Abstract Background Preclinical studies demonstrated that small chain RNA fragments accelerate the recovery of platelets numbers in animals exposed to high doses of chemotherapeutic drugs. There is anecdotal data supporting the same application in humans. The Phase I clinical trial described here was designed to investigate the relationship between the administration of small chain RNA fragments and the recovery in platelets following Chemotherapy-Induced Thrombocytopenia (CIT). Methods Cancer patients with solid tumors that experienced post chemotherapy thrombocytopenia with a nadir of < = 80,000 platelets/ml were eligible for this clinical trial. There were no exclusions based on ECOG status, tumor type, tumor burden or chemotherapeutic agents. Patients received a unique preparation of RNA derived from either E. coli or yeast. Ten patients per group received 20, 40, or 60 mg as a starting dose. Subjects self-administered RNA fragments sublingually on an every other day schedule while undergoing chemotherapy. The dose was escalated in 20 mg increments to a maximum dose of 80 mg if the nadir was < 80,000 platelets/ml at the start of the next cycle. Subjects were treated for three cycles of chemotherapy with the maximum effective dose of RNA fragments. Subjects continued on planned chemotherapy as indicated by tumor burden without RNA fragment support after the third cycle. Subjects kept a diary indicating RNA fragment and magnesium administration, and any experienced side effects. Results Patients receiving E. coli RNA fragments demonstrated a more rapid recovery in platelet count and higher nadir platelet count. None of the patients receiving the E. coli RNA fragments required a chemotherapy dose reduction due to thrombocytopenia. The optimal dose for minimizing CIT was 80 mg. Conversely, subjects receiving yeast RNA fragments with dose escalation to 80 mg required a chemotherapy dose reduction per American Society of Clinical Oncology guidelines for grade 3 and 4 thrombocytopenia. Conclusions Patients receiving myelosuppressive chemotherapy experienced an improvement in the platelet nadir and shorter recovery time when receiving concurrent E coli RNA fragments, when compared to patients who received yeast RNA fragments. These data indicate that 60 and 80 mg doses of E. coli RNA accelerated platelet recovery. Further clinical investigations are planned to quantify the clinical benefits of the E. coli RNA at the 80 mg dose in patients with chemotherapy induced thrombocytopenia. Trial Registration Clinical Trials.gov Identifier: NCT01163110
Abstract Background: Patient satisfaction with quality of care is being increasingly recognized and reported as an important outcome measure in oncology. However, it has been argued by some that patients with greater satisfaction with care quality might be the ones with better self-reported quality of life (QoL). In other words, patient satisfaction has been simply purported to be a marker of underlying patient QoL. We asked the question if cancer patients who report higher satisfaction with quality of their care are indeed the ones with better QoL. Methods: 6,914 returning cancer patients treated at four Cancer Treatment Centers of America® hospitals completed a patient satisfaction survey between July 2011 and March 2013. All patients who had not responded to a service quality questionnaire within the preceding 60 days of treatment were eligible. Overall QoL (How would you rate your overall health during the last week?) was measured on a 7-point Likert scale ranging from “very poor” to “excellent”. Overall patient satisfaction (“considering everything, how satisfied are you with your overall experience?”) was also measured on a 7-point Likert scale ranging from “completely dissatisfied” to “completely satisfied”. Spearman correlation was used to investigate the association between patient satisfaction and QoL. Results: A total of 8,642 eligible cancer patients were contacted to participate in the survey. 6,914 patients responded. As a result, the response rate for this study was 80%. The median time duration between the date first seen and the date of first survey was 7.5 months. The mean age at the time of survey was 56.6 years. 4,116 patients were newly diagnosed while 2,798 had been previously treated. 2,778 were males and 4,136 were females. The most common cancer types were breast (27.6%), prostate (13.3%), lung (11.3%), colorectal (8.9%) and pancreas (5.2%). 20%, 28%, 24% and 28% patients had stage I, II, III and IV disease respectively. 1,916 (27.7%) patients reported “excellent” QoL while 5,553 (80.3%) patients were “completely satisfied” with their care. Spearman correlation coefficient between QoL and patient satisfaction for the entire patient population was 0.20 (p<0.001). These correlations in different patient subgroups were as follows: males (0.21), females (0.20), early-stage disease (0.19), late-stage disease (0.22), newly diagnosed (0.19), previously treated (0.20), breast (0.17), colorectal (0.24), lung (0.23), pancreas (0.18), prostate (0.20); with p <0.001 for all. Conclusions: Self-reported QoL has a low correlation with patient satisfaction with care quality. Contrary to what one might expect, higher levels of self-reported QoL do not translate into higher satisfaction with oncology care. This analysis shows that self-reported QoL and satisfaction with care are weakly related dimensions of the larger cancer care quality umbrella. Citation Format: Digant Gupta, James F. Grutsch, Mark Rodeghier, Christopher G. Lis. Do cancer patients with better quality of life report higher satisfaction with the quality of care they receive. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 3849. doi:10.1158/1538-7445.AM2014-3849
