The ethical plausibility of the ‘Right To Try’ laws

This is the author accepted manuscript. The final version is available from Elsevier via the DOI in this record.‘Right To Try’ (RTT) laws originated in the USA to allow terminally ill patients to request access to early stage experimental medical products directly from the producer, removing the oversight and approval of the Food and Drug Administration. These laws have received significant media attention and almost equally unanimous criticism by the bioethics, clinical and scientific communities. They touch indeed on complex issues such as the conflict between individual and public interest, and the public understanding of medical research and its regulation. The increased awareness around RTT laws means that healthcare providers directly involved in the management of patients with life-threatening conditions such as cancer, infective, or neurologic conditions will deal more frequently with patients’ requests of access to experimental medical products. This paper aims to assess the ethical plausibility of the RTT laws, and to suggest some possible ethical tools and considerations to address the main issues they touch.This paper was funded by the European School of Oncology

Risk of cancer after assisted reproduction: a review of the available evidences and guidance to fertility counselors

Infertile women requiring ovarian stimulation and assisted reproduction techniques (ART) are faced with difficult issues. The fear that using hormones could increase their risk of cancer is the most significant. One of the main challenges for assessing cancer risk after ART is the difficulty to separate it from the underlying condition of infertility per se. The delay or the inability to achieve a pregnancy is an important risk factor for breast, endometrial and ovarian cancer. We analyzed the current literature on the topic

Communication skills and raising awareness in clinical practice: an Italian experience

Following reflection by a member of the healthcare team relating to a particularly difficult situation where communication between the healthcare professional, patient and family was felt to be challenging, there was a general consensus of interest in how we communicate, best practice methods and training opportunities. In order to look at the communication practice, skills and training within the department, it was felt best to identify how the team felt about their own communications skills as a baseline for development of this area of practice

Multiple Approaches for Individualized Fertility Protective Therapy in Cancer Patients

In the last decade, fertility preservation has risen as a major field of interest, creating new interactions between oncologists and gynecologists. Various options, such as cryopreservation of ovarian tissue, have been developed and are currently routinely proposed in many centers. However, many of the options remain experimental and should be offered to patients only after adequate counseling. This paper addresses the efficiency and the potential of the different fertility preservation approaches

Fertility preservation in ovarian tumours

A considerable number of patients with a cancer diagnosis are of childbearing age and have not satisfied their desire for a family. Despite ovarian cancer (OC) usually occurring in older patients, 3%–14% are diagnosed at a fertile age with the overall 5-year survival rate being 91.2% in women ≤44 years of age when it is found at 1A–B stage. In this scenario, testing the safety and the efficacy of fertility sparing strategies in OC patients is very important overall in terms of quality of life. Unfortunately, the lack of randomised trials to validate conservative approaches does not guarantee the safety of fertility preservation strategies. However, evidence-based data from descriptive series suggest that in selected cases, the preservation of the uterus and at least one part of the ovary does not lead to a high risk of relapse. This conservative surgery helps to maintain organ function, giving patients of childbearing age the possibility to preserve their fertility. We hereby analysed the main evidence from the international literature on this topic in order to highlight the selected criteria for conservative management of OC patients, including healthy BRCA mutations carriers

Chemotherapy-related damage to ovarian reserve in childhood cancer survivors : interpreting the evidence

Chemotherapy during childhood damages ovarian reserve and can affect future fertility. However, recent large epidemiological studies showed that the detrimental impact on fertility is less severe if women seek for pregnancy at a younger age. To explain this observation, we hypothesize that the detrimental effects of previous chemotherapy on the ovarian reserve may be attenuated in young adults for two main reasons. Firstly, recent evidence showed that the amount of ovarian reserve is not a critical factor for effective natural conceptions. Provided that the residual ovarian reserve allows regular ovulatory cycles, the chances of pregnancy are similar in women with intact or reduced ovarian reserve. Secondly, ovarian reserve depletion appears to be a phenomenon that is inversely related to the residual ovarian reserve rather than to age. From a mathematical perspective, this kind of regulation intrinsically attenuates the effects of an early loss of a significant amount of primordial follicles. In conclusion, the detrimental effects of chemotherapy on natural fertility may be less severe if women with a history of chemotherapy during childhood seek for pregnancy early. This information should be part of the counseling

Psychological issues and construction of the mother-child relationship in women with cancer during pregnancy : a perspective on current and future directions

BACKGROUND: Cancer during pregnancy is a rare event. However, knowledge about treatment has progressed in recent years with improved maternal and neonatal outcomes. The number of women who decide to continue their pregnancy and undergo cancer treatment is increasing. MAIN BODY: Women face two critical events simultaneously; oncological illness and pregnancy, with different and conflicting emotions. In addition, the last trimester of gestation sets the ground for construction of the mother-child relationship, which is of great importance for the child's development. Studies have showed that maternal exposure to stressful events during pregnancy is linked to adverse outcomes in children. Although several authors consider cancer to be a 'critical life event', studies that address the psychosocial implications of cancer in expecting mothers are scarce. There are no studies addressing the possible negative impact of a cancer diagnosis during pregnancy on the mother-child relationship and on the child's development. It is important to emphasize the need for in-depth knowledge of the contributing psychological factors involved in order to provide holistic, individualised, and supportive care. CONCLUSION: An analysis of cognitive aspects, emotional processes, and maternal attachment in cases of cancer during pregnancy may contribute to the development of a model of care, both in an evolutionary and in a psycho-oncology context, with implications for clinical practice

Frequency of Pregnancy‐Associated Cancer: A Systematic Review of Population‐Based Studies

Despite numerous available resources of evidence, the results about the frequency of pregnancy\u2010associated cancer (PAC) still show poor comparability due to dissimilarities in the study design and methodology, inclusion criteria, incoherent duration of follow\u2010up and a heterogeneous reference population. We conducted a systematic review of population\u2010based studies on PAC published up to December 2019, to provide updated research on this topic, highlighting strengths and limitations. Of the 24 papers included, 11 considered all types of tumors and 13 dealt with specific types of cancer. Differences in the procedures for estimating the frequency of PAC emerged even among population studies. However, we found consistent results for overall frequency of PAC\u2014 around 1/1000 pregnancies. Our review suggests that about 25% of PAC cases are diagnosed during pregnancy, confirming the hypothesis of an excess of diagnosis in the postpregnancy period. Sparse and inconsistent results were found regarding a potential increase in the frequency of PAC over calendar years. Alignments in the strategy to identify PAC are needed to overcome methodological weaknesses

Cancer Predisposition Genes in Adolescents and Young Adults (AYAs): a Review Paper from the Italian AYA Working Group

Purpose of Review: The present narrative systematic review summarizes current knowledge on germline gene mutations predisposing to solid tumors in adolescents and young adults (AYAs). Recent Findings: AYAs with cancer represent a particular group of patients with specific challenging characteristics and yet unmet needs. A significant percentage of AYA patients carry pathogenic or likely pathogenic variants (PV/LPVs) in cancer predisposition genes. Nevertheless, knowledge on spectrum, frequency, and clinical implications of germline variants in AYAs with solid tumors is limited. Summary: The identification of PV/LPV in AYA is especially critical given the need for appropriate communicative strategies, risk of second primary cancers, need for personalized long-term surveillance, potential reproductive implications, and cascade testing of at-risk family members. Moreover, these gene alterations may potentially provide novel biomarkers and therapeutic targets that are lacking in AYA patients. Among young adults with early-onset phenotypes of malignancies typically presenting at later ages, the increased prevalence of germline PV/LPVs supports a role for genetic counseling and testing irrespective of tumor type