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The degree to which interferon (IFN) alpha-2b offers real clinical benefits in the adjuvant therapy of melanoma at high risk of recurrence is a subject of debate. This, together with questions over optimal treatment scheme and concerns over toxicity, has limited its clinical use. On the basis of a review of the literature, an Italian Expert Panel has made practical recommendations for a consistent approach in the use of IFN. Although it is clear that more research into predictive factors to identify patients most likely to benefit from adjuvant IFN therapy is required, IFN remains the only currently available adjuvant option for melanoma. Based on meta-analyses of clinical trials, there is clear evidence that treatment with IFN is beneficial with regard to overall and recurrence-free survival (RFS). As such, IFN should be offered to patients who are at high risk of recurrence. Specific recommendations with regard to disease stage are provided.

In recent years, the number of oral anticancer drugs used in clinical practice has rapidly increased. The Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of the use of oral anticancer drugs on the daily activity of Italian oncology practices.A survey questionnaire was distributed to the coordinators of the regional sections of AIOM. A 6-month period was considered, from January 1, 2010 to June 30, 2010. The survey addressed (1) quantitative aspects of the use of oral anticancer drugs; (2) practical aspects in the management of patients treated with these drugs; (3) issues related to treatment costs and reimbursement procedures.Thirty-six questionnaires were received from institutions distributed throughout the Italian territory. Oral anticancer drugs (both chemotherapy and molecularly targeted agents) accounted for a significant proportion (17%) of prescribed treatments. Among the responding institutions, there were different dispensation procedures of oral drugs to patients: drugs were dispensed by the pharmacist (57%) or directly by the medical oncologist (23%) or nurse (20%). The medical oncologist played a major role in the communication with patients (73% alone and a further 24% in cooperation with other professional figures) and was the point of reference in the event of side effects in 97% of cases. In most cases, the reimbursement of drug costs was separated ("File F" procedure) from the flat fare received by the hospital for outpatient visits or day-hospital access.Optimal organization of oral anticancer treatment warrants the cooperation and integration of multiple professional figures. At least three figures are involved in patient management in the hospital: the medical oncologist, the nurse, and the hospital pharmacist. Oral anticancer treatments are associated with specific reimbursement issues: in the majority of cases, the cost of the drug is reimbursed separately from the cost of patient access.

Toward the characterization of a genetic profile with prognostic value, the CDKN2 locus at chromosome 9p21, harboring the CDKN2A and CDKN2B genes, may represent the main candidate genomic region to be investigated in melanoma. To determine whether a genotype of single- nucleotide polymorphisms (SNPs) within the CDKN2 locus may correlate with the melanoma outcome, we analyzed nine SNPs jointly by logistic regression among 396 melanoma patients and 383 healthy controls originating from south Italy.

Summary Background The chromosome 9p21 and its CDKN locus, with the p16 tumour suppressor gene (CDKN2A), are recognized as the genomic regions involved in the pathogenesis of melanoma. Objectives To elucidate further the role of such regions during the different phases of melanocytic tumorigenesis. Methods Tissue sections from naevi, primary and metastatic melanomas were investigated by fluorescence in situ hybridization for allelic loss at the 9p21 chromosome and by immunochemistry for p16CDKN2A expression. Results Dysplastic naevi and primary or secondary melanomas were found to carry hemizygous deletions within the entire 9p21 region at similar frequencies (varying from 55% to 62%). Allelic deletion spanning the CDKN locus was observed at significantly increased rates moving from early (7%) to advanced (28%) primary melanomas and to secondary melanoma lesions (37%) (P = 0·018). Also, inactivation of the p16 gene (CDKN2A) was absent in naevi and present at steadily increasing rates moving from primary melanomas (7% early lesions to 17% advanced lesions) to melanoma metastases (62%) (P = 0·004). Conclusions Our findings indicate that, in a model of sequential accumulation of genetic alterations, 9p21 deletions may play a role in melanocytic transformation and tumour initiation whereas rearrangements at the CDKN locus, and p16 gene (CDKN2A) inactivation may contribute to tumour progression.

8543 Background: Impairment of p16CDKN2A protein expression has been demonstrated to contribute to melanoma progression as well as to correlate with a shorter overall survival. Toward the character...

e19025 Background: MUP are estimated to comprise between 3.7% and 6% of all melanomas. It represents an interesting phenomenon not clearly explained yet and also its natural history is controversia...