This study aimed to evaluate whether patients with advanced non-small-cell lung cancer experience disrupted rest–activity daily rhythms, poor sleep quality, weakness, and maintain attributes that are linked to circadian function such as fatigue. This report describes the rest–activity patterns of 33 non-small-cell lung cancer patients who participated in a randomised clinical trial evaluating the benefits of melatonin. Data are reported on circadian function, health-related quality of life (QoL), subjective sleep quality, and anxiety/depression levels prior to randomisation and treatment. Actigraphy data, an objective measure of circadian function, demonstrated that patients' rest–activity circadian function differs significantly from control subjects. Our patients reported poor sleep quality and high levels of fatigue. Ferrans and Powers QoL Index instrument found a high level of dissatisfaction with health-related QoL. Data from the European Organization for Research and Treatment for Cancer reported poor capacity to fulfil the activities of daily living. Patients studied in the hospital during or near chemotherapy had significantly more abnormal circadian function than those studied in the ambulatory setting. Our data indicate that measurement of circadian sleep/activity dynamics should be accomplished in the outpatient/home setting for a minimum of 4–7 circadian cycles to assure that they are most representative of the patients' true condition. We conclude that the daily sleep/activity patterns of patients with advanced lung cancer are disturbed. These are accompanied by marked disruption of QoL and function. These data argue for investigating how much of this poor functioning and QoL are actually caused by this circadian disruption, and, whether behavioural, light-based, and or pharmacologic strategies to correct the circadian/sleep activity patterns can improve function and QoL.
8139 Background: Substantial resources have been spent to develop validated quality of life (QoL) tools in cancer. However, few hospitals in the US routinely utilize QoL measures to develop treatment plans in patient care. Indeed, to our knowledge, our center is the only hospital-based oncology program in the US that routinely collects QoL data on patients not participating in clinical trials. We used survival analysis to determine if we could convert continuous scales of QoL data into categorical prognostic outcomes. Methods: Baseline QoL data were collected from 310 patients treated at our center between 04/01 and 10/03. 2 QoL tools were used: Ferrans and Powers Quality of Life Index (QLI), which has 4 functional domains, and EORTC QLQ-C30, which has 5 functional domains and 9 symptom items. Using the Wilcoxon test, differences in survival were measured in serial increments of 10 points for EORTC and 3 points for QLI (these levels are associated with significant improvement in QoL). Results from Wilcoxon test were plotted as a function of QoL cutoff points. Linear and polynomial solutions were fitted and Wald statistic identified the best fit. Results: Of 310 patients, 180 were females and 130 males, with a median age of 55 years (range 21 - 82). 64.2% had failed prior treatment. Most common cancers were breast (25%), colorectal (23.3%), and lung (17.7%). Statistical analysis indicated that Health and Function Domain (Wald Test P = 0.0194) had two cutpoints at values 10 and 20. We found a statistically significant difference in survival between patients with scores < 10, 10 to 20, and > 20, the median survival being 169, 349, and 692 days respectively (p < 0.0001). Similarly, EORTC fatigue item (Wald Test P = 0.022) has two cutpoints at values 35 and 80. The median survival of patients with scores < 35, 35 to 80, and > 80 were 450, 413, and 129 days respectively (p < 0.0001). Conclusions: The transformation of a QoL research tool into a clinical management tool is a challenge. As an initial step, we showed that we could produce categorical survival outcome categories from QoL data in 310 patients with advanced cancer. The next step is to refine this analysis to produce discrete outcome categories that will facilitate physician thinking on treatment planning. No significant financial relationships to disclose.
Vitamin D deficiency has been found to be associated with a variety of cancers, including prostate, multiple myeloma, colorectal and breast cancer. Several studies have shown vitamin D levels to have an inverse relation with cancer mortality, while others have considered it a potential risk factor. Vitamin D is believed to influence cancer prevalence, risk and survival; hence the need to assess vitamin D levels in cancer. Although numerous studies have been conducted to demonstrate vitamin D deficiency as a risk factor for cancer, relatively few have studied its prevalence. Moreover, studies estimating prevalence differ from each other, with respect to study population, sample size, study design, definition of vitamin D deficiency used and method of vitamin D assessment (with most studies limited to one particular type of cancer with relatively small sample sizes). Therefore, we qualitatively reviewed the epidemiological evidence in the oncology literature on the prevalence of vitamin D deficiency and insufficiency as measured by serum vitamin D concentrations.
