Incidence Of Hand-foot Syndrome Research Articles

Incidence of hand-foot syndrome with protein kinase inhibitors in advanced hepatocellular carcinoma patients who received atezolizumab-bevacizumab combination.

Treatment of advanced HepatoCellular Carcinoma (HCC) is based on first-line (L1) combination of atezolizumab and high-dose (HD) bevacizumab while second-line (L2) refers one antiangiogenic protein kinase inhibitors (aaPKI). This prolonged antiangiogenic pressure let us to observe an increasing occurrence of Hand-Foot Syndromes (HFS) in patients receiving aaPKI after HD bevacizumab combination. This study reports observations and discussions about the evidence and hypothesis that could be made. Patients who received the L1 combination from September 1st 2020 to December 31st 2022 to identify L2 aaPKI. Demographic, biological, oncological data and occurrence of HFS were collected. In addition were collected the number of L1 combination cycles, type of aaPKI, and delay between last L1 cycle and L2 initiation. This study had a purely exploratory purpose, so no statistical analysis was planned. 17 patients received an aaPKI after the L1 HD bevacizumab combination with a median time of 26 days from last L1 cycle to L2 start. Five patients experienced HFS including grade 3 (n = 2) with sorafenib and cabozantinib. The HFS occurred with a median delay of 23 days (IQR: 21-28) from aaPKI start. Three patients experienced aaPKI-related dose-limiting toxicity. Proportion of patients experienced HFS in our cohort did not differ from pivotal trials data and the sample size do not allow to conclude. Hypotheses include timing of aaPKI start in HCC treatment, vascular toxicity at aaPKI start after HD bevacizumab discontinuation instead combination, patient-related outcome for a better understanding of these aaPKI-related HFS post HD bevacizumab.

Efficacy of apatinib on advanced ovarian cancer patients who failed first and second-line chemotherapy

Purpose: To investigate the efficacy and safety of apatinib in the treatment of advanced epithelial ovarian cancer (EOC) patients who failed first and second-line chemotherapy.
 Methods: The clinical data of 100 patients diagnosed with advanced ovarian cancer were retrospectively analyzed. They were divided into two groups, with 50 patients in each group. One group was treated with apatinib mesylate (Apatinib group), while the other group was treated with gemcitabine (Gemcitabine group). Clinical efficacy, adverse reactions, and quality-of-life scores were were assessed, while the survival status of patients was recorded during follow-up.
 Results: After treatment, the objective response rate (ORR) and disease control rate (DCR) were 24.0 % (12/50) and 70.0 % (35/50) in Apatinib group, and 12.0 % (6/50) and 52.0 % (26/50) in Gemcitabine group. In terms of adverse reactions, the incidence of hand-foot syndrome and hypertension were significantly higher in Apatinib group than in Gemcitabine group, but the incidence of nausea and vomiting, anemia, neutropenia, and thrombocytopenia were significantly lower in Apatinib group than in Gemcitabine group (p < 0.05). Follow-up results revealed the median overall survival (OS) of patients to be 10.1 and 9.0 months, respectively, in Apatinib and Gemcitabine groups. Results of the log-rank test showed that OS in Apatinib group was significantly longer than that of Gemcitabine group.
 Conclusion: Apatinib demonstrates clear effectiveness and a superior safety profile than Gemcitabine in the management of patients with advanced ovarian cancer who did not respond effectively to multiple rounds of chemotherapy.

The preventive effect of celecoxib on regorafenib-associated hand-foot syndrome in patients with liver metastasis from colorectal cancer: A single-center, retrospective, real-world study.

