scholarly journals Hydrocolloid dressing as a prophylactic use for hand–foot skin reaction induced by multitargeted kinase inhibitors: protocol of a phase 3 randomised self-controlled study

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038276
Author(s):  
Sadamoto Zenda ◽  
Asako Ryu ◽  
Atsuo Takashima ◽  
Michiko Arai ◽  
Yusuke Takagi ◽  
...  
Keyword(s):  
Supportive Care ◽  
Gastrointestinal Stromal Tumour ◽  
Controlled Study ◽  
Cancer Center ◽  
Scientific Conference ◽  
Clinical Trial Registry ◽  
Phase 3 ◽  
Multikinase Inhibitors ◽  
Hydrocolloid Dressing ◽  
Hand Foot Syndrome

IntroductionAlthough topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand–foot syndrome induced by multikinase inhibitors, there is still room for improvement. Hydrocolloid dressing is a type of wound dressing often used for wounds such as decubitus ulcers. The purpose of this study is to verify the usefulness of application of hydrocolloid dressings as prophylaxis against development of hand–foot syndrome induced by multikinase inhibitors by comparing the effects of this dressing and standard supportive care (moisturising care alone) within the same individuals.MethodsThis study is a phase 3 randomised, self-controlled study to compare prophylactic moisturising care with or without hydrocolloid dressing for hand–foot syndrome induced by multikinase inhibitors. Patients with radically unresectable advanced or recurrent colorectal carcinoma, gastrointestinal stromal tumour and hepatocellular carcinoma who scheduled to receive regorafenib or sorafenib therapy are eligible for enrolment.Supportive care for hand–foot syndrome will consist of basic moisturising care with or without hydrocolloid dressing. If hand–foot syndrome occurs, a steroid ointment will be applied two times per day at the affected sites. The primary endpoint is an incidence rate of grade 2 or more severe hand–foot syndrome (soles of the feet only) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events V.4.0. Grading of hand–foot syndrome will be performed by central review using photographs taken weekly by blinded trained physicians. The ethical approval was obtained from National Cancer Center Hospital. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conference.DiscussionIf the positive results are found in this study, it is shown that hydrocolloid dressing is effective not only as a symptom management but also as a prevention in hand–foot syndrome induced by multikinase.Trial statusThe enrolment was started in January 2019, and planned to closed in January 2021. As of February 2020, 26 patients enrolled in this study.Trial registration numberUMIN Clinical Trial Registry (UMIN000034853).Protocol versionV.1.4, 9 January 2020.

Advanced cancer patients' (CP) attitudes and perceptions regarding reasons for outpatient supportive care (SC) referral at a comprehensive cancer center: A randomized controlled study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24135-e24135
Author(s):  
Angelique Wong ◽  
Frank V. Fossella ◽  
George R. Simon ◽  
Rama Maddi ◽  
Zhanni Lu ◽  
...  
Keyword(s):  
Supportive Care ◽  
Cancer Care ◽  
Comprehensive Cancer Center ◽  
Controlled Study ◽  
Cancer Center ◽  
Cancer Type ◽  
Attitudes And Perceptions ◽  
Outpatient Supportive Care