Bioelectrical Impedance (BIA) derived phase angle is increasingly being used as an objective indicator of nutritional status in advanced cancer. Subjective Global Assessment (SGA) is a subjective method of nutritional status. The objective of this study was to investigate the association between BIA derived phase angle and SGA in advanced colorectal cancer.We evaluated a case series of 73 stages III and IV colorectal cancer patients. Patients were classified as either well-nourished or malnourished using the SGA. BIA was conducted on all patients and phase angle was calculated. The correlation between phase angle and SGA was studied using Spearman correlation coefficient. Receiver Operating Characteristic curves were estimated using the non-parametric method to determine the optimal cut-off levels of phase angle.Well-nourished patients had a statistically significantly higher (p = 0.005) median phase angle score (6.12) as compared to those who were malnourished (5.18). The Spearman rank correlation coefficient between phase angle and SGA was found to be 0.33 (p = 0.004), suggesting better nutritional status with higher phase angle scores. A phase angle cut-off of 5.2 was 51.7% sensitive and 79.5% specific whereas a cut-off of 6.0 was 82.8% sensitive and 54.5% specific in detecting malnutrition. Interestingly, a phase angle cut-off of 5.9 demonstrated high diagnostic accuracy in males who had failed primary treatment for advanced colorectal cancer.Our study suggests that bioimpedance phase angle is a potential nutritional indicator in advanced colorectal cancer. Further research is needed to elucidate the optimal cut-off levels of phase angle that can be incorporated into the oncology clinic for better nutritional evaluation and management.
3689 Background: Bioelectrical impedance analysis (BIA) is widely used in the clinical setting to assess changes in body composition. Phase angle, determined by BIA, detects changes in tissue electrical properties, which is an indicator of cellular health and integrity. Phase angle has been found to be a prognostic indicator in several chronic conditions, such as human immunodeficiency virus, liver cirrhosis, COPD, lung cancer, and patients receiving dialysis. This study was conducted to investigate the prognostic role of baseline phase angle measurements in advanced colorectal cancer. Methods: We evaluated a case series of 81 histologically confirmed stages III-IV colorectal cancer patients treated at Cancer Treatment Centers of America at Midwestern Regional Medical Center between January 2000 and March 2003. A dietitian conducted bioelectrical impedance analysis on all patients during their first admission for treatment. Resistance and reactance were measured, and phase angle was then calculated. Phase angle measurements were divided into three mutually exclusive tertiles with cut-offs of 5.17 and 6.19. Kaplan Meier method was used to calculate survival across the three categories of phase angle. Survival analyses for phase angle were also conducted after adjusting for tumor stage. Log-Rank test was used to study the equality of survival distributions across the strata. Results: Patients with phase angle below 5.17 had a median survival of 10.1 months (95% CI, 6.2 to 13.9; n = 25), those between 5.17 and 6.19 had 22.6 months (95% CI, 16.4 to 28.7; n = 29), and those above 6.19 had 25.6 months (95% CI, 21.4 to 29.8; n = 27); the difference being statistically significant (p = 0.003). Phase angle continued to be statistically significantly associated with survival even after adjusting for tumor stage (p = 0.012). Conclusions: This study demonstrates that a phase angle < 5.17, independent of tumor stage, is an adverse prognostic indicator in patients with advanced colorectal cancer. Similar studies in other cancer types with larger sample sizes are needed to further validate the prognostic significance of phase angle in the cancer treatment setting. No significant financial relationships to disclose.
3728 Background: Malnutrition is a frequent complication in advanced colorectal cancer and is a significant cause of morbidity and mortality. While nutritional status has been hypothesized to have a positive impact on Quality of Life (QoL), little is known about the relationship between the two. We investigated if nutritional status is associated with QoL in advanced colorectal cancer. Methods: A case series of 58 stage III-IV colorectal cancer treated at Cancer Treatment Centers of America between 03/01 and 01/03. Nutritional status was evaluated using Subjective Global Assessment (SGA). QoL was evaluated using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC). EORTC has 5 functional scales, 9 symptom scales, and a global health scale. Possible scores range from 0 - 100. Higher scores in global and functional scales and lower scores in symptom scales indicate better QoL. Median QoL scores were compared across 2 classes of nutritional status using nonparametric t test owing to non-normal distribution of QoL scores. Results: 34 patients were identified well nourished and 24 malnourished by the SGA. Well-nourished patients had significantly better QoL scores on global, physical and role functions as compared to malnourished patients (Table 1). Interestingly, median role function score in well-nourished patients was 40 points > than that in malnourished patients, indicating “much better” QoL from patients’ perspective. Similarly, QoL on multiple symptom scales was significantly better in well-nourished patients. Conclusions: This study suggests that malnutrition is associated with poor QoL, as measured by EORTC in advanced colorectal cancer. Prospective studies are required to determine whether nutritional intervention can have any positive impact on QoL outcomes of these patients. Table 1. QoL stratified by nutritional status. No significant financial relationships to disclose.