e15576 Background: Regorafenib, an oral multi-kinase inhibitor, is the third- or later-line therapy for colorectal cancer with liver metastasis (CRLM), but the hand-foot syndrome (HFS) is its most common adverse reaction. Celecoxib, a selective COX-2 inhibitor, can treat inflammation. This study aimed to explore whether additing celecoxib to the cancer therapy regorafenib can prevent or alleviate the HFS, improve drug tolerance, and prolong the patient’s survival. Methods: In the retrospective cohort analysis, patients with colorectal cancer and liver metastasis, to whom regorafenib and celecoxib were administered in the Department of Hepatopancreatobiliary Surgery of Beijing Cancer Hospital between November 2021 and October 2022, were included. Upon the medical records from physical examination and other means of follow-ups, the Kaplan-Meier estimator analyzed the survival function and the severity of adverse events was described according to the CTCAE v.5.0 standards. Results: Twenty-six patients were included in the analysis and 14 colorectal cancer patients had extrahepatic metastases at the onset of the treatment. All patients received regorafenib and celecoxib. Further, 15 patients were treated with a combination of immune checkpoint inhibitors, 3 patients underwent combined local-regional therapy, 1 patient received combined chemotherapy, and 7 patients received regorafenib. Among all the patients, the incidence of grades 1 & 2 HFS was 46% and no grade 3 HFS was observed. The other main adverse events were hoarseness (35%), fatigue (27%), rash (27%), and neutropenia (15%). The most frequent adverse events from the CONCUR study and current analysis are shown in Table 1. Five patients (19%) had their treatment interrupted or their drug dose reduced due to adverse events. The median follow-up time of all patients was 5.3 (range, 1.6-13.1) months, the overall survival was not reached, and the median progression free survival was 2.9 (95% CI: 1.5-4.3) months. As the overall response in all patients after treatment, 3 cases (12%) achieved PR, 11 cases (42%) had SD and 12 cases (46%) showed PD. Conclusions: The addition of celecoxib to the cancer-line therapy regorafenib in CRLM patients did not reduce the incidence of HFS, but reduced the severity of HFS (grade 3). Also, it did not shorten the survival time of the patients. The addition of celecoxib to the main therapy might alleviate some adverse effects. [Table: see text]

Real-world effectiveness and safety of trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer: A retrospective observational study using an administrative database.

44 Background: Trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) are standard of care for refractory metastatic colorectal cancer (mCRC). Several phase II trials of FTD/TPI plus bevacizumab (BEV) have been conducted, showing promising efficacy with manageable safety, and it is widely used for patients with refractory mCRC in Japan. No result has been reported for large-scale real-world data directly comparing FTD/TPI plus BEV with FTD/TPI or REG monotherapy. Here, we evaluated the efficacy and safety of FTD/TPI plus BEV in real-world clinical practice. Methods: We used a nationwide claims database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan) in Japan. Eligible patients were aged 20 years or older in mCRC who received their first dose of FTD/TPI or REG between May 2014 and January 2021. The primary outcome was overall survival (OS) in a propensity score matching (PSM) population that was performed matching using a 1:1 ratio for FTD/TPI plus BEV and control group (FTD/TPI or REG) by propensity score. To enhance robustness, sensitivity analyses of OS were performed using the inverse probability treatment weighted (IPTW) approach and the analysis in all eligible population. Main secondary outcomes were OS for subgroups, time to treatment discontinuation (TTD), adverse events (assessed in all eligible population), and post-treatment. Results: The eligible population was 2,369 for FTD/TPI plus BEV and 9,318 for control group (FTD/TPI: 6,500 and REG: 2,818). The PSM population was 1,787 for FTD/TPI plus BEV and 1,787 for control group (FTD/TPI: 1,252 and REG: 535). Median OS (mOS) was 17.0 months for FTD/TPI plus BEV and 11.6 months for control group (HR: 0.70; 95% CI: 0.63–0.78; P < 0.001) in PSM population. Similarly, mOS was longer for FTD/TPI plus BEV compared to that for control group in IPTW analyses (HR: 0.68; 95% CI: 0.65–0.71; P < 0.001) and in all eligible population (HR: 0.68; 95% CI: 0.63–0.73; P < 0.001). In all eligible population, mOS were 17.6 months for FTD/TPI plus BEV and 12.6 months for control group (FTD/TPI: 12.9 months and REG: 12.1 months). Median TTD was 101 days for FTD/TPI plus BEV and 56 days for control group in PSM population (Wilcoxon rank-sum test P < 0.001). The incidence of hand-foot syndrome was significantly higher in REG compared with that in FTD/TPI plus BEV (Fisher's Exact test P < 0.001. Leukopenia incidence was significantly higher in FTD/TPI plus BEV than that in REG (Fisher's Exact test P < 0.001. Granulocyte colony-stimulating factor was administered to 20.6%, 16.5%, and 1.1% of patients in FTD/TPI plus BEV, FTD/TPI, and REG, respectively. Conclusions: The real-world data showed that FTD/TPI plus BEV had significantly longer OS and TTD than FTD/TPI or REG in mCRC. Thus, FTD/TPI plus BEV may be a favorable regimen for refractory mCRC in clinical practice.

Capecitabine Monotherapy as Palliative Treatment for Patients with Recurrent/Metastatic Nasopharyngeal Cancer.

