experienced patients was not significantly different (p = 0.618), even though baseline albumin level and ALBI score were significantly lower in TKI experienced patients than TKI naïve (p = 0.001 and 0.005). 74 cases of BCLC Stage B included 57 with TACE history, 8 without, and 9 cases unknown. Although there was no difference between two groups in the baseline Child-Pugh score, ALBI score and AFP value, patients with TACE less than 6 times (n = 53) before LEN was significantly better in OS than those with TACE of 6 times or more (n = 12) (p = 0.025).
Conclusions
Also in TKI experienced which was excluded from the REFLECT trial, ORR, DCR and OS did not differ from TKI naïve, and LEN may be useful as TKI 2nd line and 3rd line. In BCLC Stage B patients, TACE group less than 6 times has a better prognosis after LEN treatment compared with group more than 6 times, and an early introduction of LEN for multiple TACE cases may contribute to life prognosis improvement is there.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2551 - Efficacy of dose-dense (DD) adjuvant chemotherapy (CT) in hormone receptor positive/HER2-negative early breast cancer (BC) patients (pts) according to immunohistochemically (IHC) defined luminal subtypes: an exploratory analysis of the GIM2 trial.
Presenter: Benedetta Conte
Session: Poster Display session 2
Resources:
Abstract
3426 - High dose Neo-adjuvant chemotherapy in Triple-Negative breast cancer with evidence of homologous recombination deficiency (HRD).
Presenter: Sonja Vliek
Session: Poster Display session 2
Resources:
Abstract
3792 - Risk factors for locoregional recurrence (LRR) after neoadjuvant chemotherapy: pooled analysis of prospective neoadjuvant breast cancer (BC) trials
Presenter: Gustavo Werutsky
Session: Poster Display session 2
Resources:
Abstract
4044 - Estimating radiotherapy-induced cardiovascular mortality in female breast cancer patients.
Presenter: Mark De Ridder
Session: Poster Display session 2
Resources:
Abstract
719 - 3-year follow-up of a phase III trial comparing the efficacy and safety of neoadjuvant and adjuvant trastuzumab and its biosimilar CT-P6 in HER2 positive early breast cancer (EBC)
Presenter: Justin Stebbing
Session: Poster Display session 2
Resources:
Abstract
3595 - Adjuvant chemotherapy in elderly breast cancer patients: pattern of use and impact on overall survival
Presenter: Axel Berthelot
Session: Poster Display session 2
Resources:
Abstract
3992 - Carboplatin-containing neoadjuvant chemotherapy for triple negative breast cancer (TNBC): a propensity score-matched study.
Presenter: Maria Vittoria Dieci
Session: Poster Display session 2
Resources:
Abstract
3477 - Impact of adjuvant trastuzumab emtansine (T-DM1) on incidence of metastatic breast cancer (mBC): an epidemiological model of patients with HER2-positive breast cancer (BC) who did not achieve pathological complete response (pCR) after neoadjuvant treatment (non-pCR)
Presenter: Mellissa Williamson
Session: Poster Display session 2
Resources:
Abstract
3928 - Chemotherapy (CT)-induced anaemia in patients (pts) treated with dose-dense regimen: Results of the prospectively randomised anaemia substudy from the neoadjuvant GeparOcto study
Presenter: Hans Tesch
Session: Poster Display session 2
Resources:
Abstract
2184 - The clinical impact of adjuvant dose-dense sequential chemotherapy (dds-CT) in patients with high-risk operable breast cancer (BC); pooled analysis of 6 clinical trials.
Presenter: Elena Fountzilas
Session: Poster Display session 2
Resources:
Abstract