Italy is divided into 20 regions. As a consequence of local autonomy, following marketing authorization by the Italian Medicines Agency, each drug for hospital use is not immediately available, because its approval needs to undergo further steps that can be different among regions. The Italian Society of Medical Oncology conducted the present study to describe the impact of the existence of sub-national pharmaceutical formularies on the disparity of access to new anti-cancer drugs among patients treated in different Italian regions.The availability of 8 new anti-cancer drugs at a regional level and the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency were analyzed as of April 2009.Fourteen regions and autonomous province of Trento have a regional pharmaceutical formulary. In most cases, the regional pharmaceutical formularies include the eight analyzed drugs, with therapeutic indications coherent with national marketing authorization indications. Five drugs (bevacizumab, trastuzumab, rituximab, erlotinib, sunitinib) were included in all the existing regional pharmaceutical formularies, without restrictions, whereas three drugs (cetuximab, sorafenib, pemetrexed) were found to have restrictions in some regions.The presence of multiple hierarchical levels of drug evaluation creates a potential element of disparity in the access to pharmacological therapies for Italian citizens.

Twenty patients with disseminated breast cancer unresponsive to conventional chemotherapy and chemohormonotherapy were treated with an alternating sequential schedule of ethinyl estradiol and medroxyprogesterone on the basis of correlations between hormones and estrogen and progestin receptors. Of 19 evaluable patients, six underwent partial or complete remission, while five others showed minor responses.A pilot study was conducted on 20 patients with disseminated breast cancer previously unresponsive to conventional chemotherapy and chemohormonotherapy. The 20 women were treated with ethinyl estradiol orally on days 1 and 2, medroxyprogesterone on days 3-9. After a 2-day interval, the sequential cycle was repeated. 10% of the women had complete remission and 20% more had partial remissions. More than 1/4 had minor remissions and 10% had their disease stabilized. Side effects with the therapy were practically absent. The rationale for the sequential therapy was suggested by interactions among hormones and receptors and the priming activity of estrogens on progesterone receptors. These preliminary results indicate that an alternated sequential therapy of ethinyl estradiol and medroxyprogesterone may be useful in managing advanced cancer.

A woman 35 years of age suffering from cutaneous and visceral metastatic melanoma was treated with recombinant Interferon α 2b (rIFNα2b) subcutaneously 3 × 106 U/m2 3 times a week for 3 months with no apparent effect on the course of the illness. Two months after IFN therapy the patient developed cerebral metastasis. A cycle of carmustine, 100 mg/day for 3 days, was given, and complete disappearance of the cutaneous and visceral, but not of the cerebral manifestations was observed. Two consolidation cycles based on vincristine, dacarbazine and lomustine were then administered. The patient died 26 months after beginning treatment with IFN and 18 months after chemotherapy for the cerebral metastasis. No trace of tumor at the cutaneous or visceral level was found at autopsy.

Aims and background In 2009, the Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of regional pharmaceutical formularies on the disparity of access to eight new drugs among cancer patients treated in Italian regions. The survey documented some regional restrictions for some anti-cancer drugs. In the study, we analyzed the “time to patient access” to new anti-cancer drugs in Italian regions. Methods In March 2010, we analyzed the availability of 17 new anti-cancer drugs at a regional level, specifically the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency (AIFA). In the regions with pharmaceutical formularies, we analyzed the characteristics of technical-scientific committees for the evaluation of inclusion of hospital drugs in these formularies. We also analyzed the time from EMA (CMPH) authorization to AIFA marketing authorization, the time from AIFA marketing authorization to patient availability, and the total time from EMA (CMPH) authorization to patient availability of the drugs in all Italian regions, for 11 of these drugs. Results Some drugs were included in all the regional pharmaceutical formularies, without restrictions, whereas other drugs were not included in one and others were not included in more than one formulary. Median time from EMA to AIFA was 11.2 months (range, 2.9–17.1). Median time from AIFA to patient availability was 1.4 months (range, 0.0–50.5) in regions with drug formularies versus 0.0 months in regions without drugs formularies. Median total time from EMA to patient availability was longer in regions with formularies (13.3 months; range, 2.9–65.3) than in regions without formularies (11.2 months; range, 2.9–24.0), where drugs are immediately available after AIFA marketing authorization. Moreover, the interval was very long (range, 2.9–65.3) for some drugs in regions with formularies. Conclusions The analysis confirmed that the presence of multiple hierarchical levels of drug evaluation can create disparity in drug availability for Italian citizens.