Role of CA125 in predicting ovarian cancer survival - a review of the epidemiological literature

CA125 is the gold standard tumor marker in ovarian cancer. Serum level of CA125 is used to monitor response to chemotherapy, relapse, and disease progression in ovarian cancer patients. Thus, it is reasonable to investigate whether CA125 may have utility as a prognostic indicator as well in ovarian cancer. A large number of epidemiological studies have been carried out to this effect. This review summarizes all available epidemiological literature on the association between CA125 levels and survival in ovarian cancer. To place these studies in context, we provide some background information on CA125 and its role in ovarian cancer

Distribution and determinants of patient satisfaction in oncology: A review of the literature

Cancer is one of the leading causes of morbidity and mortality in the United States. It places considerable mental, physical, and emotional stress on patients and requires them to make major adjustments in many key areas of their lives. As a consequence, the demands on health care providers to satisfy the complex care needs of cancer patients increase manifold. Of late, patient satisfaction has been recognized as one of the key indicators of health care quality and is now being used by health care institutions for monitoring health care improvement programs, gaining accreditation, and marketing strategies. The patient satisfaction information is also being used to compare and benchmark hospitals, identify best-performance institutions, and discover areas in need of improvement. However, the existing literature on patient satisfaction with the quality of cancer care they receive is inconsistent and heterogeneous because of differences in study designs, questionnaires, study populations, and sample sizes. The aim of this review was therefore to systematically evaluate the available information on the distribution and determinants of patient satisfaction in oncology

Longitudinal monitoring of CA125 levels provides additional information about survival in ovarian cancer

<p>Abstract</p> <p>Background</p> <p>We investigated the prognostic impact of changes in serum CA125 levels during the first 3 months of therapy in ovarian cancer.</p> <p>Methods</p> <p>A case series of 170 ovarian cancer patients treated at Cancer Treatment Centers of America. Based on CA125 levels at baseline and 3 months, patients were classified into 4 groups: 1) Normal (0-35 U/ml) at baseline and three months; 2) High (>35 U/ml) at baseline, normal at three months; 3) Normal at baseline, high at 3 months; 4) High at baseline and three months. Kaplan Meier method was used to calculate survival across the 4 categories.</p> <p>Results</p> <p>Of 170 patients, 36 were newly diagnosed while 134 had received prior treatment. 25 had stage I disease at diagnosis, 15 stage II, 106 stage III and 14 stage IV. The median age at presentation was 54.2 years (range 23.1 - 82.5 years). At baseline, 31 patients had normal (0-35 U/ml) serum CA125 levels while 139 had high (>35 U/ml) levels. At 3 months, 59 had normal while 111 had high levels. Patients with a reduced CA125 at 3 months had a significantly better survival than those with increased CA125 at 3 months. Patients with normal values of CA125 at both baseline and 3 months had the best overall survival.</p> <p>Conclusions</p> <p>These data show that reduction in CA125 after 3 months of therapy is associated with better overall survival in ovarian cancer. Patients without a significant decline in CA125 after 3 months of therapy have a particularly poor prognosis.</p

Can changes in health related quality of life scores predict survival in stages III and IV colorectal cancer?

