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In breast cancer survivors (BCS), the contemporaneous increase of sedentary time and reduction of physical activity (PA) requires early attention because it has negative consequences for their health. Aims of the study were to investigate: a) the correlations between PA, sedentarism, and health-related measures; b) the association between different patterns of daily activity and health-related outcomes. Two hundred and nineteen BCS (50.98 ± 6.28) were selected for this study. Psychological, anthropometric, endocrine, sleeping, and both daily sedentary time and PA variables were considered. Sedentarism and PA have opposite correlations with anthropometric variables, anxiety, depression, morning salivary cortisol, and sleeping characteristics. The first favors pathological values and the latter favors normal values. Regression tree analysis showed the impact of different daily sedentary time and PA combinations on the investigated variables and allowed the individualization of their optimal combination for health. Our results could be useful to healthcare providers and BCS.

Aims: We analysed the impact of the SARS-CoV-2 pandemic (COVID-19) on the quality of breast cancer care in certified EUSOMA (European Society of Breast Cancer Specialists) breast centres.Materials and methods: The results of the EUSOMA quality indicators were compared, based on pseudonymised individual records, for the periods 1 March 2020 till 30 June 2020 (first COVID-19 peak in most countries in Europe) and 1 March 2019 till 30 June 2019. In addition, a questionnaire was sent to the participating Centres for investigating the impact of the COVID-19 pandemic on the organisation and the quality of breast cancer care.Results: Forty-five centres provided data and 31 (67%) responded to the questionnaire. The total number of new cases dropped by 19% and there was a small significant higher tumour (p = 0.003) and lymph node (p = 0.011) stage at presentation. Comparing quality indicators (12,736 patients) by multivariable analysis showed mostly non-significant differences. Surgery could be performed in a COVID-free zone in 94% of the centres, COVID testing was performed before surgery in 96% of the centres, and surgical case load was reduced in 55% of the centres. Modifications of the indications for neoadjuvant endocrine therapy, chemotherapy, and targeted therapy were necessary in 23%, 23%, and 10% of the centres; changes in indications for adjuvant endocrine, chemo-, targeted, immune, and radiotherapy in 3%, 19%, 3%, 6%, and 10%, respectively.Conclusion: Quality of breast cancer care was well maintained in EUSOMA breast centres during the first wave of the COVID-19 pandemic. A small but significantly higher tumour and lymph node stage at presentation was observed.

Purpose Axillary management remains unclear when sentinel lymph node (SLN) results are positive in cN0 patients with breast cancer (BC). The trial ACOSOG Z0011 represented a revolution with axillary lymph node dissection (ALND) omission in SLN+ patients, despite critiques regarding non-uniformity of radiation fields. We conducted an observational study (LISEN) where whole breast radiotherapy (WBRT) was planned with tangential fields without nodal irradiation in patients eligible for the Z0011 trial. Methods Inclusion criteria were female patients with histologically proven BC, cT1-2cN0, planned conservative surgery, no neoadjuvant therapy. Patients were stratified into two groups: micrometastatic (pN1mic, group 1) and macrometastatic (pN1a, group 2) lymph nodes. Tangential field WBRT was mandatory. Clinical outcomes were analysed, measured from surgery until the first event. Results In all, 199 patients underwent conservative surgery and SLN biopsy; 133 patients meeting criteria were analysed: 41 patients (30.8%) pN1mic and 92 (69.2%) pN1a. The 5‑year disease-free survival (DFS) was 95.0% (85.9–100%) in group 1 and 93.0% (86.3–100.0%) in group 2 (p = 0.78). Overall survival (OS) was 100% (100–100%) in group 1 and 97.4% (92.4–100%) in group 2 (p = 0.74). For the whole cohort DFS and OS were 93.6% (88.2–99.4%) and 96.9% (91.5–100.0%), respectively. For groups 1 and 2, the 5‑year outcomes were 5.0% (0.0–14.4%) and 2.3% (0.0–6.1%) for local recurrence (p = 0.51), and 6.2% (0.0–17.4%) and 7.0% (0.0–13.7%) for distant metastasis (p = 0.61), respectively. In group 1, regional recurrence (RR) and local regional recurrence (LRR) were 5.0% (0.0–14.1%; p = 0.13). In group 2, RR and LRR were 0.0% (0.0–0.0%). Conclusion Our results showed good regional control in patients who met the Z0011 trial criteria. WBRT, without nodal surgery or RT, avoiding axillary morbidity, seems to be a good choice.

