Response to Lenvatinib Is Associated with Optimal RelativeDose Intensity in Hepatocellular Carcinoma: Experience in Clinical Settings

Background: Lenvatinib is currently available as the first-line treatment for advanced unresectable hepatocellular carcinoma. We evaluated the relationship between its relative dose intensity (RDI) and response in clinical settings. Methods: From March 2018 to May 2019, 93 patients were administered lenvatinib at the Nagasaki University Hospital and its related facilities. Among these, 81 patients (66 men, 15 women, median age 72.0) who received lenvatinib were analyzed retrospectively. Results: Fourteen patients were Child–Pugh grade B, and 15 had received other systemic therapy. According to Response Evaluation Criteria in Solid Tumors (RECIST), the objective response (OR) rate was 17.3%. The overall survival (OS) was significantly better in the OR group (p = 0.011). There was a significant difference in RDI between the OR and non-OR groups (p < 0.05). The area under the receiver operating characteristics curve for OR prediction by the 4, 8, 12, and 16-week RDI were 0.666, 0.747, 0.731, and 0.704, respectively. In the 8-week RDI 67.0% group, OS was significantly better than in the 8-week RDI< 67.0% group (p = 0.003). Conclusions: Because a sufficient RDI is required to achieve an OR, it is strongly recommended that lenvatinib should be administered to patients with good hepatic function and status.

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ALBI and P-ALBI grade in Child-Pugh A patients treated with drug eluting embolic chemoembolization for hepatocellular carcinoma

Acta Radiologica ◽

10.1177/0284185118799519 ◽

2018 ◽

Vol 60 (6) ◽

pp. 702-709 ◽

Cited By ~ 2

Author(s):

Ulrik Carling ◽

Bård Røsok ◽

Pål-Dag Line ◽

Eric J Dorenberg

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Function ◽

Objective Response ◽

Tumor Burden ◽

Clinical Settings ◽

Grading Systems ◽

Significant Difference ◽

Radiological Response ◽

Drug Eluting ◽

Pugh Class

Background Treatment outcome for hepatocellular carcinoma (HCC) is related to tumor burden and liver function. Grading systems assessing liver function need validation in different clinical settings. Purpose To evaluate drug-eluting embolic transarterial chemoembolization (DEE-TACE) in Child–Pugh A HCC with respect to albumin-bilirubin (ALBI) and platelet-albumin-bilirubin (P-ALBI) grade. Material and Methods Forty-nine patients with Child–Pugh class A, diagnosed with HCC and allocated to DEE-TACE treatment, were retrospectively analyzed regarding tumor and treatment characteristics, radiological response (mRECIST) one month post treatment, overall survival (OS), and adverse events (AEs; CTCAE, grades ≥3) with respect to ALBI and P-ALBI grade. Results There were 21 ALBI 1 patients, 29 P-ALBI 1 patients, and 19 patients were both ALBI and P-ALBI 1. Objective response rate was 74% with no statistically significant difference for ALBI (1 vs. 2; P = 0.08), or P-ALBI (1 vs. 2; P = 0.49). OS was 14.8 months (range = 1.7–62.0; ALBI 1 vs. 2: P = 0.08; P-ALBI 1 vs. 2: P = 0.003). OS in responders with ALBI 1 and 2 was 28.9 vs.10.2 months ( P = 0.02), and P-ALBI 1 and 2 was 26.7 vs. 8.6 months ( P < 0.001). In multivariate analyses, both ALBI 2 (HR = 2.4, P = 0.02) and P-ALBI 2 (HR = 3.3, P < 0.01) were negative prognostic factors for survival. There were 15 AEs in 13 patients, with hepatic failure only occurring in ALBI 2 and P-ALBI 2 patients. Conclusion P-ALBI grade 1 and 2 differentiated survival in Child–Pugh A patients treated with DEE-TACE. Both grading systems can differentiate survival in patients responding to treatment.

