Background: The benefits and tolerability of transarterial chemoembolization (TACE) combined with regorafenib as a second-line therapy has not been reported for unresectable hepatocellular carcinoma (HCC). To explore the benefits and tolerability of TACE combined with second-line regorafenib in patients with unresectable advanced HCC and failure to first-line treatment.Methods: This was a multicenter retrospective study of patients with progression after first-line sorafenib and/or lenvatinib between 01/2019 and 04/2020 at four tertiary hospitals in China. The patients were treated with TACE. Then, 5-7 days after the first TACE, the patients started taking regorafenib for 3 weeks every 4-week cycles. The overall survival (OS), time to progression (TTP), progression-free survival (PFS), and adverse events (AEs) were observed.Results: The median follow-up was 5.6 (range: 0.7, 17.0) months. The median age was 60 (range: 35, 79) years. There were 32 (84.2%) males. The patients underwent a median of three TACE sessions (range, 1-13). The initial doses of regorafenib were 20 mg/d (n=1, 2.6%), 80 mg/d (n=10, 26.3%), 120 mg/d (n=15, 39.5%), and 160 mg/d (n=11, 28.9%). The incidence of grade 3/4 AEs was 15.8%. Two patients stopped regorafenib due to AEs. The median OS was 14.3 months. The median PFS and TTP were 9.1 (95% CI: 4.0, 14.2) and 9.1 (95% CI: 5.5, 12.8) months, respectively.Conclusions: The present study provides real-world evidence indicating that regorafenib combined with TACE was beneficial and tolerable in patients with unresectable HCC. Additional prospective large-scale studies are required for confirmation.
e13050 Background: This study was to compare the efficacy and safety of different nab-paclitaxel dose schedule in patients with HER-2 negative recurrent/metastatic breast cancer in order to find a more suitable treatment option for Chinese patients. Methods: This is a single-center, open-label, randomized, phase II trial. Eligible female patients with HER-2 negative recurrent/metastatic breast cancer and up to 2 lines of prior chemotherapy regardless of any endocrine therapy were randomly assigned (1:1) to either nab-paclitaxel (125mg/m2 IV days 1, 8, every 21 days, 3-week group) or nab-paclitaxel (125mg/m2 IV days 1, 8, 15, every 28 days, 4-week group) until progressive disease or completion of 6-8 cycles of treatment. After completing 6-8 cycles, if the efficacy evaluation is CR, PR or SD, the investigator can decide whether to carry out maintenance therapy. The primary endpoint is PFS. Secondary endpoints are ORR, OS and safety. Results: Between March 2019 and July 2021, 104 patients with HER-2 negative breast cancer were randomly assigned to treatment (3-week group, n = 51; 4-week group, n = 53). Median follow-up was 16.4 and 15.8 months. In the 3-week and 4-week groups, respectively, 39 (76.5%) and 42 (79.2%) patients had HR positive disease and 37 (72.5%) and 43 (81.1%) patients had visceral metastasis. In two groups, respectively, 30 (58.8%) and 20 (37.7%) patients didn’t receive prior endocrine therapy. 20 (39.2%) and 32 (60.4%) patients had received 1 to 3 lines of prior endocrine therapy. 30 (58.8%) patients of 3-week group and 30 (56.6%) patients of 4-week group were enrolled at first-line chemotherapy, and 13 (25.5%) of 3-week group patients and 16 (30.2%) patients of 4-week group were enrolled at second-line chemotherapy, as third-line chemotherapy there were only 8 (15.7%) in 3-week group and 7 (13.2%) in 4-week group. Among all patients, 33 (64.7%) in the 3-week group and 16 (30.2%) in the 4-week group had received 6-8 cycles according to the regimen of study, and 32 (97.0%) of 3-week group and 15 (93.8%) of 4-week group patients who finished the regimen choose to receive maintenance treatment (endocrine or chemotherapy).In two groups, respectively, median PFS was 9.6 months and 7.5 months (HR 0.905; 95%CI 0.569-1.440) and ORR were 50.0% (23/46) and 46.9% (23/49) in the evaluable population. Median OS was 22.5 months in the 3-week group and has not yet been reached for the 4-week group. According to NCI-CTCAE V5.0, 3-week group vs 4-week group respectively, the grade 3-4 adverse events (≥2 patients) were neutropenia (13.7% vs 34.0%), leukopenia (7.8% vs 17.0%) and peripheral neurotoxicity (0 vs 3.8%). Conclusions: Preliminary results suggest that compared with the 4-week regimen, the 3-week regimen of nab-paclitaxel seems to be more suitable and adaptable for Chinese patients with advanced breast cancer. This study is still in follow-up and updated data will be presented. Clinical trial information: NCT04192331.
