Ten-year experience of the multidisciplinary Osteoncology Center.

PURPOSE: Bone metastases (BMs) are responsible for high morbidity in patients. A multidisciplinary approach involving a team of specialists offers an effective therapeutic strategy based on disease characteristics, medical history, and performance status. We evaluated the impact of our 10-year multidisciplinary experience on the management of patients with BM. METHODS: We retrospectively analyzed 2194 medical reports of 1628 patients referred to our Osteoncology Center from 2005 to 2015. Cases were discussed weekly by a multidisciplinary team. RESULTS: Eight hundred thirty-eight (38.2%) of the 2194 visits were requested because of a risk of complications from BM. Antiblastic treatment and bone-targeted therapy were modified in 709 (66.3%) and 309 (31%) of cases, respectively. Radiotherapy was scheduled in 220 (20%) of the 1099 patients for whom information was recorded. Patients completed the Brief Pain Inventory (BPI) during their first visit, 1296 (59.1%) reporting pain (median intensity 4), and 537 (41.4%) experiencing a level that interfered substantially with daily activities. New ortheses and/or antalgic therapy was prescribed accordingly. After 7 days, 208 (16%) patients were re-evaluated and a new BPI administered. A significant improvement in the worst (p < 0.0001) and current pain (p = 0.03) was seen, together with a favorable impact on daily activities (p = 0.02). Two thousand fifty-one patients completed an anonymous questionnaire on the quality of the service, the majority (69.4%) expressing high satisfaction. CONCLUSIONS: Our 10-year osteoncology experience confirms the importance of a multidisciplinary approach to optimize BM management. Further evaluations are needed in relation to quality of life, outcome, and costs.

Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes.

PURPOSE: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer. METHODS: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness. RESULTS: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC. CONCLUSIONS: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT01996540).

Chemotherapy and palliative care near end-of life: examining the appropriateness at a cancer institute for colorectal cancer patients.

BACKGROUND: Appropriate cessation of chemotherapy and timely referral of patients to hospice services are crucial for the quality of care near death. We investigated the quality of care in our Cancer Institute in very advanced metastatic colorectal cancer patients treated in real life. PATIENTS AND METHODS: We performed a retrospective analysis of electronic medical data of patients with metastatic colorectal cancer who were candidates for chemotherapy during the study period (1 January 2007-30 June 2014) and died before 31 December 2014. Quality-of-cancer-care indicators were calculated for the overuse of chemotherapy and referral to hospice. Predictive factors of chemotherapy discontinuation and hospice referral in end-of life care were investigated using parametric and nonparametric methods. RESULTS: Of the 365 patients who died before 31 December 2014, 26 (7.1%) received chemotherapy in the last 14 days of life and 36 (9.8%) started a new chemotherapy regimen in the last 30 days of life. Factors associated with the overuse of chemotherapy were being < 70 years of age for both indicators and not having received advanced chemotherapy treatments for the former indicator. The majority of patients (74.7%) had access to hospice services, of whom only a small percentage (7.2%) accessed them very near to death. CONCLUSIONS: According to the criteria used, our Institute provides a good quality of cancer care for dying colorectal cancer patients, measured by the use of chemotherapy and referral to hospice in their last days of life.

Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life.

AIM: Early palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomes and costs. PATIENTS AND METHODS: Data for this secondary analysis were taken from a trial of 207 outpatients with metastatic pancreatic cancer randomly assigned to receive standard cancer care plus on-demand EPC (standard arm) or standard cancer care plus systematic EPC (interventional arm). After 20 months' follow-up, 149 (80%) had died. Outcome measures were frequency, type and timing of chemotherapy administration, use of resources, place of death and overall survival. RESULTS: Some indices of end-of-life (EoL) aggressiveness had a favourable impact from systematic EPC. Interventional arm patients showed higher use of hospice services: a significantly longer median and mean period of hospice care (P = 0.025 for both indexes) and a significantly higher median and mean number of hospice admissions (both P < 0.010). In the experimental arm, chemotherapy was performed in the last 30 days of life in a significantly inferior rate with respect to control arm: 18.7% versus 27.8% (adjusted P = 0.036). Other non-significant differences were seen in favour of experimental arm. CONCLUSIONS: Systematic EPC showed a significant impact on some indicators of EoL treatment aggressiveness. These data, reinforced by multiple non-significant differences in most of the other items, suggest that quality of care is improved by this approach. This study is registered on ClinicalTrials.gov (NCT01996540).

Chemotherapy-induced nausea and vomiting in Italian cancer centers: results of CINVDAY, a prospective, multicenter study.