Background: To prevent and fight the increase of daily sedentary time and to promote and stimulate the positive effects of physical activity and exercise on health, both traditional interventions and new strategies are important for breast cancer survivors (BCS). The research goal was to compare the effects of weekly personal feedback, based on objectively measured physical activity, on the trends of both daily sedentary time and on the physical activity of BCS (E− group) with those of an intervention also including online supervised physical exercise sessions (E+ group), during the Italy COVID-19 lockdown. Methods: The Italian COVID-19 emergency allowed the possibility to also observe the effects of social and personal limitations. A total of 51 BCS were studied over an 18-week period and had an objective registration of day-to-day sedentary time, physical activity, and sleep. Both subsamples received weekly or fortnight personal feedback. Data were analysed considering four key periods, according to the COVID-19 emergency steps. Results: Statistical analysis showed an additive effect for sedentary time and a multiplicative effect both for light-to vigorous and light-intensity physical activities. The E− group had a high overall sedentary time and a different trend of light-to vigorous and light-intensity physical activities, with a reduction from the 1st to the 2nd periods (national and personal restrictions), showing a significant rise just at the end of the national restrictions. Conclusions: The use of an activity tracker and its accompanying app, with the reception of weekly tailored advice and supervised online physical exercise sessions, can elicit proper physical activity recomposition in BCS in the COVID-19 era.

The aim of the study was to compare the effects of weekly personal feedback, based on objectively measured physical activity, on daily sleep in breast cancer survivors (BCS) with those of an intervention that also included online supervised physical exercise sessions (OSPES). BCS benefiting from both personal feedback and OSPES (n = 24), from pre-lockdown (T0) to the first month (T1) of the national lockdown, experienced an increase in both total (p ≤ 0.001) and restorative (p ≤ 0.001) sleep time, inverting their trend from the first month of lockdown to its end (total sleeping time T1 vs. T2 0.01 ≤ p

Our goal in writing this article was to offer helpful insight for a reformed interpretation and application of Rule 23 that would make the Rule serve its intended democratic function. The idea of due process is a promise of the rule of law tempered by reasonableness, fairness, and efficiency. It embraces both the value of individual autonomy and the collective interests of the community. The idea of class actions, premised on due process, is to provide a pragmatic method of dispute resolution that is fair to the individual and responsive to the needs of the community and the challenges generated by widely spread and shared harms. In this respect, class actions operate as a tool of democracy. Rule 23 should be interpreted from this hopeful and effective perspective, one that balances individual autonomy against the legitimate needs of the community. But the Rule is not accomplishing its mission. As we show in the article, it appears to be infused with its framers’ self-doubts, and the Supreme Court treats it as an unwelcome guest in the home of traditional litigation forms—see, for example, our discussions of Ortiz v. Fibreboard Corporation (1999); Wal-Mart Stores, Inc. v. Dukes (2011); Jennings v. Rodriguez (2018); Nutraceuticals Corp. v. Lambert (2019).