e24135 Background: Current ASCO guidelines propose early access to SC in all CP to improve quality of care, quality of life, and symptoms. Very few studies have evaluated patients’ perceived criteria for referral to outpatient SC and perceptions of patients who are referred early in their disease trajectory. Methods: In this study we evaluated CP attitudes and perceptions regarding the role of and access to outpatient Supportive Care clinic (SCC) at a comprehensive cancer center. CP with life expectancy of greater than 6 months (as determined by the oncologist) and who are newly registered at MD Anderson Cancer Center were randomized to either obtain an educational brochure that explained the role of the SCC or no brochure. Both groups then completed a survey regarding the role and access to of outpatient SCC. After completion of the survey, patients were asked if they would like to be seen by the SC team. If so, they were scheduled by their oncologist for a SC consult. Results: 288 patients were evaluable: median age was 63, 43% were female, 84% were Caucasian, and the most common cancer type was lung cancer (39%). Median survival was 15 months. Patients who received a brochure reported more understanding of the role of SC vs those who did not receive a brochure (63% vs 37%, p = 0.04). Both groups felt that SC could help to address physical (47% vs 54%) and psychosocial (50% vs 50%) symptoms. Both groups felt SC could help to address questions regarding prognosis (50% vs 50%) and future care (53% vs 47%). Both groups did not feel that time (50% vs 50%) nor financial concerns (49% vs 51%) would be barriers to access SC. Both groups did not feel that receiving SC would impede their cancer care (60% vs 40%) nor change their oncologists’ perspective of them (25% vs 75%). Both groups felt they could receive SC and cancer care simultaneously (50% vs 50%). Approximately half of the patients in both groups perceived it was not too early for a referral to SC. There were no statistical differences in these groups for these findings. Conclusions: Patients who received a brochure had a better understanding of the role of SC. A very significant proportion in both groups had limited awareness of the value of SC. Oncologist driven referral and education of SC may facilitate better understanding of the value of SC. Further studies are needed.

scholarly journals Safe and persistent growth-promoting effects of vosoritide in children with achondroplasia: 2-year results from an open-label, phase 3 extension study

2021 ◽  
Author(s):  
Ravi Savarirayan ◽  
Louise Tofts ◽  
Melita Irving ◽  
William R. Wilcox ◽  
Carlos A. Bacino ◽  
...  
Keyword(s):  
Growth Velocity ◽  
Bone Growth ◽  
Growth Factor Receptor ◽  
Extension Study ◽  
Controlled Study ◽  
Open Label ◽  
Phase 3 ◽  
Double Blind ◽  
Pathogenic Variants ◽  
Growth Promoting

Abstract Purpose Achondroplasia is caused by pathogenic variants in the fibroblast growth factor receptor 3 gene that lead to impaired endochondral ossification. Vosoritide, an analog of C-type natriuretic peptide, stimulates endochondral bone growth and is in development for the treatment of achondroplasia. This phase 3 extension study was conducted to document the efficacy and safety of continuous, daily vosoritide treatment in children with achondroplasia, and the two-year results are reported. Methods After completing at least six months of a baseline observational growth study, and 52 weeks in a double-blind, placebo-controlled study, participants were eligible to continue treatment in an open-label extension study, where all participants received vosoritide at a dose of 15.0 μg/kg/day. Results In children randomized to vosoritide, annualized growth velocity increased from 4.26 cm/year at baseline to 5.39 cm/year at 52 weeks and 5.52 cm/year at week 104. In children who crossed over from placebo to vosoritide in the extension study, annualized growth velocity increased from 3.81 cm/year at week 52 to 5.43 cm/year at week 104. No new adverse effects of vosoritide were detected. Conclusion Vosoritide treatment has safe and persistent growth-promoting effects in children with achondroplasia treated daily for two years.

scholarly journals Research Trends of Acupuncture Therapy on Cancer Over the Past Two Decades: A Bibliometric Analysis

2020 ◽  
Vol 19 ◽  
pp. 153473542095944
Author(s):  
Jing Guo ◽  
Lixia Pei ◽  
Lu Chen ◽  
Hao Chen ◽  
Dongmei Gu ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Acupuncture Therapy ◽  
Supportive Care ◽  
Bibliometric Analysis ◽  
Integrative Medicine ◽  
Clinical Studies ◽  
Current Status ◽  
Cancer Center ◽  
Future Research ◽  
The Past

