Prolonged survival in patients with hand-foot skin reaction secondary to cooperative sorafenib treatment

The aim of this study was to evaluate the association between axitinib, sunitinib and temsirolimus toxicities and patient survival in metastatic renal cell cancer patients. Overall survival (OS) and progression-free survival (PFS) of metastatic renal cell cancer patients from the prospective multicenter STAR-TOR study were assessed using multivariable Cox models. A total of 1195 patients were included (n = 149 axitinib; n = 546 sunitinib; n = 500 temsirolimus). The following toxicities significantly predicted outcomes: hand–foot skin reaction (hazard ratio [HR] = 0.29) for PFS with axitinib; stomatitis (HR = 0.62) and pneumonitis (HR = 0.23) for PFS with temsirolimus; stomatitis (HR = 0.52) and thrombocytopenia (HR = 0.6) for OS with temsirolimus; fatigue (HR = 0.71) for PFS with sunitinib; hand–foot skin reaction (HR = 0.56) and fatigue (HR = 0.58) for OS with sunitinib. In conclusion, in metastatic renal cell cancer, axitinib, sunitinib and temsirolimus demonstrate specific toxicities that are protective OS/PFS predictors.

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Grade III hand-foot skin reaction induced by sorafenib

Anais Brasileiros de Dermatologia ◽

10.1590/abd1806-4841.20176631 ◽

2017 ◽

Vol 92 (4) ◽

pp. 590-591 ◽

Cited By ~ 1

Author(s):

Anca Chiriac ◽

Marius Florin Coros ◽

Cristian Podoleanu ◽

Simona Stolnicu

Keyword(s):

Skin Reaction ◽

Hand Foot Skin Reaction ◽

Grade Iii

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Safety and Efficacy of Bis-Glyceryl Ascorbate (Amitose DGA) to Prevent Hand-Foot Skin Reaction in Patients With Renal Cell Carcinoma Receiving Sunitinib Therapy: Protocol for a Phase I/II, Uncontrolled, Single-Arm, Open-Label Trial (Preprint)

10.2196/preprints.14636 ◽

2019 ◽

Author(s):

Kazuhiro Yamamoto ◽

Takeshi Ioroi ◽

Kenichi Harada ◽

Satoshi Nishiyama ◽

Chikako Nishigori ◽

...

Keyword(s):

Renal Cell Carcinoma ◽

Ascorbic Acid ◽

Phase I ◽

Cell Carcinoma ◽

Skin Reaction ◽

Renal Cell ◽

Single Center ◽

Open Label ◽

Open Label Trial ◽

Hand Foot Skin Reaction

BACKGROUND Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple-tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life and is associated with the therapeutic efficacy of multiple-TKIs. Therefore, the management and prevention of HFSR is an important issue; however, an effective method for its prevention has not been established. Specific ascorbic acid derivatives can reverse multiple-TKI-induced keratinocyte growth and pathological changes in vitro. OBJECTIVE This study was designed to evaluate the safety of bis-glyceryl ascorbate (Amitose DGA), a novel, hydrosoluble, and moisturizing ascorbic acid derivative, in patients with renal cell carcinoma (RCC) receiving sunitinib therapy. This study was also designed to evaluate Amitose DGA’s preventive efficacy for sunitinib-induced HFSR. METHODS This is a Phase I/II, single-center, uncontrolled, single-arm, open-label trial. We will recruit a total of 30 patients with RCC receiving sunitinib therapy, with a 2-week-on and 1-week-off schedule. The participants will apply Amitose DGA-containing cream over both palmar and plantar surfaces within two treatment cycles (ie, 6 weeks) of sunitinib in combination with a general moisturizing agent, in addition to standard-of-care processes. Safety assessments will include dermatological abnormalities, clinical laboratory tests, and incidence of adverse events. Efficacy assessments will include development of HFSR and therapeutic outcomes associated with sunitinib. RESULTS Recruitment to the study began in August 2017 and is ongoing in Japan. To date, 21 subjects have been recruited. Study completion is expected in 2021. CONCLUSIONS This is the first clinical study of Amitose DGA-containing cream in patients with RCC who are receiving sunitinib therapy. The single-center, single-arm, open-label design was selected to maximize subject exposure and increase the likelihood of achieving our study endpoints. The results will provide valuable and preliminary evidence of the effects of Amitose DGA-containing cream on HFSR. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000027209; https://upload.umin.ac.jp/cgi-open-bin/ctr /ctr_view.cgi?recptno=R000031174 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/14636

