[Show abstract][Hide abstract] ABSTRACT: We have previously reported that higher patient satisfaction (PS) with service quality is associated with favorable survival outcomes in a variety of cancers. However, we argued that patients with greater satisfaction might be the ones with better self-rated health (SRH), a recognized predictor of cancer survival. We therefore investigated whether SRH can supersede patient satisfaction as a predictor of survival in prostate cancer.
Nine hundred seventeen prostate cancer treated at four Cancer Treatment Centers of America® hospitals between July 2011 and March 2013. PS was measured on a 7-point scale ranging from "completely dissatisfied" to "completely satisfied". SRH was measured on a 7-point scale ranging from "very poor" to "excellent". Both were dichotomized into two categories: top box response (7) versus all others (1-6). Patient survival was the primary end point. Cox regression was used to evaluate the association between PS and survival controlling for covariates.
The response rate for this study was 72 %. Majority of patients (n = 517) had stage II disease. Seven hundred eighty-seven (85.8 %) patients were "completely satisfied". Three hundred nineteen (34.8 %) patients had "excellent" SRH. There was a weak but significant correlation between satisfaction and SRH (Kendall's tau b = 0.18; p < 0.001). On univariate analysis, "completely satisfied" patients had a significantly lower risk of mortality (HR = 0.46; 95 % CI: 0.25-0.85; p = 0.01). Similarly, patients with "excellent" SRH had a significantly lower risk of mortality (HR = 0.25; 95 % CI: 0.11-0.58; p = 0.001). On multivariate analysis, SRH was found to be a significant predictor of survival (HR = 0.31; 95 % CI: 0.12-0.79; p = 0.01) while patient satisfaction was not (HR = 0.76; 95 % CI: 0.40-1.5; p = 0.40).
SRH supersedes patient satisfaction with service quality as a predictor of survival in prostate cancer. SRH should be used as a control variable in analyses involving patient satisfaction as a predictor of clinical cancer outcomes.
Health and Quality of Life Outcomes 09/2015; 13(1):137. DOI:10.1186/s12955-015-0334-1 · 2.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background/aims:
Previously we reported that higher patient satisfaction (PS) with service quality is associated with favorable survival outcomes in a variety of cancers. However, we cautioned the readers that patients with greater satisfaction might be the ones with better self-rated health (SRH), a well-established prognosticator of cancer survival. In other words, SRH could potentially confound the PS and survival relationship. We investigated this hypothesis in non-small cell lung cancer (NSCLC).
778 NSCLC patients (327 males and 451 females; mean age 58.8 years) treated at 4 Cancer Treatment Centers of America hospitals between July 2011 and March 2013. PS was measured on a 7-point scale ranging from "completely dissatisfied" to "completely satisfied". SRH was measured on a 7-point scale ranging from "very poor" to "excellent". Both were dichotomized into 2 categories: top box response (7) versus all others (1-6). Patient survival was the primary end point. Cox regression was used to evaluate the association between PS and survival controlling for covariates.
74, 70, 232 and 391 patients had stage I, II, III and IV disease respectively. 631 (81.1%) patients were "completely satisfied". 184 (23.7%) patients had "excellent" SRH. There was a weak but significant correlation between overall PS and SRH (Kendall's tau b = 0.19; p<0.001). On univariate analysis, "completely satisfied" patients had a significantly lower risk of mortality (HR = 0.75; 95% CI: 0.57 to 0.99; p = 0.04). Similarly, patients with "excellent" SRH had a significantly lower risk of mortality (HR = 0.61; 95% CI: 0.46 to 0.81; p = 0.001). On multivariate analysis controlling for stage at diagnosis, treatment history and gender, SRH was found to be a significant predictor of survival (HR = 0.67; 95% CI: 0.50 to 0.89; p = 0.007) while PS was not (HR = 0.86; 95% CI: 0.64 to 1.2; p = 0.32). Among the individual PS items, the only significant independent predictor of survival was "teams communicating with each other concerning your medical condition and treatment" (HR = 0.59; 95% CI: 0.36 to 0.94; p = 0.03).
