Struttura Complessa di Ginecologia Oncologica Direttore: Prof. Stefano Greggi. Carcinoma della Cervice Uterina Cronoprogramma Diagnostico-Terapeutico

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1 Struttura Complessa di Ginecologia Oncologica Direttore: Prof. Stefano Greggi Carcinoma della Cervice Uterina Cronoprogramma Diagnostico-Terapeutico

2 Pap-test Anormale L-SIL H-SIL Bethesda System, 2001

3 Pap-test Anormale

4 Pap-test Anormale H-SIL 8% ICC 0% L-SIL 31% ASC-US 61% Davey, 2004

5 ASC-US INCIDENCE: % CYTOLOGIC REVISION Low reproducibility level Low PPV Downgraded to neg 40% Upgraded to L-SIL 20% Upgraded to H-SIL 2% NEGATIVE 75-85% RISK OF CIN2+ 12% RISK OF CIN3+ 5% Solomon (ALTS Group), 2001 Stoler, 2001 Sherman, 2001 Kristen (ALTS Group), 2006

6 % Upgrading CIN 2-3 Cancer Microinv. Inv. ASC-US 5-17 ASC-H CIN

7 ASC-US HPV-test Triage HPV-test HR + HR - Colposcopia Pap-test a 12 mesi + - Colposcopia Screening SICPCV, 2006

8 HPV-test Triage Raccomandazioni Statement on HPV DNA test utilization, 2009

9 p16 Triage (sperimentale) HPV-test (screening) HR - HR + p16-test + - Colposcopia HPV-test a un anno Carozzi, 2008

10 ASC-US - ASC-H - L-SIL SICPCV, 2006

11 H-SIL Carcinoma squamocellulare SICPCV, 2006

12 AGC SICPCV, 2006

13 Follow-up A 6 mesi da trattamento Citologia e colposcopia ogni 6 mesi per 2 anni Controllo annuale per altri 5 anni Ritorno a screening Colposcopia, citologia e HPV-test Colposcopia e/o citologia - HPV + Colposcopia e/o citologia + - Controllo a 6 mesi Percorso sec. lesione Pap-test e HPV-test a 12 mesi + - Colposcopia Screening SICPCV, 2006

14 Istotipi Carcinoma squamoso in situ Carcinoma squamoso inf. cheratinizzante, non-cheratinizzante, verrucoso Adenocarcinoma in situ / tipo endocerv. Adenocarcinoma endometrioide Adenocarcinoma a cellule chiare Ca. adenosquamoso Ca. adenoide cistico Ca. a piccole cellule Ca. indifferenziato Ca. neuroendocrino ~80% ~10% FIGO, 2006

15 Cervical Cancer - FIGO Staging (2009) I The carcinoma is strictly confined to the cervix (extension to the corpus would be disregarded) IA Invasive carcinoma which can be diagnosed only by microscopy, with deepest invasion 5mm and largest extension 7mm IA1 Measured stromal invasion 3mm in depth and horizontal extension 7mm IA2 Measured stromal invasion >3mm and not >5mm with an extension of not >7mm IB Clinically visible lesions limited to the cervix or pre-clinical cancers > Stage IA IB1 Clinically visible lesion 4cm in greatest dimension IB2 Clinically visible lesion >4cm in greatest dimension II Cervical carcinoma invades beyond the uterus, but not to the pelvic wall or to the lower third of the vagina IIA Without parametrial invasion IIA1 Clinically visible lesion 4cm in greatest dimension IIA2 Clinically visible lesion >4cm in greatest dimension IIB With obvious parametrial invasion III The tumor extends to the pelvic wall and/or involves lower third of the vagina and/or causes hydronephrosis or non-functioning kidney IIIA Tumor involves lower third of the vagina (No extension to the pelvic wall) IIIB Extension to the pelvic wall and/or hydronephrosis or non-functioning kidney IV The carcinoma has extended beyond the true pelvis or has involved (biopsy proven) the mucosa of the bladder or rectum. A bullous edema, as such, does not permit a case to be allotted to Stage IV IVA Spread of the growth to adjacent organs IVB Spread to distant organs