As we are celebrating the 50th anniversary of the modern class action Rule — the version adopted in 1966 — the Advisory Committee is working on further revisions of Rule 23, conferences on the topic are proliferating, and the Supreme Court and lower federal courts are trying to navigate the technicalities of the current Rule. Several doctrines in the federal system have generated a frontloading trend, i.e., a trend that pushes the analysis of the merits of the claim to the very outset of the litigation, before discovery has taken place, ultimately resulting in a denial of justice. The current Rule 23 and its proposed amendments seem to follow the same trend. In the article, I unearth the frontloading trend, show how and to what extent Rule 23 and its interpretation is part of it, and propose a new Rule 23, one designed to promote the underlying litigation principles the original Rule was meant to advance. I spent my fall 2016 at the Yale Law School to work on Charles E. Clark’s Papers that are stored in the Yale’s Archives. Clark was the driving force behind the adoption of the Federal Rules. Clark’s Papers contain Clark’s thoughts, notes, sketches, ideas on the federal rules and the federal system he was designing, his philosophy of legal analysis and judicial decisionmaking. Clark’s clear procedural vision has produced Rules that have lasted, almost untouched, for almost 80 years. Inspired by Clark’s vision and ideas, my paper articulates a theory of class actions that is truthful to the design of the original Federal Rules, and proposes a new class action rule that is consistent with that theory and with Clark’s original vision for the rules.

Any democratic judicial system must be built on the principle of due process, the fountain from which all procedural rules and doctrines flourish. Understanding the scope and contours of due process is thus crucial to the development of procedural and substantive rules that could achieve the optimal results in a democratic system. Yet the scholarly articles entirely devoted to the topic are scarce to say the least, and most of the relevant monographs have not articulated a theory of due process, but largely provide an historical overview or a survey of the rights that are commonly understood as due process rights. A theory of due process is missing and this deficiency has, in my opinion, contributed to the lack of a true understanding and, thus, truthful, real investment of the system in the principle. An article cannot do justice to the complexities and depth of the due process principle. But there are some ideas and insights I thought I might share here, to start defining the theory of procedural due process, and prompt deeper judicial investigation and scholarship on this topic.

The decision of the California Supreme Court in Bristol-Myers Squibb Co. v. Superior Court, 1 Cal.5th 783 (2016), is fully consistent with the due process standards recognized by this Court in International Shoe Co. v. Washington, 326 U.S. 310 (1945), as well as with recent doctrinal developments applying and elaborating those standards. The state high court’s substantial connection standard bridges the jurisdictional lacuna between specific and general jurisdiction and operates in a manner that is fully consistent with the federal common law doctrine of pendent personal jurisdiction. We, therefore, urge this Court to affirm the decision of the California Supreme Court.

This brief is written on behalf of a group of law professors who teach and write in the areas of Civil Procedure and Federal Courts. See Appendix (listing amici). Although we conclude that respondents have adequately pled a claim upon which relief can be granted, our principal focus is not on the merits of this case, but on the procedural standards used to assess the legal sufficiency of a pleading. Our goal is to promote a coherent and workable system of pleadings that is consistent with the Federal Rules of Civil Procedure and with this Court’s precedents interpreting those rules.

Background Aromatase inhibitors (AIs) are more effective than tamoxifen as neoadjuvant endocrine therapy (NET) for hormone receptor (HR)-positive breast cancer. Here we report the surgical and long-term outcome of elderly postmenopausal patients with locally advanced, HR-positive breast cancer treated with preoperative AIs. Methods Between January 2003 and December 2012, 144 postmenopausal patients inoperable with breast conservative surgery (BCS) received letrozole, anastrozole, or exemestane as NET. Patients underwent breast surgery and received adjuvant AIs. Adjuvant systemic therapy, chemotherapy and/or trastuzumab, and adjuvant radiotherapy were administered as appropriate, but limited to high-risk patients with few or no comorbidities. Results After a median follow-up of 49 months, 4 (3.0 %) patients had local relapse, 18 (12.5 %) had distant metastases, and 24 (17.0 %) died. BCS was performed in 121 (84.0 %) patients. A tumor size

