Supportive care in cancer-a MASCC perspective.

The term 'supportive care' arose from the medical oncology literature predominantly in the context of managing the toxicities of cancer treatment but embraces all symptom management through treatment and survivorship. Supportive care should be patient-centred with good communication which includes family and carers and applies across the cancer experience from diagnosis, treatment, survivorship to end of life care. Supportive care encompasses physical and functional, psychological, social and spiritual well-being to improve the quality of life. Supportive care must be evidence-based and thus further research is essential. Supportive care requires screening for some symptoms and tools for patients to report their outcomes. Supportive care has to accommodate new physical toxicities, emotional distress as well as financial toxicity. Supportive care is often delivered by medical oncologists but any organ-related specialist, geriatrician, palliative care clinician, pain specialist, nutritionist, psycho-oncologist, social worker, physiotherapist, nurse or allied health worker who is required to relieve a patient's symptoms or side effects may be involved in a multidisciplinary way. The field is evolving to embrace technology such as eHealth and mHealth capabilities which will enhance integrated care.

Alveolar bone histological necrosis observed prior to extractions in patients, who received bone-targeting agents.

OBJECTIVE: We reported the alveolar bone histology prior to dental extractions in cancer patients, who received bone-targeting agents (BTA). SUBJECTS AND METHODS: Fifty-four patients were included. Patients underwent extractions, and bone biopsies were taken. RESULTS: Extractions were performed due to pain, swelling, purulence, fistula, and numbness, not responding to treatment, in 40 patients (group A); extractions due to asymptomatic, non-restorable teeth, were performed in 14 patients (group B). Complete alveolar jaw bone histological necrosis was observed in 28 of 40 (70%) patients of group A and none of group B (p < .001). The development of clinical osteonecrosis (MRON) was assessed in 44 patients; 10 patients, who were also treated with Low Level Laser Treatments-LLLT, were excluded from this analysis, as the alternative therapies were a confounding factor. Twelve patients, with alveolar bone histological necrosis prior to extraction, developed medication-related osteonecrosis of the jaw (MRONJ) compared with two patients with vital or mixed vital/non-vital bone (p < .0007). BTAs >1 year and concurrent targeted therapy were also significantly associated with MRONJ (p = .016 and p = .050). CONCLUSION: Pain, swelling, purulence, fistula, and numbness were significantly associated with complete bone histological necrosis prior to extractions and increased MRONJ development. Research is justified to explore whether histological necrosis represents an early stage of osteonecrosis.

Spiritual care in cancer patients: a need or an option?

PURPOSE OF REVIEW: Because of cancer is generally perceived as a life-threatening illness, patients often develop spiritual needs upon the diagnosis. Spirituality impacts patient quality of life (QoL) and provides a context in which to derive hope and meaning to cope with illness. The goal of this review is to give an overview of the most relevant studies with a focus on the relationship between spiritual well being, QoL and hope in patients with cancer, in addition to exploring the importance of spiritual issues both for patients and healthcare professionals. RECENT FINDINGS: Spiritual well being with its dimensions of faith, meaning, and peace is a central component for the overall QoL. A strong spiritual well being decreases symptom severity, the level of hopelessness and the desire for hastened death in cancer patients. However, in the medical setting the provision of spiritual care remains poor, although patients, especially at the end of life, would like their spiritual needs to be addressed as part of the global care. SUMMARY: Care for cancer patients goes beyond just caring for the person's body. The assessment of spiritual/religious needs can be considered the first step in designing needs-tailored interventions.

The Edmonton Symptom Assessment System (ESAS) as a screening tool for depression and anxiety in non-advanced patients with solid or haematological malignancies on cure or follow-up.

