Evidence Based Decision Making In Gynecologic Cancer Paolo Zola Turin, ITALY Adriana Bermudez Buenos Aires, ARGENTINA.

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Presentation transcript:

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…

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?

keep in mind they are only teenagers…

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…

do not worry!!!