Antonis Galanos

Randomized, open label, prospective study on the effect of zoledronic acid on the prevention of bone metastases in patients with recurrent solid tumors that did not present with bone metastases at baseline

AbstractObjectives: Bisphosphonates have been used successfully in the treatment of hypercalcemia and to reduce skeletal-related complications of bone metastases. Recent in vitro and in vivo evidence suggest that they may also have direct antitumor effects via induction of apoptosis, inhibition of the invasive potential of tumor cell lines in vitro, inhibition of angiogenesis, and reduction in tumor growth indirectly via effects on accessory cells. This is a randomized, open label, prospective study that examined the effect of preventive zoledronic acid treatment on the development of bone metastases in patients with recurrent solid tumors, without bone metastases at the time of randomization. Methods: Forty patients with recurrent or metastatic advanced cancer, without bone metastases, were randomized into the trial to either receive zoledronic acid or no treatment. Patients were followed up until bone metastases were established. Results: The percentage of patients being bone metastases free at 12 mo was 60% in the zoledronic acid and 10% in the control group (p<0.0005), while the percentages at 18 mo were 20% and 5% respectively (p=0.0002). Conclusions: The results have shown that bisphosphonates as adjuvant treatment might be useful for the prevention of bone metastases; however, there is need for blinded randomized data before such an approach would be confirmed. In the meantime preventive use of bisphosphonates in patients without any bone metastases should not be used outside the scope of a clinical trial.

A Randomized Trial of Nasal Spray Salmon Calcitonin in Men With Idiopathic Osteoporosis: Effects on Bone Mineral Density and Bone Markers

In a 12‐month randomized, double‐blind, placebo‐controlled trial, we have studied the effects of intranasal salmon calcitonin (SCT) on bone mineral density (BMD) and biochemical markers of bone turnover. Twenty‐eight men with idiopathic osteoporosis aged 27‐74 years (mean, 52.4 years) were randomized to receive either nasal SCT (200 IU) or a nasal placebo daily for a period of 1 year. All the men received a daily supplement of 0.5 g of calcium. The men who received SCT had a mean (±SEM) increase in BMD of 7.1 ± 1.7% at the lumbar spine. In contrast, the men who received the placebo had an increase of 2.4 ± 1.5% (p > 0.05) for the comparison with baseline. The increase in lumbar BMD in the calcitonin group was significantly greater than that in the placebo group (p < 0.05). There were no significant changes in the femoral neck, trochanter, or Wards triangle relative to both baseline and placebo after 12 months. Treatment with nasal SCT resulted in a significantly pronounced suppression of bone resorption markers (urinary deoxypyridinoline [DPD], type I cross‐linked N‐telopeptide [NTX], and type I cross‐linked C‐telopeptide [CTX]) and to a lesser extent in bone formation markers (serum bone‐specific alkaline phosphatase [BALP], osteocalcin [OC], serum C‐terminal procollagen type I extension peptides [PICP], and serum N‐terminal procollagen type I extension peptides [PINP]), whereas the placebo did not. Therapy was tolerated well and there were no treatment‐related adverse events. We conclude that intranasal SCT (200 IU daily) is safe and effective in increasing lumbar BMD and reducing bone turnover in men with idiopathic osteoporosis.

The Hospital Anxiety and Depression Scale in Greek cancer patients: psychometric analyses and applicability

Goals of workThe aim of the present study was to validate the Greek version of the Hospital Anxiety and Depression Scale (HAD) in a palliative care unit.Patients and methodsThe scale was translated with the “forward-backward” procedure to Greek. It was administered twice, with a 1-week interval, to 120 patients with advanced cancer. Together with the HAD scale, the patients also completed the Spielberger State-Anxiety Scale (STAI-S).Main resultsFactor analyses identified a two-factor solution corresponding to the original two subscales of the HAD, which were found to be correlated. The Greek version of the HAD had Cronbach’s alphas for the anxiety and depression scales of 0.887 and 0.703, respectively. Validity as performed using known-group analysis showed good results. Both anxiety and depression subscales discriminated well between subgroups of patients differing in disease severity as defined by ECOG performance status. Correlations between the HAD scale and the STAI-S was 0.681 for the anxiety subscale and 0.485 for the depression subscale.ConclusionsThese psychometric properties of the Greek version of the HAD scale confirm it as a valid and reliable measure when administered to patients with advanced cancer.

