Transcript Evidence Based Decision Making In Gynecologic Cancer

Evidence Based
Decision Making
In Gynecologic
Cancer
Paolo Zola
Turin, ITALY
Adriana Bermudez
Buenos Aires, ARGENTINA
OVARIAN CANCER
STAGES I-II
OVARIAN CANCER
Do patients with stage IA and
stage IB (grades II and III), all
stage IC and stage II need
adjuvant chemotherapy?
OVARIAN CANCER
 Two large European trials, EORTC–
ACTION and ICON1, randomized this
kind of patients to adjuvant
chemotherapy or observation
 The pooled data from both studies,
indicate significant improvement in DFS
(p = .001) and OS (p = .008).
 These pooled data provide for an OS at
5 years of 82% with chemotherapy and
74% with observation (Level of
evidence: 1iA)
LEVEL OF EVIDENCE: 1iA
Double-blinded, randomized
controlled trials with total
mortality endpoints
Stages III-IV
OVARIAN CANCER
Does interval cytoreductive
surgery after 4 cycles of
chemotherapy increase survival?
OVARIAN CANCER
 This question has been the subject of
phase III trials.
 In the first study, performed by the
European Organization for Research
and Treatment of Cancer, patients
subjected to debulking surgery after 4
cycles of cyclophosphamide and
cisplatin (with additional cycles given
later) had an improved survival over
patients who completed 6 cycles of this
chemotherapy without surgery (Level
of evidence:1iiB)
LEVEL OF EVIDENCE 1iiB
Randomized, controlled, nonblinded
clinical trial with cause-specific
mortality as an endpoint
but…
OVARIAN CANCER
A similar trial by the
Gynecologic Oncology Group
(GOG-162), but using
paclitaxel plus cisplatin as the
chemotherapy, did not
demonstrate any advantage
from interval cytoreductive
surgery
and then?
I do not know…
I do not know…
do you?
OVARIAN CANCER
Germ cell tumors
GERM CELL TUMORS
Do all patients with tumors
other than pure
dysgerminoma and lowgrade (grade I) immature
teratoma need adjuvant
chemotherapy?
GERM CELL TUMORS
A series demonstrated excellent
survival for all types of stage I
tumors managed by
surveillance, reserving
chemotherapy for cases in
which post-surgery recurrence
is documented. (Level of
evidence: 3iiiA)
LEVEL OF EVIDENCE:
3iiiA
Nonconsecutive case series
with total mortality as an
endpoint
is this evidence
enough?
is this evidence enough?
keep in mind they are only
teenagers…
ENDOMETRIAL
CANCER
ENDOMETRIAL CANCER
Is chemotherapy better than
radiotherapy in patients
with stage III or IV disease
with residual tumors <2 cm
and no parenchymal organ
involvement?
ENDOMETRIAL CANCER
 Several randomized trials by the Gynecologic
Oncology Group have utilized the known
antitumor activity of doxorubicin
 The addition of cisplatin to doxorubicin
increased response rates and progression-free
survival (PFS) over doxorubicin alone
 The use of the combination of cisplatin and
doxorubicin resulted in improved OS
compared to whole-abdominal radiation
therapy (p = .02; 5-year survival rates of 55%
vs. 42%). (Level of evidence: 1iiA)
LEVEL OF EVIDENCE:
1iiA
Randomized, controlled,
nonblinded clinical trial with
total mortality as an endpoint
be honest to yourself,
do you employ
chemotherapy or
radiotherapy?
some more questions…
have you ever
thought about EBM at
your office?
do you prefer EBM or
your own medical
experience?
do you consider
yourself a
“scientific” doctor?
and…the final
question…
should we base all
our decision making
on EBM?
Try to find the answer by
yourself…good luck!!!
You can not…
You can not…
do not worry!!!