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7. 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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8. A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma

Author

Rosati, G., Ambrosini, G., Barni, S., Andreoni, B., Corradini, G., Luchena, G., Daniele, B., Gaion, F., Oliverio, G., Duro, M., Martignoni, G., Pinna, N., Sozzi, P., Pancera, G., Solina, G., Pavia, G., Pignata, S., Johnson, F., Labianca, R., Apolone, G., Zaniboni, A., Monteforte, M., Negri, E., Torri, V., Mosconi, P., and Fossati, R.

Published
2016
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9. 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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28. Whose ‘wish bias’?

Author

Fossati, R., Confalonieri, C., Apolone, G., Cavuto, S., and Garattini, S.

Published
2003

39. Accreditation for excellence of cancer research institutes: recommendations from the Italian Network of Comprehensive Cancer Centers

Author

Deriu, Pl, La Pietra, L, Pierotti, M, Collazzo, R, Paradiso, A, Belardelli, F, De Paoli, P, Nigro, A, Lacalamita, R, Ferrarini, M, Pelicci, P, Roli, A, Ciliberto, G, Scala, S, Amadori, A, Chiusole, D, Musto, P, Fusco, Vincenzo, Storto, G, De Maria Marchiano, Ruggero, R, Canitano, S, Apolone, G, Ravelli, M, Mazzini, E, Amadori, D, Bernabini, M, Ancarani, V, and Lombardo, C.

Subjects
Quality Control, Cancer Research, Inservice Training, Internationality, Biomedical Research, Health Personnel, Cancer Care Facilities, accreditation, quality improvement, Government Agencies, Settore MED/04 - PATOLOGIA GENERALE, Humans, Quality of Health Care, Social Responsibility, research, Accreditation, Cancer institute, Quality improvement, Research, Clinical Competence, Critical Pathways, Italy, Research Personnel, Benchmarking, Oncology, accreditation, cancer in- stitute, quality improvement, research, cancer in- stitute
Abstract

A panel of experts from Italian Comprehensive Cancer Centers defines the recommendations for external quality control programs aimed to accreditation to excellence of these institutes. After definition of the process as a systematic, periodic evaluation performed by an external agency to verify whether a health organization possesses certain prerequisites regarding structural, organizational and operational conditions that are thought to affect health care quality, the panel reviews models internationally available and makes final recommendations on aspects considered of main interest. This position paper has been produced within a special project of the Ministry of Health of the Italian Government aimed to accredit, according to OECI model, 11 Italian cancer centers in the period 2012-2014. The Project represents the effort undertaken by this network of Comprehensive Cancer Centers to find a common denominator for the experience of all Institutes in external quality control programs. Fourteen shared "statements" are put forth, designed to offer some indications on the main aspects of this subject, based on literature evidence or expert opinions. They deal with the need for "accountability" and involvement of the entire organization, the effectiveness of self-evaluation, the temporal continuity and the educational value of the experience, the use of indicators and measurement tools, additionally for intra- and inter-organization comparison, the system of evaluation models used, the provision for specific requisites for oncology, and the opportunity for mutual exchange of evaluation experiences.

Published
2013

42. Understanding remission in real-world lupus patients across five European countries.

Author

Schneider, M., Mosca, M., Pego-Reigosa, J. M., Hachulla, E., Teh, L-S, Perna, A., Koscielny, V., Pike, J., Lobosco, S., and Apolone, G.

Subjects
SYSTEMIC lupus erythematosus, DISEASE remission, PUBLIC health, SYMPTOMS, RHEUMATOLOGISTS, NEPHROLOGISTS, PATIENTS
Abstract

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease associated with increased mortality and significant personal, psychological and socioeconomic consequences. An agreed definition of remission is needed and lacking. We sought to visualize ‘remission in SLE’ in European patients considered by their physicians to be ‘in remission’ by comparing the reported symptom burden as reported by treating physicians for patients considered to be ‘in remission’ and those not considered to be ‘in remission’. Data for 1227 patients drawn from a multinational, real-world survey of patients with SLE consulting practising rheumatologists and nephrologists in France, Germany, Italy, Spain, and the UK show that physicians classed their patients as ‘in remission’ despite a considerable ongoing symptom burden and intensive immunosuppressive medication. Patients considered to be ‘in remission’ still had a mean of 2.68 current symptoms vs 5.48 for those considered to be not ‘in remission’ (p < 0.0001). The most common symptoms among those seen to be ‘in remission’ were joint symptoms, fatigue, pain, mucocutaneous involvement, haematological manifestations and kidney abnormalities. The current analysis highlights important ongoing disease activity, symptom burden and immunosuppressive medication in European patients with SLE considered by their treating physician to be ‘in remission’. For a further improvement of outcome, there is an urgent need for an international consensus on the definitions for remission among patients with SLE. [ABSTRACT FROM AUTHOR]

Published
2016
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45. Time-trend analysis of the pulmonary function after surgical treatment for esophageal cancer.

Author

LOCOCO, F., CESARIO, A., MARGARITORA, S., APOLONE, G., CAVUTO, S., LEUZZI, G., PASQUA, F., CARDACI, V., CIAVARELLA, L. PETRACCA, and GRANONE, P.

Abstract

OBJECTIVE: To evaluate, in function of time, the modification of pulmonary function after radical esophagectomy with the aim of identifying clinical and/or surgical predictors of functional worsening. PATIENTS AND METHODS: Data of 57 patients operated from 01/06 to 06/11 were retrospectively reviewed. Thirty-eight patients (67%) underwent transhiatal cervico-laparotomic (CL-Group) and 19 (33%) a Mc-Keown cervico-thoraco-laparotomic esophagectomy (CTL-Group). The pulmonary function has been evaluated before and one month after surgery. The outcome has been benchmarked with demographic/clinical characteristics, the type of operation and the presence of post-operative pulmonary complications (POPCs). RESULTS: Mean age and male/female distribution were 66.6±10.6 yrs and 39/18, respectively. A total of 14 (24% of total sample) POPCs occurred with a significantly higher occurrence in the CTL-Group (71% vs 28%, p < 0.001) and in those patients with a pre-operative concurrent pathological condition (64% in COPD patients vs 36% in patients without COPD, p = 0.021). A global worsening of the spirometric parameters (expressed as the baseline percentage change, Δ) emerged, but this decrease was significantly higher in the CTLGroup in terms of Δ-FVC (p = 0.005) and Δ-FEV1 (p = 0.005). Similarly, those patients who have experienced a POPC, showed a higher reduction of the pulmonary function regardless of the surgical approach when compared with those who did not (Δ-FVC: p = 0.053 and Δ-FEV1%: p = 0.015). CONCLUSIONS: In the context of a global reduction of pulmonary function, patients who underwent trans-thoracic esophagectomy or experienced a POPC showed a significantly worse pattern. These patients could be the "best target" for therapeutic rehabilitative strategies in the pre-operative and/or post-operative setting. This assumption is to be proven through prospective clinical trials. [ABSTRACT FROM AUTHOR]

Published
2014

47. 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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50. 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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