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Old 04-09-2014, 08:23 AM
gdpawel gdpawel is offline
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Default Why Do Cancer Surgeons Cure More Patients Than Medical Oncologists?

Robert A. Nagourney, M.D.

Who does it really serve when a clinical trial involving 597 patients results in an increase in survival by 10 days?

And when the authors of the published trial results are quoted as saying, “To our knowledge, this randomized phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine.”

Is this the best we can do?

Surgery remains the most curative form of cancer treatment. While the reasons for this are many, the most obvious being earlier stage of disease and the better performance status of the patients, there are other factors at work. Surgeons tend to be rugged individualists, prepared to make life and death decisions at a moment’s notice. The surgeon who enters the pelvis expecting an ovarian cyst only to find disseminated ovarian cancer must be prepared to conduct a total hysterectomy and bilateral ovary removal if he/she is to save the patient’s life. It is these types of aggressive interventions that have that revolutionized the treatment of advanced ovarian cancer.

What of the medical oncologists who, with the exception of leukemia and some lymphomas, confront diseases that are difficult to eradicate and for which treatments can be toxic? Trained as incrementalists, they do not expect cures so much as palliation. Their role is not to make hard decisions, but instead to rely upon precedence. Educated in the school of small advances, these physicians are not rewarded for individual successes but they are harshly criticized for any departures from community standards.

Deprived of the opportunity to make bold decisions, medical oncologists follow opinion leaders who instruct them to accrue to standardized protocols. As meaningful advances are few and far between, enormous numbers of patients must be accrued to provide sample sizes with any hope of achieving statistical significance. Among the most disturbing examples of this approach was a trial reported in patients with inoperable pancreatic cancer. The study compared single agent gemcitabine to gemcitabine plus erlotinib. The trial achieved an improvement in survival that led the FDA to approve the two-drug combination. Yet, the actual improvement in median survival was a mere 10 days. The authors beamed, “To our knowledge, this randomized phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine.” (Moore, MJ et al J Clin Oncol, 2007). To the average observer however, a clinical trial that required 569 patients to improve median survival from 5.91 months to 6.24 months (10 days) would hardly seem cause for celebration.

Medical oncologists have become so accustomed to these marginal advances that they are unmoved to depart from standard protocols lest they be accused of breeching guidelines. This might be acceptable if chemotherapy provided meaningful benefits, but the extremely modest advantages provided by even the best clinical trials scream for medical oncologists to think, well, more like surgeons.

While community oncologists think it heresy to step around a National Comprehensive Cancer Network (NCCN) guideline, investigators at the best institutions, the opinion leaders, have begun to question the merit of blind protocol accrual and come to recognize that many critical questions cannot be easily answered through the current trial process. Questions such as the role of liver resection for colon cancer patients with disease spread to the liver or the role of additional chemotherapy after that liver surgery, simply may not lend themselves to randomized trials. In a review of the topic by one of the leading investigators in the field, Dr. Nancy Kemeny from Memorial Sloan-Kettering in New York examined this dilemma, “The management plan for each patient should be decided by a multidisciplinary team, it may not be possible or ethically defensible to perform large randomized adjuvant trials comparing chemotherapy with surgery alone or comparing modern chemotherapy with older regimens. It may be reasonable to extrapolate from adjuvant trials and meta-analyses showing predominantly disease-free survival benefit. Each decision on postoperative chemotherapy should be viewed in context of prior treatment, surgical preference and individual patient characteristics.”

How refreshing. Finally a clinical investigator has recognized that patients must be managed on an “individual basis” regardless of what the clinical trial data does or does not support.

The concept of personalized medicine flies in the face of contemporary guideline driven treatment. Individualized care is on a collision course with the NCCN. It is time for medical oncologists to reclaim the high ground in doing what is right for patients, using resources that enable them to make smart decisions and to eschew standardized care. In cancer, the dictum “one size fits all” is more accurately “one size fits none.”
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Old 04-09-2014, 08:37 AM
gdpawel gdpawel is offline
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Default Why Surgery for Cancer?

