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2. Lack of Efficacy: When Opioids Do Not Achieve Analgesia from the Beginning of Treatment in Cancer Patients

Author

Corli O, Damia G, Galli F, Verrastro C, and Broggini M

Subjects
opioids, lack of analgesia, cancer pain, non-responders, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Oscar Corli,1 Giovanna Damia,2 Francesca Galli,3 Carmen Verrastro,4 Massimo Broggini2 1Unit of Pain and Palliative Care Research, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy; 2Laboratory of Molecular Pharmacology, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy; 3Laboratory of Methodology for Clinical Research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy; 4Day Hospital of Rheumatology, ASST Gaetano Pini CTO, Milan, ItalyCorrespondence: Oscar CorliUnit of Pain and Palliative Care Research, Laboratory of Methodology for Clinical Research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via G. La Masa 19, Milan 20156, ItalyTel +39 02390141Fax +39 023546277Email oscar.corli@marionegri.itIntroduction: Opioids are often used to relieve moderate to severe pain, but their analgesic response may vary. We focused on the absolute lack of analgesic response immediately after beginning opioid treatment, quantifying the proportion of patients with unchanged or worse pain on day 3 (defined as early non-responders (ENRs)) and day 7.Methods: This is a post-hoc analysis from a randomized controlled trial involving 498 cancer patients with pain, starting to receive WHO step III opioids. On days 1, 3 and 7 pain intensity (PI) was measured.Results: On day 3, 68 (13.7%) patients were ENRs, 53 no change and 15 greater PI compared to baseline. The relationships between pain and clinical characteristics showed no significant differences between ENRs and Early responders (ERs), except for PI at baseline, which was significantly lower in ENRs. ENRs on day 3 were re-assessed on day 7 to explore the patterns of analgesic response: 31.7% of patients remained NRs, 48.3% had become responders, and 20.0% were poor responders. Adverse drug reactions were similar in ERs and ENRs at each visit.Discussion: The complete lack of early response to opioids in cancer patients is clinically important and more frequent than expected. Better definition of the mechanism will allow better pain management in cancer and non-cancer patients.Keywords: opioids, lack of analgesia, cancer pain, non-responders

Published
2019

4. A comparison between the administration of oral prolonged-release oxycodone-naloxone and transdermal fentanyl in patients with moderate-to-severe cancer pain: a propensity score analysis

Author

Roberto A, Greco MT, Legramandi L, Galli F, Galli M, and Corli O

Subjects
cancer pain, oxycodone-naloxone, transdermal fentanyl, propensity score, analgesic efficacy, constipation., Medicine (General), R5-920
Abstract

A Roberto,1 MT Greco,2 L Legramandi,3 F Galli,3 M Galli,4 O Corli1 1Pain and Palliative Care Research Unit, Oncology Department, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy, 2Department of Clinical Sciences and Community, University of Milan, Milan, Italy, 3Methodology for Clinical Research Laboratory, Oncology Department, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy, 4Scientific Medical Communication srl, Novara, Italy Background: Opioids are the most important pharmacological treatment for moderate-to-severe cancer pain, but side effects limit their use. Transdermal fentanyl (TDF) and oral prolonged-release oxycodone-naloxone (OXN-PR) are effective in controlling chronic pain, with less constipation compared to other opioids. However, TDF and OXN-PR have never been directly compared.Patients and methods: Cancer patients with moderate-to-severe chronic pain were consecutively enrolled in two prospective 28-day trials, received either TDF or OXN-PR, and were assessed at baseline and after 7, 14, 21, and 28 days. The primary endpoint was 28-day analgesic response rate (average pain intensity decrease ≥30% from baseline). Other outcome measures included opioid daily dose changes over time; need for adjuvant analgesics; number of switches; premature discontinuation; presence and severity of constipation; and other adverse drug reactions. To compare the efficacy and the safety of TDF and OXN-PR, we used the propensity score analysis to adjust for heterogeneity between the two patient groups.Results: Three hundred ten out of 336 patients originally treated (119 TDF and 191 OXN-PR) were included in the comparative analysis. The amount of responders was comparable after TDF (75.3%) and OXN-PR administration (82.9%, not significant [NS]). The final opioid daily dose expressed as morphine equivalent was 113.6 mg for TDF and 44.5 mg for OXN-PR (p5% was less common after OXN-PR (19.3%) than after TDS administration (37.9%, p

Published
2017

5. Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV ‘real life’ trial on the variability of response to opioids

Author

Monfredo, M., Mistretta, R., di Salemi, P.O., Zecca, E., Cartoni, C., Brunetti, G.A., Tassinari, D., Drudi, F., Rizzi, F., Pizzuto, M., Formaglio, F., Luzi, M., Narducci, F., Boscolo, G., Mangiapia, M., Artioli, F., Lazzari, M., Dauri, M., Diodati, M., Cupaiolo, A., Mameli, S., Preti, P., Ferrari, P., Vasini, G., Roy, M.T., Piva, L., Nardi, L.F., Montanari, L., Reina, V., Fusco, F., Orsi, L., Molinari, E., Corli, O., Floriani, I., Roberto, A., Montanari, M., Galli, F., Greco, M.T., Caraceni, A., Kaasa, S., Dragani, T.A., Azzarello, G., Luzzani, M., Cavanna, L., Bandieri, E., Gamucci, T., Lipari, G., Di Gregorio, R., Valenti, D., Reale, C., Pavesi, L., Iorno, V., Crispino, C., Pacchioni, M., and Apolone, G.

Published
2016
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6. 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

Author

Guerriero F, Roberto A, Greco MT, Sgarlata C, Rollone M, and Corli O

Subjects
Oxycodone/Naloxone, geriatric, chronic non-cancer pain, constipation., Therapeutics. Pharmacology, RM1-950
Abstract

Fabio Guerriero,1,2 Anna Roberto,3 Maria Teresa Greco,4 Carmelo Sgarlata,1 Marco Rollone,2 Oscar Corli3 1Department of Internal Medicine and Medical Therapy, Section of Geriatrics, University of Pavia, 2Department of Geriatrics, Agency for Elderly People of Pavia, Santa Margherita Institute, Pavia, 3Department of Oncology, Pain and Palliative Care Research Unit, IRCCS-Mario Negri Institute for Pharmacological Research, 4Unit of Medical Statistics, Biometry and Epidemiology GA Maccacaro, Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy 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

Published
2016

7. Efficacy and tolerability of oral oxycodone and oxycodone/naloxone combination in opioid-naïve cancer patients: a propensity analysis