16 Microinvasive CC Early CC IA IB1 IIA1 Locally Advanced CC (LACC) IB2 IIA2 IIB III IVA Metastatic CC IVB

17 CONIZZAZIONE CERVICALE EVISCERAZIONE PELVICA

18 Microcarcinoma Staging Criteria FIGO IA1: stromal invasion 3 mm in depth, horizontal extension 7 mm IA2: stromal invasion 3-5 mm in depth, horizontal extension 7 mm SGO Stromal invasion 3 mm in depth, no LVSI

19 Microcarcinoma Treatment Total abdominal or vaginal hysterectomy (if VAIN, appropriate cuff of vagina should be removed) IA1 Observation after cone biopsy (particularly if fertility is desired) Modified RH (Type 2) and pelvic LND Consider extrafascial H and pelvic LND (if no LVSI) IA2 If fertility is desired: large cone biopsy + extra-perit. or lpsc pelvic LND rad. trachelectomy and extra-perit.or lpsc pelvic LND Follow-up Mainly with Pap smears annually after two normal smears at 4 and 10 mos FIGO, 2006

20 Cone: Positive margin

21 Microcarcinoma Cone Positive Margin In patient with positive margins: Vaginal Strict Follow-Up Endocervical Repeat Conization or or Stromal Hysterectomy

22 Fertility-sparing surgery Cervical Cancer 43% of cervical cancer in women <45y (10-15% during childbearing years) Radical Trachelectomy Vaginal Abdominal Laparoscopic Robotic Eligibility criteria Age < years & Strong fertility desire Diagnosis of invasive cancer (ideally, disease located primarily on the ectocervix) Exclusion of unfavorable histology Stage IA1 with LVSI, IA2, IB1<2 cm No evidence of pelvic N met and/or distant met Gynecologic oncologist experienced in laparoscopic and radical vaginal surgery Dargent, 1994

23 Fertility-sparing surgery RVT & Cancer prognosis Review n Recurrence Rates Death Rates Darsun, Sonoda, Plante, Overall recurrence and death rates comparable to early-stage cervical cancer treated by RH or RT Plant, 2004; Seli, 2005

24 Fertility-sparing surgery RVT & Pregnancy outcome Review (8 studies : 603 RVT / 256 pregnancies) Pregnancy rate 62% TAB/EUP 5% 1 st -2 nd trimester loss 27% Deliveries <32 ws 12% Review (16 studies: 355 RVT / 161 pregnancies) Pregnancy rate 70% 1 st -2 nd trimester loss 30% Boss, 2005 Deliveries >37 ws 65% Currently pregnant 6% Plante, 2008

25 Cerv Microca Conservative Treatment Algorythm CK Conization Margins - IA2 Margins + Follow-up LVSI + No Res T Repeat cone LVSI - Pelvic LND Invasive Res T RH N + N - Follow-up RH + pelvic LND

26 CERVICAL CARCINOMA Clinical Assessment FIGO Stage T size Lymphnode mets Histotype & Grade Bladder/Rectum involvement Vaginal infiltration Parametrial infiltration

27 Stadiazione Clinica Esame vaginale bimanuale e vagino-rettale (in narcosi) Colposcopia, biopsia / conizzazione Currettage endocervicale Cistoscopia Retto-sigmoidoscopia Rx torace (2 proiezioni) TAC/RMN (PET) CC apparentemente iniziale CC localmente avanzato RX torace RMN addome/pelvi Visita ginecologica in narcosi RX torace RMN addome/pelvi Uretrocistoscopia Retto-sigmoidoscopia FIGO, 2006

28 Cervical Cancer Comparison of Diagnostic Procedure Utilization ACRIN 6651/GOG 183 (n=208 ;Stage IB) Cystoscopy 64% 80% 52% 8.1% Sigmoidoscopy 44% 58% 49% 8.6% Barium enema 58% 60% 32% 0 Intravenous urogram 86% 91% 42% 1.0% Lymphangiography 18% 11% 14% 0 CT/MRI 16% 54% 70% 100% Montana, 1995 Amendola, 2005

29 Cervical Cancer MRI MRI staging for cervical cancer is now widely accepted as an optimal method for evaluation of tumor volume, uterine corpus involvement, parametrial invasion, Narayan K, 2003 but prediction of parametrial, bladder and rectal involvement is correct in 75% of cases at best Bipatt, 2003 Narayan, 2005 Follen, 2003

