новая папка / Operative Standards for Cancer Surgery Volume I 1st Edition

Editorial

BREAST SURGERY AS AN ESSENTIAL COMPONENT OF

MULTIDISCIPLINARY BREAST CANCER MANAGEMENT

The preceding chapters on breast surgery will be important and valuable for all surgeons treating breast cancer, including surgical trainees preparing for their boards. They establish a standardized surgical approach that all of us as breast surgeons should be following, regardless of our practice setting, frequency of seeing breast cancer patients, or level of training and experience. The management of breast cancer, including the surgical procedure itself, is among the most complex decision making in all of medicine and one of the most rapidly changing. Most patients will receive some combination or sequence of surgery, systemic therapy (hormone therapy, targeted therapy, or chemotherapy), and radiation therapy. Selecting these options is enhanced by the use of biomarkers that identify both metastatic risk and selection of treatments based on molecular and/or genetic markers. Then there is the individual’s perception of “quality of life” issues that must also be taken into account. The many advances being made enable us to better customize our multidisciplinary management to improve the quality and quantity of breast cancer patients regardless of their presenting stage of disease.

This series of chapters on surgical management of breast cancer, along with the other chapters in this book, represent a brilliant strategy by the editors to define optimal standards of intraoperative surgery as an essential component of multidisciplinary cancer care. Without standards, patients may get the wrong operation, however well done technically (errors of commission), or they may get inadequate surgery (errors of commission) that diminish the primary goal of surgery to properly stage the patient’s disease and to achieve complete local and regional cancer control. Either of these scenarios can result in recurrent disease that may result in debilitating symptoms and cause the patient to undergo reoperation. Or it may thwart the value of the systemic treatment (chemotherapy and/or hormone therapy), which in turn may cause a misinterpretation of recurrent disease as a failure of systemic treatment instead of an avoidable surgical failure. As a result, patients go through the devastating emotional consequences of a “cancer relapse” and the physical consequence of going to secondline systemic treatments (with lower success rates and oftentimes greater toxicity) that could have been avoided with a properly conducted operation in the correct setting. We and others have published about the value of surgical specialization, the importance of surgical standards, and how quality of surgical management can make a difference in all three goals of surgery: proper pathologic staging, local and regional cancer control, and even

improved survival rates.1,2,3,4,5,6

The goal of making the final decision about surgical management of the breast cancer—in partnership with each patient—is to maximize the long-term results with regards to local disease control, symmetry of the breasts, cosmetic appearance, and emotional state. We are achieving this today in the clinical setting where women with breast cancer are evaluated by a multidisciplinary team of breast specialists and patient advocates/survivors in a dedicated breast center. These women

P.78 come prepared with a more informed and empowered ability to participate in decision making with regard to their breast management. The teamwork and coordination between the breast imaging specialists, breast oncology surgeons, breast reconstruction surgeons, and breast radiation oncologists have also resulted in better staging and consistent patient recommendations. To ensure that all women have access to a range of surgical treatment options, we should continue to make refinements in breast surgery and a consistency of surgical outcomes, wherever the patient is being treated. In addition, we need to ensure that all women have access to educational material that is evidence-based, understandable, and balanced.

In conclusion, surgeons are constantly making recommendations to our cancer patients that balance both quantity and quality of life; nowhere is this more important than in breast cancer. Patients benefit from our

Introduction

Lung cancer is the leading cause of cancer-related death in the United States. In 2013, about 226,000 new

cases of lung cancer were diagnosed, and about 160,000 people died from the disease.1 Only 15.9% of lung

cancer patients are alive 5 years after their diagnosis.2 Improvements in treatment approaches and a better understanding of early detection, prognostic markers, and targeted therapy have elicited much progress against the disease in the past 10 years. As we gain more knowledge to further refine diagnostic and treatment modalities, the care of lung cancer patients will only become more complex and nuanced.