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Multikinase Inhibitor-Induced Hand–Foot Skin Reaction: A Review of Clinical Presentation, Pathogenesis, and Management

American Journal of Clinical Dermatology ◽

10.1007/s40257-016-0197-1 ◽

2016 ◽

Vol 17 (4) ◽

pp. 387-402 ◽

Cited By ~ 18

Author(s):

Kumutnart Chanprapaph ◽

Suthinee Rutnin ◽

Vasanop Vachiramon

Keyword(s):

Skin Reaction ◽

Clinical Presentation ◽

Multikinase Inhibitor ◽

Hand Foot Skin Reaction

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Severe sorafenib-induced hand-foot skin reaction

Dermatology Online Journal ◽

10.5070/d36w96127d ◽

2011 ◽

Vol 17 (5) ◽

Author(s):

L Cuesta ◽

I Betlloch ◽

F Toledo ◽

N Latorre ◽

A Monteagudo

Keyword(s):

Skin Reaction ◽

Hand Foot Skin Reaction

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As Clinical Markers, Hand-Foot-Skin Reaction and Diarrhea Can Predict Better Outcomes for Hepatocellular Carcinoma Patients Receiving Transarterial Chemoembolization plus Sorafenib

Canadian Journal of Gastroenterology and Hepatology ◽

10.1155/2019/2576349 ◽

2019 ◽

Vol 2019 ◽

pp. 1-7

Author(s):

Lei Liu ◽

Enxin Wang ◽

Lin Li ◽

Dongyu Chen ◽

Kun Peng ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Combination Therapy ◽

Skin Reaction ◽

Transarterial Chemoembolization ◽

Cox Regression ◽

Time Dependent ◽

Clinical Markers ◽

Study Population ◽

Hand Foot Skin Reaction

Background. Combination therapy of transarterial chemoembolization plus sorafenib (TACE-S) has been proven to be safe and effective for hepatocellular carcinoma (HCC); however, this combination therapy is associated with a high incidence of adverse events (AEs). Our study focused on the relationships between AEs and treatment outcomes and aimed to discover AE-based clinical markers that can predict the survival benefits of combination treatment. Methods. From January 2010 to June 2014, a total of 235 HCC patients treated with TACE-S were retrospectively enrolled. Major sorafenib-related AEs were prospectively recorded, and their correlations with overall survival (OS) were analysed using time-dependent covariate Cox regression analyses. Results. The majority of the patients (200, 85.1%) were male, and the median age was 51 years old. After two years of follow-up, the median OS of the study population reached 12.4 months. In all, 218 patients (92.8%) presented at least one AE, and 174 (74.0%) suffered AEs ≥2 grade. Based on time-dependent multivariate analyses, the development of hand-foot skin reaction (HFSR) ≥2 grade (HR = 0.43, 95% CI: 0.32–0.58, P<0.001) and diarrhoea ≥1 grade (HR = 0.72, 95% CI: 0.53–0.97, P=0.029) were identified as independent predictors of prolonged OS. Moreover, patients who developed both HFSR ≥2 grade and diarrhoea ≥1 grade achieved better outcomes than those patients who developed either or neither of these AEs (HR = 1.51, 95% CI: 1.11–2.06, P=0.009). Conclusions. The development of HFSR ≥2 grade or diarrhoea ≥1 grade during TACE-S treatment indicated prolonged OS, and these AEs should be considered important clinical markers for predicting patient prognoses.

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