Background Numerous chemotherapeutic agents have antitumor activity in recurrent/metastatic (R/M) nasopharyngeal cancer (NPC). Evidence of capecitabine's effectiveness as monotherapy is limited. Capecitabine tolerability in solid malignancies has ethnic and geographical variability. We investigated capecitabine's tolerability and identified potential prognostic factors for clinical outcomes in R/M NPC. Methods A consecutive retrospective cohort of patients who received capecitabine as the first recurrence, second- or third-line monotherapy for metastatic NPC (2011–2019) was reviewed concerning patient characteristics, pathological features, treatment outcomes, and toxicity. Results Fifty-one patients were eligible (median age at diagnosis: 42 [35.5–52.5] years). Most patients (78.4%) tolerated a standard oral dose of 1,250 mg/m2 capecitabine (2 weeks on/1 week off) in a 3-week cycle. The objective response rate was 49%, and the disease control rate was 66.7%, with a median response duration of 6.2 months. Hand-foot syndrome (HFS) was associated with a higher objective response rate (odds ratio, 5.1 [95% confidence interval: 1.18–21.98]; P = 0.02). The median follow-up duration was 17.8 (interquartile range: 7.8–30.4) months. The median (95% confidence interval) progression-free survival and overall survival were 6.6 (4.3–8.8) and 32.7 (25.9–39.5) months, respectively. HFS (P = 0.02), better performance status (P = 0.02), and absence of brain metastasis (P = 0.04) were associated with prolonged progression-free survival. Conclusion Capecitabine monotherapy is effective and well-tolerated as a palliative treatment for R/M NPC. Despite the lower incidence of HFS in our patients, it remained a favorable prognostic factor for objective response and progression-free survival.

The efficacy and safety of Apatinib combined with TACE in the treatment of hepatocellular carcinoma: a meta-analysis

BackgroundThe timely and effective treatments are vital to the prognosis of patients with hepatocellular carcinoma, and the role of Apatinib combined with TACE in the treatment of hepatocellular carcinoma remains unclear. Therefore, we aimed to conduct a systematic review and meta-analysis to evaluate the efficacy and safety of Apatinib combined with transcatheter arterial chemoembolization (TACE) in the treatment of hepatocellular carcinoma.MethodsWe searched for randomized controlled trials (RCTs) on Apatinib and TACE use in the treatment of hepatocellular carcinoma. Cochrane Central Register of Controlled Trials, Embase, PubMed, China Biomedical Literature Database, China Knowledge Network, Wanfang Database, and Weipu Chinese Science and Technology Journal Database were searched up to 16 April 2021. Two researchers independently screened the literature and extracted data according to the inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis. This meta-analysis protocol had been registered online (available at: https://inplasy.com/inplasy-2021-6-0047/).ResultsA total of 14 RCTs involving 936 hepatocellular carcinoma patients were included. The objective remission rate (OR = 2.93, 95% CI 2.17–3.95), 1-year survival (OR = 2.47, 95% CI 1.65–3.68), 2-year survival (OR = 2.67, 95% CI 1.41–5.04), the incidence of hand-foot syndrome (OR = 32.09, 95% CI 10.87–94.74) and the incidence of proteinuria (OR = 14.79, 95% CI 6.07–36.06) of the Apatinib + TACE group was significantly higher than that of the TACE group (all P < 0.05). There were no significant differences in the incidence of myelosuppression (OR = 1.01, 95% CI 0.61–1.67), the incidence of hypertension (OR = 7.56, 95% CI 0.95–1.67, P = 60.17) between Apatinib + TACE and TACE group (all P > 0.05).ConclusionsApatinib combined with TACE is more effective than TACE alone in the treatment of hepatocellular carcinoma, but it has certain adverse reactions.

Preventive Effects of Phenolic Compound Extra Virgin Olive Oil (EVOO) on the Incidence of Hand Foot Syndrome Induced Capecitabine

Hand foot syndrome (HFS) is a reaction that occurs on the skin of the palms and soles. feet, caused by the toxicity of chemotherapy drugs with symptoms such as tingling, pain, erythema, dry skin, swelling, increased pigmentation and itching. This condition is still a problem in the treatment of patients given capecitabine. Although HFS does not cause death, in severe cases it can affect the quality of treatment and interfere with daily activities. The cause of HFS is still unclear but from research it is known that capecitabine and its metabolites will increase the expression of the COX-2 enzyme, inhibit the arachidonic pathway, increase PGE2 activity, causing inflammatory reactions in the form of erythema, edema and pain. The phenolic components contained in EVOO, namely oleocanthal and hydroxytyrosol compounds in several studies have the same properties as celecoxib and ibuprofen as anti-COX-2, will inhibit the arachidonic synthesis pathway, reduce prostaglandin activity and reduce inflammatory reactions.

