Ernesto Zecca

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Lombardy, Italy

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Publications (48)182.36 Total impact

  • Source
    Full-text · Article · Mar 2015 · Clinical Journal of Pain
  • [Show abstract] [Hide abstract] ABSTRACT: Transdermal fentanyl is a well established treatment for cancer pain. The aim of the present study is to assess the relative bioavailability of fentanyl from two different transdermal systems by evaluating plasma drug concentrations after single administration: Fentalgon® (test), novel bilayer matrix-type patch, and Durogesic SMAT (reference), a monolayer matrix-type patch. In the Fentalgon patch the upper 6% fentanyl reservoir-layer maintains a stable concentration gradient between the lower 4% donor-layer and the skin. The system provides a constant drug delivery over 72 hours. Open-label, single-center, randomised, single-dose, two-period cross-over clinical trial, that included thirty-six healthy male volunteers. The patches were applied to non-irritated and non-irradiated skin on the intraclavicular pectoral area. Blood samples were collected at different time points (from baseline to 120 h post-removal of the devices) and fentanyl concentrations were determined using a validated LC/MS/MS method. Bioequivalence was to be claimed if the 90% confidence interval of AUC(0-t) and Cmax ratios (test/reference) were within the acceptance range of 80-125% and 75-133%, respectively. The 90% confidence intervals of AUC(0-t) ratio (116.3% [109.6-123.4%]) and Cmax ratio (114.4% [105.8-123.8%] were well included in the acceptance range and Cmax ratio would also meet the narrower bounds of 80-125%. There was no relevant difference in overall safety profiles of the two preparations investigated, which were adequately tolerated, as expected for opioid-naïve subjects. The new bilayer matrix-type patch, Fentalgon®, is bioequivalent to the monolayer matrix-type Durogesic SMAT fentanyl patch with respect to the rate and extent of exposure of fentanyl. (Eudra/CT no. 2005-000046-36). This article is protected by copyright. All rights reserved.
    No preview · Article · Jan 2015 · British Journal of Clinical Pharmacology
  • No preview · Article · Dec 2012 · Handbook of Clinical Neurology
  • [Show abstract] [Hide abstract] ABSTRACT: Introduction: Deep brain stimulation (DBS) of the posterior hypothalamus (pHyp) has been reported as an effective treatment for primary, drug-refractory and chronic cluster headache (CCH). We here describe the use of such a procedure for the treatment of secondary CCH due to a neoplasm affecting the soft tissues of the right hemiface. Methods: A 27-year-old man affected by infiltrating angiomyolipoma of the right hemiface who subsequently developed drug refractory homolateral CCH underwent DBS of the right pHyp region at the Fondazione IRCCS Istituto Nazionale Neurologico Carlo Besta. Results: After surgery, the patient presented a significant reduction in frequency of pain bouts. However, because of a subsequent infection, the entire system was removed. After re-implantation of the system, successful outcome was observed at 2 years follow-up. Discussion: This brief report shows the feasibility of pHyp DBS in secondary drug-refractory CCH syndromes; future reports are needed in order to confirm our positive result.
    No preview · Article · Nov 2012 · Cephalalgia
  • [Show abstract] [Hide abstract] ABSTRACT: The aim of this study was to describe the use of palliative sedation (PS) its indications and outcomes in patients followed up till death by an inpatient palliative care consult team (PCCT) at a tertiary cancer center. All patients referred for 5 years to the PCCT and followed up till death were eligible for the study. Both PCCT recordings and hospital charts were reviewed and a codified assessment was performed. Over a total of 2,033 consecutive consults, 129 patients died during admission and were eligible. Eighty-three had the indication to PS, 4% of all consults (95% confidence interval [95%CI], 3% to 5%) and 64% of eligible patients (95%CI, 56% to 73%). PS was more frequently indicated in males and in patients with recurrent dyspnea and recurrent agitation, while it was less frequently indicated in older people and in patients with cerebral metastases and recurrent drowsiness. The most frequent indications to PS were dyspnea (37%) and delirium (31%) alone or combined with other symptoms. PS was successfully achieved in 69 patients; the drugs most frequently used for PS were midazolam (46%), haloperidol (35%), and chlorpromazine (32%) and opioid dose escalation was higher in sedated patients (P < 0.01). PS is an important intervention in the management of terminal disease by a consulting palliative care team. Improved collaboration and communication between the hospital staff and the PCCT should be offered to meet patients' needs when PS is required.
    No preview · Article · Jul 2011 · Supportive Care in Cancer