SRH appears to confound the PS-survival relationship in NSCLC. SRH should be used as a control/stratification variable in analyses involving PS as a predictor of clinical cancer outcomes.
PLoS ONE 08/2015; 10(7):e0134617. DOI:10.1371/journal.pone.0134617 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background: Melatonin secreted only during nightly darkness promotes sleep and sets daily clocks. Cancer disrupts daily rhythms, nighttime sleep, and causes daytime fatigue. Meta-analyses report that melatonin improves cancer response and patient survival. We hypothesized that proper daily timing is essential to melatonin benefit. Methods: Eighty-four ANSCLC patients (20 Stage IIB, 64 Stage IV) from one of two centers (42 each) each receiving etoposide/cisplatin therapy, were blindly and randomly assigned to one of three arms (I, 8AM & 8PM placebo n=29; II, 8AM 20mg melatonin and 8PM placebo, n=27; III, 8AM placebo and 8PM 20mg melatonin, n=28). Each patient was followed to death; 49 were evaluable for objective response assessment by RECIST criteria. Sleep quality and quality of life (QOL) queries were made at baseline and every three months. Results: Overall survival was not significantly impacted by melatonin in a univariate analysis. Multivariate analyses reveal better survival only for those receiving evening melatonin (p=0.04, RR of death 0.454). Objective partial tumor response occurred in 10.5% of placebo, 7.7% of morning melatonin, and 29.4% of evening melatonin-treated patients. Sleep quality was enhanced and QOL declined less rapidly when PM melatonin was employed. Conclusions: Physiologic evening timing of the chronobiotic hormone melatonin is critical to its salutary effect in ANSCLC patients.
[Show abstract][Hide abstract] ABSTRACT: /st>To evaluate the relationship between self-reported satisfaction with service quality and overall survival in non-small cell lung cancer (NSCLC).
/st>A prospective cohort study.
/st>Cancer Treatment Centers of America(®) from July 2007 and December 2010.
/st>Nine hundred and eighty-six returning NSCLC patients.
/st>Overall patient experience 'considering everything, how satisfied are you with your overall experience' was measured on a 7-point Likert scale ranging from 'completely dissatisfied' to 'completely satisfied.'.
/st>Patient survival was the primary end point.
/st>The response rate for this study was 69%. Six hundred patients were newly diagnosed, while 386 were previously treated. Four hundred sixty-nine were males, while 517 were females. 101, 59, 288 and 538 patients had stage I, II, III and IV disease, respectively. Mean age was 58.9 years. Six hundred and thirty (63.9%) patients had expired at the time of this analysis. Seven hundred and sixty-two (77.3%) patients were 'completely satisfied'. Median overall survival was 12.1 months (95% confidence interval (CI): 10.9-13.2 months). On univariate analysis, 'completely satisfied' patients had a significantly lower risk of mortality compared with those not 'completely satisfied' [hazard ratio (HR) = 0.70; 95% CI: 0.59-0.84; P < 0.001]. On multivariate analysis controlling for stage at diagnosis, prior treatment history, age and gender, 'completely satisfied' patients demonstrated significantly lower mortality (HR = 0.71; 95% CI: 0.60-0.85; P < 0.001) compared with those not 'completely satisfied'.
/st>Self-reported experience with service quality was an independent predictor of survival in NSCLC patients undergoing oncologic treatment, a novel finding in the literature. Based on these provocative findings, further exploration of this relationship is warranted in well-designed prospective studies.
International Journal for Quality in Health Care 10/2013; 25(6). DOI:10.1093/intqhc/mzt070 · 1.76 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Despite the recognized relevance of symptom burden in breast cancer, there has been limited exploration of whether an individual patient's assessment of the overall quality of care received might influence outcome. We therefore evaluated the relationship between patient-reported satisfaction with service quality and survival in breast cancer.