Efficacy of Aidi Injection and Brucea javanica Oil Emulsion Injection in Rectal Cancer during CapeOX Adjuvant Chemotherapy.

Background Adjuvant chemotherapy with CapeOX regimen is widely used in resected rectal cancer, which brings benefits to patients. But drug-related toxicities are severe during this process; thus, survival outcomes may potentially be affected. This study explored the efficacy of two Chinese herbal injections, Aidi injection (ADI) and Brucea javanica oil emulsion injection (BJOEI), as adjuvant drugs in CapeOX adjuvant chemotherapy on rectal cancer patients. Methods A total of 240 cases were enrolled in this retrospective study. 80 cases received CapeOX with ADI (the ADI group), 80 cases received CapeOX with BJOEI (the BJOEI group), and the rest 80 cases received CapeOX alone (the control group). After four cycles' chemotherapy, adverse reactions (ADRs) and quality of life (QOL) were analyzed. Then, patients received follow-up for at least one year, and the endpoint was disease-free survival (DFS). Results All patients completed at least four cycles' adjuvant chemotherapy. The incidence of leukopenia and thrombocytopenia was significantly lower in the ADI group; the incidence of nausea was significantly lower in the BJOEI group; the incidence of hand-foot syndrome was significantly lower in both the ADI group and BJOEI group. Significant difference was found in the control group regarding the Karnofsky Performance Status (KPS) scores prior and posttreatment. No difference was found among three groups regarding one-year DFS. Conclusion As adjuvant drugs for rectal cancer during CapeOX chemotherapy, ADI shows advantages in decreasing leukopenia and thrombocytopenia, while BJOEI results better in remitting nausea. Both two CHIs had positive impacts on decreasing hand-foot syndrome and the maintenance of patients' QOL. It is worthy of further study and promotion for CHIs.

High dose and hepatobiliary dysfunction are associated with hand-foot syndrome in patients with lymphoma using pegylated liposomal doxorubicin: a retrospective study

PurposeIn clinical practice, the risk factors for pegylated liposomal doxorubicin-related hand-foot syndrome remain unclear. The purpose of this study was to determine the risk factors associated with hand-foot syndrome in patients with lymphoma using pegylated liposomal doxorubicin.MethodsThis retrospective descriptive analysis included patients with lymphoma who received PLD treatment (≥ 2 cycles of chemotherapy) at our cancer centre and had complete follow-up data from January 2016 to February 2020. Clinical, laboratory data, as well as the occurrence of hand-foot syndrome (incidence, location, severity, impact on follow-up chemotherapy) were obtained. The primary end point was the incidence of hand-foot syndrome, which was classified according to the “Common Terminology Criteria for Adverse Events” (Version 4.0). A multivariate logistic regression analysis was used to identify risk factors for hand-foot syndrome in patients with lymphoma using doxorubicin liposomes.FindingsA total of 167 patients met the inclusion criteria. 58 developed HFS, of which 45 occurred after the second course of chemotherapy. The multivariate logistic regression analysis revealed that a dose increase of pegylated liposomal doxorubicin and hepatobiliary dysfunction were significantly associated with an increased risk for hand-foot syndrome(dose intensity, OR = 6.479; 95% CI, 1.431–29.331 [P = 0.015]; history of gallstones, OR = 14.144, 95% CI, 1.512–132.346 [P = 0.020]; alanine aminotransferase, OR = 1.194, 95% CI, 1.056–1.350 [P = 0.005]; aspartate aminotransferase, OR = 1.162, 95% CI, 1.010–1.336 [P = 0.035]; and glutamine transpeptidase, OR = 1.092, 95% CI, 1.016–1.174 [P = 0.018]).ImplicationsThese findings contribute to the risk assessment of patients with lymphoma before using pegylated liposomal doxorubicin. For patients with the above risk factors, preventive measures should be taken in advance to reduce the incidence of HFS.

