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Carcinoma endometriale: la terapia adiuvante Quale e Quando

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

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  1. Carcinoma endometriale:la terapia adiuvanteQuale 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 • 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

  9. Cochrane review: adjuvant progestagens

  10. Radioterapia adjuvante • Fasci esterni • Brachiterapia • Combinazione delle due modalità

  11. 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

  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, 1596-1604, 2007

  13. 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

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

  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: 266-271, 2006

  17. 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

  18. Sopravvivenza libera da malattia Maggi R, BJC 95: 266-271, 2006

  19. Sopravvivenza totale Maggi R, BJC 95: 266-271, 2006

  20. 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

  21. 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

  22. 55% 42% Sopravvivenza totale HR 0.68 (95%0.52-0.89, p<0.01) Randall ME, J Clin Oncol 24: 36-44, 2006

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

  24. 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

  25. 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

  26. 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%

  27. Sopravivenza totale HR 0.65 (CI 0.40-1.06) p=0.08; estimated difference in 5-yr OS 8% from 74% to 82%

  28. 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%

  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 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

  31. Serie OSS 2005 - 2007

  32. 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

  33. 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

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