<p>Abstract</p> <p>Background</p> <p>Several studies have demonstrated the predictive significance on survival of baseline quality of life (QoL) in colorectal cancer (CRC) with little information on the impact of changes in QoL scores on prognosis in CRC. We investigated whether changes in QoL during treatment could predict survival in CRC.</p> <p>Methods</p> <p>We evaluated 396 stages III-IV CRC patients available for a minimum follow-up of 3 months. QoL was evaluated at baseline and after 3 months of treatment using EORTC QLQ-C30. Cox regression evaluated the prognostic significance of baseline, 3-month and changes in QoL scores after adjusting for age, gender and stage at diagnosis.</p> <p>Results</p> <p>After adjusting for covariates, every 10-point increase in both baseline appetite loss and global QoL score was associated with a 7% increased risk of death with HR = 1.07 (95% CI, 1.01-1.14; <it>P </it>= 0.02) and (HR = 0.93 (95% CI, 0.87-0.98; <it>P </it>= 0.01) respectively. A lower risk of death was associated with a 10-point improvement in physical function at 3 months (HR, 0.86; 95% CI, 0.78-0.94; <it>P </it>= 0.001). Surprisingly, a higher risk of death was associated with a 10-point improvement in social function at 3 months (HR, 1.08; 95% CI, 1.02-1.13; <it>P </it>= 0.008).</p> <p>Conclusions</p> <p>This study provides preliminary evidence to indicate that CRC patients whose physical function improves within 3 months of treatment have a significantly increased probability of survival. These findings should be used in clinical practice to systematically address QoL-related problems of CRC patients throughout their treatment course.</p

USE OF CASE BASED LEARNING AS A TEACHING LEARNING METHOD IN UNDERGRADUATE PATHOLOGY TEACHING- OUR EXPERIENCE.

Background The CBME Curriculum introduced by NMC is a subject based education. Newer components like alignment and integration provide an understanding of the interconnectedness between subjects and their application in patient care. Pathology bridges the basic sciences with the clinical sciences. Case Based Learning (CBL) is a pedagogical method in which the basic sciences are studied in relation to a case. It lays emphasis on the development of higher orders of cognition like interpretation and application rather than promoting learning by rote.  Aims &amp; Objectives The objectives of this study were to assess the effectiveness of CBL as a Teaching Learning (TL) method in Pathology and also to analyze the perceptions of Phase II MBBS students regarding this TL method.  Settings &amp; Design The study setting was the Department of Pathology. It was a prospective interventional study using qualitative and quantitative (mixed method) study design. All Phase II MBBS students were included in this study. 5 sessions of CBL were conducted with a pre and post-test.  Statistical Analysis Used The statistical analysis of the Pre and Post test scores was done using a Two Tailed Wilcoxon Signed Rank Test. Feedback was taken using a 5-point Likert scale and percentages were used to analyze the feedback.  Results A significant improvement (p &lt;0.001) was noted in the mean post test scores. The CBL sessions helped arouse interest in the topic (91.9%) and improve clinicopathological corelation skills (91.2%).  Conclusion CBL promotes clinical corelation skills and serves as an excellent platform for the implementation of integrated learning in Pathology. It is recommended that more topics should be taught using CBL mode of TL to make the learning experience more practical oriented.

Impact of oral vitamin D supplementation on serum 25-hydroxyvitamin D levels in oncology

