Transcript Cirurgia em Urologia Oncologica

Cirurgia em Urologia
Oncologica
XV Workshop de Urologia Oncologica
J.Edson Pontes
KCI/WSU
“Surgery is like a Savage, who attempts to
get by force, that which a civilized
men would get by stratagem.”
John Hunter (1728-1793)
Surgical Oncology is Changing
1960’s - 80’s – Super Radical Surgery
ICU care, blood banking, anesthesia techniques
1990’s – Pendulum begins to swing back
Minimally invasive surgery
2000’s – Less is more
Recognition that surgery is only one player
Better radiotherapy and better chemotherapy
Technology is the engine of change
Super Radical Surgery
1960s—1980s
• Could it be done
• Often without regard to quality of life
or function
Sentinel Lymph Node Biopsy
Standard of Care
a) Melanoma
b) Breast
c) Penile cancer
Colon, rectum, gastric, head & neck,
thyroid, gyn, urologic
Renal Cell Carcinoma
• Early 60s- radical nephrectomy for most
renal masses. 30% were benign.
• During the 80s-CT scan, early MRI- Better
definition of masses. Radical nephrectomy
mostly for cancer.
• During the 90s- RSS for small peripheral
tumors.
• In the last decade: RSS gold standard,
Laparoscopy, Cryosurgery, HIFU.
Testicular Cancer
• Bilateral RPLND in all patients with NSTT.
• Modified RPLND.
• Neo adjuvant chemotherapy for RP nodes,
followed by surgery only when residual
masses were present.
• Surveillance for stage I
Penile Cancer
• Better identification of sentinel node with
dyes and radioactive pharmaceuticals.
• Avoidance of Inguinal L.N. dissection and
its complications.
Surgical oncologist is one player on a
multi-modal team
Traditional Oncologic Approaches
• Phase I : determine toxicity following
animal studies.
• Phase II: Activity against certain tumors.
• Phase III: comparative studies against
established treatments.
Problem with large group trials now
• Many trials are begun asking questions rendered
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obsolete by changes in therapy over the life of
the trial
Modern technology, informatics, and therapeutic
interventions are changing too rapidly to sit still
for a clinical trial
Technology and MIS make many randomized
trials impossible eg. TCCAA vs. CABG or local
excision of rectal cancer vs.APR
Benefits of large Phase III studies .
• Among the curable malignancies in GU Cancers
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i.e. Wilms and Testicular Germ cell tumors, no
randomized trials were needed.
Large prospective randomized trials for Prostate
and Bladder cancer produced improvements
measured in months. Statistically significant but
clinically irrelevant!
Skill Set for Modern Surgery
• Minimally Invasive Surgery Techniques
MIS, NOTES, TEM, IGS
• High resolution ultrasound
• CT scan in O.R.
– skill sets for the modern surgeon
Advanced Surgical Technology &
Innovation Initiative (ASTII)
• Cooperation with the SSIM lab School of
Engineering
• Collaboration of surgeons and engineers
to develop novel tools for clinical use
• Presently seeking funding
• Founding member of iSURGTEC– Un of
Madrid, Un of Chicago, UCSF- surgical
Depts with interest in technology
20th century  21st century
2D slices  3D virtual patient
New vision of the patient
Da Vinci Robot
The Era of new technology brings
New Challenges!
Era of the prospective randomized
study
• 70s,80s,90s and now--Phase III trials
these trials would come to form what we
now call Level I evidence
well regulated (IRB), oversight
QUESTION
How do we introduce new ideas, new
therapies and new technology, in a time
when conventional scientific means of
assessment cannot keep up with the
explosion of knowledge and technology?
• Technology and therapeutic innovation is
occurring more rapidly than can be
assessed by conventional means
Surgical research esp. cancer
research is at a tipping point
Dilemma: How to introduce and use
innovation yet respect and protect the
rights and well being of our patients?
How can we be cautious and forward
thinking at the same time? Can we be
both scientific and non-linear at the same
time?
Hard thing to acknowledge
• Unscientific
• Anti-intellectual
• Dangerous
What should we do? (I)
• Delay innovation and new technology
• Develop new paradigms for vetting progress
• We must use technology to overcome the
obstacles created by technology
Surgical procedures have always carried with
them the elements of innovation
Ethics
Just as unethical to consign a patient to
treatment which is obsolete as to assign a
patient to treatment which is untested
Future
• Develop registries to keep tract of what
we do and outcomes
• Usefully crafted Electronic Medical Records
accessible to data acquisition
Future
• Computer modeling, planning and
simulation will inform our actions and
protect our patients
What should we do? (II)
• I have cured many cancer in mice!
• Human diversity is such, that treatment
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applicable to inbread animals with uniform
tumors( cell lines), do not work in humans.
With advances in pathology, tumors can be
individualized at the molecular/genetic level to
select treatment.
Future
Custom therapy is on the way
molecular and genetic markers in the
tumor
molecular and genetic markers in the host,
invitro assays
Targeted Therapy
Evolution in sequencing the Human
Genome
• With a budget of > $3 Billion, thousands of
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scientists it took more than a decade to map the
human genome.
Today it is possible to sequence the human
genome in about 8 days, at a cost of $10
thousand.
The possible use of “nanopore sequencing”
could bring the time down to minutes or hours
at a cost of <$1 thousand.
These are the most exciting of
times
We must ask ourselves how we will
evaluate risks/benefits and outcomes for
the individual patient with the same
scientific vigor that we have venerated
the prospective randomized trial
New Paradigm for the Future
• Based on individual uniqueness and
customization
• Based on computer modeling and
predictive simulation
• Based on solid well developed ethical
principles
Fundamental to the Discussion
• Can nonempirical constructions lead to
genuine knowledge in science?
• Can “thought experiments”, or computer
modeling have a scientific end in
themselves or are they only to be justified
as stages on the way to genuine empirical
discovery
Conclusions
Trend in surgical oncology:
Less is More
Seen in
 Minimally invasive surgery
 Selective nodal sampling-S.L.N. biopsy
 Ablation methods
 Better imaging and guidance
 Organ preservation
 New technology
Intuitive embracing of these concepts by patients circumvents
Evidence Based Practice
Conclusions
• We live in a time when new ideas will occur at a rate
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more rapid than they can be systematically tested”leapfrog”
It is not ethically superior to withhold potential
innovations any more than it is to recklessly implement
them
Population statistics will have less importance as
“custom” therapies, and computer modeling are
developed
We must rethink, restudy, redefine the ethical
principles/boundaries which will guide our use of new
ideas
Technology must be used to overcome obstacles caused
by technology
Conclusions
• Surgeons are in the best possible position to wrestle with
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these issues since “the operation” has always had the
elements of customization, use of innovative ideas, and
need for ethical decisions
Science as it is presently defined must be broadened to
include carefully considered non-empirical constructionsethically bounded
Some will call this thinking reckless, unscientific and
dangerous
Failure to do this will result in fewer innovations and stall
opportunities for true breakthroughs