Author

Lazzari M, Greco MT, Marcassa C, Finocchi S, Caldarulo C, and Corli O

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Marzia Lazzari,1 Maria Teresa Greco,2,3 Claudio Marcassa,4 Simona Finocchi,1 Clarissa Caldarulo,1 Oscar Corli2 1Emergency Care, Critical Care Medicine, Pain Medicine and Anesthesiology Department, Tor Vergata Polyclinic, University of Rome, Rome, 2Oncology Department, Pain and Palliative Care Research Unit, Mario Negri IRCCS, 3Department of Clinical Sciences and Community, University of Milan, Milan, 4Cardiology, Fondazione Maugeri IRCCS Veruno, Novara, Italy Background: World Health Organization step III opioids are required to relieve moderate-to-severe cancer pain; constipation is one of the most frequent opioid-induced side effects. A fixed combination, prolonged-release oxycodone/naloxone (OXN), was developed with the aim of reducing opioid-related gastrointestinal side effects. The objective of this study was to compare the efficacy and safety of prolonged-release oxycodone (OXY) alone to OXN in opioid-naïve cancer patients with moderate-to-severe pain. Methods: Propensity analysis was utilized in this observational study, which evaluated the efficacy, safety, and quality of life. Results: Out of the 210 patients recruited, 146 were matched using propensity scores and included in the comparative analysis. In both groups, pain intensity decreased by ≈3 points after 60 days, indicating comparable analgesic efficacy. Responder rates were similar between groups. Analgesia was achieved and maintained with similarly low and stable dosages over time (12.0–20.4 mg/d for OXY and 11.5–22.0 mg/d for OXN). Bowel Function Index (BFI) and laxative use per week improved from baseline at 30 days and 60 days in OXN recipients (-16, P

Published
2015

8. Impact of palliative care in evaluating and relieving symptoms in patients with advanced cancer. Results from the demetra study

Author

Corli, O, Pellegrini, G, Bosetti, C, Riva, L, Crippa, M, Amodio, E, Scaccabarozzi, G, Corli O., Pellegrini G., Bosetti C., Riva L., Crippa M., Amodio E., Scaccabarozzi G., Corli, O, Pellegrini, G, Bosetti, C, Riva, L, Crippa, M, Amodio, E, Scaccabarozzi, G, Corli O., Pellegrini G., Bosetti C., Riva L., Crippa M., Amodio E., and Scaccabarozzi G.

Abstract

Background: Cancer patients experience multiple symptoms throughout the course of the disease. We aimed to provide a comprehensive analysis of the symptom burden in patients with advanced cancer at admission to specialist palliative care (PC) services and seven days later to estimate the immediate impact of PC intervention. Patient and methods: The analysis was based on an observational, prospective, multicenter study (named DEMETRA) conducted in Italy on new patients accessing network specialist PC centers during the period May 2017–November 2017. The prevalence and intensity of symptoms were assessed at baseline and after seven days using three tools including the Edmonton Symptom Assessment System (ESAS). Results: Five PC centers recruited 865 cancer patients. Thirty-three different symptoms were observed at the baseline, the most frequent being asthenia (84.9%) and poor well-being (71%). The intensity of the most frequent symptoms according to ESAS ranged from 5.5 for asthenia to 3.9 for nausea. The presence and intensity of physical symptoms increased with increasing levels of anxiety and depression. After seven days, prevalence of nausea and breathlessness as well as intensity of almost all symptoms significantly decreased. Conclusions: The study confirmed the considerable symptom burden of patients with advanced cancer. PC intervention has significantly reduced the severity of symptoms, despite the patients’ advanced disease and short survival.

Published
2020

9. Clinical care conditions and needs of palliative care patients from five italian regions: Preliminary data of the demetra project

Author

Scaccabarozzi, G, Amodio, E, Riva, L, Corli, O, Maltoni, M, Di Silvestre, G, Turriziani, A, Morino, P, Pellegrini, G, Crippa, M, Scaccabarozzi G., Amodio E., Riva L., Corli O., Maltoni M., Di Silvestre G., Turriziani A., Morino P., Pellegrini G., Crippa M., Scaccabarozzi, G, Amodio, E, Riva, L, Corli, O, Maltoni, M, Di Silvestre, G, Turriziani, A, Morino, P, Pellegrini, G, Crippa, M, Scaccabarozzi G., Amodio E., Riva L., Corli O., Maltoni M., Di Silvestre G., Turriziani A., Morino P., Pellegrini G., and Crippa M.

Abstract

In order to plan the right palliative care for patients and their families, it is essential to have detailed information about patients’ needs. To gain insight into these needs, we analyzed five Italian local palliative care networks and assessed the clinical care conditions of patients facing the complexities of advanced and chronic disease. A longitudinal, observational, noninterventional study was carried out in five Italian regions from May 2017 to November 2018. Patients who accessed the palliative care networks were monitored for 12 months. Sociodemographic, clinical, and symptom information was collected with several tools, including the Necesidades Paliativas CCOMS-ICO (NECPAL) tool, the Edmonton Symptom Assessment System (ESAS), and interRAI Palliative Care (interRAI-PC). There were 1013 patients in the study. The majority (51.7%) were recruited at home palliative care units. Cancer was the most frequent diagnosis (85.4%), and most patients had at least one comorbidity (58.8%). Cancer patients reported emotional stress with severe symptoms (38.7% vs. 24.3% in noncancer patients; p = 0.001) and were less likely to have clinical frailty (13.3% vs. 43.9%; p < 0.001). Our study confirms that many patients face the last few months of life with comorbidities or extreme frailty. This study contributes to increasing the general knowledge on palliative care needs in a high-income country.

Published
2020

10. Identification of genetic polymorphisms modulating nausea and vomiting in two series of opioid-treated cancer patients

Author

Colombo, F, Pintarelli, G, Galvan, A, Noci, S, Corli, O, Skorpen, F, Klepstad, P, Kaasa, S, Pigni, A, Brunelli, C, Roberto, A, Piazza, R, Pirola, A, Gambacorti Passerini, C, Caraceni, A, Colombo F., Pintarelli G., Galvan A., Noci S., Corli O., Skorpen F., Klepstad P., Kaasa S., Pigni A., Brunelli C., Roberto A., Piazza R., Pirola A., Gambacorti Passerini C., Caraceni A. T., Colombo, F, Pintarelli, G, Galvan, A, Noci, S, Corli, O, Skorpen, F, Klepstad, P, Kaasa, S, Pigni, A, Brunelli, C, Roberto, A, Piazza, R, Pirola, A, Gambacorti Passerini, C, Caraceni, A, Colombo F., Pintarelli G., Galvan A., Noci S., Corli O., Skorpen F., Klepstad P., Kaasa S., Pigni A., Brunelli C., Roberto A., Piazza R., Pirola A., Gambacorti Passerini C., and Caraceni A. T.

Abstract

Nausea and vomiting are often associated with opioid analgesia in cancer patients; however, only a subset of patients develop such side effects. Here, we tested the hypothesis that the occurrence of nausea and vomiting is modulated by the genetic background of the patients. Whole exome sequencing of DNA pools from patients with either low (n = 937) or high (n = 557) nausea and vomiting intensity, recruited in the European Pharmacogenetic Opioid Study, revealed a preliminary association of 53 polymorphisms. PCR-based genotyping of 45 of these polymorphisms in the individual patients of the same series confirmed the association for six SNPs in AIM1L, CLCC1, MUC16, PDE3A, POM121L2, and ZNF165 genes. Genotyping of the same 45 polymorphisms in 264 patients of the Italian CERP study, also treated with opioids for cancer pain, instead confirmed the association for two SNPs in ZNF568 and PDE3A genes. Only one SNP, rs12305038 in PDE3A, was confirmed in both series, although with opposite effects of the minor allele on the investigated phenotype. Overall, our findings suggest that genetic factors are indeed associated with nausea and vomiting in opioid-treated cancer patients, but the role of individual polymorphisms may be weak.