PURPOSE: Guideline consistency in the prevention of chemotherapy-induced nausea and vomiting (CINV) remains low (29% in the Pan European Emesis Registry study) and very low (11%) in regimens with a high emetogenic risk. The aim of this study was to evaluate the guideline consistency of CINV prophylaxis for acute emesis in daily clinical practice in Italy. METHODS: This was a prospective, observational, multicenter study. Patients scheduled to receive antitumor treatment on a single prespecified day were included. Data on patient characteristics (demographic and clinical), type of anticancer therapy, and type of antiemetic therapy prescribed for acute emesis were collected on electronic data capture forms. Chemotherapy regimens and antiemetic prophylaxis were categorized according to the MASCC 2011 guidelines. The study was approved by the local ethics committees. RESULTS: From July 2013 to February 2014, a total of 502 patients were enrolled at 26 study sites. Median age was 62 years (range 27-87 years). Colorectal cancer and breast cancer were the most common malignancies. The emetogenic potential of the chemotherapy regimens used was high (HEC) (23.7%), moderate (MEC) (40.6%), low (31.3%) or minimal (4.4%). Overall, guideline consistency was 19.3%. Consistency reached 45% when the various 5HT3 receptor antagonists were considered equivalent and interchangeable in MEC regimens. Adherence to guidelines was lowest for MEC and Minimal risk groups. Ten percent of patients in HEC and MEC regimens did not receive any 5HT3 receptor antagonists. NK1 receptor antagonists were used in 8% of all regimens. CONCLUSIONS: Our study indicates that antiemetic guideline inconsistency remains an issue in daily clinical oncology practice in Italy.

Managing chronic pain: results from an open-label study using MC5-A Calmare® device.

BACKGROUND: Despite state-of-the-art therapeutic strategies for pain, some types of chronic pain remain difficult to treat. We evaluated the effectiveness of an innovative neuromodulative approach to the treatment of chronic pain using electrical stimulus integrated with pharmacological support. METHODS: The MC5-A Calmare© is a new device for patient-specific cutaneous electrostimulation which, by "scrambling" pain information with "no pain" information, aims to reduce the perception of pain intensity. We prospectively treated 73 patients with cancer- (40) and non-cancer-related (33) pain whose pain management was unsatisfactory. The primary objective of the study was to assess efficacy and tolerability of the device. Pain intensity was assessed daily with a Numerical Rating Scale (NRS) for the duration of treatment (2 weeks) and then on a weekly basis for the 2 weeks of follow-up. RESULTS: Mean pain value at T0 (pre-treatment value) was 6.2 [± 2.5 SD (standard deviation)], 1.6 (± 2.0) (p < 0.0001) at T2 (after the 10th day of treatment), and 2.9 (± 2.6) (p < 0.0001) at T4 (after the second week of follow-up, i.e., 1 month after the beginning of treatment). Response after the second week of treatment showed a clear reduction in pain for both cancer (mean absolute delta of the reduction in NRS value = 4.0) and non-cancer (mean delta = 5.2) patients. The pain score had decreased by 74% at T2. On the basis of pre-established response criteria, there were 78% of responders at T2 and 81% at T4. No side effects were reported. CONCLUSIONS: Our preliminary results suggest that cutaneous electrostimulation with the MC5-A Calmare© can be hypothesized as part of a multimodality approach to the treatment of chronic pain. Further studies on larger numbers of patients are needed to assess its efficacy, to quantify the effects of inter-operator variability, and to compare results obtained from the active device versus those from a sham machine.

Impact of palliative care unit admission on symptom control evaluated by the edmonton symptom assessment system.

The aim of the present study was to evaluate the impact of palliative care on patients' symptoms, using the Edmonton Symptom Assessment System (ESAS) to measure symptom intensity at the time of admission and variations registered during the first 7 days' hospitalization. Three hundred fourteen patients were admitted to the unit during its first year of activity. Of these, 162 patients (51.6%) completed, 62 (19.7%) partially completed, and 90 (28.7%) did not complete the ESAS. The mean (+/-SD) value of the Symptom Distress Score (SDS) (sum of the values of the different symptoms) for the 162 evaluable patients on Day 1 was 33.93 (+/-16.24). On Day 7 the mean was 28.14 (+/-15.11) (ANOVA for repeated measurements, P < 0.0001). ESAS values for patients with moderate-severe symptom intensity (average values Day 1-Day 7 and P value, ANOVA for repeated measurements) were as follows: pain (7.12-4.23, P < 0.0001), fatigue (7.46-5.68, P < 0.0001), nausea (7.12-1.96, P < 0.0001), depression (7.26-5.28, P < 0.0001), anxiety (7.13-5.14, P < 0.0001), drowsiness (7.42-6.40, P = 0.002), anorexia (7.33-4.33, P < 0.0001), well-being (6.83-3.85, P < 0.0001), and dyspnea (7.08-3.86, P < 0.0001). These data seem to indicate that the patients who benefit most from inpatient palliative care are those with the most complex symptomatology.