The years 1848 and 1938 were landmark years in the history of American procedural law. The first marked the advent of code pleading, and the second introduced the Federal Rules of Civil Procedure. Both developments were a product of reform movements that addressed what the reformers believed to be a procedural crisis generated by the inefficacy of the procedural system under attack. The goal was to create a system of procedure that was both efficient and instrumental to the vindication of substantive rights. In part, each crisis reflected a tension between formalism — the need for rules — and pragmatism — the need for flexibility. Hence, the early codes offered a code-based system that was structured but significantly less so than the common law system it replaced. The Federal Rules aimed to do the same in response to the codes. The difficulty facing both sets of reformers was that their respective tasks of reform required the imposition of rules and at the same time required a pragmatic but principled approach to applying those rules. It seems though that a rule-based system eventually drifts toward the rules and away from pragmatism. Thus, at some point the rules of code pleading came to dominate the instrumental goals of that system. The same appears to be happening with the law of federal courts, including both the Federal Rules and doctrinal procedural law beyond those rules. I believe we are now in the midst of a procedural crisis, but it is not one that requires a new set of rules. Rather it is one that requires a readjustment of the way we think about the current rules and doctrines. This article invites a rethinking of the law of federal courts, including both the rules and the doctrines. It invites a return to the principles that originally animated the Federal Rules, and to the idea of natural lawyering and judging that inspired Charles Clark. The article builds upon the idea of a convenient litigation unit as central to the dispute resolution mission of federal courts, that is, saying what the law is, adhering to the rule of law, and enforcing the checks and balances of our constitutional system.

The law of federal procedure is on the Supreme Court’s docket for the October 2016 Term, with granted petitions addressing pleading sufficiency, standing, and jurisdiction. And, of course, the Advisory Committee on Rules of Civil Procedure continues its annual tinkering with the rules in an elusive effort to micromanage federal practice. That reality, coupled with recent exchanges with colleagues on procedural interpretation and reform, has prompted these reflections on the role of procedure in our democratic system. This short essay is intended to summarize those reflections, which are more extensively elaborated in my other works.

The district court’s application of Rule 23 is fundamentally at odds with the philosophy of the Federal Rules and their intended mission to promote “the just, speedy, and inexpensive determination of every action and proceeding.” It frontloads the merits and discards the case before it can be fully developed. In essence, the district court opinion transforms a motion for certification into a motion for summary judgment. This treats the Federal Rules as independent obstacle to litigation process. But the Federal Rules must be read as outlining a system of procedure that is holistic and designed to give each case its rightful and thorough consideration. It is true that this more aggressive approach to access of justice might promote efficiency, help clear the docket, and provide solace to a wide array of institutional defendants. But judicial efficiency is only a legitimate value to the extent that it advances the project of justice; and a clear docket is not necessarily a just one. In this brief, we show how the district court’s reading and application of Rule 23 provides a crude method through which to dispose of a case, for it exalts case management considerations and the formality of procedure over substantive rights, and it does so without consideration of countervailing costs and consequences. The standard imposed by the district court is also in deep tension with the judicial obligation to provide a forum for the vindication of individual claims of right and with our constitutional commitment to the rule of law. Thus, we argue, the district court’s ruling demands reversal.

The essay offers an analysis of Venezuela v. Helmerich & Payne International, a case to be argued before the Supreme Court on November 2. That case involves the interpretation and application of the Foreign Sovereign Immunities Act (FSIA). The question presented is whether, when pleading jurisdiction under the expropriation exception to the FSIA, a higher pleading standard should be employed, one under which it is necessary to show that there “actually is” a claim, essentially requiring the plaintiff to establish something more exacting than the plausibility standard. The Petitioners’ argument in Helmerich presents a classic example of arguing from a conception — sovereign immunity — to an abstract but controlling proposition of law. A more realistic approach, one that examines the facts, is put to the side in the interest of the conception. This essay resists that approach and promotes a jurisdictional and pleading analysis that is conducive to the evolution of substantive law and the enforcement of substantive rights.