<p>Abstract</p> <p>Background</p> <p>Serum 25-hydroxyvitamin D [25(OH)D] is the major circulating form of vitamin D and a standard indicator of vitamin D status. Emerging evidence in the literature suggests a high prevalence of suboptimal vitamin D (as defined by serum 25(OH)D levels of <32 ng/ml) as well as an association between lower serum levels and higher mortality in cancer. We investigated the effect of oral vitamin D supplementation as a means for restoring suboptimal levels to optimal levels in cancer.</p> <p>Methods</p> <p>This is a retrospective observational study of 2198 cancer patients who had a baseline test prior to initiation of cancer therapy at our hospital to evaluate serum 25(OH)D levels between Jan 08 and Dec 09 as part of their initial nutritional evaluation. Patients with baseline levels of < = 32 ng/ml (n = 1651) were considered to have suboptimal serum 25(OH)D levels and were supplemented with 8000 IU of Vitamin D3 (four 2000 IU D3 capsules) daily as part of their nutritional care plan. The patients were retested at their first follow-up visit. Of 1651 patients, 799 were available for follow up assessment. The mean serum 25(OH)D levels were compared in these 799 patients across the 2 time points (baseline and first follow-up) using paired sample t-test. We also investigated the factors associated with response to vitamin D supplementation.</p> <p>Results</p> <p>Of 2198 patients, 814 were males and 1384 females. 1051 were newly diagnosed and treated at our hospital while 1147 were diagnosed and treated elsewhere. The mean age at presentation was 55.4 years. The most common cancer types were breast (500, 22.7%), lung (328, 14.9%), pancreas (214, 9.7%), colorectal (204, 9.3%) and prostate (185, 8.4%). The mean time duration between baseline and first follow-up assessment was 14.7 weeks (median 10.9 weeks and range 4 weeks to 97.1 weeks). The mean serum 25(OH)D levels were 19.1 ng/ml (SD = 7.5) and 36.2 ng/ml (SD = 17.1) at baseline and first follow-up respectively; p < 0.001. Patients with prostate and lung cancer had the highest percentage of responders (70% and 69.2% respectively) while those with colorectal and pancreas had the lowest (46.7% each). Similarly, patients with serum levels 20-32 ng/ml at baseline were most likely to attain levels > 32 ng/ml compared to patients with baseline levels < 20 ng/ml.</p> <p>Conclusions</p> <p>The response to supplementation from suboptimal to optimal levels was greatest in patients with prostate and lung cancer as well as those with baseline levels between 20-32 ng/ml. Characteristics of non-responders as well as those who take longer to respond to supplementation need to be further studied and defined. Additionally, the impact of improved serum 25(OH)D levels on patient survival and quality of life needs to be investigated.</p

Can subjective global assessment of nutritional status predict survival in ovarian cancer?

<p>Abstract</p> <p>Background</p> <p>Malnutrition is a significant problem in patients with ovarian cancer. The goal of this study was to investigate the prognostic role of Subjective Global Assessment (SGA) in patients with ovarian cancer treated in an integrative cancer treatment setting.</p> <p>Methods</p> <p>We evaluated a case series of 132 ovarian cancer patients treated at Cancer Treatment Centers of America^®from Jan 2001 to May 2006. SGA was used to assess nutritional status at baseline. Using SGA, patients were classified as well nourished (SGA A), moderately malnourished (SGA B) or severely malnourished (SGA C). Kaplan Meier method was used to calculate survival. Cox proportional hazard models were constructed to evaluate the prognostic effect of SGA independent of other factors.</p> <p>Results</p> <p>Of 132 patients, 24 were newly diagnosed while 108 had received prior treatment. 15 had stage I disease at diagnosis, 8 stage II, 85 stage III and 17 stage IV. The median age at presentation was 54.4 years (range 25.5 – 82.5 years). 66 patients were well-nourished (SGA A), 35 moderately malnourished (SGA B) and 31 severely malnourished (SGA C). Well nourished patients had a median survival of 19.3 months (95% CI: 14.1 to 24.5), moderately malnourished 15.5 months (95% CI: 5.8 to 25.1), and severely malnourished 6.7 months (95% CI: 4.1 to 9.3); the difference being statistically significant (p = 0.0003). Multivariate Cox modeling, after adjusting for stage at diagnosis and prior treatment history found that moderately malnourished and severely malnourished status were associated with a relative risk of 2.1 (95% CI: 1.2 to 3.6, p = 0.008) and 3.4 (95% CI: 1.9 to 5.8, p < 0.001) respectively as compared to well nourished status.</p> <p>Conclusion</p> <p>Univariate and multivariate survival analyses found that low SGA scores (i.e. well-nourished status) are associated with better survival outcomes. This study lends support to the role of aggressive nutritional intervention in improving patient outcomes in cancer care.</p

Dose escalation study of an anti-thrombocytopenic agent in patients with chemotherapy induced thrombocytopenia

<p>Abstract</p> <p>Background</p> <p>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).</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p> <p>Trial Registration</p> <p>Clinical Trials.gov Identifier: NCT01163110</p

