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11

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C-reactive protein to albumin ratio predicts survival in patients with unresectable hepatocellular carcinoma treated with lenvatinib

Tada, Toshifumi ; Kumada, Takashi ; Hiraoka, Atsushi ; [et al.]

Springer Science and Business Media LLC ; 2022

In: Scientific Reports Vol. 12, No. 1 ( 2022-05-19)

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In: Scientific Reports, Springer Science and Business Media LLC, Vol. 12, No. 1 ( 2022-05-19)

Abstract: We investigated the impact of C-reactive protein to albumin ratio (CAR) on predicting outcomes in 522 patients with unresectable hepatocellular carcinoma (HCC) treated with lenvatinib. We determined the optimal CAR cutoff value with time-dependent receiver operating characteristic curve analysis. Additionally, we clarified the relationship between CAR and liver function or HCC progression. Median overall survival was 20.0 (95% confidence interval (CI), 17.2–22.6) months. The optimal CAR cutoff value was determined to be 0.108. Multivariate analysis showed that high CAR (≥ 0.108) (hazard ratio (HR), 1.915; 95% CI, 1.495–2.452), Eastern Cooperative Oncology Group performance status ≥ 1 (HR, 1.429), and α-fetoprotein ≥ 400 ng/mL (HR, 1.604) were independently associated with overall survival. Cumulative overall survival differed significantly between patients with low versus high CAR ( p 〈 0.001). Median progression-free survival was 7.5 (95% CI, 6.7–8.1) months. Multivariate analysis showed that age, CAR ≥ 0.108 (HR, 1.644; 95% CI, 1.324–2.043), and non-hepatitis B, non-hepatitis C etiology (HR, 0.726) were independently associated with progression-free survival. Cumulative progression-free survival differed significantly between patients with low versus high CAR ( p 〈 0.001). CAR values were significantly higher as Japan Integrated Staging score increased ( p 〈 0.001). In conclusion, CAR can predict outcomes in patients with unresectable HCC treated with lenvatinib.

Type of Medium: Online Resource

ISSN: 2045-2322

URL: Article

DOI: 10.1038/s41598-022-12058-y

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2022

detail.hit.zdb_id: 2615211-3

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12

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Real-World Data for Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: How Does Adherence to the IMbrave150 Trial Inclusion Criteria Impact Prognosis?

Rimini, Margherita ; Persano, Mara ; Tada, Toshifumi ; [et al.]

Springer Science and Business Media LLC ; 2023

In: Targeted Oncology Vol. 18, No. 2 ( 2023-03), p. 221-233

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In: Targeted Oncology, Springer Science and Business Media LLC, Vol. 18, No. 2 ( 2023-03), p. 221-233

Type of Medium: Online Resource

ISSN: 1776-2596 , 1776-260X

URL: Article

DOI: 10.1007/s11523-023-00953-x

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2023

detail.hit.zdb_id: 2222136-0

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13

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Atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: a large real-life worldwide population

Casadei-Gardini, Andrea ; Rimini, Margherita ; Tada, Toshifumi ; [et al.]

Elsevier BV ; 2023

In: European Journal of Cancer Vol. 180 ( 2023-02), p. 9-20

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In: European Journal of Cancer, Elsevier BV, Vol. 180 ( 2023-02), p. 9-20

Type of Medium: Online Resource

ISSN: 0959-8049

URL: Article

DOI: 10.1016/j.ejca.2022.11.017

RVK:

XA 42017.A

RVK:

XA 42017

Language: English

Publisher: Elsevier BV

Publication Date: 2023

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detail.hit.zdb_id: 1468190-0

detail.hit.zdb_id: 82061-1

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14

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Sequential therapies after atezolizumab plus bevacizumab or lenvatinib first-line treatments in hepatocellular carcinoma patients

Persano, Mara ; Rimini, Margherita ; Tada, Toshifumi ; [et al.]

Elsevier BV ; 2023

In: European Journal of Cancer Vol. 189 ( 2023-08), p. 112933-

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In: European Journal of Cancer, Elsevier BV, Vol. 189 ( 2023-08), p. 112933-

Type of Medium: Online Resource

ISSN: 0959-8049

URL: Article

DOI: 10.1016/j.ejca.2023.05.021

RVK:

XA 42017.A

RVK:

XA 42017

Language: English

Publisher: Elsevier BV

Publication Date: 2023

detail.hit.zdb_id: 1120460-6

detail.hit.zdb_id: 1468190-0

detail.hit.zdb_id: 82061-1

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15

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Usefulness of Tumor Marker Score for Predicting the Prognosis of Hepatocellular Carcinoma Patients Treated with Atezolizumab Plus Bevacizumab: A Multicenter Retrospective Study

Tanaka, Kazunari ; Tsuji, Kunihiko ; Hiraoka, Atsushi ; [et al.]