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Early Predictors of Objective Response in Patients with Hepatocellular Carcinoma Undergoing Lenvatinib Treatment

Cancers ◽

10.3390/cancers12040779 ◽

2020 ◽

Vol 12 (4) ◽

pp. 779 ◽

Cited By ~ 1

Author(s):

Issei Saeki ◽

Takahiro Yamasaki ◽

Satoyoshi Yamashita ◽

Tadasuke Hanazono ◽

Yohei Urata ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Tumor Marker ◽

Odds Ratio ◽

Biochemical Markers ◽

Objective Response ◽

Evaluation Criteria ◽

Response Evaluation ◽

Early Predictors ◽

Significant Difference ◽

Response Evaluation Criteria

There are limited reports regarding early predictors of objective response (OR) in patients with hepatocellular carcinoma (HCC) treated with lenvatinib. This retrospective study including 70 patients aimed to investigate the efficacy of hepatic biochemical markers. Changes in tumor marker (alpha-fetoprotein (AFP)/des-gamma-carboxy prothrombin (DCP)) levels and albumin–bilirubin (ALBI) score between the baseline value and that estimated one month after treatment were evaluated. We identified several predictors of OR, including changes in tumor marker levels. The OR rate calculated using modified Response Evaluation Criteria in Solid Tumor (mRECIST) was 41.4%. Response was defined as a reduction in AFP and DCP levels of ≥40% from baseline. OR was significantly associated with AFP response, but not with DCP. Predictors of OR were evaluated in two groups (high-AFP group: baseline AFP ≥ 10 ng/mL; low-AFP group: remaining patients). A multivariate analysis identified AFP response (odds ratio, 51.389; p = 0.001) and ALBI score (odds ratio, 6.866; p = 0.039) as independent predictors of OR in the high-AFP and low-AFP groups, respectively. Changes in the ALBI score indicated deterioration in both responders and non-responders, with a significant difference in non-responders (p = 0.003). AFP response, baseline ALBI score, and change in the ALBI score were early predictors of OR in patients with HCC undergoing lenvatinib treatment.

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Exploratory Analysis of Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma Who Have Failed Prior PD−1/PD-L1 Checkpoint Blockade

Cancers ◽

10.3390/cancers12103048 ◽

2020 ◽

Vol 12 (10) ◽

pp. 3048

Author(s):

Tomoko Aoki ◽

Masatoshi Kudo ◽

Kazuomi Ueshima ◽

Masahiro Morita ◽

Hirokazu Chishina ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Objective Response ◽

Evaluation Criteria ◽

Dose Intensity ◽

Progression Free Survival ◽

Checkpoint Blockade ◽

Antitumor Effects ◽

Free Survival ◽

Starting Dose ◽

Cell Death Protein

Although programmed cell death protein 1 (PD−1)/PD-ligand 1 (PD-L1) blockade is effective in a subset of patients with hepatocellular carcinoma (HCC), its therapeutic response is still unsatisfactory. Alternatively, the potential impact of the lenvatinib in patients who showed tumor progression on PD−1/PD-L1 blockade is unknown. In this work, we evaluated the safety and efficacy of lenvatinib administration after PD-1/PD-L1 checkpoint blockade. The outcome and safety of lenvatinib administered after PD-1/PD-L1 blockade failure was analyzed retrospectively in 36 patients. Tumor growth was assessed every 4–8 weeks using modified Response Evaluation Criteria in Solid Tumors. The mean relative dose intensity of lenvatinib was 87.6% and 77.8% in patients receiving a starting dose of 8 (interquartile range (IQR), 77.5–100.0) mg and 12 (IQR, 64.4–100.0) mg, respectively. Since lenvatinib therapy initiation, the median progression-free survival was 10 months (95% confidence interval (CI): 8.3–11.8) and the median overall survival was 15.8 months (95% CI: 8.5–23.2). The objective response rate was 55.6%, and the disease control rate was 86.1%. No particular safety concerns were observed. Lenvatinib demonstrated considerable antitumor effects with acceptable safety in patients with progressive and unresectable HCC when administered right after PD-1/PD-L1 blockade failure.

