Survival of advanced melanoma patients treated with immunotherapy and targeted therapy: A real-world study.

INTRODUCTION: We aimed to examine the survival outcomes plus patient and treatment characteristics of advanced melanoma patients treated with first-line immunotherapy (IT), targeted therapy (TT), and chemotherapy (CTH) and compare findings with information from pivotal trials for each therapy. MATERIALS AND METHODS: We retrospectively reviewed the use of systematic IT, TT and CTH therapies in melanoma patients in four Queensland public hospitals. We estimated median duration of overall survival (OS) and survival rates (6 months, 1, and 2 years) using Kaplan-Meier methods. We compared our findings to those of clinical trials. RESULTS: Five hundred three patients who met the inclusion criteria were divided into three groups based on the first-line treatment: IT 232; TT 157; and CTH 114. OS was 18 months with IT (95% CI 13, 22); 12 months with TT (95% CI 8, 15); and 5 months with CTH (95% CI 5, 6). The demographic characteristics, treatment protocols, and durations for IT and TT were generally consistent with trials but fewer patients in our study had subsequent therapy than in the trials. The OS in our study was slightly lower than the OS reported in trials. CONCLUSION: The OS of novel cancer therapy in the real world was lower than seen in trials but is expected given these are patients who have a poorer prognosis. A future study could investigate the impact of prognostic factors on survival in the longer term. This study provides evidence that we can use routinely collected real-world data to evaluate the effectiveness of checkpoint and kinase inhibitors in patients with advanced melanoma.

Research governance authorisation: the next frontier.

Objective There is much interest in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients' electronic medical records in hospitals in order to optimise use and health outcomes. This study aimed to describe the process and challenges involved in obtaining ethical approval and research governance authorisation for a research project that started on 7 December 2018 in Queensland and make recommendations for improving the process. Methods There were three aspects: (a) ethics approval; (b) governance - site-specific assessment (SSA); and (c) governance - Public Health Act (PHA) Application Assessment. Results The process to satisfy all requirements took more than 1 year (371 days); ethics took 16 days and PHA approval 16 days. The major hurdle was the SSA, which took 98-274 days across five sites. The main issues were opaqueness in processes and inconsistences in approach leading to considerable frustration. Discussion It is recommendeded that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. Frustration of government officials and researchers led the National Health and Medical Research Council to streamline ethics approval processes, but the same cannot be said for the governance process. It is appreciated that LHN processes were developed for good and valid reasons, but the onerous and inconsistent application of these processes hinder timely and relevant research. It is time for action: follow the success of the ethics process to redesign governance. What is known about the topic? Researchers are interested in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients' electronic medical records in hospitals in order to optimise use and health outcomes. There are challenges in obtaining ethical approval and research governance authorisation for research projects. What does this paper add? We identified that the main hurdle was obtaining site-specific agreements across numerous hospital sites. What are the implications for practitioners? We recommend that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. The ethics approval process has been streamlined in recent years so we need to follow this success to redesign governance.

The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial.

Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea (CIN). The aim of this clinical trial was to address significant methodological limitations in previous trials. Patients (N = 51) were randomly allocated to receive either 1.2 g of standardised ginger extract or placebo per day, in addition to standard anti-emetic therapy, during the first three cycles of chemotherapy. The primary outcome was CIN-related quality of life (QoL) measured with the Functional Living Index- Emesis (FLIE) questionnaire. Secondary outcomes included acute and delayed nausea, vomiting, and retching as well as cancer-related fatigue, nutritional status, and CIN and vomiting-specific prognostic factors. Over three consecutive chemotherapy cycles, nausea was more prevalent than vomiting (47% vs. 12%). In chemotherapy Cycle 1, intervention participants reported significantly better QoL related to CIN (p = 0.029), chemotherapy-induced nausea and vomiting (CINV)-related QoL (p = 0.043), global QoL (p = 0.015) and less fatigue (p = 0.006) than placebo participants. There were no significant results in Cycle 2. In Cycle 3, global QoL (p = 0.040) and fatigue (p = 0.013) were significantly better in the intervention group compared to placebo. This trial suggests adjuvant ginger supplementation is associated with better chemotherapy-induced nausea-related quality of life and less cancer-related fatigue, with no difference in adverse effects compared to placebo.

Chemotherapy-Induced Nausea and Vomiting: A Narrative Review to Inform Dietetics Practice.

Chemotherapy-induced nausea and vomiting (CINV) are common symptoms experienced by patients with cancer that influence nutrition. They exert a detrimental effect on dietary intake, risk of malnutrition, and quality of life. Whereas CINV are primarily managed with medication, nutrition and dietetics practitioners play an important role in the management of CINV-related complications such as reduced dietary intake. This review discusses the burden of nausea and vomiting that patients with cancer can experience, including the effect on quality of life, nutritional status, and treatment outcomes. Implications for dietetics practice include the need to explore the nature of reported symptoms, identify predisposing risk factors, and to consider the use of a variety of interventions that are individualized to a patient's symptoms. There are little clinical data regarding effective dietetic interventions for nausea and vomiting. In summary, this review discusses dietetics-related issues surrounding CINV, including the pathophysiology, risk factors, prevalence, and both pharmacologic and dietetic treatment options.

Ginger (Zingiber officinale) and chemotherapy-induced nausea and vomiting: a systematic literature review.

Chemotherapy-induced nausea and vomiting (CINV) is a common side-effect of cytotoxic treatment. It continues to affect a significant proportion of patients despite the widespread use of antiemetic medication. In traditional medicine, ginger (Zingiber officinale) has been used to prevent and treat nausea in many cultures for thousands of years. However, its use has not been confirmed in the chemotherapy context. To determine the potential use of ginger as a prophylactic or treatment for CINV, a systematic literature review was conducted. Reviewed studies comprised randomized controlled trials or crossover trials that investigated the anti-CINV effect of ginger as the sole independent variable in chemotherapy patients. Seven studies met the inclusion criteria. All studies were assessed on methodological quality and their limitations were identified. Studies were mixed in their support of ginger as an anti-CINV treatment in patients receiving chemotherapy, with three demonstrating a positive effect, two in favor but with caveats, and two showing no effect on measures of CINV. Future studies are required to address the limitations identified before clinical use can be recommended.