MDPI AG ; 2023

In: Cancers Vol. 15, No. 17 ( 2023-08-31), p. 4348-

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In: Cancers, MDPI AG, Vol. 15, No. 17 ( 2023-08-31), p. 4348-

Abstract: Aim: This study aimed to evaluate the ability of a previously reported tumor marker (TM) score involving alpha-fetoprotein (AFP), fucosylated AFP (AFP-L3), and des gamma-carboxy prothrombin (DCP) as TMs in predicting the prognosis and therapeutic efficacy in hepatocellular carcinoma (HCC) patients administered atezolizumab plus bevacizumab (Atez/Bev) as first-line treatment. Materials/Methods: The study period covered September 2020 to December 2022 and involved 371 HCC patients treated with Atez/Bev. The values of the TMs AFP, AFP-L3, and DCP were measured upon introducing Atez/Bev. Elevations in the values of AFP (≥100 ng/mL), AFP-L3 (≥10%), and DCP (≥100 mAU/mL) were considered to indicate a positive TM. The number of positive TMs was summed up and used as the TM score, as previously proposed. Hepatic reserve function was assessed using the modified albumin–bilirubin grade (mALBI). Predictive values for prognosis were evaluated retrospectively. Results: A TM score of 0 was shown in 81 HCC patients (21.8%), 1 in 110 (29.6%), 2 in 112 (29.9%), and 3 in 68 (18.3%). The median overall survival (OS) times for TM scores 0, 1, 2, and 3 were not applicable [NA] (95% CI NA-NA), 24.0 months (95% CI 17.8-NA), 16.7 months (95% CI 17.8-NA), and NA (95% CI 8.3-NA), respectively (p 〈 0.001). The median progression-free survival (PFS) times for TM scores 0, 1, 2, and 3 were 16.5 months (95% CI 8.0-not applicable [NA]), 13.8 months (95% CI 10.6–21.3), 7.7 months (95% CI 5.3–8.9), and 5.8 months (95% CI 3.0–7.6), respectively (p 〈 0.001). OS was well stratified in mALBI 1/2a and mALBI 2a/2b. PFS was well stratified in mALBI 2a/2b, but not in mALBI 1/2a. Conclusions: The TM score involving AFP, AFP-L3, and DCP as TMs was useful in predicting the prognosis and therapeutic efficacy in terms of OS and PFS in HCC patients administered Atez/Bev as first-line treatment.

Type of Medium: Online Resource

ISSN: 2072-6694

URL: Article

DOI: 10.3390/cancers15174348

Language: English

Publisher: MDPI AG

Publication Date: 2023

detail.hit.zdb_id: 2527080-1

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16

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α‐FAtE : A new predictive score of response to atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

Rossari, Federico ; Tada, Toshifumi ; Suda, Goki ; [et al.]

Wiley ; 2024

In: International Journal of Cancer Vol. 154, No. 6 ( 2024-03-15), p. 1043-1056

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In: International Journal of Cancer, Wiley, Vol. 154, No. 6 ( 2024-03-15), p. 1043-1056

Abstract: Atezolizumab plus bevacizumab (AB) and lenvatinib can be alternatively used as first‐line systemic treatment of unresectable hepatocellular carcinoma (HCC). However, no direct comparison of the two regimens has been performed in randomized clinical trials, making the identification of baseline differential predictors of response of major relevance to tailor the best therapeutic option to each patient. Baseline clinical and laboratory characteristics of real‐world AB‐treated HCC patients were analyzed in uni‐ and multivariate analyses to find potential prognostic factors of overall survival (OS). Significant variables were incorporated in a composite score (α‐FAtE) and it was tested for specificity and sensitivity in receiver operating characteristic (ROC) curve and in multivariate analysis for OS. The score was applied in uni‐ and multivariate analyses for OS of a comparable lenvatinib‐treated HCC population. Finally, comparison between treatments was performed in patients with low and high α‐FAtE scores and predictivity estimated by interaction analysis. Time‐to‐progression (TTP) was a secondary endpoint. OS of AB‐treated HCC patients was statistically longer in those with α‐fetoprotein 〈 400 ng/mL (HR 0.62, p = .0407), alkaline phosphatase (ALP) 〈 125 IU/L (HR 0.52, p = .0189) and eosinophil count ≥70/μL (HR 0.46, p = .0013). The α‐FAtE score was generated by the sum of single points attributed to each variable among the above reported. In ROC curve analysis, superior sensitivity and specificity were achieved by the score compared to individual variables (AUC 0.794, p 〈 .02). Patients with high score had longer OS (HR 0.44, p = .0009) and TTP (HR 0.34, p 〈 .0001) compared to low score if treated with AB, but not with lenvatinib. Overall, AB was superior to lenvatinib in high score patients (HR 0.55, p = .0043) and inferior in low score ones (HR 1.75, p = .0227). At interaction test, low α‐FAtE score resulted as negative predictive factor of response to AB ( p = .0004). In conclusion, α‐FAtE is a novel prognostic and predictive score of response to first‐line AB for HCC patients that, if validated in prospective studies, could drive therapeutic choice between lenvatinib and AB.

