Multikinase inhibitor-associated hand-foot skin reaction as a predictor of outcomes in patients with hepatocellular carcinoma treated with sorafenib

Ochi, Masanori; Kamoshida, Toshiro; Ohkawara, Atsushi; Ohkawara, Haruka; Kakinoki, Nobushige; Hirai, Shinji; Yanaka, Akinori

doi:10.3748/wjg.v24.i28.3155

Cited by 6 publications

(10 citation statements)

References 37 publications

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“…Thirteen studies including a total of 2035 patients with hepatocellular carcinoma treated with sorafenib monotherapy met the eligibility criteria (Table ). Two of them were prospective, 10 were retrospective and one did not specify its prospective or retrospective nature . Most studies were done in Asia (eight papers), three in Europe, one in Asia and Europe and one in South‐America.…”

Section: Resultsmentioning

confidence: 99%

“…Biochemical data describing liver function (albumin, prothrombin time and bilirubin) was available in four studies . Alpha‐fetoprotein values were reported in seven manuscripts . Presence/absence of vascular invasion was reported in 12 manuscripts .…”

Section: Resultsmentioning

confidence: 99%

“…Alpha‐fetoprotein values were reported in seven manuscripts . Presence/absence of vascular invasion was reported in 12 manuscripts . Duration of follow‐up was provided in six studies …”

Section: Resultsmentioning

confidence: 99%

“…Overall, 2035 patients were enrolled in 13 studies . Median age was 59.9 years and patients were predominantly male.…”

Section: Resultsmentioning

confidence: 99%

“…According to the Quality In Prognosis Studies tool results, four studies scored 6‐7 points and were considered at low risk of bias, eight studies scored 8‐9 points and were considered at medium risk of bias and one study scored 10 or more points and was considered at high risk of bias.…”

Section: Resultsmentioning

confidence: 99%

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Systematic review with meta‐analysis: the critical role of dermatological events in patients with hepatocellular carcinoma treated with sorafenib

Díaz-González

Sanduzzi‐Zamparelli

Sapena

et al. 2019

Aliment Pharmacol Ther

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Background: The positive results of the REFLECT trial in terms of survival (sorafenib vs lenvatinib) offer a new first-line option for hepatocellular carcinoma. Additionally, the expected results of immunotherapy could change the first-line treatment in hepatocellular carcinoma or the clinical trial design in first and second-line. Aims: To evaluate the impact of dermatologic adverse events under sorafenib in hepatocellular carcinoma patients as a clinical marker to predict prognosis and critically evaluate outcomes within trials. Methods: A systematic search of original articles published until October 2018 was performed using PubMed/MEDLINE and a meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.Results: A total of 393 studies were identified and 13 articles with 2035 patients (79.5% Child-Pugh-A, 73.2% BCLC-C) were selected for qualitative and quantitative analysis. The main type of dermatologic adverse events was hand-foot skin reaction (47.7%) but other dermatologic adverse events were reported in 31.7% of the cases.Presence of dermatologic adverse events was associated with a lower mortality when compared with those patients without them (pooled Hazard Ratio for the univariate analysis 0.45 (95% CI: 0.38-0.53) and there was no heterogeneity for the analysis (P = 0.511; I 2 = 0.0%). Refuting this association would require the future report of 1370 negative studies. Conclusions:This meta-analysis shows a clinically meaningful association between dermatologic adverse events and a higher probability of longer survival. These data support the use of dermatologic adverse events in the clinical decision-making when informing the prognosis and when systemic treatment is decided.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Alpha‐fetoprotein values were reported in seven manuscripts . Presence/absence of vascular invasion was reported in 12 manuscripts . Duration of follow‐up was provided in six studies …”

Section: Resultsmentioning

confidence: 99%

“…Overall, 2035 patients were enrolled in 13 studies . Median age was 59.9 years and patients were predominantly male.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Systematic review with meta‐analysis: the critical role of dermatological events in patients with hepatocellular carcinoma treated with sorafenib

Díaz-González

Sanduzzi‐Zamparelli

Sapena

et al. 2019

Aliment Pharmacol Ther

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Preemptive Versus Reactive Topical Clobetasol for Regorafenib-Induced Hand-Foot Reactions: A Preplanned Analysis of the ReDOS Trial

