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Aim: We evaluated the efficacy and safety of Nuvastatic™ (C5OSEW5050ESA) in improving cancer-related fatigue (CRF) among cancer patients. Methods: This multicenter randomized double-blind placebo-controlled phase 2 trial included 110 solid malignant tumor patients (stage II–IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000 mg (N = 56) or placebo (N = 54) thrice daily for 9 weeks. The primary outcomes were fatigue (Brief Fatigue Inventory (BFI)) and Visual Analog Scale for Fatigue (VAS-F)) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration (an oxidative stress biomarker), Eastern Cooperative Oncology Group scores, adverse events, and biochemical and hematologic parameters. Analysis was performed by intention-to-treat (ITT). Primary and secondary outcomes were assessed by two-way repeated-measures analysis of variance (mixed ANOVA). Results: The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. Compared with the placebo group, the Nuvastatic™ group significantly reduced BFI-fatigue (BFI fatigue score, F (1.4, 147) = 16.554, p < 0.001, partial η2 = 0.333). The Nuvastatic™ group significantly reduced VAS-F fatigue (F (2, 210) = 9.534, p < 0.001, partial η2 = 0.083), improved quality of life (QoL) (F (1.2, 127.48) = 34.07, p < 0.001, partial η2 = 0.243), and lowered urinary F2-IsoP concentrations (mean difference (95% CI) = 55.57 (24.84, 86.30)), t (55) = 3.624, p < 0.001, Cohen’s d (95% CI) = 0.48 (0.20, 0.75)). Reported adverse events were vomiting (0.9%), fever (5.4%), and headache (2.7%). Conclusion: Nuvastatic™ is potentially an effective adjuvant for CRF management in solid tumor patients and worthy of further investigation in larger trials. Trial registration: ClinicalTrial.gov ID: NCT04546607. Study registration date (first submitted): 11–05-2020. [ABSTRACT FROM AUTHOR]

Background: Bilateral breast cancer (BBC) is an unusual clinical entity. Unlike unilateral breast cancer, there is fewer data regarding clinicopathological aspects and treatment guidelines in BBC. The present study was carried out at a tertiary oncology center in South India to analyze the clinicopathological profile of patients diagnosed with BBC. Methods: This was a retrospective observational study of patients diagnosed with BBC in the department of medical oncology from August 2012 to July 2013. Results: Out of a total of 300 breast cancer patients during a 1-year period, 15 had BBC. Synchronous and metachronous breast cancers were seen in six and nine patients, respectively. The median age at presentation for BBC was 40 years. Family history of breast cancer was present only in two cases. The median age of menarche and first child birth was 13 and 22 years, respectively. History of breast feeding was positive in all except one who was nulliparous. Out of the 15 patients, 11 were premenopausal and 4 postmenopausal. Contralateral breast cancer was detected mammographically in 4 patients and by clinical examination in 11. Out of 30 tumors, all were invasive ductal carcinomas (IDC). Nine patients had bilateral mastectomy, and five had unilateral mastectomy. Out of 30 tumors, 14 were triple negative, 9 estrogen receptor (ER)/progesterone (PR) positive, and 7 Her2neu positive. Neoadjuvant chemotherapy (NACT) was given in four synchronous and three metachronous breast cancer cases for contralateral breast cancer. All patients received chemotherapy during the course in the form of either adjuvant or palliative chemotherapy. Conclusions: BBC is an uncommon clinical entity. For women with younger premenopausal age, the incidence of BBC is higher compared with older women. As the prognosis of BBC is poor, it is crucial to be aware of this entity, and every patient with breast cancer should be regularly followed up. These patients require individualized treatment planning based on the tumor factors and treatment factors of the primary lesion. [ABSTRACT FROM AUTHOR]

BACKGROUND: Diabetes mellitus (DM) and cancer are common causes of morbidity and mortality. This study was designed to retrospectively study from hospital data the treatment outcome in three common cancers among our diabetic population. METHODOLOGY: Patients with histologically-proven breast, lung, or colorectal cancers were analyzed. Patients were stratified into those with or without diabetes. Duration of diabetes, end-organ damage and glycemic control were recorded from the case records. "Response Evaluation Criteria In Solid Tumors. (RECIST) criteria were used to assess response. Common Toxicity Criteria, version 3.0, was used to assess toxicity. Disease-free and overall survival, as well as toxicity, were calculated for both groups and compared using the Student's t test. RESULTS: A total of 119 diabetic patients who presented to the department of medical oncology over a 6-year period between 2000 and 2005, and who met the inclusion criteria, were analyzed. One control was chosen for each case randomly from the same population. Both groups were matched for baseline characteristics. The mean duration of diabetes was 2.6 years in the present study. Diabetics have significantly lower response rates and poor overall and disease-free survival. The toxicity profile is not different in both the groups. CONCLUSION: Our data supports the concept that DM is associated with an increase in mortality and poor response rates. This mechanism is probably independent of the glycemic control, comorbid conditions, or the treatment modality used for control of diabetics. We did not find any significant increase in the complication rates in our diabetic patients. The possible reason for this clinical paradox could be the relatively good glycemic control: all the diabetics in the present study have near-normal blood sugar levels throughout. [ABSTRACT FROM AUTHOR]

Non Hodgkin lymphoma, predominantly Diffuse Large B-cell Lymphoma (DLBCL) has been reported to have a significant association with Hepatitis B virus (HBV). We investigated the presence of different gene segments of HBV in plasma, B-cells and tumor tissues from DLBCL patients and explored the genetic variability of HBV within and across different compartments in a host using Next Generation Sequencing. Despite all 40 patients being HBV seronegative, 68% showed evidence of occult HBV. Sequencing of these gene segments revealed inter-compartment viral variants in 26% of them, each with at least one non-synonymous mutation. Between compartments, core gene variants revealed Arg94Leu, Glu86Arg and Ser41Thr while X gene variants revealed Phe73Val, Ala44Val, Ser146Ala and Ser147Pro. In tumor compartments per se, several mis-sense mutations were detected, notably the classic T1762A/A1764G mutation in the basal core promoter. In addition, a virus surface antigen mis-sense mutation resulting in M125T was detected in all the samples and could account for surface antigen negativity and occult HBV status. It would be interesting to further explore if a temporal accumulation of viral variants within a favored niche, like patients' lymphocytes, could bestow survival advantage to the virus, and if certain pro-oncogenic HBV variants could drive lymphomagenesis in DLBCL. [ABSTRACT FROM AUTHOR]