Increased overall survival independent of RECIST response in metastatic breast cancer patients continuing trastuzumab treatment: evidence from a retrospective study.

Recent studies have reported the potential clinical utility for metastatic breast cancer (MBC) patients of continuing trastuzumab beyond progression. Based on those results, here the authors have examined the benefits of trastuzumab-continuation by specifically evaluating RECIST responses upon first line trastuzumab-treatment as a potential predictive marker for therapeutic effect of trastuzumab-continuation beyond metastatic disease progression. The authors carried out a retrospective analysis of 272 HER2 positive MBC patients under trastuzumab treatment at 22 different oncology Italian centers during the years of 2000 and 2001 who progressed under first line trastuzumab-treatment. The primary end point of the study was the survival from the date of first documented progression upon first line trastuzumab treatment of disease. Data analysis involved the use of matching on propensity score to balance variables between treated and untreated subjects and to reduce bias. Of the 272 HER2-positive MBC patients, 154 (56.6%) continued treatment. 79 (51.3%) of those 154 patients showed responses based on RECIST criteria during first-line trastuzumab-treatment. Of the 118 patients that suspended trastuzumab, RECIST responses had been observed in 44 (37.3%). Cox proportional hazards analysis of progressed patients, matched using propensity score, showed that discontinuation of trastuzumab at metastatic disease progression was a risk factor for significantly reduced overall survival in both responder (HR = 2.23; 95% CI = 1.03-4.82) and non-responder groups (HR = 3.53, 95% CI = 1.73-7.21), with no significant differences in the two estimated HRs (P-value of the likelihood-ratio test = 0.690). Continued trastuzumab treatment after disease progression has clinically and statistically significant effects in both RECIST responder and non-responder MBC patients.

CIGNOweb.it.

We introduce CIGNOweb.it, a database of oncology resources for patients, the general public and healthcare professionals. It builds on the previous Italian cancer resource Azaleaweb and offers quality-evaluated content. It meets international bibliographic and technical standards such as the Open Archives Initiative (OAI) for web content interoperability and the Functional Requirements for Bibliographic Records (FRBR) for bibliographic description with respect to the different media, applications, and user needs. Database content is supplied in collaboration with non-profit associations, libraries and the network of Cancer Information Points that is currently being established all over Italy. Expert and customer evaluation and feedback are provided for in the system. The graphic layout has been painstakingly designed to be user-friendly for a non-expert public. CIGNOweb.it is multicentric and will in time offer health information outside the field of oncology. It is designed to become a multilingual tool to organize, optimize and access patient information produced in the languages of the "newer" European countries. It is hoped that CIGNOweb.it will support other European nations in enhancing the structure and organization of their own-language patient health information and will contribute towards making a common health information portal of the European Union a reality.

HER-2-positive breast carcinomas as a particular subset with peculiar clinical behaviors.

PURPOSE: The association between HER-2-positivity, and prognostic variables and survival have been addressed in many studies with still controversial results because of the small series analyzed. EXPERIMENTAL DESIGN: A series of 1928 primary breast carcinomas was analyzed for the prognostic potential of HER-2 overexpression. RESULTS: In our series, HER-2-positivity was not associated with nodal status, unless the number of infiltrated nodes was considered, whereas it was strongly associated with large tumors (P < 10(-4)), grade III tumors (P < 10(-4)), lymphoid infiltration (P < 10(-4)), and absence of hormone receptor expression (P < 10(-4)). HER-2 overexpression was a strong prognostic indicator in N+ patients (P < 10(-7)), whereas its prognostic impact was weak and not statistically significant in the N- patients. Analysis of the hazard ratio of relapse in relation to time from surgery indicates that the poor prognosis associated with HER-2 positivity in N+ patients was found to be attributable to a peak of relapses in the first 3-4 years from surgery. Multivariate analysis of different prognostic factors in HER-2+ and HER-2- subsets indicated that grade is the most important factor followed by nodal status, lymphoid infiltration, and tumor size in HER-2-negative breast carcinomas, whereas nodal status was the most important prognostic factor, with tumor size showing only borderline significance, in the HER-2-positive group. CONCLUSIONS: Together, the results indicate that HER-2-positive breast carcinomas represent a particular subset of tumors with peculiar clinical and pathological behaviors. Thus, conclusions drawn from clinical trials, which serve as the basis for clinical management of breast carcinomas, might not always be valid for this low-frequency subset.

Study of sunbathing in children: the preliminary evaluation of a prevention program.