30 Cervical Cancer Detection of Advanced Stage (>IIB) Cancer by Retrospective Readers of CT & MRI ACRIN 6651/GOG 183 (n=208 Stage IB) CT MRI P Value Mean sensitivity (%) Mean specificity (%) Mean PPV (%) Mean NPV (%) Hricak, 2007

31 Cervical Cancer Performance of CT & MRI in Detecting Lymph Node Involvement ACRIN 6651/GOG 183 (n=208 Stage IB) CT MRI Sensitivity (%) Specificity (%) Hricak, 2005

32 Treatment Stage IB1, IIA1 Modified RH (Type 2) or RH (Type 3) and pelvic LND Adjuvant pelvic RT plus BRT Adjuvant concurrent CTRT (Cisplatin±5FU) survival in such patients In younger patients, if post-operative radiation is likely to be given: ovaries may be preserved and suspended outside the pelvis FIGO, 2006

33 Treatment Stage IB1-IIA1 RH tipo III + LA pelvica + sampling N aortici RT pelvi + BRT Se desiderio di prole (solo per IB1): trachelectomia radicale + LA pelvica ± sampling N aortici NCCN, 2009

34 Radical Hysterectomy History & Classification Wertheim (1900) Okabayashi (1921) Meigs (1951) Nerve-sparing (1990s) Robotics (2000s) Piver-Rutledge (1974) Mota-EORTC (2008) Querleu-Morrow (2008)

35 Radical Hysterectomy Piver-Rutledge Classification Type I (Extrafascial hysterectomy): simple hysterectomy to remove the entire cervical tissue Type II (Modified RH): basically, the RH described by Wertheim, to remove more paracervical tissue while still preserving the blood supply to the distal ureters and bladder Type III (RH): first described by Meigs in 1944, with the purpose of a wide excision of parametrial and paravaginal tissue Type IV (Extended RH): complete removal of the periureteral tissue and a more extensive resection of the paravaginal tissue Type V (Partial exenteration): radical removal of disease involving the distal ureter and/or bladder Piver, 1974

36

37 THE POINT OF TRANSECTION OF THE UTEROSACRAL AND CARDINAL LIGAMENTS IN CLASS II AND III RH

38 Type 3 RH Type3RH Type2RH

39 Radical Hysterectomy Querleu-Morrow Classification Type A (Minimum resection of paracervix): extrafascial hysterectomy, corresponds to the type I RH, with a <10 mm vaginal resection Type B (Transection of paracervix at the ureter): corresponds to the type II RH, with (B2) or without (B1) additional removal of the lateral paracervical lymph nodes, and >10mm vaginal resection Type C (Transection of paracervix at junction with internal iliac vascular system): corresponds to type III RH, with the ureter completely mobilized, 15-20mm of vagina and corresponding paracolpos resected routinely; with (C1) or without (C2) autonomic nerve preservation Type D (Laterally extended resection): ultraradical procedures mostly indicated at the time of pelvic exenteration, with the entire paracervical resection at the pelvic sidewall including the hypogastric vessels (D1); type D2 includes the resection of adjacent fascial-muscular structures Querleu, 2008

40 Quality control and results comparison in RH The term paracervix replaces others such as cardinal or Mackenrodt s ligament, or parametrium, and includes that usually named as paracolpium It is recommended to include the following information in the operative report: All parts defining the type of RH (transection of paracervix and vagina, uterine artery) Surgical (fresh sample) and pathological (fixed sample) length of ventral, dorsal and lateral extent of paracervix resection Surgical/pathological minimum length of vagina resected Minimum distance between tumor and resection margins (when applicable) Querleu, 2008

41 Type A Type B1 Type C2

42 Surgery-related Complications Rad. Hysterectomy (type III) + Pelvic Lymph % Severe Perioperative Compl % Early/Late Bladder/Rectal Disf. 75% vs 10% (III vs II) Temp. Bladder Disf. Literature Review

