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Carcinoma endometriale: la terapia adiuvante Quale e Quando Vincenzo Scotto di Palumbo Ospedale Santo Spirito in Sassia Roma.

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Presentazione sul tema: "Carcinoma endometriale: la terapia adiuvante Quale e Quando Vincenzo Scotto di Palumbo Ospedale Santo Spirito in Sassia Roma."— Transcript della presentazione:

1 Carcinoma endometriale: la terapia adiuvante Quale e Quando Vincenzo Scotto di Palumbo Ospedale Santo Spirito in Sassia Roma

2 La stadiazione FIGO 1988

3 Grading e sopravvivenza

4 Invasione miometriale e sopravvivenza

5 Il problema linfonodale

6 Fattori di prognosi e sopravvivenza

7 Terapia adiuvante ormonoterapia radioterapia chemioterapia combinazioni

8 Ormonoterapia Martin-Hirsch P L, Jarvis G, Kitchener H, Lilford R. Progestagens for endometrial cancer (Cochrane Review). The Cochrane Library, Issue 1, 2008 Cochrane Gynecological Cancer Group: Progestagens for endometrial cancer Metanalysis of 6 clinical trials (4351 patients) –Only 3 trials with Stage I patients –In 3 trials also patients with advanced disease

9 Cochrane review: adjuvant progestagens

10 Radioterapia adjuvante Fasci esterni Brachiterapia Combinazione delle due modalità

11 Locoregional recurrence Locoregional recurrence All stage I patients: External beam radiotherapy vs No external beam radiotherapy Distant recurrence All stage I patients: External beam radiotherapy vs No external beam radiotherapy Adjuvant radiotherapy for stage I endometrial cancer; systematic review and meta- analysis (Cochrane Review). In: Annals of Oncology 22, , 2007

12 Endometrial cancer related deaths Subgroup analysis of patients at least 1 high risk factor, Ic or grade 3 Endometrial cancer related deaths Subgroup analysis of patients at least 2 high risk factor, Ic or grade 3 Adjuvant radiotherapy for stage I endometrial cancer; systematic review and meta- analysis (Cochrane Review). In: Annals of Oncology 22, , 2007

13 Inclusion criteria Stage 1A grade 3 Stage 1B grade 3 Stage 1C grade 1-3 Serous or clear-cell cancers Adjuvant external beam radiotherapy (EBRT) in the treatment of endometrial cancer: results of the randomized MRC ASTEC and NCIC CTC EN.5 trials EN.5 started July 1996; ASTEC July patients randomized J Orton. ASCO 2007

14 Overall Survival Recurrence-free Survival Isolated Vaginal or Pelvic Initial Recurrence J Orton. ASCO 2007 Results

15 Metanalisi su overall survival 0.2 % difference in 5-year OS (87.8% in EBRT and 88% in no EBRT) 95% CI of difference = -2.0% to 3.0% J Orton. ASCO 2007

16 Maggi R, BJC 95: , 2006

17 Inclusions criteria Stage IC grade 3 Stage IIA-IIB grade 3 with myometrial invasion > 50% Stage III Caratteristiche dello studio Maggi R, BJC 95: , 2006

18 Sopravvivenza libera da malattia Maggi R, BJC 95: , 2006

19 Sopravvivenza totale Maggi R, BJC 95: , 2006

20 Stage III or IV low volume - Any histology Residual tumour less than 2 cm after surgery 424 pts Whole abdominal radiotherapy (WAI) 30 Gy in 20 daily fractions Boost to the pelvis or to an extended field encompassing pelvic and para-aortic lymph nodes Chemotherapy Doxorubicin 60 mg/m 2 Cisplatin 50 mg/m 2 Every 3 weeks, for 8 cycles (only Cisplatin was to be infused during the 8°cycle) Randall ME, J Clin Oncol 24: 36-44, 2006