IntroductionEribulin is currently recommended for the treatment of patients with metastatic breast cancer (MBC) pre‐treated with taxanes and anthracyclines. The aim of the present study was to evaluate the effectiveness and safety of eribulin and its impact on health‐related quality of life in heavily pre‐treated patients with MBC.MethodsData from MBC patients who had received eribulin‐based therapy at Beijing Cancer Hospital between January 2020 and July 2022 were analyzed retrospectively. Progression‐free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), adverse effects (AEs) and health‐related quality of life (HRQoL) were assessed.ResultsData from 118 patients who had received eribulin to treat MBC were included. Median PFS was 4.2 months and median OS had not been reached. The ORR was 13.6% (16/118) and DCR was 75.4% (89/118). The median PFS in patients who received eribulin in second‐line (26/118), third‐line (29/118), or fourth‐line or later (63/118) was 4.5, 4.2, and 3.9 months, respectively. The median OS in patients who received eribulin in third‐ or later line (n = 92) was 14.1 months. Patients who received eribulin combination therapy had a significantly longer median PFS compared with those who received eribulin monotherapy (4.5 vs. 3.4 months, p = 0.007) and there was a trend towards a longer median OS (not reached vs. 12.1 months). The most common grade 3–4 adverse events were neutropenia (22.9%), leukocytopenia (13.6%) and asthenia/fatigue (8.5%), without significant differences in safety between eribulin monotherapy and combination therapy. Quality of life was similar in patients who received eribulin monotherapy and combination therapy, except for cognitive function and nausea and vomiting symptoms, which were better with combination therapy.ConclusionsThe present study suggests that eribulin‐based therapy is an effective treatment option and well tolerated for heavily pre‐treated patients with MBC. Eribulin combination therapy might improve PFS and HRQoL compared with eribulin monotherapy.
Purpose: Despite recent clinical improvements, HER2-positive metastatic breast cancer (MBC) is still incurable. A robust biomarker is needed in predicting the efficacy of anti-HER2 based therapy. Experimental Design: A total of 252 HER-positive MBC patients received first-line therapy were retrospectively recruited at two medical centers. Peripheral lymphocyte levels of baseline and subsequent follow-up visits were detected using flow-cytometer. The cutoff value of peripheral CD8+CD28-T cell (pTCD8+CD28-) was determined by X-tile software. The levels of TILs, immune cytokines and mutation prevalence were compared between pTCD8+CD28-high (≥18.0%) and pTCD8+CD28-low. Results: The median follow-up time was 29.6 months. pTCD8+CD28-high at baseline indicates a better PFS in patients received anti-HER2 based therapy (11.1 vs. 18.9 months, P = 0.001). During the therapeutic course, patients who maintained or regain pTCD8+CD28-high had a better PFS than those maintained pTCD8+CD28-low (15.5 vs. 11.1 vs. 7.7 months, P < 0.001). The higher IL-2 level (P = 0.034) and lower TGF-β level (P = 0.016) in the serum were connected to pTCD8+CD28-high. Highly infiltrated TILs including CD8 + CD28-T cell and higher prevalence of PD-L1 deletion (P = 0.041) were associated with pTCD8+CD28-high. The elevated pTCD8+CD28-level induced by anti-PD1 therapy was also observed in triple-negative MBC patients.Conclusions: The pTCD8+CD28-level at baseline and its dynamic change are predictive for anti-HER2 based therapy. Higher pTCD8+CD28-level is associated with an enhanced tumor immunity in HER2-positive MBC. Adding anti-PD1 therapy to HER2-targeted therapy according to pTCD8+CD28-level could be a promising alternative.
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