A random sample of 1,521 breast cancer patients treated at Cancer Treatment Centers of America. A questionnaire which covered several dimensions of patient satisfaction was administered. Items were measured on a seven-point Likert scale ranging from "completely dissatisfied" to "completely satisfied". Univariate and multivariate Cox regression was used to evaluate the association between patient satisfaction and survival.
Of 1,521 patients, 836 were newly diagnosed, and 685 had previously been treated. A number of 409, 611, 323, and 178 patients had stage I, II, III, and IV disease, respectively. A total of 1,106 (72.7 %) patients were completely satisfied with the overall service quality, while 415 (27.3 %) were not. On univariate analysis, completely satisfied patients had a significantly lower risk of mortality compared to those not completely satisfied (HR = 0.62; 95 % CI 0.50-0.76; p < 0.001). On multivariate analysis, completely satisfied patients demonstrated significantly lower mortality (HR = 0.71; 95 % CI 0.57-0.87; p = 0.001) compared to those not completely satisfied.
Patient satisfaction with service quality was an independent predictor of survival in breast cancer. Further exploration of a possible meaningful relationship between patient satisfaction with the care they receive and outcomes in breast cancer is indicated.
Supportive Care in Cancer 09/2013; 22(1). DOI:10.1007/s00520-013-1956-7 · 2.36 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Purpose
This phase I clinical trial evaluated the safety, tolerability, and pharmacokinetics of high-dose intravenous (i.v.) ascorbic acid as a monotherapy in patients with advanced solid tumors refractory to standard therapy.
Five cohorts of three patients received i.v. ascorbic acid administered at 1 g/min for 4 consecutive days/week for 4 weeks, starting at 30 g/m2 in the first cohort. For subsequent cohorts, dose was increased by 20 g/m2 until a maximum tolerated dose was found.
Ascorbic acid was eliminated by simple first-order kinetics. Half-life and clearance values were similar for all patients of all cohorts (2.0 ± 0.6 h, 21 ± 5 dL/h m2, respectively). Cmax and AUC values increased proportionately with dose between 0 and 70 g/m2, but appeared to reach maximal values at 70 g/m2 (49 mM and 220 h mM, respectively). Doses of 70, 90, and 110 g/m2 maintained levels at or above 10–20 mM for 5–6 h. All doses were well tolerated. No patient demonstrated an objective antitumor response.
Ascorbic acid administered i.v. at 1 g/min for 4 consecutive days/week for 4 weeks produced up to 49 mM ascorbic acid in patient’s blood and was well tolerated. The recommended dose for future studies is 70–80 g/m2.
Cancer Chemotherapy and Pharmacology 05/2013; 72(1). DOI:10.1007/s00280-013-2179-9 · 2.77 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Purpose
Despite the recognized relevance of symptom burden in pancreatic cancer, there has been limited exploration of whether an individual patient’s satisfaction with the overall quality of care received might influence outcome. We evaluated the relationship between patient satisfaction with health service quality and survival in patients with pancreatic cancer.
Patients and methods
A random sample of 496 pancreatic cancer patients treated at Cancer Treatment Centers of America® (CTCA) between July 2007 and December 2010. A questionnaire that covered several dimensions of patient satisfaction was administered. Items were measured on a seven-point Likert scale ranging from “completely dissatisfied” to “completely satisfied.” Patient survival was the primary end point. Cox regression was used to evaluate the association between patient satisfaction and survival.
The response rate for this study was 72%. Of the 496 patients, 345 (69.6%) reported being “completely satisfied” with the care provided. Median overall survival was 7.9 months. On univariate analysis, patients reporting they were “completely satisfied” experienced superior survival compared with patients stating they were “not completely satisfied” (hazard ratio = 0.62; 95% confidence interval: 0.50–0.77; P < 0.001). On multivariate analysis controlling for stage at diagnosis, treatment history, and specific CTCA treatment center, “completely satisfied” patients demonstrated significantly lower mortality (hazard ratio = 0.63; 95% confidence interval: 0.51–0.79; P < 0.001).