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Liver Surgery for Hepatocellular Carcinoma: Laparoscopic versus Open Approach

International Journal of Hepatology ◽

10.4061/2011/596792 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 34

Author(s):

C. G. Ker ◽

J. S. Chen ◽

K. K. Kuo ◽

S. C. Chuang ◽

S. J. Wang ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Resection ◽

Average Length ◽

Survival Rates ◽

Laparoscopic Approach ◽

Operation Time ◽

Open Approach ◽

Full Diet ◽

Or Groups ◽

Significant Difference

In this study, we try to compare the benefit of laparoscopic versus open operative procedures.Patients and Methods. One hundred and sixteen patients underwent laparoscopic liver resection (LR) and another 208 patients went for open liver resection (OR) for hepatocellular carcinoma (HCC). Patients' selection for open or laparoscopic approach was not randomized.Results. The CLIP score for LR and OR was 0.59 ± 0.75 and 0.86 ± 1.04, respectively, (). The operation time was 156.3 ± 308.2 and 190.9 ± 79.2 min for LR and OR groups, respectively. The necessity for blood transfusion was found in 8 patients (6.9%) and 106 patients (50.9%) for LR and OR groups. Patients resumed full diet on the 2nd and 3rd postoperative day, and the average length of hospital stay was 6 days and 12 days for LR and OR groups. The complication rate and mortality rate were 0% and 6.0%, 2.9% and 30.2% for LR and OR groups, respectively. The 1-yr, 3-yr, and 5-yr survival rate was 87.0%, 70.4%, 62.2% and 83.2%, 76.0%, 71.8% for LR and OR group, respectively, of non-significant difference. From these results, HCC patients accepted laparoscopic or open approach were of no significant differences between their survival rates.

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Balloon-Occluded Trans-Arterial Chemoembolization Technique with Alternate Infusion of Cisplatin and Gelatin Slurry for Small Hepatocellular Carcinoma Nodules Adjacent to the Glisson Sheath

BioMed Research International ◽

10.1155/2019/8350926 ◽

2019 ◽

Vol 2019 ◽

pp. 1-9 ◽

Cited By ~ 3

Author(s):

Toshiyuki Irie ◽

Nobuyuki Takahashi ◽

Toshiro Kamoshida

Keyword(s):

Hepatocellular Carcinoma ◽

Contrast Medium ◽

Drug Carrier ◽

Objective Response ◽

Small Hepatocellular Carcinoma ◽

Small Tumor ◽

Study Results ◽

Significant Difference ◽

Tace Group ◽

Arterial Chemoembolization

Objective. It is difficult to control small hepatocellular carcinoma (HCC) nodules adjacent to the Glisson sheath (GS) by trans-arterial chemoembolization (TACE) probably due to multiple small tumor feeders directly branching from the trunk artery. The purpose of this study was to conduct a retrospective evaluation of a new TACE technique called the repeated alternate infusion of cisplatin solution and gelatin slurry distal to balloon occlusion (RAIB-TACE), for the treatment of small HCC nodules adjacent to GS. Materials and Methods. Small nodules less than 4 cm attached to proximal portion of the subsegmental to lobar level portal branch were retrospectively selected. Between January 2011 and April 2014, 29 nodules in 29 patients were treated by super-selective lipiodol TACE/balloon-occluded TACE (B-TACE) (Lip-TACE group). Since April 2014, treatment protocols for small nodules adjacent to GS were changed, and 14 nodules in 12 patients were treated by RAIB-TACE (RAIB-TACE group). In RAIB-TACE group, alternate infusion of cisplatin solution and sparse gelatin slurry (mixture of 80 mg of gelatin fragments and 20 mL of contrast medium) were repeated until arterial flow was ceased. In Lip-TACE group, lipiodol was used as drug carrier and dense gelatin slurry (mixture of 80 mg of gelatin fragments and 2 mL of contrast medium) as embolization material. Dynamic CT/MRI was obtained 1-3 months after TACE, and response of each nodule was evaluated basing on modified RECIST criteria. Results. In RAIB-TACE group, all 14 nodules (100%) were diagnosed as CR or PR. In Lip-TACE group, 18 of 29 (62.1%) were diagnosed as CR or PR. There was a statistically significant difference in objective response ratio between the groups (p=0.008, Fisher’s test). Biloma (n=1) and benign stricture of the right hepatic duct (n=1) were seen in RAIB-TACE group. The biloma shrunk without treatment and the patient had no symptom, but the patient with biliary stricture repeated cholangitis and was treated by administration of antibiotics. Conclusion. The study results show that RAIB-TACE is more effective than lipiodol TACE/B-TACE for small hepatocellular carcinoma adjacent to GS. We speculate that one of the reasons to explain why Lip-TACE is inferior to RAIB-TACE is that viscous lipiodol or dense gelatin slurry could not flow into small tumor feeders effectively.