Purpose: Acupuncture has been used for managing cancer-related symptoms. However, there are still few studies concerning the overall trends in acupuncture therapy on cancer based on bibliometric analysis. This study aims to demonstrate the current status and trends in this field over the past 2 decades. Methods: Articles were retrieved from the Web of Science from 2000 to 2019. CiteSpace was used for co-authorship network of countries/institutions, dual-map analysis, and detecting the keywords with citation bursts. VOSviewer was used to construct networks based on co-authorship and co-citation analysis of authors, and co-occurrence of keywords. Results: A total of 927 articles and reviews were included in the final analysis. The number of publications has steadily increased with some fluctuations among years. The country and institution contributing most to this field are the USA and Memorial Sloan Kettering Cancer Center. Mao JJ was the most productive author and Molassiotis A ranked first in the cited authors. The co-occurrence analysis revealed 5 clusters (including “clinical trials,” “clinical studies on chemotherapy/radiation-induced symptoms,” “CAM therapy for cancer,” “clinical studies on vasomotor symptoms,” and “systematic reviews”). Most recent keyword bursts were “neuropathic pain,” “arthralgia,” “prevention,” “supportive care,” and “integrative medicine”. Conclusions: The annual publication output would increase rapidly in the next decade, which shows a promising future in this research field. Future research hotspots would focus on the role of acupuncture in neuropathic pain, arthralgia, prevention, supportive care, and integrative medicine.

scholarly journals POS-380 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATRASENTAN IN PATIENTS WITH IGA NEPHROPATHY (THE ALIGN STUDY)

2021 ◽  
Vol 6 (4) ◽  
pp. S164-S165
Author(s):  
H. Lambers Heerspink ◽  
D. Kohan ◽  
R. Lafayette ◽  
A. Levin ◽  
H. Zhang ◽  
...  
Keyword(s):  
Iga Nephropathy ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

The efficacy and safety of anlotinib in refractory/recurrent/advanced pediatric solid tumors: A retrospective study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11556-11556
Author(s):  
Suying Lu ◽  
Ye Hong ◽  
Huimou Chen ◽  
Liuhong Wu ◽  
Jia Zhu ◽  
...  
Keyword(s):  
Adverse Events ◽  
Effective Treatment ◽  
Solid Tumors ◽  
Objective Response ◽  
Cancer Center ◽  
Treatment Schedule ◽  
Efficacy And Safety ◽  
Pediatric Solid Tumors ◽  
Hand Foot Syndrome ◽  
Grade 3

11556 Background: Refractory and recurrent advanced pediatric solid tumors are short of effective treatment and with a dismal outcome, thus an urgent need for novel and effective treatment. The aim of the study is to evaluate the efficacy and safety of anlotinib, a novel and oral multi-target receptor tyrosine kinase inhibitor, in refractory or recurrent advanced pediatric solid tumors. Methods: The retrospective, single-institutional, observed study was conducted in Sun Yat-sen University cancer center in China. Refractory, recurrent, or advanced pediatric solid tumors patients treated with anlotinib between 2018 to 2020 were evaluated. Results: Forty-one patients and thirty patients were enrolled in the study to evaluated efficacy and safety, respectively. The objective response ratio (ORR) was 12.2% (95%CI 1.7-22.7): complete response (n = 0) and partial response (n = 5) (Table). The disease control rate (DCR) was 65.9% (95%CI 50.7-81). The median progression-free survival (PFS) was 2.87 months (95%CI 0.86-4.88). According to anlotinib treatment schedule, all patients were divided into three groups: anlotinib monotherapy (A, n = 16), anlotinib combined with immune checkpoint inhibitor treatment (A + ICI, n = 6), anlotinib combined with salvage chemotherapy (A + SC, n = 19). The ORR, DCR and median PFS for three groups were 6.3% (95%CI 7.1-19.6), 56.3% (95%CI 28.9-83.6), 2.43months, 16.7% (95%CI 26.2-59.5), 66.7% (95%CI 12.5-120.9), 1.13months, 15.8% (95%CI 2.3-33.8), 73.7% (95%CI 51.9-95.5), 2.87months, respectively. There was no significantly difference between three groups in aforementioned response index. The incidence rates of any grade and grade 3-4 adverse events were 80% and 20%, respectively. Bleeding (20%), hand-foot syndrome (13.3%), and diarrhea (13.3%) were the most common adverse events. Grade 3-4 adverse events include hypertension, hand-foot syndrome, diarrhea, anemia, and thrombocytopenia. There was no adverse events-related death. Conclusions: For heavily pretreated pediatric solid tumors, anlotinib may be an effective treatment with tolerable adverse events. Further prospective randomized controlled clinical study is warranted.[Table: see text]