P-174: Clinical study of bortezomib-based regimens of BCD, PAD and VDD for newly diagnosed multiple myeloma – an analysis of 400 cases in a single center of China

<h3>Background</h3> Objective To investigate the clinical efficacy and safety of bortezomib-based regimens of BCD (bortezomib, cyclophosphamide and dexamethasone), PAD (bortezomib, doxorubicin and dexamethasone) and VDD (bortezomib, pegylated liposomal doxorubicin and dexamethasone). <h3>Methods</h3> 400 newly diagnosed multiple myeloma (MM) patients enrolled in two prospective non-randomized cohort studies in a single center were retrospectively analyzed from April 2008 to August 2017. <h3>Results</h3> Among all the patients, 194 cases (48.5%) received BCD, 84 cases (21.0%) received PAD, and 122 cases (30.5%) received VDD. 1) Analysis of clinical features: Serum albumin (ALB) level was lower in the BCD group than the other two (P<0.001), and the proportion of patients in the International Stage System (ISS) stage III was higher in the BCD and VDD groups than the PAD group (P=0.002). Patients younger than 65 years were much more in the PAD group than the other two. Correspondingly, the proportion of patients receiving autologous hematopoietic stem cell transplantation (ASCT) was significantly higher in the PAD group. 2) The overall response rates (ORR) of the patients in BCD, PAD and VDD groups were 87.5%, 83.6% and 83.0% respectively, and there was no significant difference between the three groups. More patients attained complete response (CR) in the VDD group than the other two (P=0.049).The rate of minimal residual disease (MRD) negativity was slightly higher (60%) in PAD group which may be related to the higher ASCT proportion in this group, but the difference was not statistically significant (P=0.272). 3) Whether combined with alkylating agents (BCD) or combined with anthracyclines (PAD and VDD), there was no significant difference of the median progression-free survival (PFS) and the median overall survival (OS). Also there was no significant difference in PFS and OS between BCD, PAD and VDD groups. 4) In the safety aspect, there was no significant difference in non-hematologic toxicities such as peripheral neuropathies, cardiac events, gastrointestinal reactions, thrombus and bleeding events between the three groups. The incidence of hand-foot syndrome in VDD group was 5.8%, all of which were grade 1/2. In terms of hematologic toxicity, the incidence of grade 3/4 neutropenia and thrombocytopenia was significantly higher in the PAD group than the other two groups. There was no significant difference between the BCD and VDD group. <h3>Conclusion</h3> As the bortezomib-based three-drug regimens combined with traditional chemotherapeutic agents, BCD, PAD and VDD can all achieve remission in more than 80% newly diagnosed MM patients as induction therapy. The efficacy and long-term outcomes are comparable between the three regimens. In the aspects of safety, the BCD and VDD groups had a lower risk of grade 3/4 hematological toxicity.

Effect of Urea Cream on Hand-Foot Syndrome in Patients Receiving Chemotherapy: A Meta-analysis.

Hand-foot syndrome (HFS) is a specific adverse effect of certain chemotherapy that may lead to dosage reduction or chemotherapy discontinuation in patients with cancer. Topical urea cream may reduce symptom severity in patients with HFS. However, these studies have not provided consonant results. To determine the effectiveness of urea cream, we conducted a meta-analysis of clinical trials to evaluate the prevention and treatment of HFS. PubMed, EMBASE, and Cochrane Library databases were searched for studies published before September 2020. The study registered at PROSPERO (CRD 42020203164). Incidence of HFS reported in studies at any grade and at second grade or greater was assessed within 3 to 12 weeks. Secondary outcomes were time to HFS, incidence of skin-related adverse events, chemotherapy dose reduction, and quality of life. Seven trials involving 1387 patients were reviewed. In the prophylactic subgroup, patients with urea cream intervention showed a significantly lower incidence of HFS at second grade or greater (risk ratio, 0.72; 95% confidence interval, 0.58-0.90) and a nonsignificant lower incidence of any-grade HFS (risk ratio, 0.79; 95% confidence interval, 0.58-1.08) than those not receiving urea cream intervention. Urea cream has advantages to reduce the incidence of severe HFS. Urea cream is a safe and viable topical prevention strategy that can reduce the incidence of high-grade HFS in patients undergoing chemotherapy. We recommend a routine treatment option before chemotherapy for the patients.

S-1 and Capecitabine for the Treatment of Colorectal Cancer: A Meta-Analysis

Colorectal cancers common tumors that develop in the large intestines. The incidence of colorectal cancer is second only to gastric and esophageal cancers. Both S-1 and capecitabine are the third-generation fluorouracil-based chemotherapeutic drugs. We hope to summarize the therapeutic effects of tecotae and capecitabine in patients with colorectal cancer through this Meta-analysis. We performed a meta-analysis of the findings in the current literature. We performed a systematic review of outcomes associated with S-1 and capecitabine used to treat advanced colorectal cancer based on findings from both English and Chinese publications listed in PubMed, Embase, CNKI, Wanfang, EBSCO, Web of Science and the Cochrane Library. End-points included ORR, DCR, OS, and PFS; adverse events (grades 1–2 and 3–4) were also evaluated. Statistical analysis was performed using RevMan 5.3. A total of 12 studies were eventually included, involving a total of 3,375 patients. Of this group, 1,683 and 1,692 patients underwent treatment with S-1 or capecitabine, respectively. There were no greatly differences with respect to ORR, DCR, or OS; however, PFS was bettered in the group of S-1 compared to those treated with capecitabine. The incidence of leukopenia, diarrhea and anorexia were all higher among those in S-1 group compared to the capecitabine group, but a higher incidence of hand-foot syndrome was linked with use of capecitabine. Use of S-1 for the treatment of colorectal cancer may result in superior outcomes when compared to use of capecitabine.