Analgesic effect of Salmon calcitonin suppositories in patients with acute pain due to recent osteoporotic vertebral crush fractures : A prospective double-blind, randomized, placebo-controlled clinical study

OBJECTIVE To evaluate the analgesic efficacy of calcitonin suppositories (200 IU) in comparison with bed rest and paracetamol tablets, as a rescue analgesic. DESIGN A prospective, double-blind, randomized, placebo-controlled, clinical trial. PATIENTS Forty patients (8 men and 32 postmenopausal women), who had recently (within the last 5 days) suffered a nontraumatic osteoporotic vertebral fracture. SETTING AND INTERVENTIONS All patients were admitted to the hospital, divided randomly into two groups and received either one calcitonin or placebo suppository once a day, respectively, for 28 days. All patients were allowed to take paracetamol tablets (500 mg), with a maximum dose of six tablets daily. OUTCOME MEASURES Spinal pain evaluation was performed at the beginning of the study (before the initiation of treatment) and then daily until the end of the study (day 28) using the Huskinssons visual analog scale (VAS) and a painmeter device, by direct pressure on the fractured vertebra. Pain was evaluated with the patients attempting or performing four different locomotor functions, e.g., bed rest, sitting, standing, and walking functions. Biochemical urine and plasma measurements were carried out before the initiation of treatment and on days 14 and 28. RESULTS All calcitonin-treated patients experienced an overall statistically significant (all p values < 0.001) decrease of spinal pain as assessed by the VAS and the painmeter device. Pain relief allowed for early mobilization and the gradual restoration of the locomotive functions in the calcitonin-treated group. Placebo-treated patients remained in bed for almost the whole of the observation period. At the end of the study (28th day), fasting osteocalcin, hydroxyproline/creatinine, and calcium/creatinine ratio values were statistically significantly (all p values < 0.001), lower in the calcitonin-treated than in the placebo-treated patients. In the placebo group these values showed a gradual increase. In the calcitonin-treated group side effects mainly included dizziness and enteric irritation caused by the suppositories. Enteric irritation was also present in the placebo-treated group. CONCLUSIONS Salmon calcitonin suppositories (200 IU daily) caused a dramatic decrease in spinal pain in patients with recent osteoporotic vertebral fractures and influenced the early mobilization and the gradual restoration of their locomotor functions.

Mortality Rates of Patients with a Hip Fracture in a Southwestern District of Greece: Ten-Year Follow-Up with Reference to the Type of Fracture

Increased mortality after a hip fracture has been associated with age, sex, and comorbidity. In order to estimate the long-term mortality with reference to hip fracture type, we followed 499 patients older than 60 years who had been treated surgically for a unilateral hip fracture for 10 years. At admission, patients with femoral neck fractures (n = 172) were 2 years younger than intertrochanteric patients (77.6 ± 7.7 [SD] vs. 79.9 ± 7.4 [SD], P = 0.001) and had a greater prevalence of heart failure (57% vs. 40.3%, P = 0.03). Similar mortality rates were observed at 1 year in both types of fracture (17.9% vs. 11.3%, log rank test P = 0.112). Mortality rates were significantly higher for intertrochanteric fractures at 5 years (48.8% vs. 34.7%, P = 0.01) and 10 years (76% vs. 58%, P = 0.001). Patients 60–69 years old with intertrochanteric fractures had significantly higher 10-year mortality than patients of similar age with femoral neck fractures (P = 0.008), while there was no difference between the groups aged 70–79 (P > 0.3) and 80–89 (P = 0.07). Women were less likely to die in 5 years (relative risk [RR] = 0.57, 95% confidence interval [CI] 0.41–0.79, P = 0.0007) and 10 years (RR = 0.65, 95% CI 0.49–0.85, P = 0.002). Age, sex, the type of fracture, and the presence of heart failure were independent predictors of 10-year mortality (Cox regression model P < 0.0001). The intertrochanteric type was independently associated with 1.37 (95% CI 1.03–1.83) times higher probability of death at 10 years (P = 0.002). In conclusion, the type of fracture is an independent predictor of long-term mortality in patients with hip fractures, and the intertrochanteric type yields worse prognosis.

Hip Fracture Epidemiology in Greece During 1977–1992

Abstract. Hip fracture, the most dramatic complication of osteoporosis, constitutes a serious health problem of the elderly, with great socioeconomic consequences. Hip fracture epidemiology has been studied by many investigators. Until now, reported studies in Greece include either data from only one region, or they do not include all the epidemiological parameters concerning hip fractures. We studied hip fractures that occurred in Greece in 1992 and compared the findings with those of previous years (1977, 1982, 1987), in order to identify age and sex incidence and increase rate during 1977–1992. There has been an average annual increase of 7.6%, thus total hip fractures in Greece increased from 5,100 in 1977 (54.75 fractures/100,000 inhabitants) to 10,953 in 1992 (107.30 fractures/100,000 inhabitants). In 1992, 70% of the patients were women. During the 1977–1992 period, age-adjusted incidence for people aged over 50 increased in both sexes (from 173.54 fractures/100,000 inhabitants in 1977 to 314.07 fractures/100,000 inhabitants in 1992, an increase of age-adjusted incidence of 80.97%). Approximately 50% of the patients in 1992 were aged 80 and over, whereas in 1977 there were only 22.49% patients of the same age. The increase in hip fracture numbers is greater than expected due to population aging, suggesting the existence of other factors influencing this increase. The most affected age group is 80 and over.