Published
2020

12. Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV ‘real life’ trial on the variability of response to opioids

Author

Corli, O., Floriani, I., Roberto, A., Montanari, M., Galli, F., Greco, M. T., Caraceni, A., Kaasa, S., Dragani, T. A., Azzarello, G., Luzzani, M., Cavanna, L., Bandieri, E., Gamucci, T., Lipari, G., Di Gregorio, R., Valenti, D., Reale, C., Pavesi, L., Iorno, V., Crispino, C., Pacchioni, M., Apolone, G., Monfredo, M., Mistretta, R., di Salemi, P.O., Zecca, E., Cartoni, C., Brunetti, G.A., Tassinari, D., Drudi, F., Rizzi, F., Pizzuto, M., Formaglio, F., Luzi, M., Narducci, F., Boscolo, G., Mangiapia, M., Artioli, F., Lazzari, M., Dauri, M., Diodati, M., Cupaiolo, A., Mameli, S., Preti, P., Ferrari, P., Vasini, G., Roy, M.T., Piva, L., Nardi, L.F., Montanari, L., Reina, V., Fusco, F., Orsi, L., and Molinari, E.

Published
2016
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14. Pain and Frailty in Hospitalized Older Adults

Author

Ardoino, I, Franchi, C, Nobili, A, Mannucci, P, Corli, O, Bellelli, G, Ardoino, Ilaria, Franchi, Carlotta, Nobili, Alessandro, Mannucci, Pier Mannuccio, Corli, Oscar, Bellelli, Giuseppe, Ardoino, I, Franchi, C, Nobili, A, Mannucci, P, Corli, O, Bellelli, G, Ardoino, Ilaria, Franchi, Carlotta, Nobili, Alessandro, Mannucci, Pier Mannuccio, Corli, Oscar, and Bellelli, Giuseppe

Abstract

Introduction Pain and frailty are prevalent conditions in the older population. Many chronic diseases are likely involved in their origin, and both have a negative impact on quality of life. However, few studies have analysed their association. Methods In light of this knowledge gap, 3577 acutely hospitalized patients 65 years or older enrolled in the REPOSI register, an Italian network of internal medicine and geriatric hospital wards, were assessed to calculate the frailty index (FI). The impact of pain and some of its characteristics on the degree of frailty was evaluated using an ordinal logistic regression model after adjusting for age and gender. Results The prevalence of pain was 24.7%, and among patients with pain, 42.9% was regarded as chronic pain. Chronic pain was associated with severe frailty (OR = 1.69, 95% CI 1.38-2.07). Somatic pain (OR = 1.59, 95% CI 1.23-2.07) and widespread pain (OR = 1.60, 95% CI 0.93-2.78) were associated with frailty. Osteoarthritis was the most common cause of chronic pain, diagnosed in 157 patients (33.5%). Polymyalgia, rheumatoid arthritis and other musculoskeletal diseases causing chronic pain were associated with a lower degree of frailty than osteoarthritis (OR = 0.49, 95%CI 0.28-0.85). Conclusions Chronic and somatic pain negatively affect the degree of frailty. The duration and type of pain, as well as the underlying diseases associated with chronic pain, should be evaluated to improve the hospital management of frail older people.

Published
2020

20. Oral Prolonged-Release Oxycodone-Naloxone: Analgesic Response, Safety Profile, and Factors Influencing the Response in Patients With Advanced Cancer

Author

Corli, O, Iorno, V, Legramandi, L, Rulli, E, Roberto, A, Azzarello, G, Schiavon, S, Cavanna, L, De Santis, S, Cartoni, C, Di Marco, P, Dauri, M, Mistretta, R, Bortolussi, R, Clerico, M, Pacchioni, M, Crispino, C, Marabese, M, Corsi, N, Natoli, S, Lipari, G, Luzi, M, Palumbo, G, and Trentin, L

Subjects
patients with cancer, Constipation, Analgesic, Irritability, Settore MED/06, 03 medical and health sciences, 0302 clinical medicine, 030202 anesthesiology, oxycodone-naloxone, Medicine, factors influencing the response, Adverse effect, Oxycodone/naloxone, business.industry, Cancer, analgesia, constipation, medicine.disease, Safety profile, Anesthesiology and Pain Medicine, Anesthesia, Settore MED/41, medicine.symptom, business, Cancer pain, 030217 neurology & neurosurgery
Abstract

Background Oxycodone-Naloxone (OXN) aims to reduce opioid-related constipation while being successfully analgesic. Methods We evaluated the analgesic response, prevalence, and severity of side effects in 176 cancer patients with moderate to severe pain and treated with OXN. Patients were followed for 28 days and evaluated every seven. Pain intensity, changes of therapy, and adverse drug reactions were recorded at each visit. The primary efficacy endpoint was the proportion of responders (≥30% reduction of pain intensity from baseline to final) and final average pain score ≤4 on a 0-10 scale. Results Average and worst pain intensity, and breakthrough pain (BTP) prevalence decreased over time and 81.3% of patients were responders. The starting daily dose of OXN was raised from 25.1±13.0 mg to 44.1±29.9 mg, and dose escalation >5%/day was observed in 19.4% of patients; 40.8-46.2% and 11.0-17.0% experienced any and severe grade of constipation during the follow-up visit, respectively. Digestive system tumor, thyroid endocrinopathies, psychological irritability, and BTP increased the risk of analgesic non-response. Conclusions OXN had strong analgesic effect in moderate to severe cancer pain patients: the safety profile is in line with the common adverse effects of opioids and severe constipation was uncommon. This article is protected by copyright. All rights reserved.

Published
2019

21. Oral prolonged-release Oxycodone-Naloxone: analgesic response, safety profile, and factors influencing the response in advanced cancer patients

Author

Corli, O, Iorno, V, Legramandi, L, Rulli, E, Roberto, A, Azzarello, G, Schiavon, S, Cavanna, L, De Santis, S, Cartoni, C, Di Marco, P, Dauri, M, Ristretta, R, Bortolussi, R, Clerico, M, Pacchioni, M, Crispino, C, Marabese, M, and Corsi, Nagc

Subjects
Oxycodone-Naloxone, analgesia, cancer patients, constipation, factors influencing the response, Settore MED/41 - Anestesiologia
Published
2019

