Anna Roberto

Quality of Cancer Pain Management: An Update of a Systematic Review of Undertreatment of Patients With Cancer

PURPOSE Pain is a frequent symptom in patients with cancer, with substantial impact. Despite the availability of opioids and updated guidelines from reliable leading societies, undertreatment is still frequent. METHODS We updated a systematic review published in 2008, which showed that according to the Pain Management Index (PMI), 43.4% of patients with cancer were undertreated. This review included observational and experimental studies reporting negative PMI scores for adults with cancer and pain published from 2007 to 2013 and retrieved through MEDLINE, Embase, and Google Scholar. To detect any temporal trend and identify potential determinants of undertreatment, we compared articles published before and after 2007 with univariable, multivariable, and sensitivity analyses. RESULTS In the new set of 20 articles published from 2007 to 2013, there was a decrease in undertreatment of approximately 25% (from 43.4 to 31.8%). In the whole sample, the proportion of undertreated patients fell from 2007 to 2013, and an association was confirmed between negative PMI score, economic level, and nonspecific setting for cancer pain. Sensitivity analysis confirmed the robustness of results. CONCLUSION Analysis of 46 articles published from 1994 to 2013 using the PMI to assess the adequacy of analgesic therapy suggests the quality of pharmacologic pain management has improved. However, approximately one third of patients still do not receive pain medication proportional to their pain intensity.

Impact of endometriosis on quality of life and mental health: pelvic pain makes the difference

Abstract Introduction: No prior study of endometriosis has investigated the psychological impact of having asymptomatic endometriosis versus endometriosis with pelvic pain in a systematic way. This study aimed at examining the impact of endometriosis on quality of life, anxiety and depression by comparing asymptomatic endometriosis, endometriosis with pelvic pain, and healthy, pain-free controls. The psychological impact of different types of endometriosis pain was also tested. Methods: One hundred and ten patients with surgically diagnosed endometriosis (78 with pelvic pain and 32 without pain symptoms) and 61 healthy controls completed two psychometric tests assessing quality of life, anxiety and depression. Endometriosis participants indicated on a numerical rating scale the intensity of four types of pain (dysmenorrhea, dyspareunia, non-menstrual pelvic pain and dyschezia). Results: Endometriosis patients with pelvic pain had poorer quality of life and mental health as compared with those with asymptomatic endometriosis and the healthy controls. No significant differences were found between asymptomatic endometriosis and the control group. Dysmenorrhea had significant effects only on physical quality of life; non-menstrual pelvic pain affected all the variables; no significant effects were found for dyspareunia and dyschezia. Conclusions: Pain significantly affects women’s experience of endometriosis. The medical treatment of endometriosis with pain may not be sufficient and psychological intervention is recommended.

Long-term efficacy and safety of oxycodone–naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study

Background Two-thirds of older people suffer from chronic pain and finding valid treatment options is essential. In this 1-yearlong investigation, we evaluated the efficacy and safety of prolonged-release oxycodone–naloxone (OXN-PR) in patients aged ≥70 (mean 81.7) years. Methods In this open-label prospective study, patients with moderate-to-severe noncancer chronic pain were prescribed OXN-PR for 1 year. The primary endpoint was the proportion of patients who achieved ≥30% reduction in pain intensity after 52 weeks of treatment, without worsening bowel function. The scheduled visits were at baseline (T0), after 4 weeks (T4), and after 52 weeks (T52). Results Fifty patients completed the study. The primary endpoint was achieved in 78% of patients at T4 and 96% at T52 (P<0.0001). Pain intensity, measured on a 0–10 numerical rating scale, decreased from 6.0 at T0 to 2.8 at T4 and to 1.7 at T52 (P<0.0001). Mean daily dose of oxycodone increased from 10 to 14.4 mg (T4) and finally to 17.4 mg (T52). Bowel Function Index from 35.1 to 28.7 at T52. No changes were observed in cognitive functions (Mini-Mental State Examination evaluation), while daily functioning improved (Barthel Index from 53.1 to 61.0, P<0.0001). The Screener and Opioid Assessment for Patients with Pain-Revised score at 52 weeks was 2.6 (standard deviation 1.6), indicating a low risk of aberrant medication-related behavior. In general, OXN-PR was well tolerated. Conclusion This study of the long-term treatment of chronic pain in a geriatric population with OXN-PR shows satisfying analgesic effects achieved with a stable low daily dose, coupled with a good safety profile and, in particular, with a reduction of constipation, often present during opioid therapy. Our findings support the indications of the American Geriatrics Society, suggesting the use of opioids to treat pain in older people not responsive to acetaminophen or nonsteroidal anti-inflammatory drugs.

Open-access clinical trial registries: the Italian scenario

BackgroundCitizens, patients and their representatives are increasingly insisting on working with health professionals to organize and discuss research protocols. The International Committee of Medical Journal Editors recommended setting up a public clinical trial registry where anyone can find key information about a trial. Around the world, governments have, in fact, now begun to legislate mandatory disclosure of all clinical trials. The aims of the present survey were to assess the availability of clinical trial registries for Italian citizens and to examine the transparency of the data items reported.MethodsThe availability of open-access clinical trial registries was surveyed on a sample of 182 websites, including research institutes and centers of excellence (IRCCS-teaching hospitals), hospitals and associations. For each registry we downloaded a sample of two trials to assess the correspondence of the data items reported. Results from the Italian and international registries were compared.ResultsFifteen percent of the sample had an open-access registry of clinical trials. Comparison of the data items available, in terms of completeness and transparency, from institutional and international registries indicated wide variability.ConclusionsItalian citizens, patients and their associations have scant access to local registries of clinical trials, and international registries are generally more informative. On the European level, advocacy and lobby actions are needed among citizens and patients to boost the diffusion of open-access clinical trial registries without language barriers, thereby facilitating participation, access to information, and the coordination of clinical research.