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Impact of Baseline ALBI Grade on the Outcomes of Hepatocellular Carcinoma Patients Treated with Lenvatinib: A Multicenter Study

Cancers ◽

10.3390/cancers11070952 ◽

2019 ◽

Vol 11 (7) ◽

pp. 952 ◽

Cited By ~ 40

Author(s):

Kazuomi Ueshima ◽

Naoshi Nishida ◽

Satoru Hagiwara ◽

Tomoko Aoki ◽

Tomohiro Minami ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Liver Function ◽

Adverse Events ◽

Objective Response Rate ◽

Response Rate ◽

Objective Response ◽

Evaluation Criteria ◽

Treatment Discontinuation ◽

The Impact ◽

Group 1

Background: This study investigated the impact of baseline liver function according to the Child–Pugh score and ALBI (albumin-bilirubin) grade on the outcomes of patients with unresectable hepatocellular carcinoma treated with lenvatinib. Methods: A total of 82 lenvatinib treated patients were included. The correlations of baseline liver function according to the Child–Pugh score and ALBI grade with treatment outcomes, including objective response rate per mRECIST (modified Response Evaluation Criteria in the Solid Tumor), time to treatment failure, treatment duration, and likelihood of treatment discontinuation due to adverse events, were assessed in patients with hepatocellular carcinoma treated with lenvatinib. Patients were divided into four groups: (1) Child–Pugh score 5 and ALBI grade 1 (group 1), (2) Child–Pugh score 5 and ALBI grade 2 (group 2), (3) Child–Pugh score 6 (group 3), and (4) Child–Pugh score ≥7 (group 4). Univariate and multivariate analyses were performed to identify the factors contributing to the objective response rate and likelihood of discontinuation due to adverse events. Results: Among the 82 patients analyzed, group 1 had the highest objective response rate (57.1%) and the lowest likelihood of treatment discontinuation because of adverse events (11.1%) among the four groups (p < 0.05 and p < 0.05). Multivariate analysis identified ALBI grade 1 and baseline AFP level <200 ng/mL as the significant predictors of a high objective response rate (p < 0.05 and p < 0.01), and confirmed that patients with ALBI grade 1 had the lowest probability of treatment discontinuation due to adverse events (p < 0.01). Conclusions: Patients with Child–Pugh score of 5 and ALBI grade 1 predicted a higher response rate and lower treatment discontinuation due to adverse events by lenvatinib treatment.

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Early Tumor Shrinkage as a Predictive Factor for Outcomes in Hepatocellular Carcinoma Patients Treated with Lenvatinib: A Multicenter Analysis

Cancers ◽

10.3390/cancers12030754 ◽

2020 ◽

Vol 12 (3) ◽

pp. 754 ◽

Cited By ~ 3

Author(s):

Aya Takahashi ◽

Michihisa Moriguchi ◽

Yuya Seko ◽

Toshihide Shima ◽

Yasuhide Mitsumoto ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Characteristic Curve ◽

Objective Response ◽

Evaluation Criteria ◽

Treatment Decision ◽

Progression Free Survival ◽

Tumor Shrinkage ◽

Discrimination Ability ◽

Early Tumor Shrinkage ◽

Early Tumor

We investigated the association between early tumor shrinkage (ETS) and treatment outcome in patients with hepatocellular carcinoma treated with lenvatinib (LEN). A retrospective analysis was performed in 104 patients. ETS was defined as tumor shrinkage at the first evaluation in the sum of target lesions’ longest diameters from baseline according to the Response Evaluation Criteria in Solid Tumors (RECIST). The median overall survival (OS) was not reached, whereas the median progression-free survival (PFS) was 5.0 months. The receiver operating characteristic curve analysis in differentiating long-term responders (PFS ≥ 5.0 months) from short-term responders (PFS < 5.0 months) revealed an ETS cut-off value of 10%. ETS ≥ 10% was significantly correlated with better PFS and OS compared with ETS < 10%. Additionally, ETS ≥ 10% showed a better discrimination ability on prognosis compared with modified RECIST-based objective response at the first evaluation. Multivariate analysis confirmed ETS ≥ 10% as an independent predictor of better OS, as well as a Child–Pugh score of 5 and macrovascular invasion. In conclusion, ETS ≥ 10% was strongly associated with outcome in patients treated with LEN. This biomarker could allow earlier assessment of the treatment response and guide treatment decision-making for HCC.