At the core of every liberal democracy is a commitment to a wide range of individual rights. The recognition and evolution of those rights is a lively topic of public debate. Procedural law, on the other hand, is well below the public radar. Yet, federal practice and procedure are silently eroding our system of democracy through a mechanical and fragmented approach to procedure that is increasingly detached from the litigation mission in a manner that elevates form over substance, prevents the creation and enforcement of rights, and ultimately denies access to justice. This article is part of a larger project intended to change the way we think about and approach procedural law and procedural reform at the federal level. My goal is to unearth the unifying principles of federal procedure and practice, and use them to design a system that promotes the coherent, fair, and efficient creation and enforcement of substantive rights. To that end, I elaborate a theory of federal procedure and practice that assigns to the claim, the essential litigation unit, a central role in litigation analysis and reform. Testing the federal rules and procedural doctrines against the claim helps us see when procedure, operating at a very high level of abstraction and formalism, suffocates substantive law and justice, thus failing to accomplish its essential mission of means in the creation and enforcement of substantive rights. Once identified the flaws in our procedural system, the project formulates reform proposals that are intended to return the rules and doctrines to the right balance between formalism and pragmatism, one essential for the rules and doctrines to accomplish their mission. Zooming in on the claim is crucial in this respect.

Purpose The aim of this study is to evaluate the long-term outcome of patients with locally advanced breast cancer treated with neoadjuvant systemic chemotherapy (NST) in routine clinical practice. Methods Four hundred and nine patients were identified between January 1999 and December 2011. All patients received NST followed by surgery, adjuvant treatments and radiotherapy, as appropriate. Results At Kaplan–Meier analysis, patients with surgical stage III disease were more likely to develop distant metastasis and die from breast cancer (p

Comparative analysis of civil proceedings requires an in-depth study of the structure and most distinguishing elements of each country involved. It has the goal of identifying the rationales and features that make each country unique. It is commonly misconceived that common law systems rely solely on the authority of precedent and civil law systems rely only on the authority of statutes and codes. This article demonstrates that the Italian and the U.S. legal systems are not purely inquisitorial nor purely adversarial, but that they share similarities and can learn from each other.

FANCM binds and remodels replication fork structures in vitro. We report that in vivo, FANCM controls DNA chain elongation in an ATPase-dependent manner. In the presence of replication inhibitors that do not damage DNA, FANCM counteracts fork movement, possibly by remodelling fork structures. Conversely, through damaged DNA, FANCM promotes replication and recovers stalled forks. Hence, the impact of FANCM on fork progression depends on the underlying hindrance. We further report that signalling through the checkpoint effector kinase Chk1 prevents FANCM from degradation by the proteasome after exposure to DNA damage. FANCM also acts in a feedback loop to stabilize Chk1. We propose that FANCM is a ringmaster in the response to replication stress by physically altering replication fork structures and by providing a tight link to S-phase checkpoint signalling.

This book studies the US Supreme Court and its current common law approach to judicial decision making from a national and transnational perspective. The Supreme Court's approach appears detached from and inconsistent with the underlying fundamental principles that ought to guide it, which often leads to unfair and inefficient results. This book suggests the adoption of a judicial decision-making model that proceeds from principles and rules, using them as premises for developing consistent unitary theories to meet current social conditions. This model requires that judicial opinions be informed by a wide range of considerations, including established legal standards, the insights derived from deductive and inductive reasoning, the lessons learned from history and custom, and an examination of the social and economic consequences of the decision.

The regulation of telomerase action, and its coordination with conventional DNA replication and chromosome end “capping,” are still poorly understood. Here we describe a genetic screen in yeast for mutants with relaxed telomere length regulation, and the identification of Pol12, the B subunit of the DNA polymerase α (Pol1)-primase complex, as a new factor involved in this process. Unlike many POL1 and POL12 mutations, which also cause telomere elongation, the pol12-216 mutation described here does not lead to either reduced Pol1 function, increased telomeric single-stranded DNA, or a reduction in telomeric gene silencing. Instead, and again unlike mutations affecting POL1, pol12-216 is lethal in combination with a mutation in the telomere end-binding and capping protein Stn1. Significantly, Pol12 and Stn1 interact in both two-hybrid and biochemical assays, and their synthetic-lethal interaction appears to be caused, at least in part, by a loss of telomere capping. These data reveal a novel function for Pol12 and a new connection between DNA polymerase α and Stn1. We propose that Pol12, together with Stn1, plays a key role in linking telomerase action with the completion of lagging strand synthesis, and in a regulatory step required for telomere capping.