Jatoi

Ahn

et al. 2021

The Oncologist

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Background Hand‐foot skin reaction (HFSR) is the most common regorafenib‐induced adverse event and is in need of effective prevention and palliation. Materials and Methods The Regorafenib Dose Optimization Study (ReDOS), a four‐arm, previously published trial with a 1:1:1:1 randomization scheme, was analyzed in a manner in keeping with the original protocol to assess whether clobetasol 0.05% cream (a corticosteroid) applied to the palms and soles twice per day for 8 weeks was more effective when prescribed preemptively (before the development of HFSR) versus reactively (after the development of HFSR). Patients were assessed during the first two cycles of regorafenib. Results Sixty‐one patients received preemptive clobetasol, and 55 received reactive clobetasol. Groups were balanced on demographics. Over the first two cycles, no evidence of HFSR occurred in 30% with preemptive clobetasol versus 13% with reactive clobetasol (p = .03). During the first cycle, 54% and 45% of patients had no HFSR with preemptive and reactive clobetasol, respectively (p = .35). During the second cycle, 33% and 15% had no HFSR with preemptive and reactive clobetasol, respectively (p = .02). During the second cycle, rates of grade 1, 2, and 3 HFSR were 30%, 8%, and 3%, respectively, with preemptive clobetasol and 43%, 18%, and 7%, respectively, with reactive clobetasol (p = .12). Patient‐reported outcomes showed HFSR compromised nearly all activities of daily living with worse quality of life in patients who received reactive versus preemptive clobetasol. No clobetasol‐induced adverse events were reported. Conclusion Preemptive clobetasol might lessen regorafenib‐induced hand‐foot reactions compared with reactive therapy. Further confirmatory studies are needed in a larger patient cohort. Implications for Practice Regorafenib causes hand‐foot skin reactions. Preemptive clobetasol, a high‐potency topical corticosteroid, appears to lessen the severity of this adverse event. Although further study is needed, the favorable adverse event profile of this intervention might prompt clinicians to discuss this option with their patients.

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Effect of radiotherapy on survival in advanced hepatocellular carcinoma patients treated with sorafenib: a nationwide cancer-registry-based study

Chu

Kuo

Liu

et al. 2021

Sci Rep

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Sorafenib is the standard treatment for advanced hepatocellular carcinoma (HCC) patients. This study aims to determine whether combining radiotherapy with sorafenib administration increases its efficacy. The study cohort included 4763 patients with diagnosed advanced HCC who received sorafenib between January 2012 and December 2015, as reported in medical records in the Taiwan Cancer Registry database. The effect of sorafenib with or without radiotherapy on survival was calculated using the Kaplan–Meier method and compared using the log-rank test. A Cox proportional hazards model was used for multivariate analysis. Patients receiving sorafenib plus radiotherapy had greater 1-year survival than did those receiving sorafenib alone (P < 0.001). Uni- and multivariate analyses also showed that radiotherapy increased survival after adjusting for confounders (adjusted HR 0.57; 95% CI 0.51–0.63). Further stratified analysis according to the timing of radiotherapy relative to sorafenib treatment revealed that patients who underwent radiotherapy after sorafenib had greater 1-year survival than did those undergoing radiotherapy within sorafenib use or sorafenib alone (adjusted HR 0.39; 95% CI 0.27–0.54). Combined treatment with sorafenib and radiotherapy results in greater HCC patient survival and should be considered an option for treating this challenging disease.

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Multikinase inhibitor-associated hand-foot skin reaction as a predictor of outcomes in patients with hepatocellular carcinoma treated with sorafenib

Abstract: Intervention by pharmacists increased drug adherence. Under increased adherence, MKI-associated HFSR was an advantageous surrogate marker. Intervention by healthcare providers needs to be performed for adequate sorafenib treatment.

Cited by 6 publications

References 37 publications

Systematic review with meta‐analysis: the critical role of dermatological events in patients with hepatocellular carcinoma treated with sorafenib

Systematic review with meta‐analysis: the critical role of dermatological events in patients with hepatocellular carcinoma treated with sorafenib

Preemptive Versus Reactive Topical Clobetasol for Regorafenib-Induced Hand-Foot Reactions: A Preplanned Analysis of the ReDOS Trial

Effect of radiotherapy on survival in advanced hepatocellular carcinoma patients treated with sorafenib: a nationwide cancer-registry-based study

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