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Experience with Sorafenib in 3 Hospitals in Sao Paulo

Annals of Hepatology ◽

10.5604/01.3001.0012.4898 ◽

2018 ◽

Vol 17 (5) ◽

pp. 0-10

Author(s):

Rogério Camargo-Pinheiro-Alves ◽

Daniele E. Viera-Alves ◽

Arthur Malzyner ◽

Otavio Gampel ◽

Thaisa de F. Almeida-Costa ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Overall Survival ◽

Complex Disease ◽

Objective Response ◽

Evaluation Criteria ◽

Treatment Strategies ◽

Sao Paulo ◽

Advanced Hepatocellular Carcinoma ◽

São Paulo ◽

Sorafenib Therapy

Introduction and aim. Sorafenib has been the standard of care for first-line treatment of advanced hepatocellular carcinoma, a complex disease that affects an extremely heterogenous population. Thereby requiring multidisciplinary individualized treatment strategies that match the disease characteristics and the patients’ specific needs. Material and methods. Data for 175 patients who received sorafenib for hepatocellular carcinoma in three different hospitals in Sao Paulo, Brazil over a span of nine years were retrospectively analyzed. Results. The median age was 62 years. Percentages of patients with Child-Pugh A, B and C liver cirrhosis were 61%, 31% and 5%, respectively. Approximately half of the patients had Barcelona Clinic Liver Cancer stage B disease, and the other half had stage C. The median treatment duration was 253 days. Sorafenib dose was reduced to 400 mg/day in 41% of the patients due to toxicity. Overall objective response rate as per Response Evaluation Criteria in Solid Tumors and its modified version was 39%. Patients who received transarterial chemoembolization (TACE) at any point during sorafenib therapy were significantly more likely to experience an objective response. After a median follow-up of 339 days, the median overall survival was 380 days. Child-Pugh cirrhosis, tumor response and concomitant chemoembolization were independent prognostic factors for overall survival in multivariate analysis. Conclusion. Our results suggest that, in experienced hands, sorafenib therapy may benefit carefully selected hepatocellular carcinoma patients for whom other therapies are initially contraindicated, including those patients with Child-Pugh B liver function and those patients who are subsequently treated with concomitant TACE.

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Higher Enhancement Intrahepatic Nodules on the Hepatobiliary Phase of Gd-EOB-DTPA-Enhanced MRI as a Poor Responsive Marker of Anti-PD-1/PD-L1 Monotherapy for Unresectable Hepatocellular Carcinoma

Liver Cancer ◽

10.1159/000518048 ◽

2021 ◽

pp. 1-14

Author(s):

Tomoko Aoki ◽

Naoshi Nishida ◽

Kazuomi Ueshima ◽

Masahiro Morita ◽

Hirokazu Chishina ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Checkpoint Inhibitors ◽