Radiosurgery for intracranial meningiomas: A systematic review and meta-analysis

BACKGROUND Radiosurgery(RS), both in single and multiple sessions, have been performed for intracranial meningiomas. Different aspects are still controversial on this field. The aim of this systematic review is to summarize the current literature on long-term efficacy and safety of RS for meningiomas. METHODS Online databases were searched for studies published until April 2015. The primary outcomes were disease control and progression-free-survival(PFS). The secondary outcomes were symptom control and radiation-induced toxicity. RESULTS The estimate of disease control rate ranged from 87.0% to 100.0% at 5 years and from 67.0% to 100.0% at 10 years. The PFS rate ranged 78.0%-98.9% and 53.1%-97.2% at 5 and 10 years, respectively. The overall symptom control was 92.3%, the overall toxicity was 8.1%. CONCLUSIONS RS can be considered a safe and effective treatment. Efforts are needed in standardizing the definition of local and symptom control and toxicity in order to properly compare different treatment schedules.

Reply to S. Mercadante et al

Reply to a commentary submitted to Journal of Clinical Oncology by S. Mercadante et al. URI: http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2015.61.3190 [1] Authors: GRECO Maria Teresa ROBERTO Anna CORLI Oscar DEANDREA Silvia BANDIERI Elena CAVUTO Silvio APOLONE Giovanni Publication Year: 2015 Type: Articles in Journals Publisher: AMER SOC CLINICAL ONCOLOGY ISSN: 0732-183X DOI: 10.1200/JCO.2015.61.3190 [2] Citation: JOURNAL OF CLINICAL ONCOLOGY p. 2119-2120 no. 18 vol. 33 Source URL: https://ec.europa.eu/jrc/en/publication/articles-journals/reply-s-mercadante-et-al Links [1] http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2015.61.3190 [2] http://dx.doi.org/10.1200/JCO.2015.61.3190

Pain management and outcomes in cancer patients: comparison between oncological and palliative sets of care

Background: medical oncologists and palliative care physicians have different tasks even if they play a similar role when coping with pain of their patients. In spite of this converging goal, oncologists and palliative care therapists can not have the same approach and impact in managing pain. This study analyzes how pain is treated and which outcomes derive from in 1 461 cancer patients separately cared by oncologists or palliative care physicians. Methods: data derive from an observational, multicentre, prospective, longitudinal study carried out in 110 Italian hospitals. After inclusion, the data were recorded weekly for a 28 days period of follow-up. Results: 876 patients (60%) were cared by oncologists and 585 (40%) by palliative care physicians. The two professional categories tended to similarly manage the drugs of WHO analgesic ladder, while rescue and adjuvant therapies were more frequently used by palliative care physicians. Opioids daily dose increased from 68.3 to 92.5 mg/day (Effect size=0.282) among oncologists and from 70.8 to 107.8 mg/day (Effect size=0.402) among palliative care physicians. The switch of opioids was applied in 12.3% and in 19.1% (p=0.1634), respectively. Pain intensity decreased in both groups but more strongly in the palliative context. The full responders patients were 50% in oncology wards and 58.9% in palliative care (p=0.0588). Conclusions: this study indicates how much oncologists and palliative care physicians differ in managing cancer pain. The observational nature of this study reflects the natural and unaffected choice of the professionals. As intrinsic limit the study only describes their behaviors without a stringent comparative evaluation.

Working together to improve the credibility and transparency of clinical research

Jones and colleagues’ article is important for the scientific community as well as consumers and patients.1 For patients who give their informed consent to enter a randomised clinical trial it is difficult to accept that a large proportion (29%) of clinical trial results are not published and will not be available for clinical practice and further research. All …

Is Shifting to a Progestin Worthwhile When Estrogen-Progestins Are Inefficacious for Endometriosis-Associated Pain?

The purpose of this study was to assess the proportion of patients satisfied with their treatment after a change from a low-dose oral contraceptive (OC) to norethisterone acetate (NETA) because of inefficacy of OC on pain symptoms. To this end, prospective, self-controlled study was conducted on 153 women using OC as a treatment for endometriosis and with persistence of one or more moderate or severe pain symptoms. At baseline and during 12 months after a shift from OC to oral NETA, 2.5 mg/d, pelvic pain was measured by means of a 0- to 10-point numerical rating scale and a multidimensional categorical rating scale. Variations in health-related quality of life, psychological status, and sexual function were also evaluated with validated scales. At the end of the study period, participants indicated the degree of satisfaction with their treatment according to a 5-degree scale from very satisfied to very dissatisfied. A total of 28 women dropped out of the study, the main reason was intolerable side effects (n = 15). At 12-month assessment, 70% of participants were very satisfied or satisfied with NETA treatment (intention-to-treat analysis). Statistically significant improvements were observed in health-related quality of life, psychological status, and sexual function. At per-protocol analysis, almost half of the patients (58/125) reported suboptimal drug tolerability. However, complaints were not severe enough to cause dissatisfaction, drug discontinuation, or request for surgery. These encouraging results could be used to counsel women with symptomatic endometriosis not responding to OC and to inform their decisions on modifications of disease management.

Nonresponsiveness and Susceptibility of Opioid Side Effects Related to Cancer Patients’ Clinical Characteristics: A Post-Hoc Analysis

The response to opioids is not always positive in cancer patients. A considerable proportion of patients do not respond (nonresponders [NRs]) or experience severe toxicity. The aim of this analysis was to assess the role of demographic characteristics, pain features, comorbidities, and ongoing therapy on the lack of efficacy and on the occurrence of severe adverse drug reactions (ADRs).