23. The stigma of low opioid prescription in the hospitalized multimorbid elderly in Italy

Author

Marengoni, A, Nobili, A, Corli, O, Djade, Cd, Bertoni, D, Tettamanti, M, Pasina, L, Corrao, S, Salerno, F, Marcucci, M, Mannucci, Pm, Mannucci, M, Franchi, C, Negri, M, Sparacio, E, Alborghetti, S, Di Costanzo, R, Prisco, D, Silvestri, E, Cenci, C, Delitala, G, Carta, S, Atzori, S, Spalluti, A, Serra, Mg, Bleve, Ma, Panico, C, Vanoli, M, Gasbarrone, L, Maniscalco, G, Gunelli, M, Tirotta, D, Brucato, A, Ghidoni, S, Bernardi, M, Bassi, Sl, Santi, L, Agnelli, G, Marchesini, E, Mannarino, E, Lupattelli, G, Rondelli, P, Paciullo, F, Fabris, F, Cristina, M, Pala, M, Fabbian, F, Ruvio, M, Cappelli, S, Paolisso, G, Rizzo, Mr, Laieta, T, Salvatore, T, Carlo, F, Durante Mangoni, E, Pinto, D, Olivieri, O, Stanzial, Am, Fellin, R, Volpato, S, Fotini, S, Barbagallo, M, Dominguez, L, Plances, L, Pepe, I, Licata, G, Calvo, L, Valenti, M, Borghi, C, Strocchi, E, Rinaldi, Er, Zoli, M, Fabbri, E, Magalotti, D, Auteri, A, Pasqui, Al, Puccetti, L, Pasini, Fl, Capecchi, Pl, Bicchi, M, Sabba, C, Vella, Fs, Marseglia, A, Luglio, Cv, Palasciano, G, Modeo, Me, Aquilino, A, Raffaele, P, Pugliese, S, Capobianco, C, Murri, Ia, Postiglione, A, Barbella, Mr, De, F, Fenoglio, L, Brignone, C, Bracco, C, Giraudo, A, Musca, G, Cuccurullo, O, Cricco, L, Cappellini, Md, Fabio, G, Seghezzi, S, Fargion, S, Bulgheroni, M, Lombardi, R, Magrini, F, Peyvandi, F, Moreo, G, Ferrari, B, Roncari, L, Monzani, V, Magnini, M, Mari, D, Dionigi, P, Prolo, S, Montefiascone, S, Micale, G, Podda, M, Accordino, S, Monti, V, Corazza, Gr, Miceli, E, Lenti, Mv, Padula, D, Balduini, Cl, Quaglia, F, Murialdo, G, Bovio, M, Dallegri, F, Quercioli, A, Barreca, A, Secchi, Mb, Ghelfi, D, Balsamo, C, Chin, S, Carassale, L, Caporotundo, S, Anastasio, L, Carbone, M, Valentia, V, Traisci, G, De Feudis, L, Davı, G, Teresa, M, Sestili, S, Bergami, E, Rizzioli, E, Cagnoni, C, Bertone, L, Manucra, A, Soccorso, P, Buratti, A, Tognin, T, Liberato, Nl, Bernasconi, G, Bianchi, Gb, Giaquinto, S, Riccardo, G, Predabissi, V, Purrello, F, Di Pino, A, Cortellaro, M, Magenta, M, Perego, F, Meroni, Mr, Cicardi, M, Marina, Ag, Sacco, A, Bonelli, A, Dentamaro, G, Rozzini, R, Falanga, L, Giordano, A, Perin, Pc, Lorenzati, B, Gruden, G, Bruno, G, Montrucchio, G, Greco, E, Tizzani, P, Fera, G, Di Luca, Ml, Renna, D, Perciccante, A, Coralli, A, Tassara, R, Melis, D, Menardo, G, Ferri, C, Striuli, R, Scipioni, R, Salmi, R, Gaudenzi, P, Gamberini, S, Ricci, F, Anna, Us, Morabito, C, Fava, R, Semplicini, A, Gottardo, L, Vendemiale, G, Forlano, R, Bolondi, L, Rasciti, L, Serio, I, Masala, C, Mammarella, A, Rossi Fanelli, F, Delfino, M, Violi, F, Basili, S, Perri, L, Falcone, M, Landolfi, R, Grieco, A, Gallo, A, Gemelli, A, Franceschi, F, De Marco, G, Chiara, C, Marta, S, Bellusci, M, Setti, D, Pedrazzoli, F, Romanelli, G, Pirali, C, Amolini, C, Rosei, Ea, Rizzoni, D, Castoldi, L, Picardi, A, Gentilucci, Uv, Mazzarelli, C, Gallo, P, Guasti, Luigina, Castiglioni, Luana, Maresca, ANDREA MARIA, Squizzato, Alessandro, Contini, Sara, Molaro, Marta, Annoni, G, Corsi, M, Zazzetta, S, Gerardo, S, Bertolotti, M, Mussi, C, Scotto, R, Ferri, Ma, Veltri, F, Arturi, F, Succurro, E, Sesti, G, Gualtieri, U, Grecia, Sm, Perticone, F, Sciacqua, A, Quero, M, Bagnato, C, Loria, P, Becchi, Ma, Martucci, G, Fantuzzi, A, Maurantonio, M, Corinaldesi, R, De Giorgio, R, Serra, M, Grasso, V, Ruggeri, E, Carozza, Lm, Pignatti, F., Marengoni A, Nobili A, Corli O, Djade CD, Bertoni D, Tettamanti M, Pasina L, Corrao S, Salerno F, Marcucci M, Mannucci PM, REPOSI investigator, Bernardi M, Borghi C, Strocchi E, Zoli M, Bolondi L, Corinaldesi R, De Giorgio R., Marengoni, A, Nobili, A, Corli, O, Djignefa Djade, C, Bertoni, D, Tettamanti, M, Pasina, L, Corrao, S, Salerno, F, Marcucci, M, Mannucci, PM, Barbagallo, M, Dominguez Rodriguez, LJ, Marengoni, Alessandra, Nobili, Alessandro, Corli, Oscar, Djade, Codjo Djignefa, Bertoni, Diana, Tettamanti, Mauro, Pasina, Luca, Corrao, Salvatore, Salerno, Francesco, Marcucci, Maura, Mannucci, Pier, Mannuccio, Rizzo, Mr, Djade, C, Mannucci, P, and Annoni, G

Subjects
Registrie, Male, Poison control, Older person, Comorbidity, Practice Patterns, Drug Prescription, Older persons, Pain, Analgesic opioids, 80 and over, Registries, Practice Patterns, Physicians', Pain Measurement, Aged, 80 and over, Analgesics, Analgesic opioids, Older persons, Pain, Emergency Medicine, Internal Medicine, Analgesics, Opioid, Hospitalization, Italy, Female, Tramadol, Human, medicine.drug, medicine.medical_specialty, Attitude of Health Personnel, Analgesic, Opioid, elderly, Drug Prescriptions, Injury prevention, medicine, Humans, Medical prescription, Aged, Physicians', business.industry, Codeine, Settore MED/09 - MEDICINA INTERNA, Analgesic opioid, medicine.disease, Older persons, Pain, Analgesic, opioids, Emergency medicine, business
Abstract

The primary aim of this study was to evaluate the prevalence of opioid prescriptions in hospitalized geriatric patients. Other aims were to evaluate factors associated with opioid prescription, and whether or not there was consistency between the presence of pain and prescription. Opioid prescriptions were gathered from the REgistro POliterapie Societa` Italiana di Medicina Interna (REPOSI) data for the years 2008, 2010 and 2012. 1,380 in-patients, 65+ years old, were enrolled in the first registry run, 1,332 in the second and 1,340 in the third. The prevalence of opioid prescription was calculated at hospital admission and discharge. In the third run of the registry, the degree of pain was assessed by means of a numerical scale. The prevalence of patients prescribed with opioids at admission was 3.8 % in the first run, 3.6 % in the second and 4.1 % in the third, whereas at discharge rates were slightly higher (5.8, 5.3, and 6.6 %). The most frequently prescribed agents were mild opioids such as codeine and tramadol. The number of total prescribed drugs was positively associated with opioid prescription in the three runs; in the third, dementia and a better functional status were inversely associated with opioid prescription. Finally, as many as 58 % of patients with significant pain at discharge were prescribed no analgesic at all. The conservative attitude of Italian physicians to prescribe opioids in elderly patients changed very little between hospital admission and discharge through a period of 5 years. Reasons for such a low opioid prescription should be sought in physicians’ and patients’ concerns and prejudices.