About 85% of lung cancers are non-small cell lung cancer (NSCLC), and approximately 90% of NSCLCs are related to tobacco exposure. Despite recent advances in both screening and imaging, only approximately 30% of NSCLCs are diagnosed at an early stage, meaning that the majority of these cancers are diagnosed when they are no longer amenable to complete surgical resection. The paradigm of care for NSCLC patients lies in multidisciplinary evaluation, a process that integrates the expertise of specialists such as surgeons, medical oncologists, radiation oncologists, pulmonologists, radiologists, and pathologists to provide individualized therapy. Within this paradigm, surgical resection has long been the standard treatment for patients with resectable stage I to IIIA NSCLC. However, surgeons’ practices for providing such treatment vary greatly. Large database analysis have revealed differences in morbidity, mortality, and long-term patient outcome when lung resections are performed by specialty-trained thoracic surgeons over cardiothoracic surgeons or general

surgeons.3 Setting standards to define systematic approaches to staging lung cancer and treating lung cancer patients is imperative to minimizing such wide variations in surgical practice. Doing so will improve the consistency and completeness of common thoracic oncologic surgeries and thereby improve patient outcomes.

Scope

Although surgery is often integrated with other modalities in lung cancer care, this section focuses on only the technical components and considerations governing the key operations that are important to ensuring that lung cancer patients receive highquality multidisciplinary care. These key operations include procedures that are the cornerstones of clinical staging (e.g., mediastinal staging) and surgical treatment (e.g., lung resection).

The section also provides a broad set of collective recommendations guiding the surgical care of lung cancer patients. These recommendations take into account the fact that patients’ care requirements depend on individual clinical scenarios and may vary to a high degree and that best practices are continuously evolving as new evidence accrues. Each key operation is discussed in terms of its oncologic principles, specific steps, and common but avoidable pitfalls, and both minimally invasive and open approaches to these operations are discussed. At the end of each chapter, a clinically relevant question regarding a topic of current debate and ongoing scientific research is explored.

In this section, we purposefully avoid duplicating clinical guidelines for lung cancer care, such as those

established by the American College of Chest Physicians,4 by not

P.83 straying into the realm of clinical management algorithms. Although such guidelines can serve as a resource to guide the delivery of patient care, they do not explicitly address the technical aspects of the surgeries that impact outcomes. In fulfilment of this need, the following chapters describe the way in which insights taken from clinical science should be integrated into surgical approaches for lung cancer. In addition, because lung cancer surgery has many “craft” issues, stylistic tips to improve the ease or efficiency with which surgeons can perform a particular maneuver or step of an operation are also provided. Whenever possible, we describe the way in which

the recommendations were derived and the level of evidence on which these recommendations were based. In this way, we distinguish sound consensus opinions regarding the minimum expected elements of a procedure from suggestions aimed at optimizing the outcomes of the procedure.

Purpose

The purpose of this section is to describe a minimal standard for the actions that should be taken in the surgical care of lung cancer patients, with the ultimate goal of improving the quality of care these patients receive. In this way, the aim of the following chapters is to “raise the floor” rather than define the absolute ceiling of what can be achieved; further improvement is always possible. This standard should serve as a guide for surgeons who are focused on delivering high-quality care to achieve the best outcomes for their patients. Underpinning this section is the belief that the vast majority of surgeons are committed to this goal and that the lack of a definition of what constitutes good quality care is a major impediment to achieving it.

The recommendations given in the following chapters are as data-driven and evidence-based as possible. However, many of the issues discussed in this section generally have not been addressed directly in previous studies. Thus, some recommendations must be extrapolated from indirect data. In addition, the consensus opinion of the selected experts tasked with writing the following chapters permeated the production of this section, which included identifying key questions, defining gaps in knowledge or performance, judging the applicability of indirect data, and debating the validity of opinions in the absence of data. The result of this process reflects not only the authors’ efforts to provide recommendations that are as grounded in data as possible but also their use of whatever means necessary to establish a minimal standard for the surgical care of patients with lung cancer.

