NOX66 as Monotherapy, and in Combination With Carboplatin, in Patients With Refractory Solid Tumors: Phase Ia/b Study.

BACKGROUND: Although oral and intravenous forms of idronoxil have been well tolerated, the safety of NOX66, with idronoxil formulated as a rectal suppository, is not known. This Phase Ia/b clinical study (protocol No. NOX66-001A), known as Chemotherapy Enhancement Program-1, is the first to assess NOX66 in patients with refractory solid tumors. OBJECTIVE: The study aimed to determine the safety profile of NOX66 both as a monotherapy and in combination with carboplatin, and to evaluate whether or not NOX66 has a meaningful anticancer effect when combined with carboplatin in this patient population. METHODS: Chemotherapy Enhancement Program-1 was a multicenter, open-label, nonrandomized, 2-dose cohort study of NOX66 as monotherapy (Phase Ia) and in combination with carboplatin (Phase Ib). Patients with refractory solid tumors who had stopped responding to standard treatments were eligible to participate. Twenty patients were screened and 19 enrolled in the study. They were divided into 2 groups: cohort 1 (n = 8) received 1 suppository daily (400 mg) and cohort 2 (n = 11) received 2 suppositories daily (800 mg) for 14 consecutive days followed by 7 days of rest. Patients who completed Phase Ia without significant toxicity continued to Phase Ib, where NOX66 was combined with carboplatin for up to 6x 28-day treatment cycles, with low-dose carboplatin (600 mg) for cycles 1B through 3B and standard dose carboplatin (900 mg) for cycles 4B through 6B. The main outcomes assessed were safety (n = 18) and efficacy signals (n = 14). RESULTS: NOX66 generally was well tolerated at 400 mg and 800 mg, both as monotherapy and in combination with carboplatin in patients with refractory solid tumors. The safety profile was consistent for oncology patients, with 77.8% experiencing at least 1 treatment-emergent adverse event. The most common adverse events were blood and lymphatic system disorders (44.4%), with only anemia considered as possibly related to NOX66. Although the study was primarily designed to assess safety and tolerability, the efficacy measurements demonstrated that most patients had stable disease or better by study end. CONCLUSIONS: The favorable safety profile of NOX66 provides reassurance to justify continuation of clinical research. The efficacy findings are encouraging in terms of the chemosensitizing potential of NOX66 in refractory solid tumors. (Curr Ther Res Clin Exp. 2021; 82:XXX-XXX).

The Attitudes, Needs, and Requirements at End of Life in the Republic of Georgia (Comparative Analysis of Groups of Patients With Cancer and Elders).

INTRODUCTION: In developing a model of palliative care, the attitudes, needs, and requirements of its beneficiaries recognizing the limited remaining life expectancy need to be met. We aimed to map and compare these issues at the end of life in the groups of patients with advanced cancer and elderly individuals. MATERIALS AND METHODS: The prospective study based on the analysis of semistructured interviews was conducted. Fifty individuals aged older than 85 and 50 incurable patients with advanced cancer were studied. Transcripts of interviews were analyzed qualitatively (the interviews were divided into logically completed themes, and the compliance of each with one of the levels of Abraham Maslow pyramid was determined) and quantitatively (data comparisons of 2 groups were tested in bivariate analysis using Pearson χ2 or Fisher exact test. Two-sided significance tests were used; P value of <.05 was deemed significant). RESULTS: It was assumed that 120 themes were relevant to a certain level of Maslow pyramid. Their comparison showed small differences in the narratives of the patients with advanced cancer and elderly individuals aged 85 and older-concerning the past, present, and future terms of lives. In studied themes explicitly prevail the stories that are consistent with satisfaction of the upper levels of the hierarchy of needs and demands of Maslow: social relation (belonging), love, esteem, and transcendence. CONCLUSION: The attitudes, needs, and requirements at the end of life of the people are basically similar, regardless of what determined the sense of limitation of the remaining life-incurable disease or advanced age.

Mismatch between physicians and family members views on communications about patients with chronic incurable diseases receiving care in critical and intensive care settings in Georgia: a quantitative observational survey.

BACKGROUND: Physicians working in critical and intensive care settings encounter death of chronic incurable patients on a daily basis; however they have scant skills on how to communicate with the patients and their family members. The aim of the present survey is to examine communication of critical and intensive care physicians with patients' family members receiving treatment due to chronic incurable diseases/conditions and to compare the views of families with physicians working in critical and intensive care settings. METHODS: The survey was conducted in four cities of Georgia (Tbilisi, Kutaisi, Batumi and Telavi) in 2014. Physicians working in critical and intensive care settings and family members were asked to fill in separate questionnaires, covering various aspects of communication including patients' prognosis, ways of death occurrence, treatment plans and religion. Participants ranked their responses on a scale ranging from "0" to "10", where "0" represented "never" and "10"-"always". After data collection, responses were recoded into three categories: 0-3 = never/rarely, 4-7 = somewhat and 8-10 = often/always. Differences were tested using Pearson's chi-square or Fisher's exact test as appropriate. P value of < 0.05 was considered as significant. RESULTS: Sixty-five physicians and 59 patients' family members participated in this cross-sectional study. Majority of their responses was statistically significantly different. Only one quarter (23.7 %) of family members of patients receiving medical aid in critical and intensive care settings were satisfied with the communication level. In contrast, 78.5 % of physicians considered their communication with families as positive (p < 0.0001). CONCLUSIONS: The survey revealed the mismatch between the views on communication of critical and intensive care settings physicians and family members of the patients with chronic incurable diseases receiving care in critical and intensive care settings. In order to provide the best care for chronic incurable patients and their family members, physicians working in critical and intensive care settings must have relevant clinical knowledge and ability to provide effective communication. Present results reflect important potential targets for educational interventions including critical and intensive care physicians training through online modules.