O Pagani

Ente Ospedaliero Cantonale, Bellinzona, Ticino, Switzerland

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Publications (91)538.07 Total impact

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    The Breast 09/2014; 23(5):489-502. · 2.49 Impact Factor
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    Annals of Oncology 09/2014; 25(10):871-88. · 7.38 Impact Factor
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    ABSTRACT: Background Adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen, in postmenopausal women with hormone-receptor-positive breast cancer. Methods In two phase 3 trials, we randomly assigned premenopausal women with hormone-receptor-positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years. Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin, oophorectomy, or ovarian irradiation. The primary analysis combined data from 4690 patients in the two trials. Results After a median follow-up of 68 months, disease-free survival at 5 years was 91.1% in the exemestane-ovarian suppression group and 87.3% in the tamoxifen-ovarian suppression group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.72; 95% confidence interval [CI], 0.60 to 0.85; P<0.001). The rate of freedom from breast cancer at 5 years was 92.8% in the exemestane-ovarian suppression group, as compared with 88.8% in the tamoxifen-ovarian suppression group (hazard ratio for recurrence, 0.66; 95% CI, 0.55 to 0.80; P<0.001). With 194 deaths (4.1% of the patients), overall survival did not differ significantly between the two groups (hazard ratio for death in the exemestane-ovarian suppression group, 1.14; 95% CI, 0.86 to 1.51; P=0.37). Selected adverse events of grade 3 or 4 were reported for 30.6% of the patients in the exemestane-ovarian suppression group and 29.4% of those in the tamoxifen-ovarian suppression group, with profiles similar to those for postmenopausal women. Conclusions In premenopausal women with hormone-receptor-positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence. (Funded by Pfizer and others; TEXT and SOFT ClinicalTrials.gov numbers, NCT00066703 and NCT00066690 , respectively.).
    New England Journal of Medicine 06/2014; · 54.42 Impact Factor
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    ABSTRACT: The 1st International Consensus Conference for Breast Cancer in Young Women (BCY1) took place in November 2012, in Dublin, Ireland organized by the European School of Oncology (ESO). Consensus recommendations for management of breast cancer in young women were developed and areas of research priorities were identified. This manuscript summarizes these international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).
    Breast (Edinburgh, Scotland) 04/2014; · 2.09 Impact Factor
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    ABSTRACT: Estramustine phosphate sodium (EMP) is an oral agent poorly developed-although active-in patients with metastatic breast cancer (MBC). To resume interest in EMP in MBC, we analyzed a retrospective series of consecutive patients with estrogen receptor-positive disease. EMP was given orally at a dose of 140 mg daily. Treatment discontinuation rates due to progressive disease/toxicity and response rates were assessed. Twenty postmenopausal patients with mainly visceral disease were treated with EMP, in five cases in combination with other anticancer drugs. Median numbers of previous chemotherapies and hormonal treatments were six and four, respectively. From the entire cohort, one complete response and four partial responses were observed. The proportions of patients free of progression at 6 and 12 months were 39 and 8 %, respectively. Six patients discontinued EMP, three each for toxicity and adverse events. Good disease control was obtained in heavily pretreated MBC patients receiving EMP. Toxicity was manageable and reversible although treatment discontinuation has to be considered. A prospective study should be encouraged to identify the optimal use of the drug.
    International Journal of Clinical Oncology 04/2014; · 1.41 Impact Factor
  • Simona Di Lascio, Olivia Pagani
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    ABSTRACT: A distinctive subset of metastatic breast cancer is represented by the so called 'oligometastatic' disease, characterized by single/few detectable metastatic lesions. A more aggressive multidisciplinary approach can be considered in this patient population: available data report favorable results of 'radical' local therapy for limited metastatic disease at least in a subset of selected patients. Selection bias and the retrospective nature of data do not allow for generalization of the results: the use of such approaches must be individualized and managed within a multidisciplinary team of dedicated specialists. Improvement in surgical and radiation techniques, development of new tools to deliver local chemotherapy, and new procedures (i.e. cryosurgery, laser and microwave ablation) mandate careful evaluation of such single and combined modalities in controlled clinical trials. A more accurate identification of patients with limited metastases and better definition of treatment endpoints will also allow correct patient selection for locally aggressive therapies. This paper focusses on local treatment of the primary tumor and of the most frequent distant disease sites in the presence of oligometastatic disease.