Objective Response ◽

Evaluation Criteria ◽

Progression Free Survival ◽

Imaging Biomarker ◽

Hepatobiliary Phase ◽

Enhanced Mri ◽

Phase Images ◽

Magnetic Resonance Imaging Mri

Introduction: Immune checkpoint inhibitors (ICIs) are promising agents for the treatment of hepatocellular carcinoma (HCC). However, the establishment of noninvasive measure that could predict the response to ICIs is challenging. This study aimed to evaluate tumor responses to ICIs using the hepatobiliary phase of gadolinium-ethoxybenzyl-diethylenetriamine (Gd-EOB-DTPA)-enhanced magnetic resonance imaging (MRI), which was shown to reflect Wnt/β-catenin activating mutation. Methods: A total of 68 intrahepatic HCC nodules from 18 patients with unresectable HCC and Child-Pugh class A liver function who received anti-programmed cell death 1 (PD-1)/programmed death-ligand 1 (PD-L1) monotherapy were enrolled in this study. All patients had viable intrahepatic lesions evaluable using the hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI within the 6 months prior to the treatment. The relative enhancement ratio was calculated, and the time to nodular progression (TTnP) defined as 20% or more increase in each nodule was compared between higher or hypo-enhancement HCC nodules. Then, the progression-free survival (PFS) and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) were compared between patients with and without HCC nodules with higher enhancement on hepatobiliary phase images. Results: The median PFS was 2.7 (95% confidence interval [CI]: 1.4–4.0) months in patients with HCC nodules with higher enhancement (n = 8) and 5.8 (95% CI: 0.0–18.9) months in patients with hypointense HCC nodules (n = 10) (p = 0.007). The median TTnP of HCC nodules with higher enhancement (n = 23) was 1.97 (95% CI: 1.86–2.07) months and that of hypointense HCC nodules (n = 45) was not reached (p = 0.003). The ORR was 12.5% (1/8) versus 30.0% (3/10); the disease control rate was 37.5% (3/8) versus 70.0% (7/10), respectively, in patients with or without higher enhancement intrahepatic HCC nodules. Conclusion: The TTnP on HCC nodules with higher enhancement and the median PFS in patients who carried higher enhancement intrahepatic HCC nodules were significantly shorter than those in hypointense HCC nodules with anti-PD-1/PD-L1 monotherapy. The intensity of the nodule on the hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI is a promising imaging biomarker for predicting unfavorable response with anti-PD-1/PD-L1 monotherapy in patients with HCC.

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Outcomes and toxicities in sarcopenic patients with metastatic solid tumors treated with check point inhibitors.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e14166 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e14166-e14166

Author(s):

Laura Haik ◽

Aurore Gonthier ◽

Eric Frison ◽

Marine Gross-Goupil ◽

Charlotte Domblides ◽

...

Keyword(s):

Lung Cancer ◽

Multivariate Analysis ◽

Solid Tumors ◽

Performance Status ◽

Objective Response ◽

University Hospital ◽

Check Point ◽

Anthropometric Parameters ◽

Significant Difference ◽

Check Point Inhibitors

e14166 Background: Evidence suggests that sarcopenia is a significant predictor of worst outcomes and treatment toxicities in metastatic solid tumors patients (pts). We investigated whether sarcopenia was associated with outcomes and severe toxicities (ST) in patients treated with check point inhibitors (CPI). Methods: All consecutive metastatic solid tumors patients treated with CPI from January 2013 to December 2017 in Bordeaux University Hospital (France) were retrospectively reviewed. Sarcopenia was evaluated using computed tomography (CT) obtained within 1 month before treatment initiation. Skeletal muscle mass index (SMI) were measured from axial L3 CT section. Sarcopenia was defined as SMI ≤ 52.4 cm2/m2 for males and SMI ≤ 38.5 cm2/m2 for women. Clinical characteristics included Performance Status (PS) and anthropometric parameters. ST included grade III-IV according to NCI-CTC v4.0 and any grade of toxicity leading to treatment interruption. Results: Among 261 pts included, 179 (69%) had metastatic lung cancer and 151 (58%) had previously received one line of treatment. Median age was 61 years old and there were 198 males (76%). PS status was 1 in 55% of pts. CPI treatment was: anti PD1, anti PD-L1, anti CTLA-4 and CPI combination in 192, 43, 3 and 20 pts, respectively. The prevalence of sarcopenia was 64%. At inclusion, sarcopenia was associated with poor PS (p = 0.002), anorexia (p < 0.001), lower albumin (p = 0.002) and hemoglobin (p < 0.001). Objective Response Rate (ORR) was 28% in sarcopenic pts and 26% in non-sarcopenic pts. Median progression free survival (PFS) was 6.9 and 7.6 months in sarcopenic pts and non-sarcopenic pts respectively (p = 0.5). In multivariate analysis, sarcopenia was not associated with PFS or ORR. Median overall survival (mOS) was 10.2 months in lung cancer, without significant difference between sarcopenic and non-sarcopenic patients (mOS: 9 months and 17 months respectively, p = 0.06). In general population, ST occurred in 36 (14%) pts; among which 23 (64%) presented sarcopenia. In multivariate analysis, sarcopenia was not associated with ST (OR = 1.16, p = 0.71). Conclusions: Sarcopenia was not associated with outcomes or toxicities in metastatic solid tumors patients treated with CPI in this study.

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