BACKGROUND: Symptoms' assessment should be considered a clinical practice routine in all cancer stages. The Edmonton Symptom Assessment System (ESAS) is a ten-item patient-rated symptom assessment developed and validated for population affected by cancer in different languages and cultures. The main objective of this study was to assess the performance of ESAS items on anxiety and depression when detecting Hospital Anxiety Depression Scale (HADS) 'cases'. METHODS: A cross-sectional study was carried out on 194 non-advanced patients with solid (108) or hematologic malignancies on cure or follow up, Karnofsky Performance Status ≥ 70, life expectancy > 6 months and no metastases. Patients were assessed by means of ESAS and by HADS. Receiving operator characteristic (ROC) analysis of ESAS anxiety and depression items versus cases of severe (cutoff 11) anxiety and depression according to HADS-specific subscales was performed. RESULTS: Depression and anxiety ESAS items correlated strongly (0.707, Spearman). Area under the curve ranged between 0.84 and 0.96 for the two ESAS items when detecting severe anxiety or depression HADS cases (cutoff = 11). ESAS anxiety or depression scores >3 detected quite well the severe depression HADS cases (Sensibility = 75-Specificity = 84, Sensibility = 87-Specificity = 90, respectively). CONCLUSIONS: Anxiety or depression ESAS items score >3 can be applied as a useful, easy and not time consuming screening tool for assessing anxiety and depression in non-advanced patients with solid or haematological malignancies.

Efficacy and safety of 12-weekly versus 4-weekly zoledronic acid for prolonged treatment of patients with bone metastases from breast cancer (ZOOM): a phase 3, open-label, randomised, non-inferiority trial.

BACKGROUND: Zoledronic acid reduces skeletal-related events in patients with breast cancer, but concerns have been raised about prolonged monthly administration. We assessed the efficacy and safety of a reduced dosing frequency of zoledronic acid in women treated previously with monthly zoledronic acid. METHODS: We did this non-inferiority, phase 3 trial in 62 centres in Italy. We enrolled patients with breast cancer who had one or more bone metastases and had completed 12-15 months of monthly treatment with zoledronic acid. Patients were randomly assigned with a permutated block (size four to eight) random list stratified by centre in a 1:1 ratio to zoledronic acid 4 mg once every 12 weeks or once every 4 weeks, and followed up for at least 1 year. Neither patients nor investigators were masked to treatment allocation. The primary outcome was skeletal morbidity rate (skeletal-related events per patient per year) in the intention-to-treat population. We used a non-inferiority margin of 0.19. The trial is registered with EudraCT, number 2005-004942-15. FINDINGS: We screened 430 patients and enrolled 425, of whom 209 were assigned to the 12-week group and 216 to the 4-week group. The skeletal morbidity rate was 0.26 (95% CI 0.15-0.37) in the 12-week group versus 0.22 (0.14-0.29) in the 4-week group. The between-group difference was 0.04 and the upper limit of one-tailed 97.5% CI was 0.17, which is lower than the non-inferiority margin. The most common grade 3-4 adverse events were bone pain (56 [27%] patients in the 12-week group vs 65 [30%] in the 4-week group), nausea (24 [11%] vs 33 [15%]), and asthenia (18 [9%] vs 33 [15%]). Renal adverse events occurred in one patient (<1%) in the 12-week group versus two (1%) in the 4-week group. One patient (<1%) in the 4-week group had grade 1 acute renal failure. Osteonecrosis of the jaw occurred in four patients in the 12-week group versus three in the 4-week group. No treatment-related deaths were reported. Median N-terminal telopeptide concentration changed from baseline more in the 12-week group than in the 4-week group after 12 months (12.2% vs 0.0%; p=0.011). INTERPRETATION: Our results raise the possibility of decreasing administration of zoledronic acid to a 12-weekly regimen to reduce exposure during the second year, while maintaining its therapeutic effects. However, the effects on N-terminal telopeptide should be investigated further before changing current practice. FUNDING: Novartis Farma.

Relationships among unmet needs, depression, and anxiety in non-advanced cancer patients.