In this exploratory analysis, patient satisfaction with health service quality was an independent predictor of survival in pancreatic cancer. Further exploration of a possible meaningful relationship between patient satisfaction with the care they have received and outcome in this difficult malignancy is indicated.
[Show abstract][Hide abstract] ABSTRACT: Despite the recognized relevance of symptom burden in colorectal cancer, there has been limited exploration of whether an individual patient's assessment of the overall quality-of-care received might influence outcome. We evaluated the relationship between patient-reported experience with service quality and survival in 702 returning colorectal cancer patients treated at our institution between July 2007 and December 2010. Overall patient experience "considering everything, how satisfied are you with your overall experience?" was measured on a 7-point Likert scale ranging from completely dissatisfied to completely satisfied. It was dichotomized into two categories: top box response (7) versus all others (1-6). Cox regression was used to evaluate the association between patient experience and survival. Of 702 patients, 506 were "completely satisfied" while 196 were not. On univariate analysis, "completely satisfied" patients had a significantly lower risk of mortality compared to those "not completely satisfied" (hazard ratio [HR] = 0.78; 95% confidence interval [CI]: 0.61-0.98; p = .04). Similarly, on multivariate analysis controlling for stage at diagnosis, treatment history, age, and gender, "completely satisfied" patients demonstrated significantly lower mortality (HR = 0.74; 95% CI: 0.58-0.95; p = .02). Patient experience with service quality was an independent predictor of survival in colorectal cancer, a novel finding in the literature.
[Show abstract][Hide abstract] ABSTRACT: Although breast cancer is a highly treatable disease, some women reject conventional treatment opting for unproven "alternative therapy" that may contribute to poor health outcomes. This study sought to understand why some women make this decision and to identify messages that might lead to greater acceptance of evidence-based treatment.
This study explored treatment decision making through in-depth interviews with 60 breast cancer patients identified by their treating oncologists. Thirty refused some or all conventional treatment, opting for alternative therapies, whereas 30 accepted both conventional and alternative treatments. All completed the Beck Anxiety Inventory and the Rotter Locus of Control scale.
Negative first experiences with "uncaring, insensitive, and unnecessarily harsh" oncologists, fear of side effects, and belief in the efficacy of alternative therapies were key factors in the decision to reject potentially life-prolonging conventional therapy. Refusers differed from controls in their perceptions of the value of conventional treatment, believing that chemotherapy and radiotherapy were riskier (p < .0073) and less beneficial (p < .0001) than did controls. Controls perceived alternative medicine alone as riskier than did refusers because its value for treating cancer is unproven (p < .0001). Refusers believed they could heal themselves naturally from cancer with simple holistic methods like raw fruits, vegetables, and supplements.
According to interviewees, a compassionate approach to cancer care plus physicians who acknowledge their fears, communicate hope, educate them about their options, and allow them time to come to terms with their diagnosis before starting treatment might have led them to better treatment choices.
The Oncologist 04/2012; 17(5):607-12. DOI:10.1634/theoncologist.2011-0468 · 4.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Malnutrition is a significant factor in predicting cancer patients' quality of life (QoL). We systematically reviewed the literature on the role of nutritional status in predicting QoL in cancer. We searched MEDLINE database using the terms "nutritional status" in combination with "quality of life" together with "cancer". Human studies published in English, having nutritional status as one of the predictor variables, and QoL as one of the outcome measures were included. Of the 26 included studies, 6 investigated head and neck cancer, 8 gastrointestinal, 1 lung, 1 gynecologic and 10 heterogeneous cancers. 24 studies concluded that better nutritional status was associated with better QoL, 1 study showed that better nutritional status was associated with better QoL only in high-risk patients, while 1 study concluded that there was no association between nutritional status and QoL. Nutritional status is a strong predictor of QoL in cancer patients. We recommend that more providers implement the American Society of Parenteral and Enteral Nutrition (ASPEN) guidelines for oncology patients, which includes nutritional screening, nutritional assessment and intervention as appropriate. Correcting malnutrition may improve QoL in cancer patients, an important outcome of interest to cancer patients, their caregivers, and families.