Depression, hopelessness, and sleep in cancer patients' desire for death

Objective: The aim of this study was to evaluate the prevalence of clinical characteristics and risk factors for hastened death in advanced cancer patients. Methods: Patients completed the Greek version of Schedule of Attitudes toward Hastened Death (G-SAHD), a sleep quality measure, the Pittsburgh Sleep Quality Index (PSQI), a Greek version of a depression inventory, the Beck Depression Inventory (BDI), a hopelessness scale, the Beck Hopelessness Scale (BHS), and a Visual Analogue Scale (VAS) for the assessment of pain. Patients: The final sample consisted of 102 terminally ill cancer patients attending a Palliative Care Unit. Results: Statistically significant associations were found between G-SAHD and patients performance status (ECOG) (χ2 = 8.62, p = 0.003). Strongest associations were observed between desire for death, depression, and hopelessness (r = 0.468, p < 0.0005, r = 0.678, p < 0.0005, respectively). In the prediction of G-SHAD the contribution of “hopelessness” (p < 0.0005), “depression” (p < 0.0005), “use of sleeping medication” (p < 0.0005), and “sleep quality” (p=0.001) was high (59% of variance). Conclusion: Depression, hopelessness, and sleep quality appeared to have a statistically significant relationship with desire for hastened death. Health care professionals finding desire for death in advanced cancer patients should not only consider depression and hopelessness, but also other factors such as poor sleep quality in their diagnostic formulations in order to provide the appropriate treatment.

Self-Efficacy, Depression, and Physical Distress in Males and Females With Cancer

Aims: To examine the relationship between self-efficacy with depression and physical distressing symptoms in males and females with cancer. Methods: A total of 41 males and 49 females with cancer completed the General Perceived Self-Efficacy Scale (GSE), depression scale, from the Hospital Anxiety and Depression Scale (HAD-D), and the MD Anderson Symptom Inventory (MDASI). Results: Correlations were found between depression and self-efficacy in males (r = -.501, P = .001) and females (r = -.588, P < .0005). The multivariate regression analysis revealed that education and depression could influence self-efficacy in male population. Urogenital versus breast cancer as well as depression seemed to influence females’ self-efficacy. Conclusions: Patients who had higher self-efficacy had lower depressive symptoms. Men with depressive symptoms and women with breast cancer and depression are more likely to have low self-efficacy than patients with other cancer types.

Traumatic distress and positive changes in advanced cancer patients.

This study investigated the traumatic distress and posttraumatic growth in 58 advanced cancer patients receiving palliative treatment in a Pain Relief and Palliative Care Unit. The patients completed the Greek version of the Impact of Events Scale-Revised and the Posttraumatic Growth Inventory. Statistically significant associations were found among Impact of Events Scale-RevisedGreek “Relating to Others” (r = 0.311, P = .017), “New Possibilities” ( r = 0.248, P = .050), and “Appreciation of Life” ( r = 0.419, P = .001), and the Posttraumatic Growth Inventory scores (r = 0.323, P = .013). Similarly, “Appreciation of Life” correlated significantly with “Avoidance” (r = 0.318, P = .015), “Intrusion” (r = 0.365, P = .005), and “Hyperarousal” (r = 0.398, P = .002). Statistically significant associations were also found between “Relating to Others” and “Intrusion” (r = 0.414, P = .001). The study concluded that in advanced cancer patients, the higher the impact event, the more improvement in their relationships with others, enhanced life appreciation, and more positive consequences after trauma.

Post‐traumatic growth in advanced cancer patients receiving palliative care

GOALS OF WORK To develop the Greek version of the Post-traumatic Growth Inventory (PTGI-Gr), and assess its psychometric properties in a palliative care patient sample. PATIENTS AND METHODS The scale was translated with the forward-backward procedure to Greek. It was administered twice, with a 3-day interval, to 131 eligible patients with advanced cancer. Together with the PTGI, the patients also completed the Greek version of the Impact of Events Scale-Revised scale (IES-R-Gr). The reliability was assessed by the internal consistency (Cronbachs alpha coefficients), test/retest (Spearmans r value), and inter-item correlations. Validity was demonstrated by factor analysis, inter-scale correlations, construct validity with the IES-R-Gr, and combined with the Eastern Cooperative Oncology Group (ECOG) performance status. MAIN RESULTS The PTGI-Gr yielded a five-factor structure, explaining 73.5% of the variance. Cronbachs alphas for the five factors ranged from .66 to .87, respectively. Overall test-retest reliability was satisfactory with a range between .85 and .92 (p<.0005), and inter-item correlations ranged between .47 and .63. Inter-scale correlations were found satisfactory (p<.0005, p<.005, and p<.05). Validity as performed using combined validity analysis showed good results. Satisfactory construct validity was supported by the correlation analysis between the PTGI-Gr and the IES-R-Gr scales. CONCLUSIONS PTGI-Gr is an instrument with satisfactory psychometric properties, and is a valid research tool for the post-traumatic growth of advanced cancer patients.