    Breast Care 02/2014; 9(1):7-14. · 0.68 Impact Factor
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    ABSTRACT: The 1st International Consensus Conference for Breast Cancer in Young Women (BCY1) took place in November 2012, in Dublin, Ireland organized by the European School of Oncology (ESO). Consensus recommendations for management of breast cancer in young women were developed and areas of research priorities were identified. This manuscript summarizes these international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).
    The Breast. 01/2014;
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    ABSTRACT: A 76-year-old woman presented with symptoms suggestive of acute sinusitis. Previously, her breast carcinoma was treated with right lumpectomy, adjuvant chemotherapy and breast radiotherapy. She remained free from recurrence for the following 8 years. After initial treatment with antibiotics, the local symptom worsened with exophthalmos, eye blindness and development of an ulceration of the hard palate. MRI showed irregular enhancement of the nasal cavity extended to the maxillary sinus and ethmoidal lamina and concomitant infiltration of the orbit and skull base. A biopsy of the palatal ulcer showed a poorly differentiated adenocarcinoma and was compared with the histology of the primary breast tumour and it was concluded for the same morphology. After discussion at the multidisciplinary team, a specific chemotherapy has been activated with an initial local response. Further surgical resection was not thought appropriate and the patient has subsequently undergone palliative radiotherapy to the right paranasal lesions to improve local disease control.
    BMJ case reports. 01/2014; 2014.
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    ABSTRACT: The degree of adherence to oral anticancer agents may influence treatment efficacy. Tamoxifen and toremifene usage data from two International Breast Cancer Study Group (IBCSG) studies were used to evaluate the impact of treatment adherence on the efficacy of these two selective estrogen receptor modulators (SERMs). Between 1993 and 1999, IBCSG Trial 13-93 randomized premenopausal women with node-positive disease to tamoxifen or no endocrine therapy and IBCSG Trial 14-93 compared tamoxifen and toremifene in postmenopausal women with node-positive disease. 690 women with estrogen-receptor positive enrolled in these two trials were alive and disease-free 4 years after the start of SERM. The median follow up for this analysis was 9.0 years. Using a Kaplan-Meier landmark analysis at 4 years, the 609 women completing at least 4 years of SERM had improved 10-year disease-free survival (DFS) (71 %) compared with the 81 women taking less than 4 years (64 %), but these differences did not reach statistical significance [DFS hazard ratio (<4 year/4+ year) 1.31, 95 % CI 0.86-1.98), p value = 0.20]. Women who completed less than 4 years of SERM treatment (12 %) appeared not to have achieved the full benefit from their therapy. These results suggest that more effort should be made to educate women regarding the benefits of a full course of treatment. This is especially important in light of the results of the recently reported ATLAS and aTTom trials which suggest a benefit of 10 years of tamoxifen.
    Breast Cancer Research and Treatment 11/2013; · 4.47 Impact Factor
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    ABSTRACT: In 2003 the International Breast Cancer Study Group (IBCSG) initiated the TEXT and SOFT randomized phase III trials to answer two questions concerning adjuvant treatment for premenopausal women with endocrine-responsive early breast cancer: 1-What is the role of aromatase inhibitors (AI) for women treated with ovarian function suppression (OFS)? 2-What is the role of OFS for women who remain premenopausal and are treated with tamoxifen? TEXT randomized patients to receive exemestane or tamoxifen with OFS. SOFT randomized patients to receive exemestane with OFS, tamoxifen with OFS, or tamoxifen alone. Treatment was for 5 years from randomization. TEXT and SOFT successfully met their enrollment goals in 2011. The 5738 enrolled women had lower-risk disease and lower observed disease-free survival (DFS) event rates than anticipated. Consequently, 7 and 13 additional years of follow-up for TEXT and SOFT, respectively, were required to reach the targeted DFS events (median follow-up about 10.5 and 15 years). To provide timely answers, protocol amendments in 2011 specified analyses based on chronological time and median follow-up. To assess the AI question, exemestane + OFS versus tamoxifen + OFS, a combined analysis of TEXT and SOFT became the primary analysis (n = 4717). The OFS question became the primary analysis from SOFT, assessing the unique comparison of tamoxifen + OFS versus tamoxifen alone (n = 2045). The first reports are anticipated in mid- and late-2014. We present the original designs of TEXT and SOFT and adaptations to ensure timely answers to two questions concerning optimal adjuvant endocrine treatment for premenopausal women with endocrine-responsive breast cancer. Trial Registration TEXT: Clinicaltrials.govNCT00066703 SOFT: Clinicaltrials.govNCT00066690.