Adjuvant capecitabine in locoregionally advanced nasopharyngeal carcinoma: A multicenter randomized controlled phase III trial.

6005 Background: We conducted a multicenter, randomized controlled phase III clinical trial (NCT02143388) to investigate the efficacy and toxicity of adjuvant capecitabine (AC) in addition to concurrent cisplatin and radiotherapy (CCRT) compared to CCRT alone in high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC) patients. Methods: Eligibility criteria included AJCC/UICC 7th ed TNM stage III-IVb and one of the following features: T3-4N2 or T1-4N3 or pre-treatment plasma EBV DNA concentration of &gt;20,000 copy/ml or gross primary tumor volume (GTVnx) of &gt;30 cm3 or a maximum standard uptake value (SUVmax) of &gt;10.0 by 18FDG PET-CT within the primary tumor or multiple neck node metastases, with any larger than 4 cm. All patients were randomly assigned in a 1:1 ratio to receive CCRT (3-weekly cisplatin at 100 mg/m2 for 2-3 cycles) followed by AC (1000 mg/m2 bi-daily for 14 days every 21-day cycle for 8 cycles), or CCRT alone. The prescribed radiation doses were 68-72 Gy/30-32 fractions to the PTVnx, 60-68 Gy/30-32 fractions to PTVnd, 60-64Gy/30-32 fractions to PTVhigh-risk, 54-58Gy/30-32 fractions to PTVlow-risk. Primary end point was failure-free survival (FFS). Results: Between Mar 2014 to Jul 2018, 180 patients were recruited (90 patients in CCRT+AC arm and 90 in CCRT alone arm). All patients completed RT and ≥2 cycles of concurrent cisplatin in both treatment arms (cumulative dose intensities for cisplatin were 200 mg/m2 in both arms). 85 (94.4%) patients went on to receive AC, with 71 (78.9%) patients completing 8 cycles; 19 (22.4%) patients had dose reduction of AC. With a median follow-up of 44.8 mo, the 3-y FFS was significantly superior in the CCRT+AC arm than the CCRT arm for the intention-to-treat cohort (87.7% vs 73.3%; HR: 0.52 [95% CI: 0.29-0.77], P = 0.037). 3-year overall, distant metastasis-free and locoregional relapse-free survival were 92.6% vs 88.9% (HR [95% CI]: 0.66 [0.28-1.59]), 88.8% vs. 81.1% (HR: 0.67 [0.33-1.33]) and 91.5% vs 80.0% (HR: 0.50 [0.25-1.00]), respectively. Incidences of G3-4 acute toxicities were 57.8% (52 of 90) in CCRT+AC arm and 51.1% (46 of 90) in CCRT alone arm, with a higher incidence of hand foot syndrome (3.5% vs 0%), xerostomia (11.1% vs 3.3%), mucositis (23.3% vs 16.7%), and anemia (5.6% vs 2.2%) in the CCRT+AC arm. G3-4 late toxicities occurred in 13.3% (12 of 90) and 9.0% (8 of 89), respectively. Conclusions: The addition of capecitabine to CCRT conferred a superior disease control than CCRT alone in high-risk LANPC. Survivals in ITT and PP set. Clinical trial information: NCT02143388. [Table: see text]

Pegylated liposomal doxorubicin-induced hand-foot syndrome predicted by serum metabolomic profiling and prevented by calcium dobesilate

Pegylated liposomal doxorubicin-induced hand-foot syndrome predicted by serum metabolomic profiling and prevented by calcium dobesilate

The effectiveness of EVOSKIN®Palm and sole moisturizing cream in treating capecitabine-associated hand-foot syndrome: a randomized double-blind clinical trial.