INTRODUCTION: In oncology settings, less attention is given to patients' unmet needs and to existential and emotional distress compared to physical symptoms. We aimed to evaluate correlations between unmet needs and emotional distress (self-reported anxiety and depression) in a consecutive cohort of cancer patients. The influence of sociodemographic and clinical factors was also considered. METHODS: A total of 300 patients with cancer recruited from an outpatient Supportive Care Unit of a Comprehensive Cancer Centre completed the Need Evaluation Questionnaire and the Edmonton Symptom Assessment System (ESAS). Unmet needs covered 5 distinct domains (informational, care/assistance, relational, psychoemotional, and material). RESULTS: After removal of missing data, we analyzed data from 258 patients. Need for better information on future health concerns (43%), for better services from the hospital (42%), and to speak with individuals in the same condition (32%) were the most frequently reported as unmet. Based on the ESAS, 27.2% and 17.5% of patients, respectively, had a score of anxiety or depression >3 and needed further examination for psychological distress. Female patients had significantly higher scores for anxiety ( p < 0.001) and depression ( p = 0.008) compared to male patients. Unmet needs were significantly correlated with both anxiety ( rs = 0.283) and depression ( rs = 0.284). Previous referral to a psychologist was significantly associated with depression scores ( p = 0.015). Results were confirmed by multiple regression analysis. CONCLUSIONS: Screening for unmet needs while also considering sociodemographic and clinical factors allows early identification of cancer patients with emotional distress. Doing so will enable optimal management of psychological patient-reported outcomes in oncology settings.

Prevention and management of osteonecrosis of the jaw secondary to bone-targeted therapy in patients with kidney cancer.

PURPOSE OF REVIEW: The aim of this revision is prevention and management of osteonecrosis of the jaw (ONJ) secondary to bone-targeted therapy in patients with kidney cancer. RECENT FINDINGS: Patients with kidney cancer treated with zoledronate suffered from ONJ earlier compared with patients with breast cancer or multiple myeloma; among men, ONJ occurred at 24 months of zoledronic acid treatment in more than 80% of the patients and much earlier, in respect to patients with prostate cancer or multiple myeloma. Protective factors against an ONJ can be sequential prescription of different bisphosphonates and female sex. Less data are available on ONJ secondary to denosumab administration in patients with kidney cancer. SUMMARY: Bone metastases, developing in about 30% of the patients with metastatic renal cell carcinoma, are typically osteolytic on imaging and cause significant morbidity and poor quality of life. Incidence of skeletal-related events has been reported to reach 3.38 per year in such patients. To decrease the incidence of ONJ, a maxillofacial examination must be performed in all patients before treatment with bisphosphonates, in particular in patients with metastatic renal cell carcinoma treated with sunitinib alone or in association with zoledronate. The management of ONJ consider a conservative approach.

Temporal course and predictive factors of analgesic opioid requirement for chemoradiation-induced oral mucositis in oropharyngeal cancer.

BACKGROUND: Oral mucositis (OM)-related pain affects most patients with head and neck cancer during treatments, but its management is not standardized. METHODS: We retrospectively collected data about the opioid therapy used for OM-induced pain in all patients with oropharyngeal cancer treated with chemoradiotherapy (CRT) between 2009 and 2013. To compare the different opioids, a conversion into oral morphine equivalent daily dose (OMEDD) was performed. The highest OMEDD (h-OMEDD) and the opioids' weekly increase were associated with patient, tumor, or treatment-related characteristics in order to identify predictive factors of opioid consumption. RESULTS: Ninety-seven percent of patients received opioids. The h-OMEDD was significantly correlated with a higher OM-grade and a lower smoking history. The weekly opioids' increase was higher in patients with lower smoking history and human papillomavirus (HPV) positivity. CONCLUSION: Opioid therapy remains the mainstay for OM-related pain management during CRT. The role of previous smoking and HPV on opioid use needs further confirmations. © 2016 Wiley Periodicals, Inc. Head Neck 38: E1521-E1527, 2016.

Is pain reporting to health care professionals age-related? A cross sectional multicenter study in a hospital setting.