Type of Medium: Online Resource

ISSN: 0020-7136 , 1097-0215

URL: Issue

URL: Article

DOI: 10.1002/ijc.v154.6

DOI: 10.1002/ijc.34799

RVK:

XA 10000

Language: English

Publisher: Wiley

Publication Date: 2024

detail.hit.zdb_id: 218257-9

detail.hit.zdb_id: 1474822-8

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17

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Early Relative Change in Hepatic Function with Lenvatinib for Unresectable Hepatocellular Carcinoma

Hiraoka, Atsushi ; Kumada, Takashi ; Atsukawa, Masanori ; [et al.]

S. Karger AG ; 2019

In: Oncology Vol. 97, No. 6 ( 2019), p. 334-340

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In: Oncology, S. Karger AG, Vol. 97, No. 6 ( 2019), p. 334-340

Abstract: 〈 b 〉 〈 i 〉 Background/Aim: 〈 /i 〉 〈 /b 〉 Lenvatinib (LEN) has been developed for the treatment of unresectable hepatocellular carcinoma (u-HCC). We aimed to elucidate the relative change in hepatic reserve function early following LEN treatment in affected patients. 〈 b 〉 〈 i 〉 Materials/Methods: 〈 /i 〉 〈 /b 〉 From March 2018 to April 2019, 123 u-HCC patients (median age 71 years; male:female ratio 95:28; Child-Pugh score 5:6:7 = 65:50:8; modified albumin-bilirubin [mALBI] grade 1:2a:2b:3 = 44:28:50:1, Barcelona Clinic Liver Cancer stage A:B:C = 1:49:73) were enrolled. Relative changes in hepatic reserve function at 2 and 4 weeks after starting LEN were retrospectively evaluated. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 The median survival was 11.3 months. The Child-Pugh score declined from the start to 4 weeks after commencing LEN (score 5:6:7:8:9:≥10 = 65:50:8:0:0:0 vs. 50:39:22:8:0:4, 〈 i 〉 p 〈 /i 〉 & #x3c; 0.001). A comparison among ALBI scores at the start of LEN and those at 2 and 4 weeks revealed significant relative changes (–2.36 ± 0.45 to –2.20 ± 0.49 at 2 weeks, –2.15 ± 0.50 at 4 weeks, 〈 i 〉 p 〈 /i 〉 & #x3c; 0.001, Bonferroni method), while there was no significant difference between those at 2 and 4 weeks ( 〈 i 〉 p 〈 /i 〉 = 0.210, Bonferroni method). Assessments of relative changes of ALBI score in patients divided by mALBI grade 1, 2a, and 2b or more showed a significant decline in score regardless of grade (–2.82 ± 0.17 to –2.53 ± 0.34, 〈 i 〉 p 〈 /i 〉 & #x3c; 0.001; –2.46 ± 0.10 to –2.31 ± 0.33, 〈 i 〉 p 〈 /i 〉 = 0.017; and –1.90 ± 0.26 to –1.75 ± 0.42, 〈 i 〉 p 〈 /i 〉 = 0.009, respectively). 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 Decline in hepatic function is common in the early stage (≤4 weeks, especially within 2 weeks) after introducing LEN. It is important to introduce molecular targeting agent drugs for u-HCC in patients with better hepatic function, who show transarterial catheter chemoembolization failure, as much as possible, along with consideration of the negative influence of LEN on the early response of hepatic function.

