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

Cancers ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 779 ◽  
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.

Sorafenib in Combination With Gemcitabine in Recurrent Epithelial Ovarian Cancer: A Study of the Princess Margaret Hospital Phase II Consortium

2010 ◽  
Vol 20 (5) ◽  
pp. 787-793 ◽  
Author(s):  
Stephen A. Welch ◽  
Hal W. Hirte ◽  
Laurie Elit ◽  
Russel J. Schilder ◽  
Lisa Wang ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Stable Disease ◽  
Response Rate ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Ca 125 ◽  
Response Evaluation ◽  
Time To Progression ◽  
Response Evaluation Criteria

Objectives:Antiangiogenic strategies have demonstrated efficacy in epithelial ovarian cancer (EOC). Sorafenib is a novel multitargeted kinase inhibitor with antiangiogenic activity. Gemcitabine has known activity against EOC. A phase 1 clinical trial of this combination suggested activity in ovarian cancer with no dose-limiting toxicity. This phase 2 study was designed to examine the safety and efficacy of gemcitabine and sorafenib in patients with recurrent EOC.Methods:Patients with recurrent EOC after platinum-based chemotherapy and who had subsequently received up to 3 prior chemotherapy regimens were eligible. Gemcitabine (1000 mg/m2 intravenous [IV]) was administered weekly for 7 of 8 weeks in the first cycle, then weekly for 3 weeks of each subsequent 4-week cycle. Sorafenib (400 mg p.o. bid) was given continuously. The primary end point for this trial was objective response rate by the Response Evaluation Criteria in Solid Tumors. Secondary endpoints included Gynecologic Cancer Intergroup (GCIG) CA-125 response, time to progression, overall survival, and toxicity.Results:Forty-three patients were enrolled, and 33 completed at least 1 cycle. Two patients had a partial response (Response Evaluation Criteria in Solid Tumors objective response rate = 4.7%). Ten patients (23.3%) maintained response or stable disease for at least 6 months. GCIG CA-125 response was 27.9%. The median time to progression was 5.4 months, and the median overall survival was 13.0 months. Hematologic toxicity was common but manageable. The most common nonhematologic adverse events were hand-foot syndrome, fatigue, hypokalemia, and diarrhea.Conclusion:This trial of gemcitabine and sorafenib in recurrent EOC did not meet its primary efficacy end point, but the combination was associated with encouraging rates of prolonged stable disease and CA-125 response.

The evolving landscape of criteria for evaluating tumor response in the era of cancer immunotherapy: From Karnofsky to iRECIST

2018 ◽  
Vol 104 (2) ◽  
pp. 88-95 ◽  
Author(s):  
Alessandro Inno ◽  
Giuseppe Lo Russo ◽  
Matteo Salgarello ◽  
Giulia Corrao ◽  
Raffaella Casolino ◽  
...  
Keyword(s):  
Tumor Response ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Therapy Response ◽  
Clinical Activity ◽  
Special Focus ◽  
Response Evaluation ◽  
Recist 1.1 ◽  
New Anticancer Drugs ◽  
Response Evaluation Criteria

The objective response is an important endpoint to evaluate clinical activity of new anticancer drugs. Standardized criteria for evaluating response are needed for comparing results of different trials and represent the basis for advances in cancer therapy. Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 are the most used in clinical practice and in clinical trials; however, they are not able to capture atypical responses seen with immunotherapy drugs. We describe the evolution of response criteria with a special focus on the immune-related criteria.

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

Cancers ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 1769 ◽  
Author(s):  
Sasaki ◽  
Fukushima ◽  
Haraguchi ◽  
Miuma ◽  
Miyaaki ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Dose Intensity ◽  
Hepatic Function ◽  
University Hospital ◽  
Clinical Settings ◽  
Operating Characteristics ◽  
Or Groups ◽  
Significant Difference

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.

TACE combined with apatinib for the treatment of BCLC stage C of hepatocellular carcinoma: A restrospective controlled study.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 445-445
Author(s):  
Xuefeng Kan ◽  
Bin Xiong ◽  
Yong Wang ◽  
Bin Liang ◽  
Guofeng Zhou ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Medical Records ◽  
Tumor Response ◽  
Evaluation Criteria ◽  
Controlled Study ◽  
Response Evaluation ◽  
Baseline Characteristics ◽  
Grade 3 ◽  
Response Evaluation Criteria ◽  
Time To Tumor Progression

445 Background: To access the safety and effcacy of transarterial chemoembolization (TACE) combined with apatinib (TACE-apatinib) for the treatment of Barcelona Clinic Liver Cancer (BCLC) stage C of hepatocellular carcinoma (HCC). Methods: The medical records of 290 consecutive patients with BCLC stage C of HCC who underwent TACE-apatinib or TACE-alone from June 2015 to June 2017 were retrospectively reviewed. a-Fetoprotein (AFP) response at 4 weeks after treatment in the two groups were evaluated. Tumor response in the two groups were assessed according to modified Response Evaluation Criteria in Solid Tumors (m-RECIST) criteria. The time to tumor progression (TTP) and overall survival (OS) of patients in the two groups were evaluated respectively. Results: One hundred and ninety patients were included in the analysis; 95 patients underwent TACE-apatinib and 95 underwent TACE-alone. The baseline characteristics of patients between the two groups were comparable. The disease control rate (DCR) of tumor and AFP response in TACE-apatinib group was significantly greater than that of TACE-alone group ( P < 0.001). The median TTP was 14.0 months in the TACE-apatinib group and 3.0 months in the TACE-alone group, and the median OS was 17 months in the TACE-apatinib group and 6.0 months in the TACE-alone group. Apatinib-related adverse events of grade 3 occurred in 14 patients in TACE-apatinib group, and there was no occurrence of grade 4 adverse event. Conclusions: The adverse effects of apatinib were acceptable, and TACE-apatinib improved the outcomes for patients with BCLC stage C of HCC in comparison to TACE-alone.

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