BACKGROUND: Failure to report pain by older patients is usually considered a major obstacle to receive adequate pain management. OBJECTIVES: To compare the frequency of reporting pain to health care professionals (HCPs) among older (≥ 65 yrs) and younger adults (< 65 yrs) and to evaluate whether age and setting of care influence pain reporting to HCPs. RESULTS: Overall, 3285 patients (54.7 ≥ 65 yrs) were interviewed. Despite analgesic therapy, 2821 patients had pain. Among these, 1178 patients (41.8%) had severe pain. The frequency of patients not reporting pain to HCPs is significantly lower among older vs. younger adults (18.1 vs. 23.6%; p < 0.001). Multiple multilevel logistic regression, however, shows that nonreporting pain is not age-related, but is associated with: nonmalignant pain (OR = 1.53; 95% CI: 1.00 - 2.35; p = 0.05), a short hospitalization (OR = 1.58; 95% CI: 1.20 - 2.07; p = 0.001), admission to a hospital without a 'pain-free hospital' project (OR = 2.00; 95% CI: 1.18 - 3.39; p = 0.011). CONCLUSIONS: The results suggest that failure to report pain does not appear to be associated with the age of the patient in itself, but with type of pain and clinical context. Both patients and physicians should be encouraged to actively address pain management. Further research is needed.

Strategic pain management: the identification and development of the IAHPC opioid essential prescription package.

The aim of this study was to determine by consensus the components of an opioid essential prescription package (OEPP) to be used when initiating a prescription for the control of moderate to severe chronic pain. Palliative care physicians (n=60) were sampled from the International Association for Hospice and Palliative Care (IAHPC) membership list to represent a range of countries of varying economic levels and diverse geographical regions. Using a Delphi study method, physicians were asked to rank preferences of drug and dosing schedule for first-line opioid, antiemetic, and laxative for the treatment of adults with chronic pain due to cancer and other life-threatening conditions. Overall response rates after two Delphi survey rounds were 95% (n=57) and 82% (n=49), respectively. A consensus (set at ≥75% agreement) was reached to include morphine as first-line opioid at a dose of 5 mg orally every 4 hours. Consensus was reached to include metoclopramide as a first-line antiemetic, but there was no consensus on "regular" or "as needed" administration. No consensus was reached regarding a first-line laxative, but a combination of senna and docusate secured 59% agreement. There was consensus (93% agreement) that laxatives should always be given regularly when opioid treatment is started. Further work is needed to establish a recommended dose of metoclopramide and a type and dose of laxative. The resulting OEPP is international in scope and is designed to ensure that opioids are better tolerated by reducing adverse effects of opioids, which could lead to more sustained improvements in pain management.

Normal-release oral morphine starting dose in cancer patients with pain.

OBJECTIVES: To evaluate whether the current European Association for Palliative Care recommendation regarding the starting dose of 5 mg of normal-release morphine (NRM) sulfate oral solution every 4 hours in opioid naive patients or 10 mg in patients already being treated with "weak" opioids is effective and could be proposed as starting routine dose in clinical practice. Secondary aims were to estimate the percentage of patients who were high responders to NRM and to study the association of baseline patient characteristics with both high analgesic responsivity and the need of opioid dose escalation. METHODS: Consecutive strong opioid-naive patients with cancer pain were enrolled in a multicenter uncontrolled phase 4 clinical trial. Oral NRM was administered at 2 different dosages: 5 and 10 mg every 4 hours, respectively, for opioids-naive (group A) and nonopioids-naive (group B) patients as starting therapy. Average daily dosages of NRM and opioid escalation index (OEI) were calculated and the reduction in pain score was tested through Student t test both in group A and in group B patients. RESULTS: One hundred fifty-nine consecutive patients were enrolled and data analysis was conducted on 151 (95%) patients. On an average the OEIs were: 3.2 in group A and 6.5 in group B and a significant reduction in pain score both after 3 and 5 days from baseline (P<0.001) was shown in both groups. In multivariate analysis both Karnofsky Performance Status and episodic pain showed to be independent prognostic factors of a high analgesic response. The presence of neuropathic pain showed to be associated with a higher OEI. DISCUSSION: These data show that empiric standard doses of NRM during titration, recommended by European Association for Palliative Care, are effective in clinical practice.