Results of the phase 1b soft-tissue sarcoma (STS) portion of the global randomized, double-blind, placebo-controlled study of tazemetostat (TAZ) plus doxorubicin (DOX) as frontline therapy for advanced epithelioid sarcoma (ES).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 11563-11563
Author(s):  
Sant P. Chawla ◽  
Gerald Steven Falchook ◽  
Melissa Amber Burgess ◽  
James Lin Chen ◽  
Robin Lewis Jones ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Safety Profile ◽  
Controlled Study ◽  
Pharmacokinetic Data ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Limited Effectiveness ◽  
Phase 1B ◽  
Frontline Therapy

11563 Background: ES is a rare, aggressive subtype of STS for which cytotoxic chemotherapy has limited effectiveness. TAZ, an FDA-approved EZH2 inhibitor, has shown single-agent clinical activity and a favorable safety profile in patients with metastatic or locally advanced ES. In preclinical studies, TAZ has shown synergistic antitumor activity with DOX, which is often used as frontline treatment for STS. Here, we present results of the phase 1b study (NCT04204941), designed to assess the recommended phase 3 dose (RP3D), safety, and efficacy of TAZ + DOX in patients with advanced STS. Methods: The open-label, phase 1b portion of this study enrolled adult patients with previously untreated advanced STS. A standard 3 + 3 design was used to assess TAZ 400 mg, 600 mg, and 800 mg orally twice daily in combination with DOX (75 mg/m2 intravenously on day 1 of each cycle, for up to 6 cycles) as frontline therapy. Dose-limiting toxicities (DLTs) were predefined in the protocol. The RP3D of TAZ was determined by Scientific Review Committee review of the safety and pharmacokinetic data from the phase 1b trial, with a target DLT rate of < 33%. Results: As of February 1, 2021, 16 patients are enrolled, including 2 with ES; 10 are still receiving TAZ + DOX and 6 have discontinued (5 due to disease progression, 1 due to patient withdrawal). The median age was 49.5 years (range, 29–82) and all had unresectable STS. Median (range) time on treatment was 13 (0.1–51.1+) weeks across all dose levels evaluated. Two DLTs, both of febrile neutropenia, were observed, one in the TAZ 600 mg + DOX cohort (n = 1/6, 17%), and one in the TAZ 800 mg + DOX cohort (n = 1/3, 33%). When used in combination with DOX, the RP3D of TAZ was 800 mg. Grade 3 or 4 treatment-related treatment-emergent adverse events (TR-TEAEs) occurred in 13/16 (81.3%) patients. The most common (≥ 20%) TR-TEAEs were neutropenia (n = 11, 69%), anemia (n = 10, 63%), fatigue (n = 10, 63%), stomatitis (n = 9, 56%), nausea (n = 8, 50%), febrile neutropenia (n = 7, 44%), constipation (n = 6, 38%), vomiting (n = 6, 38%), and decreased appetite (n = 5, 31%). TR-TEAEs were defined as attributable to either study agent. Conclusions: The combination of TAZ + DOX was generally well tolerated in this dose finding study in patients with advanced STS. The RP3D to be tested in the phase 3 randomized, double blind, placebo controlled study is TAZ 800 mg twice daily + DOX. The safety profile of this combination is consistent with the respective safety information for TAZ and for DOX. The TR-TEAEs include known toxicities of DOX or TAZ. Further comparison with DOX + placebo in the phase 3 trial will aid in assessing efficacy and safety of the combination of TAZ + DOX. The global phase 3 confirmatory trial will enroll patients with ES who have unresectable disease and have had no prior systemic therapy. Clinical trial information: NCT04204941.

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