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Marqibo (vincristine sulfate liposome injection, VSLI) is a novel liposomal formulation of vincristine sulfate (VCR) being developed for the systemic treatment of cancer. This study evaluated the pharmacokinetics (PK) of Marqibo in subjects with melanoma and impaired hepatic function. Calculated PK parameters were similar in subjects with impaired liver function compared with those in subjects with adequate liver function. Subjects with impaired liver function universally had a monoexponential total plasma VCR concentration versus time decline, whereas two thirds of subjects with adequate liver function had a biexponential decline profile. Because one third of subjects with normal hepatic function demonstrated monoexponential disposition, lack of biexponential disposition in the hepatically impaired subjects cannot be clearly attributed to liver impairment. VSLI was generally well tolerated in all subjects. [ABSTRACT FROM PUBLISHER]

We determined the relationship between symptom severity and distress for multiple cancer symptoms, and examined patient demographic influences on severity and distress in advanced cancer. A Cochran-Armitage trend test determined whether symptom distress increased with severity. Chi-square, Fisher's exact test and logistic regression analysis examined moderate/severe ('clinically important') and distressful symptoms by age (≤65 versus >65), gender, primary site group, and ECOG performance status. Forty-six symptoms were analyzed in 181 individuals. More than 50% of individuals with clinically important symptoms rated them as distressful. The median percentage of individuals with mild but still distressful symptoms was 25%, with a range of 0% (bad dreams) to 73% (sore mouth). In both univariate and multivariate analysis, younger (≤65 years) patients, females, and those with poor performance status had more clinically important and a higher prevalence of distressful symptoms (only anxiety was more frequently distressful to older individuals). Clinically important symptoms and two of those considered distressful varied by primary site group. After control for severity, symptom distress did not differ by primary site group. The prevalence of distress increased with greater symptom severity. Younger individuals, those with poor performance status, and females had greater symptom severity and distress. Mild symptoms were often distressful. After adjustment for severity, age, gender, and performance status all influenced symptom distress. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients treated with antibiotics have worse outcomes from cancer immunotherapy. While antibiotics are known to affect intestinal flora, it is not clear how they affect overall immune function. The aim of our study was to identify differences in immune parameters according to antibiotic exposure. Among 251 total patients, the 135 (54%) who received antibiotics had lower response rates and shorter survival. We identified significant differences in multiple antibodies according to antibiotic exposure, including antibodies specific for nucleolin, MDA5, c-reactive protein, LC1, heparin sulfate, Matrigel, and CENP.B. In lung cancer patients, antibiotics were associated with differences in IFN-γ, IL-8, and macrophage inflammatory protein cytokines. Administration of antibiotics to patients receiving cancer immunotherapy is associated with changes in circulating antibodies and cytokines, although it is not clear if antibiotics cause these differences. Given the frequency of antibiotic use in cancer populations and potentially detrimental effects on immunotherapy outcomes, more research in this area may guide patient management. Antibiotic administration is associated with worse clinical outcomes and changes to the gut microbiome in cancer patients receiving immune checkpoint inhibitors (ICI). However, the effects of antibiotics on systemic immune function are unknown. We, therefore, evaluated antibiotic exposure, therapeutic responses, and multiplex panels of 40 serum cytokines and 124 antibodies at baseline and six weeks after ICI initiation, with p < 0.05 and false discovery rate (FDR) < 0.2 considered significant. A total of 251 patients were included, of whom the 135 (54%) who received antibiotics had lower response rates and shorter survival. Patients who received antibiotics prior to ICI initiation had modestly but significantly lower baseline levels of nucleolin, MDA5, c-reactive protein, and liver cytosol antigen type 1 (LC1) antibodies, as well as higher levels of heparin sulfate and Matrigel antibodies. After ICI initiation, antibiotic-treated patients had significantly lower levels of MDA5, CENP.B, and nucleolin antibodies. Although there were no clear differences in cytokines in the overall cohort, in the lung cancer subset (53% of the study population), we observed differences in IFN-γ, IL-8, and macrophage inflammatory proteins. In ICI-treated patients, antibiotic exposure is associated with changes in certain antibodies and cytokines. Understanding the relationship between these factors may improve the clinical management of patients receiving ICI. [ABSTRACT FROM AUTHOR]

Anal melanoma is an uncommon and aggressive cancer. Different surgical modalities have been used in managing the disease with no clear evidence to favor one approach over another. The medical records of patients with anal melanoma treated at the H. Lee Moffitt Cancer and Research Institute between 1987 and 2004 were reviewed. Published anal melanoma studies, including more than ten patients with outcome data, also were reviewed. Twelve patients were identified (8 percent of all cancer of the anal canal). Nine were females with a median age of 67 (range, 27–86) years. Four patients had nodal involvement, and one had bone metastases at the time of diagnosis. Five patients had abdominoperineal resection, and six had local excision. Adjuvant radiation therapy with or without interferon was used. Five of the 11 patients without metastatic disease relapsed or died within the first year of diagnosis (4 had local excision and 1 had abdominoperineal resection). Median time to relapse was 6.5 (range, 4–31) months. The liver was the most common site for relapse. Only one patient treated with local excision followed by interferon was a long survivor (no evidence of recurrence at 54 months). Anorectal melanoma is a rare and challenging disease. The preoperative staging influences the treatment schedule. In the absence of strong survival benefit of abdominoperineal resection in managing the nonmetastatic form of the disease, it is reasonable to consider local excision as the initial treatment of choice. Adjuvant radiation therapy is well tolerated and is promising in improving locoregional control. [ABSTRACT FROM AUTHOR]

Purpose:(a) To report the medical complexity of cancer and noncancer patients receiving palliative medicine (PM) consultation at a tertiary medical center and (b) to describe the consult recommendations made for this group.Patients and methods:Prospective data collection was performed on all consultations (cancer, n = 175; non-cancer, n = 35) done by first author (JDC) as a PM fellow at the Cleveland Clinic Foundation between July 1998 and April 1999. A computer database was used to query for demographics, complexity of medical problems, current medications, mortality, symptoms, nursing problems, and consult recommendations.Results:A median of three (range, 0-12) acute medical problems and three (range, 0-16) chronic medical problems were identified for each patient. Patients were taking a median of six medications (range, 0-20). They had a median of five symptoms (range, 0-13) with pain (73 percent) being most common, followed by weakness (40 percent) and shortness of breath (40 percent). Cancer patients were twice as likely to have more than five symptoms (48 percent versus 23 percent) (chi-square = 0.006). The most common nursing problems were ambulation or fall risk (15 percent) and skin integrity (11 percent). A median of five (range, 1-11) management recommendations were made as part of each consultation. These included medication changes in 81 percent, nonmedication changes in 53 percent, and follow-up services in 100 percent. The median survival from the time of consultation for the known dead was 29 days with 65 percent living more than 14 days.Conclusion:Multiple recommendations were made with most patients surviving long enough potentially to benefit. Consultation in palliative medicine is a sophisticated intervention involving considerable acuity and complexity of care. [ABSTRACT FROM PUBLISHER]