This study sought to test the effectiveness of EVOSKIN®Palm and sole moisturizing cream (PSMC) in preventing and treating hand-foot syndrome (HFS) during capecitabine chemotherapy. Stage II/III colorectal cancer patients receiving capecitabine adjuvant chemotherapy were randomly allocated to receive either EVOSKINPSMC or physiological saline treatments for their hands and feet. Treatment was initiated along with adjuvant chemotherapy and continued till the end of chemotherapy. Participants' skin responses were evaluated every 3 weeks. During the study, 51 participants in the EVOSKIN PSMC group and 54 participants in the physiological saline group completed at least three cycles of capecitabine chemotherapy. The total incidence of HFS in the EVOSKIN PSMC group was lower than that in the physiological saline group (56.8% vs. 75.9%, P=0.006), as was the incidence of Grade 3/4 HFS (6.0% vs. 18.5%, P=0.011). The incidence of HFS became significant after 6weeks of chemotherapy. Further, the incidence of severe HFS was significant from as early as 3weeks after the commencement of chemotherapy despite the use of EVOSKIN PSMC to manage the condition. Notably, the incidence of Grade 1/2 HFS was not statistically significant between the two groups (26/51 vs. 32/54, 52.0% vs. 59.2%, P=0.194). The incidence of severe HFS among individuals using oral capecitabine can be reduced by the prophylactic treatment of EVOSKIN PSMC, this treatment is reasonable and acceptable for patients with capecitabine chemotherapy.

Maintenance Chemotherapy with S-1 Following SOX Regimen Chemotherapy Improves Prognosis of Stage 3 Gastric Cancer After D2 Gastrectomy: A 5-Year Analysis.

ObjectiveTo assess the effectiveness and safety of treatment consisting of maintenance chemotherapy (MCT) with S-1 following S-1 plus oxaliplatin (SOX) chemotherapy for stage 3 gastric cancer (GC) after D2 gastrectomy.MethodsIn this retrospective study, we enrolled 255 patients with stage 3 GC who underwent D2 gastrectomy between February 2011 and May 2014. The SOX regimen chemotherapy was administrated to all of the patients as adjuvant therapy. The SOX regimen consisted of S-1 (for patients with a body surface area [BSA] of less than 1.25 m2, 80 mg/d; 100 mg/d for BSA=1.25 m2- <1.5 m2, and 120 mg/d for BSA≥1.5 m2, in 2 divided doses for 14 d) and oxaliplatin (130 mg/m2 given on Day 1), repeated every 21 d for 8 cycles. Following SOX chemotherapy, 122 of these patients received maintenance chemotherapy (the MCT group) with S-1, whereas 133 patients (the control group) received no MCT. The MCT consisted of S-1 (80, 100, or 120 mg daily based on BSA, in 2 divided doses for 14 d), repeated every 21 d for 8 cycles at most. The chemotherapy was discontinued if unacceptable toxicity or disease progression occurred or upon the request of the patient. All cases were followed up, and overall survival (OS), recurrence-free survival (RFS), and toxicities were compared.ResultsThe MCT group exhibited a distinctly higher 5-year OS (P=0.0425) and RFS (P=0.0479) than those of the control group. The incidence of hand-foot syndrome was markedly greater in the MCT group (P=0.0026). No toxicity-related death occurred.ConclusionMaintenance chemotherapy with S-1 following the SOX regimen chemotherapy provides significant survival benefit for stage 3 GC after D2 gastrectomy.

Pyridoxine for prevention of hand-foot syndrome caused by chemotherapy agents: a meta-analysis.

Hand-foot syndrome (HFS) is a common systemic skin toxicity syndrome caused by chemotherapy agents. However, there is no uniform clinical treatment for HFS. It is reported that pyridoxine (vitamin B6) can be used to prevent HFS, but the evidence is insufficient. To determine whether pyridoxine can be used to prevent HFS caused by chemotherapy agents. Literature database searches were performed on PubMed, Web of Science, Embase, Cochrane Library and China National Knowledge Infrastructure. The efficacy of pyridoxine was evaluated by the incidence of HFS (any grade) or severe HFS (grade≥2). Fourteen studies involving 1570 patients were included in this meta-analysis. There were no significant differences between the pyridoxine and control groups in the prevention of HFS (OR=0.84, 95% CI 0.67-1.05, P=0.09) or in the incidence of grade ≥2 HFS (OR=0.87, 95% CI 0.70-1.09, P=0.39, respectively). The subgroup analysis of pyridoxine dose also showed no significant difference between the two groups in preventing HFS grade ≥2 (OR=0.79, 95% CI 0.62-0.99, P=0.30). We did not find adequate evidence to support the idea that the use of pyridoxine can prevent HFS and reduce the incidence of HFS grade ≥2. However, the preventive use of pyridoxine might have a tendency to reduce the incidence of HFS.