21 Sopravvivenza libera da malattia Randall ME, J Clin Oncol 24: 36-44, 2006 HR 0.71 (95%CI , p<0.01)

22 Sopravvivenza totale Randall ME, J Clin Oncol 24: 36-44, 2006 HR 0.68 (95% , p<0.01) 55% 42%

23 Conclusions Randall ME, J Clin Oncol 24: 36-44, 2006

24 A randomized phase III study on adjuvant treatment with radiation (RT) +/- chemotherapy (CT) in early stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991) NSGOEORTC Thomas Hogberg, ASCO Inclusion criteria Stage IC, II or III cancer plus grade 3 histology Serous or clear-cell cancers Aneuploid tumors plus grade 3 histology Aneuploid tumors plus stage IC, II or III cancer

25 A randomized phase III study on adjuvant treatment with radiation (RT) +/- chemotherapy (CT) in early stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991) NSGOEORTC RANDOMIZATION Thomas Hogberg, ASCO. 2007

26 HR 0.62 (CI ) p=0.03; estimated difference in 5-yr PFS 7% from 72% to 79% Sopravivenza libera da malattia

27 Sopravivenza totale HR 0.65 (CI ) p=0.08; estimated difference in 5-yr OS 8% from 74% to 82%

28 Considerazioni degli autori HR 0.35 (CI ) p=0.009; estimated difference in 5-yr PFS 14% from 73% to 87%

29 Conclusions Despite that 27% of patients randomized to CT+RT received no, or only party of the prescribed CT, CT+RT was better than RT alone as adjuvant therapy for patients with early endometrial cancer at high risk for micrometastases

30 GOG 184 Endometrial carcinoma Surgical stage III Hysterectomy and BSO <2 cm Residual disease Optimal Lymph Node Sampling Endometrial carcinoma Surgical stage III Hysterectomy and BSO <2 cm Residual disease Optimal Lymph Node Sampling Pelvic +/- Para-Aortic Irradiation +/- Intravaginal Brachytherapy Pelvic +/- Para-Aortic Irradiation +/- Intravaginal Brachytherapy RANDOMIZEDRANDOMIZED RANDOMIZEDRANDOMIZED Regimen I* Doxorubicin** 45mg/mq Cisplatin 50mg/mq G-CSF*** 5mcg/kg 2-11 Regimen I* Doxorubicin** 45mg/mq Cisplatin 50mg/mq G-CSF*** 5mcg/kg 2-11 Regimen II* Doxorubicin** 45mg/mq day 1 Cisplatin 50mg/mq day 1 Paclitaxel 160mg/mq day 2 G-CSF*** 5mcg/kg 3-12 Regimen II* Doxorubicin** 45mg/mq day 1 Cisplatin 50mg/mq day 1 Paclitaxel 160mg/mq day 2 G-CSF*** 5mcg/kg 3-12 *q weeks 3 x 6 courses **Maximum total doxorubicin dose is 270 mg/mq for both regimen Register

31 LaparotomiaLaparoscopia Età media7564 BMI medio Stadio:Ia61 Ib73 Ic71 IIa10 IIb21 IIIa41 IIIc11 IVb10 Istotipo:Adenocarcinomi297 Sieropapilliferi11 Adenosquamosi10 N. medio di linfonodi Tempo operatorio medio (min) Perdita ematica media (cc)10582 Serie OSS

32 OSS policy st I Ia G1, G2 osservazione Ia G3RT pelvica se presenti RF Ib G1, G2 osservazione Ib G3 RT pelvica se presenti RF IcG1osservazione IcG2, G3RT pelvica + CT istotipi speciali RF età>60a, LVI, dimensioni del T, coinvolgimento della parte bassa del corpo

33 OSS policy st II, III IIa G1osservazione IIbG2, G3RT pelvica IIIa G1, G2osservazione se solo cit + IIIa G3RT pelvica + CT IIIbCT + RT IIIcCT + RT pelvi ev LA

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