[Show abstract][Hide abstract] ABSTRACT: Cancer patients routinely develop symptoms consistent with profound circadian disruption, which causes circadian disruption diminished quality of life. This study was initiated to determine the relationship between the severity of potentially remediable cancer-associated circadian disruption and quality of life among patients with advanced lung cancer.
We concurrently investigated the relationship between the circadian rhythms of 84 advanced lung cancer patients and their quality of life outcomes as measured by the EORTC QLQ C30 and Ferrans and Powers QLI. The robustness and stability of activity/sleep circadian daily rhythms were measured by actigraphy. Fifty three of the patients in the study were starting their definitive therapy following diagnosis and thirty one patients were beginning second-line therapy. Among the patients who failed prior therapy, the median time between completing definitive therapy and baseline actigraphy was 4.3 months, (interquartile range 2.1 to 9.8 months).
We found that circadian disruption is universal and severe among these patients compared to non-cancer-bearing individuals. We found that each of these patient's EORTC QLQ C30 domain scores revealed a compromised capacity to perform the routine activities of daily life. The severity of several, but not all, EORTC QLQ C30 symptom items correlate strongly with the degree of individual circadian disruption. In addition, the scores of all four Ferrans/Powers QLI domains correlate strongly with the degree of circadian disruption. Although Ferrans/Powers QLI domain scores show that cancer and its treatment spared these patients' emotional and psychological health, the QLI Health/Function domain score revealed high levels of patients' dissatisfaction with their health which is much worse when circadian disruption is severe. Circadian disruption selectively affects specific Quality of Life domains, such as the Ferrans/Powers Health/Function domain, and not others, such as EORTC QLQ C30 Physical Domain.
These data suggest the testable possibility that behavioral, hormonal and/or light-based strategies to improve circadian organization may help patients suffering from advanced lung cancer to feel and function better.
BMC Cancer 05/2011; 11(1):193. DOI:10.1186/1471-2407-11-193 · 3.36 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Many cancer patients report poor sleep quality, despite having adequate time and opportunity for sleep. Satisfying sleep is dependent on a healthy circadian time structure and the circadian patterns among cancer patients are quite abnormal. Wrist actigraphy has been validated with concurrent polysomnography as a reliable tool to objectively measure many standard sleep parameters, as well as daily activity. Actigraphic and subjective sleep data are in agreement when determining activity-sleep patterns and sleep quality/quantity, each of which are severely affected in cancer patients. We investigated the relationship between actigraphic measurement of circadian organization and self-reported subjective sleep quality among patients with advanced lung cancer.
This cross-sectional and case control study was conducted in 84 patients with advanced non-small cell lung cancer in a hospital setting for the patients at Midwestern Regional Medical Center (MRMC), Zion, IL, USA and home setting for the patients at WJB Dorn Veterans Affairs Medical Center (VAMC), Columbia, SC, USA. Prior to chemotherapy treatment, each patient's sleep-activity cycle was measured by actigraphy over a 4-7 day period and sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
The mean age of our patients was 62 years. 65 patients were males while 19 were females. 31 patients had failed prior treatment while 52 were newly diagnosed. Actigraphy and PSQI scores showed significantly disturbed daily sleep-activity cycles and poorer sleep quality in lung cancer patients compared to healthy controls. Nearly all actigraphic parameters strongly correlated with PSQI self-reported sleep quality of inpatients and outpatients.
The correlation of daily activity/sleep time with PSQI-documented sleep indicates that actigraphy can be used as an objective tool and/or to complement subjective assessments of sleep quality in patients with advanced lung cancer. These results suggest that improvements to circadian function may also improve sleep quality.
Journal of Circadian Rhythms 05/2011; 9(1):4. DOI:10.1186/1740-3391-9-4
[Show abstract][Hide abstract] ABSTRACT: 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.
