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Carcinoma endometriale: la terapia adiuvante Quale e Quando. Vincenzo Scotto di Palumbo Ospedale Santo Spirito in Sassia Roma. La stadiazione FIGO 1988. Grading e sopravvivenza. Invasione miometriale e sopravvivenza. Il problema linfonodale. Fattori di prognosi e sopravvivenza.

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carcinoma endometriale la terapia adiuvante quale e quando

Carcinoma endometriale:la terapia adiuvanteQuale e Quando

Vincenzo Scotto di Palumbo

Ospedale Santo Spirito in Sassia

Roma

terapia adiuvante
Terapia adiuvante
  • ormonoterapia
  • radioterapia
  • chemioterapia
  • combinazioni
ormonoterapia
Ormonoterapia
  • 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

Martin-Hirsch P L, Jarvis G, Kitchener H, Lilford R. Progestagens for endometrial cancer (Cochrane Review). The Cochrane Library, Issue 1, 2008

radioterapia adjuvante
Radioterapia adjuvante
  • Fasci esterni
  • Brachiterapia
  • Combinazione delle due modalità
slide11
Locoregional recurrenceAll 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, 1596-1604, 2007

slide12

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, 1596-1604, 2007

slide13

Adjuvant external beam radiotherapy (EBRT) in the treatment of endometrial cancer: results of the randomized MRC ASTEC and NCIC CTC EN.5 trials

Inclusion criteria

  • Stage 1A grade 3
  • Stage 1B grade 3
  • Stage 1C grade 1-3
  • Serous or clear-cell cancers

EN.5 started July 1996; ASTEC July 1998

905 patients randomized

J Orton. ASCO 2007

slide14

Results

Recurrence-free Survival

Overall Survival

Isolated Vaginal or Pelvic Initial Recurrence

J Orton. ASCO 2007

metanalisi su overall survival
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

slide17

Caratteristiche dello studio

  • Inclusions criteria
  • Stage IC grade 3
  • Stage IIA-IIB grade 3 with myometrial invasion > 50%
  • Stage III

Maggi R, BJC 95: 266-271, 2006

sopravvivenza libera da malattia
Sopravvivenza libera da malattia

Maggi R, BJC 95: 266-271, 2006

slide19

Sopravvivenza totale

Maggi R, BJC 95: 266-271, 2006

stage iii or iv low volume any histology residual tumour less than 2 cm after surgery 424 pts
Stage III or IV “low volume” - Any histologyResidual tumour less than  2 cm after surgery424 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/m2
    • Cisplatin 50 mg/m2

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

sopravvivenza libera da malattia21
Sopravvivenza libera da malattia

HR 0.71 (95%CI 0.55-0.91, p<0.01)

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

sopravvivenza totale

55%

42%

Sopravvivenza totale

HR 0.68 (95%0.52-0.89, p<0.01)

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

conclusions
Conclusions

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

slide24

NSGO

EORTC

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)

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

Thomas Hogberg, ASCO. 2007

slide25

NSGO

EORTC

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)

RANDOMIZATION

Thomas Hogberg, ASCO. 2007

sopravivenza libera da malattia
Sopravivenza libera da malattia

HR 0.62 (CI 0.40-0.97) p=0.03;

estimated difference in 5-yr PFS 7% from 72% to 79%

slide27

Sopravivenza totale

HR 0.65 (CI 0.40-1.06) p=0.08;

estimated difference in 5-yr OS 8% from 74% to 82%

considerazioni degli autori
Considerazioni degli autori

HR 0.35 (CI 0.16-0.77) p=0.009;

estimated difference in 5-yr PFS 14% from 73% to 87%

conclusions29
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

gog 184
GOG 184

Register

Regimen I*

Doxorubicin**

45mg/mq

Cisplatin

50mg/mq

G-CSF***

5mcg/kg 2-11

R

A

N

D

O

M

I

Z

E

D

  • Endometrial carcinoma
  • Surgical stage III
  • Hysterectomy and BSO
  • <2 cm Residual disease
  • Optimal Lymph Node
  • Sampling

Pelvic

+/-

Para-Aortic

Irradiation

+/-

Intravaginal

Brachytherapy

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

oss policy st i
OSS policy st I
  • Ia G1, G2 osservazione
  • Ia G3 RT pelvica se presenti RF
  • Ib G1, G2 osservazione
  • Ib G3 RT pelvica se presenti RF
  • Ic G1 osservazione
  • Ic G2, G3 RT pelvica + CT istotipi speciali
  • RF età>60a, LVI, dimensioni del T, coinvolgimento della parte bassa del corpo
oss policy st ii iii
OSS policy st II, III
  • IIa G1 osservazione
  • IIb G2, G3 RT pelvica
  • IIIa G1, G2 osservazione se solo cit +
  • IIIa G3 RT pelvica + CT
  • IIIb CT + RT
  • IIIc CT + RT pelvi ev LA