The role of the surgeon is to perform the workup and then determine if cancer is present or not. Once cancer is diagnosed, the surgeon will work with the medical oncologist and radiation oncologist as a team to decide in a multidisciplinary fashion what the best treatment is, if needed.

For decades, any surgeon was considered competent to exercise all surgical skills, including cancer surgery. Indeed, while most surgeons may be acceptably competent, the specialty of surgical oncology is increasingly important. The surgical oncologist is most often the first specialist to see a patient before other oncologic specialists.

Surgical procedures for cancer are often complex and technically demanding. Studies have shown that patients have better outcomes, the lowest complications and death rates when they are treated by experienced surgical oncologists. In addition, cutting-edge techniques can often provide superior results over tried-and-true methods that have been around for many years.

Surgical oncologists are clinical scientists with knowledge of and experience in cancer surgery that come from additional training, limitation of the scope of general surgical practice, familiarity with the biology and natural history of cancers, and the role of the other oncologic specialties in their diagnosis and management.

Surgery can be used to provide local control in advanced disease. It's not just the surgery or the surgeon, it's the process. Three factors affect outcomes. Patient factors, which you can only partially control, such as diabetes, hypertension, etc. Physician factors, skill, training experience and judgement. And process factors, which are the hardest to control and include the infrastructure of the institution. Hospitals that do higher volumes of surgeries have correspondingly lower mortality rates than those who do fewer of the procedures. This has important implications for both patients and doctors.

The tissue resected by a surgeon and analyzed by a pathologist is the source of crucial information that informs the decisions and actions of medical oncologists. It is the surgically resected tissue that possesses the information needed to define the specific characteristics of a patient's tumor, the specific therapies to which the tumor would be expected to respond and even the specific risks of adverse reactions to given therapies.

The reasons for surgery have to do with understanding the Biology of Tumor Growth and Metastasis.

In the beginnings of a tumor, most cells are in the proliferative pool

When the tumor is clinically detectable, most cells are NOT in the proliferative pool - some die and some enter a resting state (Go)

Rate: tumor growth depends on excess cell production over cell loss

Cell cycle: malignant cells use the same 5 phases as normal cells (duration of cycle differs however – G1)

Growth fraction: proportion of cells within a tumor in proliferative pool varies for different tumors - has a profound effect on chemotherapy

Mitotic figures: crude measure of growth rate; way to find out how many are in the growth fraction

Angiogenesis: important for tumor growth - brings in nutrients, pathway for metastasis - if inhibitied Ž starve the tumor; tumor cannot grow beyond 1-2 mm without a blood supply

Takes a long time for tumor to become detectable, however once detected, takes a short time to become lethal - one cell Ž 30 population doublings Ž 109 cells (1 gram, 1cm3) Ž clinically detectable - 10 more population doublings Ž 1012 cells (1000 grams) Ž lethal

What are the stages?

Cancer cells that are "out surviving" their normal counterparts often do so in a quiescent stage (GO Gx). The GO phase is a period in the cell cycle in which cells exist in a quiescent state, where the cell is neither dividing nor preparing to divide (the cells do not go through mitosis whatsoever). These cells only do what they are initially suppose to do, and do not prepare for a division. In order to capture these cells, drugs must be present in the body when these cells awaken from their dormancy.

Cell proliferation is characterized by four distinct phases: G1 phase (Gap1), S phase (DNA synthesis), G2 phase (Gap2) and M phase (mitosis). Non-proliferative or “resting cells” are referred to as being in G0 phase (GO Gx). Flow cytometry has been increasingly used to analyze cell cycle. This is achieved by performing either univariate analysis of deoxyribonucleic acid (DNA) content or multivariate analysis of DNA content and proteins associated with cell cycle.

That is why some researchers believe the reason for better survival for patients who could undergo complete resection without any tumor left behind is that these tumors are biologically less aggressive and would do better regardless of the type of treatment they receive, and that the removal of lymph nodes at the time of surgery may additionally contribute to a better outcome.