    Breast (Edinburgh, Scotland) 10/2013; · 2.09 Impact Factor
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    ABSTRACT: Treatment of metastatic breast cancer has substantially changed in the last decades. Availability of new cytotoxics and targeted therapies as well as changes in treatment philosophy and strategy have all contributed to a significant improvement in both survival and patients' quality of life. The multidisciplinary approach, personalised treatments based on tumour characteristics, patient's and disease history, as well as re-definition of treatment goals, aiming at the lowest possible impact on patients' life by replacing aggressive multidrug chemotherapy with single-agent cytotoxic treatment or endocrine±targeted therapies, have all been the bases of the new treatment paradigm. More recently the development of the international advanced breast cancer (ABC) consensus guidelines have further contributed to this improvement. This review will focus on the major achievements and challenges in the different tumour subtypes and sites, with a focus on future research topics and trends.
    Cancer Treatment Reviews 10/2013; · 6.02 Impact Factor
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    ABSTRACT: Breast cancer patients may have unmet supportive care needs during treatment, including symptom management of treatment-related toxicities, and educational, psychosocial, and spiritual needs. Delivery of supportive care is often a low priority in low- and middle-income settings, and is also dependent on resources available. This consensus statement describes twelve key recommendations for supportive care during treatment in low- and middle-income countries, identified by an expert international panel as part of the 5th Breast Health Global Initiative (BHGI) Global Summit for Supportive Care, which was held in October 2012, in Vienna, Austria. Panel recommendations are presented in a 4-tier resource-stratified table to illustrate how health systems can provide supportive care services during treatment to breast cancer patients, starting at a basic level of resource allocation and incrementally adding program resources as they become available. These recommendations include: health professional and patient and family education; management of treatment related toxicities, management of treatment-related symptoms of fatigue, insomnia and non-specific pain, and management of psychosocial and spiritual issues related to breast cancer treatment. Establishing supportive care during breast cancer treatment will help ensure that breast cancer patients receive comprehensive care that can help 1) improve adherence to treatment recommendations, 2) manage treatment-related toxicities and other treatment related symptoms, and 3) address the psychosocial and spiritual aspects of breast cancer and breast cancer treatments.
    The Breast 10/2013; 22(5):593–605. · 2.49 Impact Factor
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    ABSTRACT: Breast cancer in young women (<40 years) is a rare and complex clinical and psychosocial condition, which deserves multidisciplinary and personalized approaches. In young women with hormone-receptor positive disease, 5 years of adjuvant tamoxifen, with or without ovarian suppression/ablation, is considered the standard endocrine therapy. The definitive role of adjuvant aromatase inhibitors has still to be elucidated: the upcoming results of the Tamoxifen and EXemestane Trial (TEXT) and Suppression of Ovarian Function Trial (SOFT) trials will help understanding if we can widen our current endocrine therapeutic options. The optimal duration of adjuvant endocrine therapy in young women also remains an unresolved issue. The recently reported results of the ATLAS and aTToM trials represent the first evidence of a beneficial effect of extended endocrine therapy in premenopausal women and provide an important opportunity in high-risk young patients. In the metastatic setting, endocrine therapy should be the preferred choice for endocrine responsive disease, unless there is evidence of endocrine resistance or need for rapid disease and/or symptom control. Tamoxifen in combination with ovarian suppression/ablation remains the 1st-line endocrine therapy of choice. Aromatase inhibitors in combination with ovarian suppression/ablation can be considered after progression on tamoxifen and ovarian suppression/ablation. Fulvestrant has not yet been studied in pre-menopausal women. Specific age-related treatment side effects (i.e., menopausal symptoms, change in body image and weight gain, cognitive function impairment, fertility damage/preservation, long-term organ dysfunction, sexuality) and the social impact of diagnosis and treatment (i.e., job discrimination, family management) should be carefully addressed when planning long-lasting endocrine therapies in young women with hormone-receptor positive early and advanced breast cancer.
    Journal of thoracic disease. 06/2013; 5(Suppl 1):S36-46.