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    [Show abstract] [Hide abstract] ABSTRACT: Numerical rating scales (NRS), and verbal rating scales (VRS) showed to be reliable and valid tools for subjective cancer pain measurement, but no one of them consistently proved to be superior to the other. Aim of the present study is to compare NRS and VRS performance in assessing breakthrough or episodic pain (BP-EP) exacerbations. In a cross sectional multicentre study carried out on a sample of 240 advanced cancer patients with pain, background pain and BP-EP intensity in the last 24 hours were measured using both a 6-point VRS and a 0-10 NRS. In order to evaluate the reproducibility of the two scales, a subsample of 60 patients was randomly selected and the questionnaire was administered for a second time three to four hours later. The proportion of "inconsistent" (background pain intensity higher than or equal to peak pain intensity) evaluations was calculated to compare the two scales capability in discriminating between background and peak pain intensity and Cohen's K was calculated to compare their reproducibility. NRS revealed higher discriminatory capability than VRS in distinguishing between background and peak pain intensity with a lower proportion of patients giving inconsistent evaluations (14% vs. 25%). NRS also showed higher reproducibility when measuring pain exacerbations (Cohen's K of 0.86 for NRS vs. 0.53 for VRS) while the reproducibility of the two scales in evaluating background pain was similar (Cohen's K of 0.80 vs. 0.77). Our results suggest that, in the measurement of cancer pain exacerbations, patients use NRS more appropriately than VRS and as such NRS should be preferred to VRS in this patient's population.
    Full-text · Article · Apr 2010 · Health and Quality of Life Outcomes
  • No preview · Article · Oct 2009 · Annals of Oncology
  • [Show abstract] [Hide abstract] ABSTRACT: Aim of this study was to validate the use of subjective average pain assessment over an 8-h time period to evaluate cancer pain intensity. A sample of 95 consecutive cancer inpatients were asked to score on 0-10 numerical scales the intensity of their pain at hourly intervals, and then, at the 8th hour, to rate their average pain intensity over the last 8h. Agreement between the average of the 8 hourly measures (8hA) and the single patient-rated average (PA8h) was examined with the intraclass correlation coefficient (ICC) and the absolute difference (AD) between the two measurements. Associations between AD, gender, age older than 70, somatic pain, visceral pain, neuropathic pain, pain on movement and the presence of pain exacerbations during the 8-h period, were also examined. Average pain intensity scores were very similar with the two measurement schedules: 3.4 for 8hA and 3.7 for PA8h, with a median AD of 0.44 points. Only six patients (6.3%) showed ADs higher than 2 points. Also the ICC (0.85) showed a substantial agreement between the two schedules. Among the examined variables, gender, age over 70years and presence of pain exacerbations showed a significant association with the agreement level. Overall, our results support the validity of a subjective average pain measurement over 8-h period in cancer patients.
    No preview · Article · Sep 2009 · European journal of pain (London, England)
  • Augusto Caraceni · Cinzia Martini · Ernesto Zecca
    [Show abstract] [Hide abstract] ABSTRACT: La definizione di dolore adottata dalla Associazione Internazionale per lo Studio del Dolore recita: “Il dolore è un’esperienza sensoriale ed emozionale spiacevole, associata ad un attuale o potenziale danno tissutale, o descritta in termini di tale danno” [1], quindi ne sottolinea due aspetti fondamentali: la soggettività e la multidimensionalità. Infatti, l’esperienza del dolore risulta dal coinvolgimento di componenti fisiche, emotive e cognitive. Due modelli molto noti di teorizzazione dell’esperienza del dolore si basano sul riconoscimento, in un caso, di tre componenti principali: sensorialediscriminativa, motivazionale-affettiva e cognitivovalutativa [2]; nell’altro, di due fattori: intensità e interferenza con altre attività [3].
    No preview · Article · Jan 2009
  • A Caraceni · E Zecca · C Martini · A Pigni · P Bracchi
    No preview · Article · Jul 2008 · Palliative Medicine
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    [Show abstract] [Hide abstract] ABSTRACT: The BJC is owned by Cancer Research UK, a charity dedicated to understanding the causes, prevention and treatment of cancer and to making sure that the best new treatments reach patients in the clinic as quickly as possible. The journal reflects these aims. It was founded more than fifty years ago and, from the start, its far-sighted mission was to encourage communication of the very best cancer research from laboratories and clinics in all countries. The breadth of its coverage, its editorial independence and it consistent high standards, have made BJC one of the world's premier general cancer journals. Its increasing popularity is reflected by a steadily rising impact factor.
    Full-text · Article · Sep 2006 · British Journal of Cancer