Why Surgery?

Surgery is an integral part of the multimodality treatment of many cancers. The line of reasoning frequently used to explain the value of surgery included five points.

First, surgery is thought to remove resistant clones of tumor cells and thus decrease the likelihood of the early onset of drug resistance.

Second, the removal of large masses likely to be associated with poorly vascularized areas of tumor improves the probability of delivering adequate drug doses to the remaining cancer cells.

Third, the higher growth fraction in better vascularized small masses enhanced the effect of chemotherapy.

Fourth, smaller masses required fewer cycles of chemotherapy and thus decreased the likelihood of drug resistance.

Fifth, removal of bulky disease enhances the immune system. Patients who present with a large mass are suffering because of that mass and they need that tumor out to relieve symptoms and to save life due to symptoms. It's important to deal with the bulk.

Sources:

Mayo Clinic
American Board of Surgeons
Society of Surgical Oncology
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Old 04-09-2014, 08:48 AM
gdpawel gdpawel is offline
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Default Surgical Specimen Is the Personalized Part of Personalized Cancer Medicine

The Surgical Specimen Is the Personalized Part of Personalized Cancer Medicine

Carolyn C. Compton, M.D., PhD.

Office of Biorepositories and Biospecimen Research, National Cancer Institute, Bethesda, MD USA

As a pathologist, I have been evaluating cancer resection specimens throughout my career and have come to have a deep appreciation of the challenges of surgical oncology. Happily for patients, surgeons cure cancer on a fairly regular basis by excising it with expert technique and detailed knowledge of human anatomy and tumor biology. The tissue resected by the surgeon and analyzed by the pathologist is the source of crucial information that, in turn, informs the decisions and actions of our medical oncology colleagues.

As cancer medicine looks forward to a new era of molecularly defined cancer subtypes and targeted therapies, however, the role of both surgeon and pathologist is evolving to require an ever greater degree of professional attention towards the surgical resection specimen. It is the surgically resected tissue that possesses the molecular information needed to define the specific molecular characteristics of the patient’s tumor, the specific therapies to which the tumor would be expected to respond, and even the specific risks of adverse reactions to given therapies predicted by the patient’s genetic make-up. This molecular information forms the basis of the “personalized” approaches envisioned for cancer patients in an age of molecular medicine. The professional responsibility to assure that the specimen’s molecular composition and integrity are safeguarded is shared by both the surgeon and the pathologist. Current momentum towards molecular medicine is rapidly elevating this professional responsibility to one of the most important aspects of cancer patient care.

Currently, however, safeguarding the molecular integrity or documenting surgical variables that impact the molecular composition of the resection specimen is not widely considered to be primary aspects of the surgeon’s professional responsibility. Manipulations of the tissue within the surgical procedure itself may have dramatic effects on the molecular make-up of that tissue. However, these manipulations are neither recorded nor controlled when and where possible. Variables such as anesthesia type and duration, drugs administered preoperatively and intraoperatively, and devascularization/ischemia time for the resected tissue may dramatically alter molecular profiles and/or molecular integrity. Once successfully resected, the specimen may spend varying amounts of time at room temperature in the surgical suite and/or holding unit before being delivered to Pathology, which may further alter the molecular composition and quality of the tissue.

Without the surgeon’s extension of professional responsibility to the resected tissue to control, when feasible, and track such variables, the advantages of personalized adjuvant approaches may be lost to the patient. In molecular medicine, the resected tissue becomes the major determinant of all downstream therapy. Therefore, the care of the specimen must be addressed co-equally with the care of the patient. This elevated bar for ensuring tissue integrity and molecular quality also must be addressed by pathologists. The fresh specimen will need to be overseen by the pathologist with the same immediacy and professional attention. More than ever, surgeons and pathologists will be required to work together closely to achieve the goal of meeting the new standards of “specimen care” required for molecular analysis.