Published
2015

24. Prevalence, characteristics and treatment of chronic pain in elderly patients hospitalized in internal medicine wards

Author

Corsi, N, Roberto, A, Cortesi, L, Nobili, A, Mannucci, Pm, Corli, O, Prisco, D, Silvestri, E, Emmi, G, Bettiol, A, Caterina, C, Biolo, G, Zanetti, M, Guadagni, M, Zaccari, M, Chiuch, M, Vanoli, M, Grignani, G, Pulixi, Ea, Bernardi, M, Bassi, Sl, Santi, L, Zaccherini, G, Lupattelli, G, Mannarino, E, Bianconi, V, Paciullo, F, Alcidi, R, Nuti, R, Valenti, R, Ruvio, M, Cappelli, S, Palazzuoli, A, Girelli, D, Busti, F, Marchi, G, Barbagallo, M, Dominguez, L, Cocita, F, Beneduce, V, Plances, L, Corrao, S, Natoli, G, Mularo, S, Raspanti, M, Cavallaro, F, Zoli, M, Lazzari, I, Brunori, M, Fabbri, E, Magalotti, D, Arno, R, Pasini, Fl, Capecchi, Pl, Palasciano, G, Modeo, Me, Di Gennaro, C, Cappellini, Md, Maira, D, Di Stefano, V, Fabio, G, Seghezzi, S, Mancarella, M, De Amicis, Mm, De Luca, G, Scaramellini, N, Cesari, M, Rossi, Pd, Damanti, S, Clerici, M, Conti, F, Bonini, G, Ottolini, Bb, Di Sabatino, A, Miceli, E, Lenti, Mv, Pisati, M, Dominioni, Cc, Murialdo, G, Marra, A, Cattaneo, F, Pontremoli, R, Beccati, V, Nobili, G, Secchi, Mb, Ghelfi, D, Anastasio, L, Sofia, L, Carbone, M, Cipollone, F, Guagnano, Mt, Valeriani, E, Rossi, I, Mancuso, G, Calipari, D, Bartone, M, Delitala, G, Berria, M, Pes, C, Delitala, A, Muscaritoli, M, Molfino, A, Petrillo, E, Zuccala, G, D'Aurizio, G, Romanelli, G, Marengoni, A, Zucchelli, A, Manzoni, F, Volpini, A, Picardi, A, Gentilucci, Uv, Gallo, P, Dell'Unto, C, Annoni, G, Corsi, M, Bellelli, G, Zazzetta, S, Mazzola, P, Szabo, H, Bonfanti, A, Arturi, F, Succurro, E, Rubino, M, Tassone, B, Sesti, G, Serra, Mg, Bleve, Ma, Gasbarrone, L, Sajeva, Mr, Brucato, A, Ghidoni, S, Fabris, F, Bertozzi, I, Bogoni, G, Rabuini, Mv, Cosi, E, Scarinzi, P, Amabile, A, Omenetto, E, Prandini, T, Manfredini, R, Fabbian, F, Boari, B, De Giorgi, A, Tiseo, R, De Giorgio, R, Paolisso, G, Rizzo, Mr, Borghi, C, Strocchi, E, Ianniello, E, Soldati, M, Sabba, C, Vella, F, Suppressa, P, Agosti, P, Schilardi, A, Loparco, F, De Vincenzo, Gm, Comitangelo, A, Amoruso, E, Fenoglio, L, Falcetta, A, Bracco, C, Fracanzani, Al, Fargion, S, Tiraboschi, S, Cespiati, A, Oberti, G, Sigon, G, Peyvandi, F, Rossio, R, Ferrari, B, Colombo, G, Monzani, V, Savojardo, V, Folli, C, Ceriani, G, Salerno, F, Pallini, G, Dallegri, F, Ottonello, L, Liberale, L, Caserza, L, Salam, K, Liberato, Nl, Tognin, T, Bianchi, Gb, Giaquinto, S, Purrello, F, Di Pino, A, Piro, S, Rozzini, R, Falanga, L, Spazzini, E, Ferrandina, C, Montrucchio, G, Petitti, P, Peasso, P, Favale, E, Poletto, C, Salmi, R, Gaudenzi, P, Violi, F, Perri, L, Landolfi, R, Montalto, M, Mirijello, A, Guasti, L, Castiglioni, L, Maresca, A, Squizzato, A, Campiotti, L, Grossi, A, Bertolotti, M, Mussi, C, Lancellotti, G, Libbra, Mv, Dondi, G, Pellegrini, E, Carulli, L, Galassi, M, Grassi, Y, Perticone, F, Perticone, M, Battaglia, R, FIlice, M, Maio, R, Stanghellini, V, Ruggeri, E, del Vecchio, S, Salvi, A, Leonardi, R, Damiani, G, Capeci, W, Gabrielli, A, Mattioli, M, Martino, Gp, Biondi, L, Pettinari, P, Ghio, R, Dal Col, A, Minisola, S, Colangelo, L, Cilli, M, Labbadia, G, Afeltra, A, Marigliano, B, Pipita, Me, Castellino, P, Zanoli, L, Pignataro, S, Gennaro, A, Blanco, J, Saracco, V, Fogliati, M, Bussolino, C, Mete, F, Gino, M, Cittadini, A, Vigorito, C, Arcopinto, M, Salzano, A, Bobbio, E, Marra, Am, Sirico, D, Moreo, G, Gasparini, F, Prolo, S, Pina, G, Ballestrero, A, Ferrando, F, Berra, S, Dassi, S, Nava, Mc, Graziella, B, Baldassarre, S, Fragapani, S, Gruden, G, Galanti, G, Mascherini, G, Petri, C, Stefani, L, Girino, M, Piccinelli, V, Nasso, F, Gioffre, V, Pasquale, M, Scattolin, G, Martinelli, S, Turrin, M, Sechi, L, Catena, C, Colussi, G, Passariello, N, Rinaldi, L, Berti, F, Famularo, G, Tarsitani, P, Castello, R, Pasino, M, Ceda, Gp, Maggio, Mg, Morganti, S, Artoni, A, Del Giacco, S, Firinu, D, Losa, F, Paoletti, G, Costanzo, G, Montalto, G, Licata, A, Malerba, V, Montalto, Fa, Lasco, A, Basile, G, Catalano, A, Malatino, L, Stancanelli, B, Terranova, V, Di Marca, S, Di Quattro, R, La Malfa, L, Caruso, R, Mecocci, P, Ruggiero, C, Boccardi, V, Meschi, T, Lauretani, F, Ticinesi, A, Nouvenne, A, Minuz, P, Fondrieschi, L, Pirisi, M, Fra, Gp, Sola, D, Porta, M, Riva, P, Quadri, R, Larovere, E, Novelli, M, Scanzi, G, Mengoli, C, Provini, S, Ricevuti, L, Simeone, E, Scurti, R, Tolloso, F, Tarquini, R, Valoriani, A, Dolenti, S, Vannini, G, Tedeschi, A, Trotta, L, Volpi, R, Bocchi, P, Vignali, A, Harari, S, Lonati, C, Cattaneo, M, Nieves, Rd, Alberto, Mm, Pedro, Ar, Vanessa, Lp, Lara, T, Xavier, Cv, Francesc, F, Jesus, Dm, Esperanza, Bt, Esther, Dcb, Maria, Sp, Romero, M, Blanca, Pl, Cristina, Lgc, Victoria, Vgm, Saez, L, Bosco, J, Susana, Sb, Marta, Ag, Concepcion, Gb, Antonio, Fm, Hernandez, Mg, Borrego, Mp, Raquel, Pc, Florencia, Pr, Beatriz, Go, Sara, Cg, Alfonso, Gcc, Marta, Pm, Alberto, Rc, Antonio, Aa, Montserrat, Gg, Angel, Brm, Manuel, Mj, Ignacio, Nv, Lucia, A, Alfonso, L, David, Rb, Iniguez, Vi, Monica, Rp, Landolfi, R (ORCID:0000-0002-7913-8576), Montalto, M (ORCID:0000-0001-8819-3684), Corsi, N, Roberto, A, Cortesi, L, Nobili, A, Mannucci, Pm, Corli, O, Prisco, D, Silvestri, E, Emmi, G, Bettiol, A, Caterina, C, Biolo, G, Zanetti, M, Guadagni, M, Zaccari, M, Chiuch, M, Vanoli, M, Grignani, G, Pulixi, Ea, Bernardi, M, Bassi, Sl, Santi, L, Zaccherini, G, Lupattelli, G, Mannarino, E, Bianconi, V, Paciullo, F, Alcidi, R, Nuti, R, Valenti, R, Ruvio, M, Cappelli, S, Palazzuoli, A, Girelli, D, Busti, F, Marchi, G, Barbagallo, M, Dominguez, L, Cocita, F, Beneduce, V, Plances, L, Corrao, S, Natoli, G, Mularo, S, Raspanti, M, Cavallaro, F, Zoli, M, Lazzari, I, Brunori, M, Fabbri, E, Magalotti, D, Arno, R, Pasini, Fl, Capecchi, Pl, Palasciano, G, Modeo, Me, Di Gennaro, C, Cappellini, Md, Maira, D, Di Stefano, V, Fabio, G, Seghezzi, S, Mancarella, M, De Amicis, Mm, De Luca, G, Scaramellini, N, Cesari, M, Rossi, Pd, Damanti, S, Clerici, M, Conti, F, Bonini, G, Ottolini, Bb, Di Sabatino, A, Miceli, E, Lenti, Mv, Pisati, M, Dominioni, Cc, Murialdo, G, Marra, A, Cattaneo, F, Pontremoli, R, Beccati, V, Nobili, G, Secchi, Mb, Ghelfi, D, Anastasio, L, Sofia, L, Carbone, M, Cipollone, F, Guagnano, Mt, Valeriani, E, Rossi, I, Mancuso, G, Calipari, D, Bartone, M, Delitala, G, Berria, M, Pes, C, Delitala, A, Muscaritoli, M, Molfino, A, Petrillo, E, Zuccala, G, D'Aurizio, G, Romanelli, G, Marengoni, A, Zucchelli, A, Manzoni, F, Volpini, A, Picardi, A, Gentilucci, Uv, Gallo, P, Dell'Unto, C, Annoni, G, Corsi, M, Bellelli, G, Zazzetta, S, Mazzola, P, Szabo, H, Bonfanti, A, Arturi, F, Succurro, E, Rubino, M, Tassone, B, Sesti, G, Serra, Mg, Bleve, Ma, Gasbarrone, L, Sajeva, Mr, Brucato, A, Ghidoni, S, Fabris, F, Bertozzi, I, Bogoni, G, Rabuini, Mv, Cosi, E, Scarinzi, P, Amabile, A, Omenetto, E, Prandini, T, Manfredini, R, Fabbian, F, Boari, B, De Giorgi, A, Tiseo, R, De Giorgio, R, Paolisso, G, Rizzo, Mr, Borghi, C, Strocchi, E, Ianniello, E, Soldati, M, Sabba, C, Vella, F, Suppressa, P, Agosti, P, Schilardi, A, Loparco, F, De Vincenzo, Gm, Comitangelo, A, Amoruso, E, Fenoglio, L, Falcetta, A, Bracco, C, Fracanzani, Al, Fargion, S, Tiraboschi, S, Cespiati, A, Oberti, G, Sigon, G, Peyvandi, F, Rossio, R, Ferrari, B, Colombo, G, Monzani, V, Savojardo, V, Folli, C, Ceriani, G, Salerno, F, Pallini, G, Dallegri, F, Ottonello, L, Liberale, L, Caserza, L, Salam, K, Liberato, Nl, Tognin, T, Bianchi, Gb, Giaquinto, S, Purrello, F, Di Pino, A, Piro, S, Rozzini, R, Falanga, L, Spazzini, E, Ferrandina, C, Montrucchio, G, Petitti, P, Peasso, P, Favale, E, Poletto, C, Salmi, R, Gaudenzi, P, Violi, F, Perri, L, Landolfi, R, Montalto, M, Mirijello, A, Guasti, L, Castiglioni, L, Maresca, A, Squizzato, A, Campiotti, L, Grossi, A, Bertolotti, M, Mussi, C, Lancellotti, G, Libbra, Mv, Dondi, G, Pellegrini, E, Carulli, L, Galassi, M, Grassi, Y, Perticone, F, Perticone, M, Battaglia, R, FIlice, M, Maio, R, Stanghellini, V, Ruggeri, E, del Vecchio, S, Salvi, A, Leonardi, R, Damiani, G, Capeci, W, Gabrielli, A, Mattioli, M, Martino, Gp, Biondi, L, Pettinari, P, Ghio, R, Dal Col, A, Minisola, S, Colangelo, L, Cilli, M, Labbadia, G, Afeltra, A, Marigliano, B, Pipita, Me, Castellino, P, Zanoli, L, Pignataro, S, Gennaro, A, Blanco, J, Saracco, V, Fogliati, M, Bussolino, C, Mete, F, Gino, M, Cittadini, A, Vigorito, C, Arcopinto, M, Salzano, A, Bobbio, E, Marra, Am, Sirico, D, Moreo, G, Gasparini, F, Prolo, S, Pina, G, Ballestrero, A, Ferrando, F, Berra, S, Dassi, S, Nava, Mc, Graziella, B, Baldassarre, S, Fragapani, S, Gruden, G, Galanti, G, Mascherini, G, Petri, C, Stefani, L, Girino, M, Piccinelli, V, Nasso, F, Gioffre, V, Pasquale, M, Scattolin, G, Martinelli, S, Turrin, M, Sechi, L, Catena, C, Colussi, G, Passariello, N, Rinaldi, L, Berti, F, Famularo, G, Tarsitani, P, Castello, R, Pasino, M, Ceda, Gp, Maggio, Mg, Morganti, S, Artoni, A, Del Giacco, S, Firinu, D, Losa, F, Paoletti, G, Costanzo, G, Montalto, G, Licata, A, Malerba, V, Montalto, Fa, Lasco, A, Basile, G, Catalano, A, Malatino, L, Stancanelli, B, Terranova, V, Di Marca, S, Di Quattro, R, La Malfa, L, Caruso, R, Mecocci, P, Ruggiero, C, Boccardi, V, Meschi, T, Lauretani, F, Ticinesi, A, Nouvenne, A, Minuz, P, Fondrieschi, L, Pirisi, M, Fra, Gp, Sola, D, Porta, M, Riva, P, Quadri, R, Larovere, E, Novelli, M, Scanzi, G, Mengoli, C, Provini, S, Ricevuti, L, Simeone, E, Scurti, R, Tolloso, F, Tarquini, R, Valoriani, A, Dolenti, S, Vannini, G, Tedeschi, A, Trotta, L, Volpi, R, Bocchi, P, Vignali, A, Harari, S, Lonati, C, Cattaneo, M, Nieves, Rd, Alberto, Mm, Pedro, Ar, Vanessa, Lp, Lara, T, Xavier, Cv, Francesc, F, Jesus, Dm, Esperanza, Bt, Esther, Dcb, Maria, Sp, Romero, M, Blanca, Pl, Cristina, Lgc, Victoria, Vgm, Saez, L, Bosco, J, Susana, Sb, Marta, Ag, Concepcion, Gb, Antonio, Fm, Hernandez, Mg, Borrego, Mp, Raquel, Pc, Florencia, Pr, Beatriz, Go, Sara, Cg, Alfonso, Gcc, Marta, Pm, Alberto, Rc, Antonio, Aa, Montserrat, Gg, Angel, Brm, Manuel, Mj, Ignacio, Nv, Lucia, A, Alfonso, L, David, Rb, Iniguez, Vi, Monica, Rp, Landolfi, R (ORCID:0000-0002-7913-8576), and Montalto, M (ORCID:0000-0001-8819-3684)