The humanistic burden of Pompe disease: are there still unmet needs? A systematic review

Background: Humanistic burden considers the impact of an illness on a patient's health-related quality of life (HRQoL), activities of daily living (ADL), caregiver health, and caregiver QoL. Humanistic burden also considers treatment satisfaction and adherence to treatment regimens. Pompe disease is an autosomal recessive, progressive, multisystemic neuromuscular disease. Approval of enzyme-replacement therapy (ERT) markedly improved prognosis for patients, but considerable morbidity and a substantial humanistic burden remain. This article characterizes the humanistic burden of Pompe disease through a systematic literature review. Methods: A systematic search of MEDLINE (R) and Embase (R) with back-referencing and supplementary literature searches was performed to retrieve data from interventional and non- interventional studies on the humanistic burden of Pompe disease. Publications were screened according to predefined criteria, extracted, and assessed for quality. Extracted data were narratively synthesized. Results: No publications on the humanistic burden of infantile-onset Pompe disease (IOPD) were identified. As such, of 17 publications included here, all are in patients with late-onset Pompe disease (LOPD). Thirteen publications were initiated after approval of ERT, two were initiated before, and two overlapped the approval of ERT. The review shows that LOPD patients have a significantly lower HRQoL than the general population, even if treated with ERT. On transitioning to ERT, treatment was associated with improvement in the physical component score of the SF-36 and fatigue, although the SF-36 mental component score remained stable. Physical HRQoL remained below population norms after 4 years of ERT. Significantly more ERT-treated patients reported pain than controls, and bodily pain worsened in later years following ERT initiation. Treatment-naive LOPD patients had significantly poorer ADL functioning compared with the general population, although ERT stabilized deteriorating functioning impairment. ERT studies showed caregivers provide 17.7 h/week informal care on average. Fifty percent, 40% and <20% of caregivers reported mental health, physical health, and financial/relational problems, respectively. In ERT-naive patients, wheelchair use and home ventilatory support was associated with lower physical HRQoL and ADL functioning. In ERT-treated patients, key factors predicting worse HRQoL and ADL functioning were higher respiratory distress, poorer sleep quality, greater pain, and more fatigue. Conclusions: Pompe disease has a substantial humanistic burden, with strong inter-relationships among and between humanistic burden parameters and clinical progression

Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer

<p>Abstract</p> <p>Background</p> <p>A frequent manifestation of advanced lung cancer is malnutrition, timely identification and treatment of which can lead to improved patient outcomes. Bioelectrical impedance analysis (BIA) is an easy-to-use and non-invasive technique to evaluate changes in body composition and nutritional status. We investigated the prognostic role of BIA-derived phase angle in advanced non-small cell lung cancer (NSCLC).</p> <p>Methods</p> <p>A case series of 165 stages IIIB and IV NSCLC patients treated at our center. The Kaplan Meier method was used to calculate survival. Cox proportional hazard models were constructed to evaluate the prognostic effect of phase angle, independent of stage at diagnosis and prior treatment history.</p> <p>Results</p> <p>93 were males and 72 females. 61 had stage IIIB disease at diagnosis while 104 had stage IV. The median phase angle was 5.3 degrees (range = 2.9 – 8). Patients with phase angle <= 5.3 had a median survival of 7.6 months (95% CI: 4.7 to 9.5; n = 81), while those with > 5.3 had 12.4 months (95% CI: 10.5 to 18.7; n = 84); (p = 0.02). After adjusting for age, stage at diagnosis and prior treatment history we found that every one degree increase in phase angle was associated with a relative risk of 0.79 (95% CI: 0.64 to 0.97, P = 0.02).</p> <p>Conclusion</p> <p>We found BIA-derived phase angle to be an independent prognostic indicator in patients with stage IIIB and IV NSCLC. Nutritional interventions targeted at improving phase angle could potentially lead to an improved survival in patients with advanced NSCLC.</p