Our knowledge about the affects of iatrogenic variables such as surgical manipulation, intraoperative drug delivery, and pathological handling on the molecular profiles that reflect the biology in resected tissues is growing rapidly.1–5 Postoperative tissue ischemia time, for example, has been shown to alter gene and protein expression profiles within minutes following surgical excision in colectomy specimens and prostatectomy specimens.1–3 Not surprisingly, even before resection has been completed, intraoperative manipulations have been shown to markedly alter gene transcription levels during radical prostatectomies.4 The effects of different peri- and intraoperative variables on molecular profiles in different types of tissues are just beginning to be understood, but it is clear that surgeons and pathologists alike contribute significantly to the final molecular composition and integrity of the resected tissue.5

Procedures that maximize specimen quality respect the fact that resected tissues are vital and biologically reactive. Until they are fixed or frozen, biospecimens are viable and capable of reacting to physiological stress. They are a living part of the patient from which they come and are responsive to changes in temperature, perfusion, oxygenation, and other physiological and biochemical variables, both pre- and intraoperatively as well as postoperatively. Typically, once a tumor is successfully resected, the surgeon’s attention turns to patient and relatively little is directed towards the specimen. Unless an intraoperative consultation such as a frozen section is requested and the specimen is immediately addressed for this purpose, it may sit unattended for varying periods of time before being prepared for delivery to the pathology laboratory. The conditions of delivery itself may vary, as may the immediacy of the specimen handling once it has arrived in the pathology laboratory. Furthermore, some of the newer surgical techniques, such as robotically assisted prostate resections, may further compromise the quality of the resection specimen if it is allowed to remain in the operative site at body temperature for significant amounts of time after devascularization.

In this emerging age of molecular medicine, a new level of awareness of and attention to “the state of the specimen” will be required by surgeons, operating room staff, pathologists, and pathology staff. All play essential roles in the series of events leading up to stabilization of the tissue that impact its molecular make-up and molecular integrity. Surgeons are the initiators and controllers of many of these events and therefore represent the “gatekeepers.” The powerful molecular analysis technologies now at our disposal and the increasingly sensitive and specific analysis platforms under development provide us with unprecedented abilities to define the molecular features of cells and tissues. However, they also pose new risks by providing us with the ability to derive the wrong answer with even greater speed and accuracy unless the analytes are of high quality and are derived from high-quality specimens. It is our joint professional responsibility to follow procedures that will ensure the quality of the biospecimen and to document the specimen handling history for the patient’s record.

In this dawning era of molecular medicine, where a hard-won understanding of the molecular details of cancer is leading to more powerful and accurate diagnostics and therapeutics, I foresee surgeons and pathologists playing a new and more pivotal role in cancer medicine. They are the custodians of the specimens and therefore the molecules that represent the personalized part of personalized medicine. Surgeons will continue to cure cancer with greater success rates through earlier detection and excision; but as the custodians of the tissue, they will also be central to improving cancer management through molecularly targeted interventions.

References

1. Spruessel A, Steimenn G, Jung M, Lee SA, Carr T, Fentz A-K, et al. Tissue ischemia time affects gene and protein expression patterns within minutes following surgical excision. BioTechniques. 2004;30:1030–7.

2. Dash A, Maine IP, Varambally S, Shen R, Chinnaiyan AM, Rubin MA. Changes in differential gene expression because of warm ischemia time of radical prostatectomy specimens. Am J Pathol. 2002;161:1743–8.

3. Lin DW, Coleman IM, Hawley S, Huang CY, Dumpit R, Gifford D, et al. Influence of surgical manipulation on prostate gene expression: implications for molecular correlates of treatment effects and disease prognosis. J Clin Oncol. 2006;23:3763–70.

4. Schlomm T, Näkel E, Lübke A, Buness A, Chun FK-H, Steuber T, et al. Marked gene transcript level alterations occur early during radical protatectomy. Eur Urol. 2008;53:333–46.