Type of Medium: Online Resource

ISSN: 0030-2414 , 1423-0232

URL: Article

DOI: 10.1159/000502095

RVK:

XH 3305

Language: English

Publisher: S. Karger AG

Publication Date: 2019

detail.hit.zdb_id: 1483096-6

detail.hit.zdb_id: 250101-6

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18

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Role of the Prognostic Nutritional Index in Predicting Survival in Advanced Hepatocellular Carcinoma Treated with Atezolizumab Plus Bevacizumab

Persano, Mara ; Rimini, Margherita ; Tada, Toshifumi ; [et al.]

S. Karger AG ; 2023

In: Oncology Vol. 101, No. 5 ( 2023), p. 283-291

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In: Oncology, S. Karger AG, Vol. 101, No. 5 ( 2023), p. 283-291

Abstract: 〈 b 〉 〈 i 〉 Introduction: 〈 /i 〉 〈 /b 〉 The prognostic nutritional index (PNI) is a multiparametric score introduced by Onodera based on the blood levels of lymphocytes and albumin in patients with gastrointestinal neoplasms. Regarding hepatocellular carcinoma (HCC), its prognostic role has been shown in patients treated with sorafenib and lenvatinib. The aim of this real-world study was to investigate the association between clinical outcomes and PNI in patients being treated with atezolizumab plus bevacizumab. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 The overall cohort of this multicentric study included 871 consecutive HCC patients from 5 countries treated with atezolizumab plus bevacizumab in first-line therapy. The PNI was calculated as follows: 10 × serum albumin concentration (g/dL) + 0.005 × peripheral lymphocyte count (number/mm 〈 sup 〉 3 〈 /sup 〉 ). 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Data regarding lymphocyte counts and albumin levels were available for 773 patients; therefore, these patients were included in the final analysis. The cut-off point of the PNI was determined to be 41 by receiver operating characteristic analysis. 268 patients (34.7%) were categorized as the PNI-low group, while the remaining 505 (65.3%) patients as the PNI-high group. At the univariate analysis, high PNI was associated with longer overall survival (OS) (22.5 vs. 10.1 months, HR 0.34, 〈 i 〉 p 〈 /i 〉 & #x3c;0.01) and progression-free survival (PFS) (8.7 vs. 5.8 months, HR 0.63, 〈 i 〉 p 〈 /i 〉 & #x3c;0.01) compared to patients with low PNI. At the multivariate analysis, high versus low PNI resulted as an independent prognostic factor for OS (HR 0.49, 〈 i 〉 p 〈 /i 〉 & #x3c;0.01) and PFS (HR 0.82, 〈 i 〉 p 〈 /i 〉 = 0.01). There was no difference in objective response rate between the two groups (high 26.1% vs. low 19.8%, 〈 i 〉 p 〈 /i 〉 = 0.09), while disease control rate was significantly higher in the PNI-high group (76.8% vs. 66.4%, 〈 i 〉 p 〈 /i 〉 = 0.01). 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 PNI is an independent prognostic factor for OS and PFS in HCC patients on first-line treatment with atezolizumab plus bevacizumab.

Type of Medium: Online Resource

ISSN: 0030-2414 , 1423-0232

URL: Article

DOI: 10.1159/000528818

RVK:

XH 3305

Language: English

Publisher: S. Karger AG

Publication Date: 2023

detail.hit.zdb_id: 1483096-6

detail.hit.zdb_id: 250101-6

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Lenvatinib as Second-Line Treatment after Atezolizumab plus Bevacizumab for Unresectable Hepatocellular Carcinoma: Clinical Results Show Importance of Hepatic Reserve Function

Hiraoka, Atsushi ; Kumada, Takashi ; Tada, Toshifumi ; [et al.]

S. Karger AG ; 2023

In: Oncology Vol. 101, No. 10 ( 2023), p. 624-633

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In: Oncology, S. Karger AG, Vol. 101, No. 10 ( 2023), p. 624-633