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    ABSTRACT: In clinical practice, the surveillance and follow-up of patients with breast cancer (BC) is quite variable. At the 7th European Breast Cancer Conference, the ESO-MBC Task Force convened a series of lectures, followed by open debate, on the use of physical examination, imaging, and laboratory tests in patients with early-stage BC, and for restaging evaluations and follow-up among patients with MBC. Based on the available data, the Task Force recommends against intensive, routine radiologic or blood-based surveillance (with the exception of mammography) in patients with early-stage BC. As systemic therapies for MBC continue to improve, this question might be re-visited in the context of a carefully controlled clinical trial in specific BC subtypes. For patients with MBC, response to therapy should generally be assessed 2–3 months after initiation of treatment, and thereafter every 2–4 months for endocrine therapy or every 2–4 cycles for chemotherapy, depending on the dynamics of the disease, the location and extent of metastatic involvement, and type of treatment. Additional testing should be performed irrespective of the planned intervals if progression of disease is suspected (e.g. in the case of specific symptoms). Use of tumor markers is not recommended for surveillance of early-stage patients, but may be helpful in monitoring response to therapy in patients with metastatic disease. However, change in tumor markers alone should not be used for decision-making. Moving forward, enhanced efforts to document quality of life over time should be made in order to more fully evaluate the risk/benefit ratio of available options.
    The Breast. 06/2013; 22(3):203–210.
  • Alexandre Christinat, Olivia Pagani
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    ABSTRACT: In unselected populations, less than 10% of breast cancers are associated with germline mutations in predisposing genes. Breast cancer type 1 and 2 (BRCA1 and BRCA2) susceptibility genes are the most common involved genes and confer a 10-30 times higher risk of developing the disease compared to the general population. A personal or family history suggestive of inherited breast cancer syndrome may be further evaluated to assess the risk of genetic predisposition and the presence of a genetic mutation. Breast cancer genetic counseling should include a careful risk assessment with associated psychosocial evaluation and support, possible molecular testing, personalized discussion of results. Knowledge of BRCA status can influence individualized cancer risk-reduction strategies. i.e. active surveillance, prophylactic surgery and/or pharmacoprevention.
    Breast (Edinburgh, Scotland) 05/2013; · 2.09 Impact Factor
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    ABSTRACT: Background Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease. Methods Between Feb 2, 2003, and Jan 31, 2012, we recruited postmenopausal women aged 40–70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specific criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratified by country and was done with blocks (size six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation; only the trial statistician was unmasked. The primary endpoint was histologically confirmed breast cancer (invasive cancers or non-invasive ductal carcinoma in situ). Analyses were done by intention to treat. This trial is registered, number ISRCTN31488319. Findings 1920 women were randomly assigned to receive anastrozole and 1944 to placebo. After a median follow-up of 5·0 years (IQR 3·0–7·1), 40 women in the anastrozole group (2%) and 85 in the placebo group (4%) had developed breast cancer (hazard ratio 0·47, 95% CI 0·32–0·68, p<0·0001). The predicted cumulative incidence of all breast cancers after 7 years was 5·6% in the placebo group and 2·8% in the anastrozole group. 18 deaths were reported in the anastrozole group and 17 in the placebo group, and no specific causes were more common in one group than the other (p=0·836). Interpretation Anastrozole effectively reduces incidence of breast cancer in high-risk postmenopausal women. This finding, along with the fact that most of the side-effects associated with oestrogen deprivation were not attributable to treatment, provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer. Funding Cancer Research UK, the National Health and Medical Research Council Australia, Sanofi-Aventis, and AstraZeneca.
    The Lancet 01/2013; · 39.21 Impact Factor
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    ABSTRACT: EUSOMA (The European Society of Breast Cancer Specialists) is committed to writing recommendations on different topics of breast cancer care which can be easily adopted and used by health professionals dedicated to the care of patients with breast cancer in their daily practice. In 2011, EUSOMA identified the management of young women with breast cancer as one of the hot topics for which a consensus among European experts was needed. Therefore, the society recently organised a workshop to define such recommendations. Thirteen experts from the different disciplines met for two days to discuss the topic. This international and multidisciplinary panel thoroughly reviewed the literature in order to prepare evidence-based recommendations. During the meeting, two working groups were set up to discuss in detail diagnosis and loco-regional and systemic treatments, including both group aspects of psychology and sexuality. The conclusions reached by the working groups were then discussed in a plenary session to reach panel consensus. Whenever possible, a measure of the level of evidence (LoE) from 1 (the highest) to 4 (the lowest) degree, based on the methodology proposed by the US Agency for Healthcare Research and Quality (AHRQ), was assigned to each recommendation. The present manuscript presents the recommendations of this consensus group for the management of young women with breast cancer in daily clinical practice.