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    [Show abstract] [Hide abstract] ABSTRACT: The aim of this review was to evaluate the methods of pain measurement in controlled clinical trials in oncology published between 1999 and 2002. An electronic literature search strategy was used according to established criteria applied to the Medline database and PubMed search engine. Articles were selected to include only studies that had chronic cancer pain as the primary or secondary objective of a controlled clinical trial. A specific evaluation scheme was used to examine how pain measurement methods were chosen and implemented in the study procedures. The search strategy identified 613 articles, and 68 were selected for evaluation. Most articles (69%) chose unidimensional pain measurement tools, such as visual analogue scales, numerical rating scales and verbal rating scales, whereas others used questionnaires. The implementation of the pain assessment method was problematic in many studies, especially as far as time frame of pain assessment (70%), administration modalities (46%), and use of non-validated measurement methods (10%). Design of study and data analysis were often unclear about the definition of pain outcome measure (40%), patient compliance with pain assessment (98%), and impact of missing data (56%). Statistical techniques were seldom appropriate to the type of data collected and often inadequate to describe the pain variable under study. It is clear from this review that most authors were aware of the need of valid pain measurement tools to be used in clinical trials. However, too often these tools were not appropriately used in the trial, or at least their use was not described with sufficient accuracy in the trial methods.
    Full-text · Article · Jun 2005 · Journal of Pain and Symptom Management
  • [Show abstract] [Hide abstract] ABSTRACT: To determine the analgesic effect of the addition of gabapentin to opioids in the management of neuropathic cancer pain. One hundred twenty-one consecutive patients with neuropathic pain due to cancer, partially controlled with systemic opioids, participated in a multicenter, randomized, double-blind, placebo-controlled, parallel-design, 10-day trial from August 1999 to May 2002. Gabapentin was titrated from 600 mg/d to 1,800 mg/d in addition to stable opioid dose. Extra opioid doses were available as needed. Zero to 10 numerical scale was used to rate average daily pain. The average pain score over the whole follow-up period was used as main outcome measure. Secondary outcome measures were: intensity of burning pain, shooting/lancinating pain, dysesthesias (also scored on 0 to 10 numerical scale), number of daily episodes of lancinating pain, presence of allodynia, and daily extra doses of opioid analgesics. Overall, 79 patients received gabapentin and 58 (73%) completed the study; 41 patients received placebo and 31 (76%) completed the study. Analysis of covariance (ANCOVA) on the intent-to-treat population showed a significant difference of average pain intensity between gabapentin (pain score, 4.6) and placebo group (pain score, 5.4; P =.0250). Among secondary outcome measures, dysesthesia score showed a statistically significant difference (P =.0077; ANCOVA on modified intent-to-treat population = 115 patients with at least 3 days of pain assessments). Reasons for withdrawing patients from the trial were adverse events in six patients (7.6%) receiving gabapentin and in three patients receiving placebo (7.3%). Gabapentin is effective in improving analgesia in patients with neuropathic cancer pain already treated with opioids.
    No preview · Article · Aug 2004 · Journal of Clinical Oncology
  • [Show abstract] [Hide abstract] ABSTRACT: Accurate pain assessment is considered essential for effective management of cancer pain. The aim of this study was to evaluate the compliance of hospitalized patients with chronic cancer pain, referred to an inpatient palliative care consultation service, with self-assessment of pain intensity by means of a daily pain form. The form was distributed daily by the pain consult nurse and required three daily pain intensity measurements on 0 to 10 numerical scales, separately for pain at rest and pain on movement. Of 174 consecutive patients, 106 (61%) participated in the study and were followed up for a median of 10.6 days (range 1-32 days). Compliance was defined as the number of assessment forms completed over the number of evaluation days available for each patient. Mean compliance was 58%. The main reasons for not completing the form were related to subjective psychological variables (44%), physical distress (26%), and absence of pain (16%). Lack of understanding of the method was reported as the main reason for non-compliance by only 1% of patients.
    No preview · Article · Jun 2004 · Journal of Pain and Symptom Management
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    [Show abstract] [Hide abstract] ABSTRACT: Breakthrough pain (BKP) is a transitory flare of pain that occurs on a background of relatively well controlled baseline pain. Previous surveys have found that BKP is highly prevalent among patients with cancer pain and predicts more severe pain, pain-related distress and functional impairment, and relatively poor quality of life. An international group of investigators assembled by a task force of the International Association for the Study of Pain (IASP) evaluated the prevalence and characteristics of BKP as part of a prospective, cross-sectional survey of cancer pain. Fifty-eight clinicians in 24 countries evaluated a total of 1095 patients with cancer pain using patient-rated items from the Brief Pain Inventory (BPI) and observer-rated measures. The observer-rated information included demographic and tumor-related data, the occurrence of BKP, and responses on checklists of pain syndromes and pathophysiologies. The clinicians reported BKP in 64.8% of patients. Physicians from English-speaking countries were significantly more likely to report BKP than other physicians. BKP was associated with higher pain scores and functional interference on the BPI. Multivariate analysis showed an independent association of BKP with the presence of more than one pain, a vertebral pain syndrome, pain due to plexopathy, and English-speaking country. These data confirm the high prevalence of BKP, its association with more severe pain and functional impairment, and its relationship to specific cancer pain syndromes. Further studies are needed to characterize subtypes of BKP. The uneven distribution of BKP reporting across pain specialists from different countries suggests that more standardized methods for diagnosing BKP are needed.
