[Italian physician's needs for medical information. Retrospective analysis of the medical information service provided by Novartis Pharma to clinicians]. / I bisogni informativi dei medici italiani Analisi retrospettiva del servizio di medical information offerto da Novartis Farma ai clinici.

The physician's need for medical information updates has been studied extensively in recent years but the point of view of the pharmaceutical industry on this need has rarely been considered. This paper reports the results of a retrospective analysis of the medical information service provided to Italian physicians by an important pharmaceutical company, Novartis Pharma, from 2004 to 2012. The results confirm clinicians' appreciation of a service that gives them access to tailored scientific documentation and the number of requests made to the network of medical representatives has been rising steadily, peaking whenever new drugs become available to physicians. The analysis confirms what -other international studies have ascertained, that most queries are about how to use the drugs and what their properties are. The results highlight some differences between different medical specialties: for example, proportionally, neurologists seem to be the most curious. This, as well as other interesting snippets, is worth further exploration. Despite its limits in terms of representativeness, what comes out of the study is the existence of an real unmet need for information by healthcare institutions and that the support offered by the pharmaceutical industry could be invaluable; its role could go well beyond that of a mere supplier to National Healthcare Systems, to that of being recognised as an active partner the process of ensuring balanced and evidence-based information. At the same time, closer appraisal of clinicians' needs could help the pharma industries to improve their communication and educational strategies in presenting their latest clinical research and their own products.

Phase II study of imatinib in advanced chordoma.

PURPOSE: To explore the antitumor activity of imatinib in patients with advanced platelet-derived growth factor ß (PDGFB)/PDGF receptor ß (PDGFRB)-positive chordomas. PATIENTS AND METHODS: In a collaborative Italian-Swiss, prospective, phase II clinical study conducted from November 2004 through April 2006, 56 patients with advanced PDGFB and/or PDGFRB chordoma received 800 mg/d of imatinib until progression. The primary end point was the overall tumor response rate (ORR), defined by RECIST. Secondary, exploratory end points included tissue response (ie, changes in tumor density or signal intensity/contrast enhancement, and/or [18F]-fluorodeoxyglucose positron emission tomography [PET] uptake), overall survival, progression-free survival (PFS), and pain score. RESULTS: Among 50 patients evaluable by RECIST, the best response was one partial response (PR) obtained at 6 months (ORR, 2%). There were 35 patients with stable disease (SD, 70%) and a 64% clinical benefit rate (ie, RECIST complete response + PR + SD ≥ 6 months). A minor dimensional response (< 20%) was detected in nine patients. A maximum standard uptake value decrease ≥ 25% was observed in 10 (39%) of 26 patients evaluable for PET response at 3 months. Changes in the Brief Pain Inventory score were consistent with the response assessment. Median PFS (intention-to-treat population, 56 patients) was 9 months. No unexpected toxicities were observed. CONCLUSION: This is the largest phase II study in chordoma to date. It confirms anecdotal evidence that imatinib has antitumor activity in this orphan disease, and therefore, it is worth further investigation.

Natural history of imatinib-naive GISTs: a retrospective analysis of 929 cases with long-term follow-up and development of a survival nomogram based on mitotic index and size as continuous variables.

Gastrointestinal stromal tumor (GIST) natural history per se has not been extensively investigated yet, with most data being drawn from large studies with a relevant referral bias. Hence, the estimation of prognosis still remains a critical issue. We retrospectively evaluated 929 GISTs resected between 1980 and 2000 in 35 Italian institutions. A total of 526 patients were found to be suitable for refining risk assessment through the development of a survival nomogram. Median follow-up was 126 months. On testing for potential prognostic parameters, age, tumor site, size, and mitotic index proved to be predictors of OS on both univariable and multivariable Cox model analyses, whereas necrosis and cytonuclear atypia were significant on univariable analysis only. The discriminative ability of the model, including the parameters selected after a backward procedure (C=0.72), improved compared with the National Institutes of Health 2002 (C=0.64) and the National Comprehensive Cancer Network 2007 (C=0.63). On the basis of these data we developed a prognostic nomogram for survival that considers site, size, and mitotic index as continuous variables, providing estimates stratified for patients aged ≤65 and >65 years. This nomogram is a tool based on survival. It overcomes problems that result from artificial categorization of continuous variables. We believe that in the future this should also be attempted by nomograms based on the risk of relapse.

Imatinib mesylate in the treatment of newly diagnosed or refractory/resistant c-KIT positive acute myeloid leukemia. Results of an Italian Multicentric Phase II Study.

We evaluated safety and efficacy of imatinib (600 mg) in 36 c-KIT+ acute myeloid leukemia patients not amenable to receive conventional chemotherapy. No patient achieved complete remission. One patient obtained a hematologic improvement (platelet increase with transfusion independence). Median overall survival was 3 months (0.5-44+). Non-hematologic toxicity was overall mild.

Efficacy and safety of zoledronic acid in patients with breast cancer metastatic to bone: a multicenter clinical trial.

PURPOSE: This study evaluated the efficacy and safety of zoledronic acid in breast cancer patients with newly diagnosed bone metastases. MATERIALS AND METHODS: Patients diagnosed with bone metastases < or = 6 weeks prior to first visit were enrolled. Zoledronic acid (4 mg) was administered via a 15-minute infusion every 3 or 4 weeks for 12 infusions. Skeletal-related events (SREs) were defined as pathologic bone fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy. Primary efficacy end points were the proportion of patients with at least one SRE and the time to first SRE. Secondary end points included pain, analgesic use, and quality of life. RESULTS: Among 312 patients enrolled, 30% experienced at least one SRE during the 12-month study, and 22% experienced only one SRE. The median time to first SRE was not reached in the intent-to-treat population. Mean pain and analgesic scores declined from baseline, and quality-of-life scores remained stable to study end. The most frequently reported adverse events, regardless of relationship to study drug, were pyrexia (22%) and bone pain (10%). Serum creatinine levels did not significantly increase from baseline throughout the study. CONCLUSIONS: Breast cancer patients with newly diagnosed bone metastases who were treated with zoledronic acid had a low incidence of SREs compared with patients who received placebo in randomized phase III trials, and pain was decreased from baseline. This study demonstrated the favorable risk:benefit ratio of zoledronic acid for the prevention of skeletal complications.