Experimental and therapeutic medicine 03/2011; 2(2):181-193. DOI:10.3892/etm.2011.205 · 1.27 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: "Willingness to recommend" questions are being increasingly used to measure and manage patient loyalty. Yet, there is little data in the literature correlating the "willingness to recommend" question with commonly used perceived service quality items in surveys to identify the key drivers of the optimal patient experience. We therefore evaluated the relationship between perceived service quality and subsequent single top box "willingness to recommend" scores among oncology patients.
A total of 2018 returning cancer patients treated at Cancer Treatment Centers of America® (CTCA) responded to an internally developed service quality questionnaire, which covered the following dimensions: operations and services, treatment and care with a multidisciplinary team and patient endorsements. Items were measured on a 7-point Likert-type scale ranging from "completely dissatisfied" to "completely satisfied." Patient willingness to, "recommend this facility to friends and associates" was measured on an 11-point scale ranging from "not at all likely" to "extremely likely", which was subsequently dichotomized into two categories: top box response (10) versus all others (0-9). The relationship between perceived service quality and "willingness to recommend" was assessed via Kendall's tau b correlation and univariate and multivariate logistic regression.
Of the 2018 patients, 959 were newly diagnosed while 1059 were previously treated. 902 were males and 1116 females. The mean age was 54.2 years and the most frequent diagnoses were breast (412), lung (294), prostate (260), colorectal (179) and pancreas (169). 1553 patients said they were "extremely likely" to recommend CTCA to friends and associates, resulting in 77% "top box" responses while 465 (23%) responded in all other categories. The key service quality drivers that were statistically significant in the final logistic model were "team helping you understand your medical condition", "staff genuinely caring for you as an individual", "whole person approach to patient care" and "CTCA medical oncologist."
In this multi-center study, we demonstrate the predictive significance of perceived service quality as it relates to patient willingness to recommend an oncology service provider. This study is unique in reporting on the role of perceived service quality as a predictor of patient willingness to recommend in a large sample of cancer patients.
BMC Health Services Research 02/2011; 11(1):46. DOI:10.1186/1472-6963-11-46 · 1.71 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: There are several methods of assessing nutritional status in cancer of which serum albumin is one of the most commonly used. In recent years, the role of malnutrition as a predictor of survival in cancer has received considerable attention. As a result, it is reasonable to investigate whether serum albumin has utility as a prognostic indicator of cancer survival in cancer. This review summarizes all available epidemiological literature on the association between pretreatment serum albumin levels and survival in different types of cancer.
A systematic search of the literature using the MEDLINE database (January 1995 through June 2010) to identify epidemiologic studies on the relationship between serum albumin and cancer survival. To be included in the review, a study must have: been published in English, reported on data collected in humans with any type of cancer, had serum albumin as one of the or only predicting factor, had survival as one of the outcome measures (primary or secondary) and had any of the following study designs (case-control, cohort, cross-sectional, case-series prospective, retrospective, nested case-control, ecologic, clinical trial, meta-analysis).
Of the 29 studies reviewed on cancers of the gastrointestinal tract, all except three found higher serum albumin levels to be associated with better survival in multivariate analysis. Of the 10 studies reviewed on lung cancer, all excepting one found higher serum albumin levels to be associated with better survival. In 6 studies reviewed on female cancers and multiple cancers each, lower levels of serum albumin were associated with poor survival. Finally, in all 8 studies reviewed on patients with other cancer sites, lower levels of serum albumin were associated with poor survival.
Pretreatment serum albumin levels provide useful prognostic significance in cancer. Accordingly, serum albumin level could be used in clinical trials to better define the baseline risk in cancer patients. A critical gap for demonstrating causality, however, is the absence of clinical trials demonstrating that raising albumin levels by means of intravenous infusion or by hyperalimentation decreases the excess risk of mortality in cancer.
[Show abstract][Hide abstract] ABSTRACT: 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).
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.
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.
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.
Clinical Trials.gov Identifier: NCT01163110.
BMC Cancer 10/2010; 10(1):565. DOI:10.1186/1471-2407-10-565 · 3.36 Impact Factor