Quality of Care

Quality care has been defined as “the degree to which health services … increase the likelihood of desired

health outcomes and are consistent with current professional knowledge.”5 This section focuses on those aspects of lung cancer surgery that, if performed with consistent accuracy and care, likely contribute to better outcomes. However, defining and implementing quality metrics, which generally requires validation that such measures are clearly linked to better outcomes and can be applied in a variety of settings, is beyond the scope of this chapter. In addition, implementing quality metrics is inherently linked to measurement; this chapter focuses only on what should be done and does not address the ways in which one might measure this.

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Multidisciplinary Care

Although it is not a matter of surgical care, strictly speaking, working in a multidisciplinary fashion is so integral to modern cancer care that it merits emphasizing. Great surgical care done on an island will always have more limited impact. The knowledge required to effectively treat lung cancer patients is expanding rapidly and is far beyond what any one person can grasp. The care of lung cancer patients has come to involve many different treatment modalities, and providing optimal surgical care requires nuanced input from experts in multiple disciplines, including radiology and pathology.

The key to providing effective multidisciplinary care is the establishment of a regular forum in which experts from various fields discuss individual cases and collectively make treatment decisions. Simply obtaining input from another specialist when one believes it necessary is not enough. The forum enables surgeons to obtain other experts’ input about knowledge gaps they otherwise would not have identified, let alone addressed. Optimal care is best ensured with multidisciplinary input.

Many European countries mandate that cancer cases be discussed in multidisciplinary forums. Similarly, the

American College of Chest Physicians, after systematically reviewing the available literature, has recommended

that patients with stage I to III lung cancer be evaluated by a multidisciplinary team.6,7 However, quantifying the impact of this approach on patient outcomes has proven difficult, as outcomes are the result of multiple factors. Furthermore, recent studies have shown that the quality of multidisciplinary tumor board discussions can vary

significantly.8,9,10,11 A discussion of the implementation of a multidisciplinary tumor board is beyond the scope of this section; however, the setting in which surgical care is delivered (i.e., as part of a multidisciplinary team approach) and the quality of the team members’ interactions are likely important factors contributing to lung cancer patients’ quality of care and outcomes.

Staging Evaluation

Accurately identifying the clinical disease stage is a critical first step in caring for a patient with lung cancer. A detailed description of the way in which this is accomplished is the subject of clinical guidelines and beyond the scope of this section. Given the importance of accurate lung cancer staging, however, these guidelines are briefly reviewed here.

The first step in staging lung cancer is to make a clinical diagnosis and assess the certainty of this diagnosis. In the vast majority of patients with a lung mass, a diagnosis of lung cancer can be made quite reliably on the basis of radiographic findings and the patient’s risk of developing lung cancer. If the probability of lung cancer is high (>80%), proceeding with stage evaluation is more efficient than obtaining a biopsy.

Stage evaluation begins with an assessment of the likelihood of distant metastases. This assessment begins with asking the patient about the organ-specific symptoms (e.g., headache, cognitive deficit, bone pain) and nonspecific symptoms (e.g., fatigue, anorexia) of distant metastases. Staging modalities include computed tomography (CT) and positron emission tomography (PET) imaging. Current NSCLC staging

P.85 schema is shown in Figure I-1. Such a clinical evaluation is highly reliable (˜95%) if negative in patients with a stage cI cancer by CT; however, there is a 30% false negative rate if the CT demonstrates mediastinal node enlargement suggesting more advanced stage disease (stage cIII). If the clinical evaluation is positive or if CT findings demonstrate mediastinal node enlargement (clinical stage III disease), additional

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imaging studies for distant metastases are recommended and typically include PET and brain magnetic

resonance imaging.12

FIGURE I-1 TNM classification of non-small cell lung cancer based on American Joint Committee on Cancer 7th edition revisions to the staging schema. Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Seventh Edition (2010) published by Springer Science and Business Media LLC, www.springer.com.