AIMS AND BACKGROUND: Sunburn during childhood is associated with an increased risk for developing melanoma in an adult age. The aim of the present study was to define the validity of our educational program in order to teach the positive effects and risks of sun exposure during childhood. PATIENTS AND METHODS: We conducted a population-based, case-control study in primary schools of three towns in Northern Italy (Brescia, Bergamo and Trento) between 2001 and 2002. The study was carried out on 1945 pupils (aged 8-9 years) and included 1309 case children who received an educational program before the summer to increase awareness towards sun exposure and 636 control children who did not. Parents of case and control children were interviewed using a questionnaire about their children's skin characteristics, sun protective behavior and sunburns. The questionnaire was completed twice, before and after the summer, to verify the changes of sun exposure habits. RESULTS: A significant decrease in sunburns was demonstrated in the group of subjects who received the educational program, indicating the validity of our operative procedure (from 14.6% to 10%, P = 4 x 10(-4). CONCLUSIONS: Our educational melanoma program may be important to disseminate in a wider range of children a correct education on sun exposure during childhood.

National Cancer Information Service in Italy: an information points network as a new model for providing information for cancer patients.

The international literature data report that good information and communication are fundamental components of a therapeutic process. They contribute to improve the patient-health care professional relationship, to facilitate doctor-patient relationships, therapeutic compliance and adherence, and to the informed consent in innovative clinical trials. We report the results of a multicentric national initiative that developed a 17-information-structure network: 16 Information Points located in the major state-funded certified cancer centers and general hospitals across Italy and a national Help-line at the nonprofit organization AIMaC (the Italian oncologic patients, families and friends association), and updated the already existing services with the aim to create the National Cancer Information Service (SION). The project is the result of a series of pilot and research projects funded by the Italian Ministry of Health. The Information Service model proposed is based on some fundamental elements: 1) human interaction with experienced operators, adequately trained in communication and information, complemented with 2) virtual interaction (Help line, Internet, blog, forum and social network); 3) informative material adequate for both scientific accuracy and communicative style; 4) adequate locations for appropriate positioning and privacy (adequate visibility); 5) appropriate advertising. First results coming from these initiatives contributed to introduce issues related to "Communication and Information to patients" as a "Public Health Instrument" to the National Cancer Plan approved by the Ministry of Health for the years 2010-2012.

Sentinel and nonsentinel node status in stage IB and II melanoma patients: two-step prognostic indicators of survival.

PURPOSE: To evaluate the prognostic significance of sentinel node biopsy in the management of stage IB and II melanoma patients, and to evaluate the status of nonsentinel nodes as a "second step key factor" to assess the prognosis of these patients. PATIENTS AND METHODS: We conducted an analysis of data collected in a prospective database. RESULTS: From February 1994 to June 2005, 1,108 consecutive patients with stage IB and II melanoma were submitted to sentinel node biopsy; 176 patients (15.9%) had occult node metastases. The frequency of positive nodes increased with increasing Breslow's thickness. The largest diameter of metastatic foci and their localization within the lymph node were associated with the risk of nonsentinel node metastases only. The 5-year survival of patients with positive sentinel nodes was 81.4% in patients with one positive node and 39.6% in patients with two positive nodes (P = .056). Multivariate analysis indicated that status of sentinel nodes is a key factor and that sex and Breslow's thickness maintain statistically significant relevance. Ulceration, which was associated with survival when considered as single factor (P < .001) had no impact on survival in the multivariate analysis (P = .10). To evaluate the relevance of metastases to nonsentinel nodes, we identified four groups of patients. CONCLUSION: Evaluation of the sentinel node is a useful procedure to identify patients to be submitted for complete lymph node dissection. The procedure makes it possible to assess the best prognosis of patients.

Proposal of a novel system for the staging of thymic epithelial tumors.

BACKGROUND: We designed and assessed a new TNM staging system (herein called the INT [Istituto Nazionale Tumori] system) for thymic epithelial tumors in order to overcome the perceived drawbacks of Masaoka's system, which represents the current standard. METHODS: In all, 123 cases were evaluated. The histologic types according to the World Health Organization (WHO) classification were as follows: subtype A: 5 cases; AB: 40; B1: 16; B2: 29; B3: 16; and C: 17 cases. There were 45 Masaoka's stage I, 33 stage II, 26 stage III, and 19 stage IV cases. A total of 11 INT definitions were grouped into three stages: locally restricted disease (75 cases), which included Masaoka's stage I and selected stage II cases (no pleural invasion); locally advanced disease (37 cases), which included Masaoka's stage III cases plus those staged II owing to pleural invasion and those staged IV owing to intrathoracic nodal or limited pleuropericardial involvement; and systemic disease (11 cases), which included the remaining Masaoka's stage IV cases. RESULTS: Completeness of resection, WHO types, and both staging systems were significant prognostic factors (p < 0.0001) on univariate analysis. The 95-month progression-free survival rates according to Masaoka's system were stage I: 100%; II: 93.6%; III: 46.3%; and IV: 23.2%. The INT system corresponding figures were as follows: locally restricted disease: 98.6%; locally advanced disease: 46.9%; and systemic disease: 11.7%. The INT system was the prognostic factor with the greatest impact (p = 0.0218) on multivariate analysis (Masaoka's system: p = 0.2012; completeness of resection: p = 0.6855; histology: p = 0.9386). CONCLUSIONS: The INT system allows finer disease descriptions than Masaoka's system, resulting in a stage grouping with higher prognostic distinctiveness.