    European journal of cancer (Oxford, England: 1990) 10/2012; · 4.12 Impact Factor
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    Alexandre Christinat, Olivia Pagani
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    ABSTRACT: Breast cancer is the most common tumor in childbearing women. In the last decades, considerable improvement in breast cancer-related death has been achieved with adjuvant therapies (chemotherapy, endocrine and targeted therapies, radiotherapy) but at cost of significant long-term sequels, including infertility. Reproductive issues are of great importance to young women, in particular for those who did not complete their families before breast cancer diagnosis: patients should be adequately informed at the time of diagnosis about the risk of infertility and the available methods for fertility preservation. This review will focus on incidence and impact of infertility secondary to breast cancer treatment, the available options for ovarian function preservation, including embryo and oocyte cryopreservation, ovarian tissue cryopreservation, and ovarian suppression with gonadotropin-releasing hormone agonists. We will also discuss the optimal time of subsequent pregnancy, the potential risks for the mother and the fetus, and the impact of therapies on breastfeeding.
    Maturitas 09/2012; 73(3):191-6. · 2.84 Impact Factor
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    Olivia Pagani, Hatem Azim
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    ABSTRACT: Most young breast cancer survivors consider reproductive issues to be of great importance, but many questions remain undervalued and unanswered. Overall, available data support the safety and feasibility of pregnancy and breastfeeding after breast cancer. The accuracy of the evidence is however limited by: i) the retrospective and frequently incomplete population-based nature of the data, ii) data not representing the entire population, iii) patient-related effects, iv) underpowered sample size, and v) lack of control for biological factors and risk determinants. We review the available evidence in light of these limitations which outline the need for prospective data collection and focused priority research.
    Breast Care 06/2012; 7(3):210-214. · 0.68 Impact Factor
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    ABSTRACT: In the BIG 1-98 trial objective cognitive function improved in postmenopausal women 1 year after cessation of adjuvant endocrine therapy for breast cancer. This report evaluates changes in subjective cognitive function (SCF). One hundred postmenopausal women, randomised to receive 5 years of adjuvant tamoxifen, letrozole, or a sequence of the two, completed self-reported measures on SCF, psychological distress, fatigue, and quality of life during the fifth year of trial treatment (year 5) and 1 year after treatment completion (year 6). Changes between years 5 and 6 were evaluated using the Wilcoxon signed-rank test. Subjective cognitive function and its correlates were explored. Subjective cognitive function and the other patient-reported outcomes did not change significantly after cessation of endocrine therapy with the exception of improvement for hot flushes (P=0.0005). No difference in changes was found between women taking tamoxifen or letrozole. Subjective cognitive function was the only psychosocial outcome with a substantial correlation between year 5 and 6 (Spearman's R=0.80). Correlations between SCF and the other patient-reported outcomes were generally low. Improved objective cognitive function but not SCF occur following cessation of adjuvant endocrine therapy in the BIG 1-98 trial. The substantial correlation of SCF scores over time may represent a stable attribute.
    British Journal of Cancer 04/2012; 106(10):1618-25. · 5.08 Impact Factor

Publication Stats

1k Citations
538.07 Total Impact Points

Institutions

  • 1998–2014
    • Ente Ospedaliero Cantonale
      Bellinzona, Ticino, Switzerland
  • 2013
    • Oncologist Institute of Southern Switzerland
      Bellinzona, Ticino, Switzerland
    • Medical University of Gdansk
      • Department of Oncology and Radiotherapy
      Danzig, Pomeranian Voivodeship, Poland
  • 2006–2013
    • International Breast Cancer Study Group
      Berna, Bern, Switzerland
    • University of Zurich
      Zürich, Zurich, Switzerland
  • 2005–2012
    • Schweizerischen Arbeitsgemeinschaft für Klinische Krebsforschung
      Berna, Bern, Switzerland
  • 2009
    • University of Sydney
      • School of Public Health
      Sydney, New South Wales, Australia
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      Meldola, Emilia-Romagna, Italy
  • 2007
    • Inselspital, Universitätsspital Bern
      • Department of Medical Oncology
      Berna, Bern, Switzerland
  • 1998–2007
    • IEO - Istituto Europeo di Oncologia
      • Department of Medical Oncology
      Milano, Lombardy, Italy
    • Dana-Farber Cancer Institute
      • Department of Biostatistics and Computational Biology
      Boston, MA, United States
  • 2004–2005
    • Kantonsspital St. Gallen
      San Gallo, Saint Gallen, Switzerland
  • 2000
    • University of Lugano
      Lugano, Ticino, Switzerland