5. Signoretti S, Bratslavsky G, Waldman FM, Reuter VE, Haaga J, Merino M, et al. Tissue-based research in kidney cancer: current challenges and future directions. Clin Cancer Res. 2008;14:3699–705.
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  #4  
Old 04-09-2014, 08:49 AM
gdpawel gdpawel is offline
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Default Laboratory Oncology

Larry Weisenthal, M.D., PhD.

The tumor holds the key to a patient's clinical outcome and survival. Each specimen must be individualized. Performing cell function analysis deserves the same degree of professional time and attention as major extirpative or debulking surgery or radiotherapy.

All sorts of specimens, from nice, sterile, viable sugar-cubed size pieces of tumor tissue from a sterile site to mucinous, contaminated low viability specimens from inside the colon lumen to several liters of bloody fluid to fried liver (from electrocautery biopsies of liver tumors) to small needle biopsies to bone marrow and blood specimens.

For solid tumors, testing is done with three-dimensional (3D) clusters (microclusters). It takes a lot of work to glean viable tumor cells and get a quantitative yield and separate tumor cells from normal and dead cells and get rid of mucin and what is called "brain matrix" from specimens of glioblastoma, and then to isolate the viable cell clusters from the discohesive, single cells and so on. Two specimens are seldom alike.

Not infrequently though, patients have a fairly major, invasive surgery primarily to get tumor for testing, so failure (an inevaluable assay) is not an option. Going after a surgical/biopsy specimen has a role in eliminating ineffective agents and avoid unnecessary toxicity and in directing "correct" therapy.

There would be a huge advantage to the patient to receive a "positive/sensitive" drug, compared to a "negative/resistant" drug. The time and energy required to conduct an excisional biopsy pales in comparison to the time, energy and lost opportunities associated with months of ineffective, toxic therapy.

Reliable, sensitive and specific cell-death endpoints are needed in a functional cytometric profiling assay. At least three different cell-death endpoints are used for every specimen (of the five that are immediately at disposal). You've got to make sure that the signal that is being measured is really from tumor and not normal cells and different endpoints have different advantages and disadvantages, depending on the type of specimen.

In certain instances, one cell-death endpoint is biologically more valid than another. When you get the same result with multiple endpoints, there is confidence in the results. When there is disagreement, and there is no readily understandable reason for the disagreement, much more caution is done in using this information for treatment recommendations.

Functional cytometric profiling is not a simple, turn-key solution. It is more a professional service, more than a simple laboratory test. It is sometimes thought of as a practicing the specialty of "Laboratory Oncology." I am an early member of an emerging new medical specialty, which I refer to as Laboratory Oncology. The function of the laboratory oncologist is to utilize available forms of laboratory testing of tumor biopsies to best individualize (personalize) cancer treatment with drugs, radiation, and/or surgery.

These forms of laboratory testing are based on multiple approaches, including traditional anatomic pathology, molecular genetics, and cell biology (typically through the application of cell culture methodologies). The importance of Laboratory Oncology is that there is an exploding growth in the number of anti-cancer drugs, which tend to be of only partial and unpredictable efficacy, which are often toxic, and which are extremely expensive. There is a huge need for existing and improved methodologies to best match treatment to the patient.
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Old 09-29-2015, 03:24 PM
gdpawel gdpawel is offline
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Default Surgery has a bigger impact on cancer than any other treatment modality

Surgery has a bigger impact on cancer than any other treatment modality, with potential to cure more than 50% of patients, and yet worldwide, fewer than 25% of cancer patients have access to safe and affordable care.

There is a huge shortfall in the worldwide provision of cancer surgery, say experts, and they suggest that a combination of research, improvements to surgical systems, and the incorporation of surgery into national cancer plans is needed to tackle the crisis.

The shortfall is revealed in a major analysis presented here at the European Cancer Congress 2015 and published simultaneously in Lancet Oncology as part of a Commission on access to cancer services. It found that worldwide, less than 25% of cancer patients have access to safe, affordable surgery, while in low-income countries, up to 95% do not receive basic surgical care.