Abstract

Background: Chronic pain is a frequent characteristic of elderly people and represents an actual and still poorly debated topic.Objective: We investigated pain prevalence and intensity, and its pharmacological therapy in elderly patients hospitalized in 101 internal medicine wards.Methods: Taking advantage of the "REgistro POliterapie Societa Italiana Medicina Interna" (REPOSI), we collected 2535 patients of whom almost a quarter was older than 85 years old. Among them, 582 patients were affected by pain (either chronic or acute) and 296 were diagnosed with chronic pain.Results: Patients with pain showed worse cognitive status, higher depression and comorbidities, and a longer duration of hospital stay compared to those without pain (all p<.0366). Patients with chronic pain revealed lower level of independency in their daily life, worse cognitive status and higher level of depression compared to acute pain patients (all p<.0156). Moreover, most of them were not treated for pain at admission (73.4%) and half of them was not treated with any analgesic drug at discharge (50.5%). This difference affected also the reported levels of pain intensity. Patients who received analgesics at both admission and discharge remained stable (p=.172). Conversely, those not treated at admission who received an analgesic treatment during the hospital stay decreased their perceived pain (p<.0001).Conclusions: Our results show the need to focus more attention on the pharmacological treatment of chronic pain, especially in hospitalized elderly patients, in order to support them and facilitate their daily life after hospital discharge.

Published
2018

31. ATREUS Trial: A Phase II Study On The Activity Of Trabectedin In Pretreated Epithelioid Or Biphasic/Sarcomatoid Malignant Pleural Mesothelioma (MPM)

Author

Hollander, L., primary, Cortinovis, D., additional, Floriani, I., additional, Grosso, F., additional, Ceresoli, G.L., additional, Zucali, P.A., additional, D'Incalci, M., additional, Tiseo, M., additional, Abbate, M.I., additional, Canova, S., additional, Ugo, F., additional, Marchini, S., additional, Allavena, P., additional, Bianchi, M., additional, Corli, O., additional, Vukcaj, S., additional, Zai, S., additional, and Bidoli, P., additional

Published
2015
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34. Effects of transdermal buprenorphine on patients-reported outcomes in cancer patients: results from the Cancer Pain Outcome Research (CPOR) Study Group

Author

Apolone, G., Corli, O., Negri, E., Mangano, S., Montanari, M., Greco, M., Cancer Pain Outcome Research Study Group (CPOR SG) Investigators, Bertetto, O., Caraceni, A., De Conno, F., Labianca, R., Maltoni, M., Nicora Maria, F., Torri, V., and Zucco, F.

Subjects
Male, medicine.medical_specialty, Settore MED/09 - Medicina Interna, Settore MED/06 - Oncologia Medica, Administration, Cutaneous, Fentanyl, Internal medicine, Neoplasms, medicine, Humans, Prospective Studies, Karnofsky Performance Status, Transdermal, Aged, Pain Measurement, business.industry, Cancer, Comparative trial, Middle Aged, medicine.disease, Buprenorphine, Pain, Intractable, Analgesics, Opioid, Anesthesiology and Pain Medicine, Treatment Outcome, Italy, Anesthesia, Female, Neurology (clinical), Transdermal Buprenorphine, business, Cancer pain, medicine.drug
Abstract

Pain still afflicts most cancer patients, mainly in the metastatic phases, and under-treatment is well documented. Transdermal delivery systems (TDS) containing fentanyl or buprenorphine could potentiality have advantages over oral and parenteral routes, but evidence from comparative trials are scanty. In the framework of a wider initiative, an Outcome Research Study was carried out in Italy in 2006 to evaluate the effects of various analgesic options, particularly buprenorphine TDS.This is a multicenter, open-label, prospective, nonrandomized study. Data were collected using a web-based standardized system, with a follow-up up of to 3 months. Pain intensity, the primary outcomes of the study, was measured using 11-point numerical rating scales from the Brief Pain Inventory.One-hundred ten centers recruited 1801 cases, most of which (60%) were receiving a strong opioid at the time of inclusion. Of these, 257 had TDS buprenorphine as first choice. Of the remaining 709 patients who at the time of inclusion were not on a strong opioid, 325 changed to a strong opioid and in 43% it was TDS buprenorphine. During the follow-up, physicians had to increase the dosage to control pain (average increase between 16% and 17%). About 34% of patients had an improvement of at least 2 points in worst pain, 15% had a 20% improvement in pain relief, and 40% in satisfaction. Results were in line with those of patients receiving other World Health Organization-level III opioids.Despite the limitations owing to the observational design, these findings may be useful to clinicians to judge the value of the drug under evaluation better and to help researchers design further comparative studies.