Extending chemotherapy with capecitabine following CAPOX chemotherapy improves survival of Stage 3 gastric carcinoma after radical surgery: a 5-year analysis.

To assess the effectiveness and safety of treatment consisting of extending chemotherapy (ECT) with capecitabine following capecitabine plus oxaliplatin (CAPOX) chemotherapy for stage 3 gastric carcinoma (GC) after D2 gastrectomy. In this retrospective study, we included 214 patients with stage 3 GC who underwent D2 gastrectomy between January 2012 and April 2014. The CAPOX regimen chemotherapy was administrated to all of the patients as adjuvant therapy. The CAPOX regimen consisted of capecitabine (1000 mg/m2, in 2 divided doses for 14 d) and oxaliplatin (130 mg/m2 given on Day 1), repeated every 21 d for 8 cycles. Following CAPOX chemotherapy, 102 of these patients received extending chemotherapy (the ECT group) with capecitabine, whereas 112 patients (the control group) received no ECT. The ECT consisted of capecitabine (1000 mg/m2, in 2 divided doses for 14 d), repeated every 21 d for 8 cycles at most. The chemotherapy was discontinued if unacceptable toxicity or disease progression occurred or upon the request of the patient. All cases were followed up, and overall survival (OS), recurrence-free survival (RFS), and toxicities were compared. The ECT group exhibited a distinctly higher 5-year OS (p=0.0468) and RFS (p=0.0483) than those of the control group. The incidence of hand-foot syndrome was markedly greater in the ECT group (p=0.0043). No toxicity-related death occurred. Extending chemotherapy with capecitabine following the CAPOX regimen chemotherapy provides significant survival benefit for stage 3 GC after D2 gastrectomy.

Management of cytotoxic chemotherapy-induced hand-foot syndrome.

Improvements in systemic cancer treatments have resulted in more patients surviving for prolonged periods of time on treatment. This has made treatment-related toxicity and quality of life concerns increasingly relevant. Hand-foot syndrome (HFS) is a common skin reaction to systemic therapy that should be anticipated with chemotherapeutic treatments such as pegylated liposomal doxorubicin, docetaxel, and fluoropyrimidines. In this review we discuss current knowledge of the diagnosis, incidence, pathogenesis, and management of hand-foot syndrome (HFS). Although HFS is not life threatening, it can cause significant discomfort and impairment of function, especially in elderly patients, and may seriously impact quality of life. The incidence of HFS is dependent on the chemotherapeutic drug used, the treatment schedule, and the median duration of treatment. Effective measures for prevention and treatment of HFS include systemic and topical treatments, dose reductions, and switching to other drugs in the same class that are associated with lower rates of HFS. These approaches allow patients to continue cancer treatment while reducing negative impacts on quality of life. Awareness and early recognition are important to ensure timely treatment and avoidance of dose reductions or treatment discontinuation. We provide useful recommendations to guide the management of HFS in clinical practice.

An Observational Study of Team Management Approach for CapeOX Therapy in Patients with Advanced and Recurrent Colorectal Cancer: SMILE Study (The Study of Metastatic colorectal cancer to investigate the Impact of Learning Effect).

Objectives: In recent years, CapeOX therapy for patients with colorectal cancer is widely used. We previously reported that a multidisciplinary approach decreases the worsening of adverse events and increases patient satisfaction. In this study, we conducted a multicenter, prospective, observational study to evaluate the incidence of adverse events, health-related quality of life (HRQOL) of the patient, and efficacy of a management (intervention) according to the support system (SMILE study). Methods: As the interventional method, the following more than one method was carried out in each institute, 1: support with telephone, 2: dosing instruction by a pharmacist, 3: skin care instruction by a nurse, and 4: patient instruction by a doctor. The primary endpoint was the incidence of hand-foot syndrome (HFS) of more than grade 2. The secondary endpoint was the HRQOL evaluation and efficacy. The questionnaire (HADS) was administered before the start of the chemotherapy and in 1, 2, 4, 5, and 8 courses to evaluate quality of life (QOL). Results: From April 2011 to September 2012, 80 patients were enrolled from 14 sites, and all patients were the subjects of analysis. The demographic background was as follows: man/woman: 46/34, age median: 63 (36-75), and management interventional method 1/2/3/4: 36/68/73/78. The overall percentage of HFS that exceeded grade 2 within 6 months was 16.3%. It was 11.1% with the telephone support group and 20.5% without the telephone support group (p = 0.26). Conclusions: A multi-professional telephone support may reduce the deterioration of HFS. Further study which includes larger cohort is needed in the future.