With cancer incidence rates rising as people live longer, the number of procedures needed annually is set to reach 45 million. However, without major investment, three-quarters of cancer patients in low- and middle-income countries (LIMCs) are expected to die from cancer in 2030, compared with less than half in high-income countries.

Together, the cumulative losses to the global economy resulting from a lack of surgical care could top $20 trillion, or 1.3% of the projected global economic output.

"This Commission clearly outlines the enormous scale of the problem posed by the global shortfall in access to cancer surgery and current deficiencies in pathology and imaging," said Richard Sullivan, MD, PhD, Institute of Cancer Policy, King's Health Partners Comprehensive Cancer Centre, King's College London, United Kingdom, in a release.

"The evidence outlined by the Commission, contributed by some of the world's leading experts in the field, leaves no doubt of the dire situation we are facing. It is imperative that surgery is at the heart of global and national cancer plans," he said.

"A powerful political commitment is needed in all countries to increase investment and training in publicly funded systems of cancer surgery," Dr Sullivan emphasized.

However, there is hope for the future. "The good news is that surgery is effective and surgery is cost-effective.... In fact, it's the most cost-effective treatment," coauthor Riccardo Audisio, MD, FRCS(Engl), consultant surgical oncologist and honorary professor at the University of Liverpool, United Kingdom, and president of the European Society of Surgical Oncology, said during a press briefing.

"The bad news, unfortunately, is that only one in five surgery patients will receive the appropriate surgical treatment," he added.

Discussing how to bridge that gap, he said: "It all revolves around setting guidelines or, if you want, instead of dreaming of guidelines that cannot be implemented because of the local facilities, we are looking to establish minimum standards, and 'minimum standards' is something that needs to be accomplished from the top academic places to the very basic institutes."

More Than 80% Cancers Need Surgery

To develop the Commission, the authors used published evidence, such as the findings from Global Surgery 2030, commissioner meetings, and original analyses to examine the state of surgery globally and across all income settings. The aim was to produce evidence-based solutions to strengthen cancer surgical systems, education, and research.

The analysis showed that, of the 15.2 million cancer cases diagnosed worldwide in 2015, more than 80% will need surgery. Of the new cancer cases, 57% will have occurred in LMICs. Moreover, of the 8.8 million cancer deaths predicted for 2015, 65% will have occurred in LMICs.

The Commission found, however, that less than 25% of cancer patients worldwide have access to safe, affordable surgical care when it is needed, with only 5% of patients in low-income countries and 22% of those in middle-income countries having access to basic cancer surgery. There is also a serious shortage of cancer surgeons in 82% of countries.

By 2030, it was projected there will be 21.6 million new cancer cases, of whom 17.3 million will require surgery and 10.0 million of whom will be from LMICs. Overall, 45 million cancer surgery procedures will be needed annually. It is also expected that 75% of cancer patients in LMICs will die in 2030, compared with 46% of those in high-income countries.

Without urgent investment in cancer surgery services, the Commission argues, the global economic losses from cancers that could have been treated by surgery will total $12 trillion in 2030. The proportional impact of this loss equates to an annual loss of gross domestic product (GDP) of 1.0% to 1.5% in high-income countries and 0.5% to 1.0% in LMICs.

When looking at the impact of cancer morbidity and mortality in terms of the value of statistical life, which can be equated to financial losses, it was calculated that the global annual economic welfare losses are estimated at $7 trillion for surgical cancer mortality and $400 billion for surgical cancer morbidity. This represents an annual loss of GDP of 10% and 6% in high- and upper-middle-income countries, respectively.

The researchers also emphasized that there are micro-, as well as macro-, economic losses resulting from a lack of access to surgery for cancer patients. For example, a study of out-of-pocket costs, catastrophic expenditure, and discontinuation of treatment in more than 4500 patients in Southeast Asia revealed that 31% of patients with surgically operable cancer experienced financial catastrophe and 23% discontinued treatment.

