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 CANCERThis 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 CANCERA 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 low-

grade (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!!!