Abstract: 〈 b 〉 〈 i 〉 Introduction: 〈 /i 〉 〈 /b 〉 Lack of an established methodology for post-progression systemic treatment following atezolizumab plus bevacizumab (Atez/Bev) administration is an important clinical issue. The present study aimed to elucidate the potential of lenvatinib as a second-line treatment option after Atez/Bev failure. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 From 2020 to 2022, 101 patients who received lenvatinib as second-line treatment were enrolled (median 72 years, males 77, Child-Pugh A 82, BCLC-A:B:C:D = 1:35:61:4), while 29 treated with another molecular targeting agent (MTA) during the period as second-line treatment were enrolled as controls. The therapeutic efficacy of lenvatinib given as second-line treatment was retrospectively evaluated. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 Median progression-free survival/median overall survival for all patients was 4.4/15.7 months and for those with Child-Pugh A was 4.7 months/not-reached. When prognosis was compared with patients who received another MTA, there was no significant difference for PFS (3.5 months, 〈 i 〉 p 〈 /i 〉 = 0.557) or OS (13.6 months, 〈 i 〉 p 〈 /i 〉 = 0.992), and also no significant differences regarding clinical background factors. mRECIST findings showed that objective response and disease control rates in patients treated with lenvatinib were 23.9% and 70.4%, respectively (CR:PR:SD:PD = 3:14:33:21), while those shown by RECIST, ver. 1.1, were 15.4% and 66.2%, respectively (CR:PR:SD:PD = 1:10:36:24). Adverse events (any grade ≥10%) were appetite loss (26.7%) (grade 1:2:3 = 2:15:10), general fatigue (21.8%) (grade 1:2:3 = 3:13:6), protein in urine (16.8%) (grade 1:2:3 = 0:4:13), and hypertension (13.9%) (grade 1:2:3 = 1:8:5). 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 Although lenvatinib treatment might not provide a pseudo-combination immunotherapy effect following Atez/Bev failure, lenvatinib when used as second-line treatment after Atez/Bev failure might be expected to be comparable as compared to its use as first-line treatment.

Type of Medium: Online Resource

ISSN: 0030-2414 , 1423-0232

URL: Article

DOI: 10.1159/000531316

RVK:

XH 3305

Language: English

Publisher: S. Karger AG

Publication Date: 2023

detail.hit.zdb_id: 1483096-6

detail.hit.zdb_id: 250101-6

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Geriatric nutritional risk index as an easy‐to‐use assessment tool for nutritional status in hepatocellular carcinoma treated with atezolizumab plus bevacizumab

Hiraoka, Atsushi ; Kumada, Takashi ; Tada, Toshifumi ; [et al.]

Wiley ; 2023

In: Hepatology Research Vol. 53, No. 10 ( 2023-10), p. 1031-1042

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In: Hepatology Research, Wiley, Vol. 53, No. 10 ( 2023-10), p. 1031-1042

Abstract: The present study focused on Geriatric Nutritional Risk Index (GNRI), which is based on bodyweight and serum albumin, and known as an easy‐to‐use nutritional assessment tool in clinical settings, to elucidate the prognostic predictive ability of GNRI in patients treated with atezolizumab plus bevacizumab (Atez/Bev) for hepatocellular carcinoma (HCC). Methods A total of 525 HCC patients treated with Atez/Bev, based on their classification of unsuitable status for curative treatments and/or transarterial catheter chemoembolization, were enrolled (Child–Pugh A:B:C = 484:40:1, Barcelona Clinic Liver Cancer stage 0:A:B:C:D = 7:25:192:283:18). Prognosis was evaluated retrospectively using GNRI. Results Atez/Bev was used in 338 of the present cohort as first‐line systemic chemotherapy (64.4%). Median progression‐free survival based on GNRI indicating normal, mild decline, moderate decline, and severe decline was 8.3, 6.7, 5.3, and 2.4 months, respectively, whereas median overall survival was 21.4, 17.0, 11.5. and 7.3 months, respectively (both p 〈 0.001). The concordance index (c‐index) values of GNRI for predicting prognosis (progression‐free survival/overall survival) were superior to those of Child–Pugh class and albumin‐bilirubin grade (0.574/0.632 vs. 0.527/0.570 vs. 0.565/0.629). As a subanalysis, muscle volume loss was observed in 37.5% of 256 patients with computed tomography data available. Along with GNRI decline, frequency of muscle volume loss became progressively larger (normal vs. mild vs. moderate vs. severe = 17.6% vs. 29.2% vs. 41.2% vs. 57.9%, p 〈 0.001), and a GNRI value of 97.8 was predictive of its occurrence (AUC 0.715, 95% CI 0.649–0.781; specificity/sensitivity = 0.644/0.688). Conclusion These findings indicate that GNRI is an effective nutritional prognostic tool for predicting prognosis and muscle volume loss complication in HCC patients treated with Atez/Bev.

Type of Medium: Online Resource

ISSN: 1386-6346 , 1872-034X

URL: Issue

URL: Article

DOI: 10.1111/hepr.v53.10

DOI: 10.1111/hepr.13934

Language: English

Publisher: Wiley

Publication Date: 2023

detail.hit.zdb_id: 2006439-1

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