If distant metastases are not present, determining the status of the mediastinal nodes becomes crucial. In the setting of a clinical stage I lung cancer indicated by CT with or without PET, the chance of mediastinal node

involvement is so low that invasive pretreatment node biopsy is not recommended.12 If CT reveals tumor infiltration into the mediastinum (i.e., if one can no longer recognize or measure discrete enlarged mediastinal nodes), one can be certain of mediastinal involvement based on imaging alone and invasive confirmation of node

involvement is not needed.12 However, invasive biopsy is needed to confirm CT or PET findings of discrete node enlargement (cIII disease), as the modalities have false positive rates of 15% to 40% in this setting. Similarly, in patients with central tumors or evidence of N1 node involvement, CT and PET findings that are negative for disease in the mediastinum must be confirmed using invasive methods owing to false negative rates of 20% to

30%.12

Confirmation of mediastinal node status can be accomplished invasively by mediastinoscopy, esophageal

ultrasonography, or endobronchial ultrasonography and needle aspiration. Although many studies have compared these procedures, the decision to use one or another in a particular patient often depends on nuances in the ease with which particular nodes can be accessed; the availability, skill, and experience of the operator and cytologist or pathologist; and logistical concerns. Perhaps most important of these factors is the thoroughness with which a procedure is performed. Defining the technical aspects of these procedures is the focus of this section.

A general principle of mediastinal assessment is that it should be done systematically. Guidelines from the

European Society of Thoracic Surgeons and the American College of Chest Physicians12,13 recommend exploration and biopsy of representative nodes in the five mediastinal node stations (2R, 2L, 4R, 4L, and 7). Studies have shown that N2 involvement is detected approximately twice as often with systematic sampling than

with selective nodal sampling.14,15,16,17 Similarly, clinical guidelines recommend that intraoperative nodal staging involve systematic sampling or either a complete or lobe-specific mediastinal node dissection for the

same reasons.18,19,20

Current Staging and Synoptic of Staging System

The recurrent theme of this chapter on lung cancer will be the careful assessment of lymph node involvement. Although T status is of importance, in patients without metastatic disease, nodal involvement (both N1 and N2) is

perhaps the greatest determinant of treatment failure and decreased long-term survival (Fig. I-2).21

In some instances, the presence of nodal disease in the mediastinum (N2) (Fig. I-3) precludes surgical resection.

This is an area of active debate to determine the best therapy for these patients.22 It is best practice to review clinical staging data in a prospective manner, with a dedicated thoracic team including surgeons, pulmonologists, and medical and radiation oncologists to determine the role, if any, of neoadjuvant therapy in patients with more

advanced disease.6 Furthermore, accurate pathologic staging is necessary to determine the role of adjuvant therapy. The need for a meticulous and methodical approach to staging cannot be overemphasized.

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FIGURE I-2 Effect of nodal involvement on staging for non-small cell lung cancer. See Figure I-1 for designation of N0 to N3 descriptors.

Since the initial adoption of a staging system proposed by Dr. Clifton Mountain in the mid-1970s was created using a single institution database of patients, the Union Internationale Contre le Cancer and the American Joint Committee on Cancer have revised the staging system based on large international database of patients. The most recent changes were adopted in 2009, and this discussion focuses on this seventh version (see Fig. I-1).

Although the summary figure details the staging system, the authors wish to highlight some of the significant departures from the previous versions of the staging manual:

T1 tumors are subclassified as T1a or T1b based on size.

T2 tumors are subclassified as T2a or T2b based on size. T2a tumors also comprise other T2 descriptors as long as the tumor is ≤ 5 cm.

Tumors > 7 cm are considered T3.

Multiple tumors in the same lobe are classified as T3.

Additional tumors in another ipsilateral lobe are considered T4.

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