    Full-text · Article · May 2004 · Palliative Medicine
  • [Show abstract] [Hide abstract] ABSTRACT: Breakthrough pain (BKP) is a transitory flare of pain that occurs on a background of relatively well controlled baseline pain. Previous surveys have found that BKP is highly prevalent among patients with cancer pain and predicts more severe pain, pain-related distress and functional impairment, and relatively poor quality of life. An international group of investigators assembled by a task force of the International Association for the Study of Pain (IASP) evaluated the prevalence and characteristics of BKP as part of a prospective, cross-sectional survey of cancer pain. Fifty-eight clinicians in 24 countries evaluated a total of 1095 patients with cancer pain using patient-rated items from the Brief Pain Inventory (BPI) and observer-rated measures. The observer-rated information included demographic and tumor-related data, the occurrence of BKP, and responses on checklists of pain syndromes and pathophysiologies. The clinicians reported BKP in 64.8% of patients. Physicians from English-speaking countries were significantly more likely to report BKP than other physicians. BKP was associated with higher pain scores and functional interference on the BPI. Multivariate analysis showed an independent association of BKP with the presence of more than one pain, a vertebral pain syndrome, pain due to plexopathy, and English-speaking country. These data confirm the high prevalence of BKP, its association with more severe pain and functional impairment, and its relationship to specific cancer pain syndromes. Further studies are needed to characterize subtypes of BKP. The uneven distribution of BKP reporting across pain specialists from different countries suggests that more standardized methods for diagnosing BKP are needed.
    No preview · Article · Apr 2004 · Palliative Medicine
  • C Brunelli · A Caraceni · C Martini · E Zecca
    No preview · Conference Paper · May 2003
  • [Show abstract] [Hide abstract] ABSTRACT: A number of controlled studies have recently demonstrated the role of disodium pamidronate in the prevention of skeletal complications in patients with metastatic bone disease due to breast cancer and multiple myeloma. They have also shown that it relieves pain and is well tolerated. The aim of this open prospective study was to evaluate the acceptability of a new schedule of pamidronate infusion and to assess pain, analgesic consumption and the Karnofsky Performance Status (KPS) in patients with metastatic bone pain treated with pamidronate in association or not with chemotherapy, radiotherapy, and hormone therapy. Patients with different types of cancer and at least one painful bone metastasis were treated with two cycles of 60 mg intravenous (iv) pamidronate weekly for three consecutive doses, with a 3-week interval between the two cycles (six infusions over 7 weeks), followed by one infusion every 3 weeks for a total of 24 infusions. Two hundred patients were enrolled in the study, of whom 94 received at least the first six infusions; 25 patients received all 24 infusions. Pamidronate was well tolerated in the majority of the patients both during the first six infusions and during the whole study period. In the patients under study, pain intensity decreased compared with T0 after the first two infusions (second week of treatment). The mean equivalent daily dose of oral morphine required ranged from 21.5 to 41.5 mg/day and was low and stable during the study. For the patients who remained in the study, the KPS remained around 70 during the whole treatment period and intrasubject analysis showed a substantial stability of the KPS within each subject. A first fracture occurred within 321 days in 25% of the whole population under study. Pamidronate represents a further valid therapy to add to an already consolidated list of therapies such as radiotherapy, chemotherapy, hormone therapy and orthopaedic intervention in the pain management of patients with bone metastases. Future studies are necessary to evaluate the role of pamidronate and the appropriate schedule in patients with advanced or terminal cancer who are no longer being treated with oncological therapies.
    No preview · Article · Aug 2001 · Palliative Medicine
  • No preview · Article · Mar 2001 · Journal of Pain and Symptom Management
  • No preview · Article · Mar 2001 · Journal of Pain and Symptom Management

Publication Stats

2k Citations
182.36 Total Impact Points

Institutions

  • 1995-2012
    • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
      • s.c. Cure Palliative, Terapia del Dolore e Riabilitazione
      Milano, Lombardy, Italy
  • 1999
    • University of Milan
      Milano, Lombardy, Italy
  • 1990-1993
    • CRO Centro di Riferimento Oncologico di Aviano
      • Unit of Pain Therapy and Palliative Care
      Aviano, Friuli Venezia Giulia, Italy