Solutions — "Not One-Size-Fits-All"

Turning to potential solutions for the issues that the Commission identified, Dr Sullivan said: "Well, first of all, it's about building systems, and this is not a one-size-fits-all."

"We're talking around 277 different surgical procedures across six complexity levels. At least 110 of those require specialist cancer surgeons, in gynecological oncology, urology, head and neck.... So it's different horses for different courses," he said.

"The first thing we call for, of course, is to have surgery integrated into national cancer control plans [NCCPs]," he said, and many more of these are needed. "When we looked at NCCPs which are out there at the moment, only about 50% of countries globally have NCCPs.

"Only 9% of those programs actually have elements that you could identify as developing capacity and capability in cancer surgery, and that needs to radically increase," he explained.

However, Dr Audisio commented, "policy makers at all levels still have little awareness of the central importance of surgery to cancer control. Even recent studies of capacity building for cancer systems in Africa barely acknowledged the importance of surgery, focusing mainly on chemotherapy instead."
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Old 09-29-2015, 03:28 PM
gdpawel gdpawel is offline
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Massive Deficit in Research

Another important aspect that the Commission identified for improving surgical oncology was research. "The analysis...shows that, globally, the amount of research dedicated to cancer surgery is less than 5%, which is unbelievable, but it's true," said Dr Sullivan.

"Most of the money at the moment goes into fundamental research, and you won't be surprised [that it's for] medicines and biomarkers. The reality is that for radiation, surgery, palliative care, we come a long way down the list."

He added: "Even more worrying for the future is a that lot of this research is focused in high-income countries. So, of the totality of surgical cancer research, only about 17% is relevant to a lot of the emerging and low-income economies. That's a massive deficit in research."

The Commission estimated that just 1.3% of the annual global cancer research and development budget goes toward surgery. Moreover, 93.0% of global research in cancer surgery is carried out by only 34 of 195 countries.

Nevertheless, Dr Audisio does not believe that clinical trials per se are the best way of plugging the research gap.

"You need to know that only less than 2% of the cancer population is entering trials, and this skews the results, because it's not representative of the real population," he said.

"It's not representative because, when compared to real patients, these patients are different. They are more educated, they've got less aggressive treatment, they are better nourished, and so on."

Dr Audisio continued: "The findings are therefore different and, most importantly, trials with negative findings are never published, so what do you do? You look at the results of several trials to make a meta-analysis, but, by definition, you forget the negative trials that you don't consider in your meta-analysis because they are not worth mentioning."

He noted that observational studies of real-world outcomes have shown that surgical procedures can achieve up to 50% survival in cancer patients.

"So you don't need the trial; you have huge evidence that this is what is working," Dr Audisio said. "The trial mentality only works when you don't have end results to sell, when you cannot convince your providers that it's worth investing a huge amount of money into a treatment which is achieving 3-month, 6-month local disease-free gains."

We're talking curing over 50% of cancer patients.

Referring to the differences in outcomes between surgery and "a new molecular magic bullet," he said: "We are talking curing patients. We're not talking delaying for months or weeks, we're talking curing over 50% of cancer patients. That's a strong message."

He added: "It's not extending survival or improving wellbeing, this is saving human lives. This is something which is not being taken into account."

Summarizing, Dr Audisio said: "I am very grateful for being given the opportunity to run up the surgical oncology flag and to remind the community how crucially important [it] is."

Coauthor Mark Shrime, MD, from the program in global surgery and social change at Boston Children's Hospital, Harvard Medical School, reports received personal fees from Ethicon.

European Cancer Congress (ECC) 2015: Abstract LBA9. Presented September 28, 2015.

Citation: Cancer Surgery Crisis — Urgent Action Needed. Medscape. Sep 28, 2015.

Global cancer surgery: delivering safe, affordable, and timely cancer surgery

[url]http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2815%2900223-5/abstract

Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development

[url]http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60160-X/abstract
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