Published
2009

36. Expert conference on cancer pain assessment and classification, the need for international consensus: working proposals on international standards

Author

Kaasa, S, Apolone, G, Klepstad, P, Loge, JH, Hjermstad, MJ, Corli, O, Strasser, F, Heiskanen, T, Costantini, M, Zagonell, V, Grønvold, Mogens, Fainsinger, R, Jensen, MP, Farrar, JT, McQuay, H, Rothrock, N E, Cleary, J, Deguines, C, Caraceni, A, Kaasa, S, Apolone, G, Klepstad, P, Loge, JH, Hjermstad, MJ, Corli, O, Strasser, F, Heiskanen, T, Costantini, M, Zagonell, V, Grønvold, Mogens, Fainsinger, R, Jensen, MP, Farrar, JT, McQuay, H, Rothrock, N E, Cleary, J, Deguines, C, and Caraceni, A

Published
2011

40. Managing severe cancer pain: the role of transdermal buprenorphine: a systematic review

Author

Deandrea,S, Corli,O, Moschetti,I, Apolone,Giovanni, Deandrea,S, Corli,O, Moschetti,I, and Apolone,Giovanni

Abstract

S Deandrea1,2, O Corli1, I Moschetti3, G Apolone11Center for the Evaluation and Research on Pain (CERP), Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy; 2Istituto di Statistica Medica e Biometria “GA Maccacaro”, Università degli studi di Milano, Milan, Italy; 3Italian Cochrane Center, Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, ItalyAbstract: Pain is a frequent and important symptom in cancer patients. Among the available strong opioids, transdermal buprenorphine has been licensed in Europe since 2002, and results from a few clinical studies suggest that it may be a good alternative to the other oral or transdermal opioids. To assess the best available evidence on its efficacy and safety, we carried out a systematic literature review with the aim of pooling relevant studies. We identified 19 eligible papers describing 12 clinical studies (6 randomized controlled trials and 6 observational prospective studies), including a total of about 5000 cancer patients. Given the poor quality of reports and the heterogeneity of methods and outcomes, pooling was not feasible as the type of data was not appropriate for combining the results statistically. A meta-analysis based on individual data is ongoing in the context of the Cochrane Collaboration. In conclusion, although the narrative appraisal of each study suggests a positive risk benefit profile, well designed and statistically powered controlled clinical trials are needed to confirm this preliminary evidence.Keywords: systematic review, transdermal buprenorphine, cancer pain

Published
2009

45. Which variables are associated with pain intensity and treatment response in advanced cancer patients?--Implications for a future classification system for cancer pain.

Author

Knudsen AK, Brunelli C, Kaasa S, Apolone G, Corli O, Montanari M, Fainsinger R, Aass N, Fayers P, Caraceni A, Klepstad P, and European Palliative Care Research Collaborative

Abstract

BACKGROUND: This study is part of a research program to reach consensus on an international cancer pain classification system. A confirmative and explorative approach was applied to investigate which of the variables identified in the literature, by experts and patients that are associated with pain. METHODS: Data from an international, multicentre, cross-sectional study of cancer patients treated with opioids were investigated. Dependent variables were: average pain, worst pain, and pain relief (11-point Numerical Rating Scales). Forty-six independent variables were chosen based upon previous studies. Bivariate analyses identified independent variables associated with at least one of the dependent ones; 21 were included in multivariate linear regression analyses. RESULTS: Two thousand two hundred and seventy-eight patients were investigated; 52% males, mean age 62 years, mean Karnofsky Performance Status 59%, mean daily opioid oral equivalent dose 341 mg. Fifty-eight percent had breakthrough pain. Mean pain scores were: average pain 3.5, worst pain 5.3 and pain relief 74%. Variables most strongly associated with these three dependent variables were: breakthrough pain, psychological distress, sleep, and opioid dose. CONCLUSIONS: Breakthrough pain and psychological distress were confirmed as key variables of a future classification system. Candidate variables were: sleep, opioid dose, pain mechanism, use of non-opioids, pain localisation, cancer diagnosis, location of metastases, and addiction. [ABSTRACT FROM AUTHOR]

Published
2011
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47. Pattern and quality of care of cancer pain management. Results from the Cancer Pain Outcome Research Study Group.

Author

Apolone, G., Corli, O., Caraceni, A., Negri, E., Deandrea, S., Montanari, M., Greco, M. T., and Cancer Pain Outcome Research Study Group (CPOR SG) Investigators

Subjects
*CANCER pain, *CANCER patient medical care, *PUBLIC health, *MEDICAL care research, *PAIN management, *MEDICAL quality control, *RESEARCH, *PAIN, *CROSS-sectional method, *RESEARCH methodology, *MEDICAL cooperation, *EVALUATION research, *TREATMENT effectiveness, *COMPARATIVE studies, *QUALITY of life, *TUMORS, *ALGORITHMS, *DISEASE complications
Abstract

Most patients with advanced or metastatic cancer experience pain and despite several guidelines, undertreatment is well documented. A multicenter, open-label, prospective, non-randomised study was launched in Italy in 2006 to evaluate the epidemiology, patterns and quality of pain care of cancer patients. To assess the adequacy of analgesic care, we used a standardised measure, the pain management index (PMI), that compares the most potent analgesic prescribed for a patient with the reported level of the worst pain of that patient together with a selected list of clinical indicators. A total of 110 centres recruited 1801 valid cases. 61% of cases were received a WHO-level III opioid; 25.3% were classified as potentially undertreated, with wide variation (9.8-55.3%) according to the variables describing patients, centres and pattern of care. After adjustment with a multivariable logistic regression model, type of recruiting centre, receiving adjuvant therapy or not and type of patient recruited (new or already on follow-up) had a significant association with undertreatment. Non-compliance with the predefined set of clinical indicators was generally high, ranging from 41 to 76%. Despite intrinsic limitations of the PMI that may be considered as an indicator of the poor quality of cancer pain care, results suggest that the recourse to WHO third-level drugs still seems delayed in a substantial percentage of patients. This delay is probably related to several factors affecting practice in participating centres and suggests that the quality of cancer pain management in Italy deserves specific attention and interventions aimed at improving patients' outcomes. [ABSTRACT FROM AUTHOR]

Published
2009
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49. Adherence to ESMO guidelines on cancer pain management and their applicability to specialist palliative care centers: An observational, prospective, and multicenter study.

Author

Carbonara, L., Casale, G., De Marinis, M. G., Bosetti, C., Valle, A., Carinci, P., D'andrea, M. R., and Corli, O.

Subjects
*CANCER patients, *PATIENT satisfaction, *PHYSICIAN adherence, *CANCER pain, *CANCER patient care
Abstract

Introduction Aim Method Results Conclusions Pain management in late‐stage cancer patients is a complex clinical problem. The historical guidelines were from the World Health Organization (WHO). Recently, ESMO produced guidelines consistent with 52 recommendations applicable to the entire period of disease since the pain appears.To evaluate the appropriateness and applicability of ESMO guidelines (EGL) in advanced cancer patients admitted to palliative care.An observational, prospective, multicentric study conducted by specialist palliative care centers on cancer patients in the advanced stage. The 52 recommendations were divided into eight macro areas. The adherence levels were expressed as a percentage for each recommendation and have been broken down as high (>75%), medium (50%–75%), and low (<50%). In the case of not adhering to a recommendation, the comment was “not applicable” (NA) or not evaluable (NE).Four hundred seventy‐six patients were enrolled in the study. Thirty‐five recommendations were considered NA or NE, especially because their application took too long to achieve clinical results, given the condition of the patients. Some interesting opinions on the choice of drugs emerged. At the end of the study, pain dropped from 5.0 to 2.6, patients' satisfaction increased from 3.3 to 4.6, and quality of life improved from 4.4 to 5.5.Palliative physicians' adherence to EGL was medium. The main contribution of this study was to evaluate their applicability and clinical results in far‐advanced patients assisted by palliative care. The selection of useful recommendations and expert opinions can make a contribution to clinical practice. [ABSTRACT FROM AUTHOR]

Published
2024
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