43

44 LN Involvement by Stage FIGO, 2006

45 Treatment Stage IB2, IIA2 Primary CTRT Primary RH and pelvic LND + Adjuvant RT Neoadjuvant CTRT (3 courses of platinum based CT) + RH and pelvic LND ± Adjuvant post-operative CT or RT If positive common iliac or paraaortic nodes: extended field radiation should be considered FIGO, 2006

46 Treatment Stage IIB Primary CTRT (RT plus BRT) Primary pelvic exenteration (Stage IVA not involving pelvic sidewall) If positive common iliac or paraaortic nodes: extended field radiation should be considered IIB-IVA Primary CT (Cisplatin) Unclear impact of CT on palliation and survival IVB FIGO, 2006

47 Treatment Stage IB2-IVA IB2-IIA2 RH tipo III + LA pelvica + sampling N aortici CTRT (RT pelvi + Cisplatino + BRT) CTRT (RT pelvi + Cisplatino + BRT) + isterectomia adiuvante IIB-IVA CTRT (RT pelvi + Cisplatino + BRT) NCCN, 2009

48 Terapia Adiuvante & Follow-up N pelvici + Margini + Parametrio + RT pelvi + CT(P) ± BRT (margini vaginali +) N - RT pelvi (volume, invasione stromale, LVSI) ± CT(P) Follow-up EO gen & gin Pap-test Rx Torace Laboratorio CT/MRI/PET ogni 3 mesi (1 anno) ogni 4 mesi (2 anno) ogni 6 mesi (3-5 anno) annuali (> 6 anno) ogni anno (opzionale) ogni 6 mesi (opzionali) su indicazione clinica NCCN, 2009

49 (Neo)adjuvant Setting

50 NACT Rationale NACT SHRINKAGE OF PRIMARY TUMOR TREATMENT OF LOCO-REGIONAL AND DISTANT MICROMETASTASES ADDITIONAL LOCAL TREATMENT BETTER DISEASE CONTROL SURVIVAL BENEFIT

51 NACT + Surgery vs Exclusive RT (LACC) Italian Multicenter Randomized Study, 2001

52 Stage IB2-IIB

53 Stage III

54 NACT & Radical Surgery (Locally Advanced Cervical Cancer) Review & Meta-analysis Endpoint Survival DFS Loco-regional DFS Metastases-free survival Nr. of events / patient 368/ / / /872 HR (p value) 0.65 ( ) 0.68 (0.0001) 0.68 (0.0001) 0.63 ( ) The absolute improvement in survival of 15% (8-21%) at 5- years obtained by NACT is of the same magnitude as that achieved with the standard cisplatin-based CTRT Cochrane Coll., 2009

55 Cervical Cancer (age 18-75) EORTC Trial Study Coordinators: S. Greggi G. Kenter F. Landoni IB2; IIA2; IIB RANDOM NACT + Radical Surgery Exclusive CTRT

56 Flow-Chart Sospetto K cervice uterina Biopsia cervicale Ca invasivo Ca microinvasivo Ca non definito / CIN III Stadiazione clinica Conizzazione Cervicale RMN addome / pelvi Colposcopia, Rx torace, SCC Ag, Visita gin. in narcosi, Cistoscopia e Rettoscopia Ca invasivo Ca microinvasivo IB1 IB2 - II III - IVA IVB IA1 (margini -) IA2 IR tipo B o C + LA pelvica o CTRT CTNA + IR tipo C + LA pelvica o CTRT CTRT o Pelvectomia + LA pelvica CT sistemica FU Vedi algoritmo dedicato MRC - Parametri - N - MRC + parametri + N + Inf stroma cerv >90% FU RT CT +/- RT

57 Follow-up Carcinoma della Cervice non Radiotrattato 1 e 2 anno 3 e 4 anno 5 anno > 5 anno A 30 gg Ogni 3 mesi Ogni 6 mesi Ogni 6 mesi Ogni 12 mesi Ogni 12 mesi Ogni 12 mesi Visita ginecologica X X X X X E.O. generale X X X X X Colposcopia X X X X Pap-Test X X X X Rx torace X X X RMN addome-pelvi* X X X Urinocoltura (+ ev. Abg) X X X CA125 X X X SCC X X X

58 Follow-up Carcinoma della Cervice Radiotrattato 1 e 2 anno 3 e 4 anno 5 anno > 5 anno A 45 gg Ogni 3 mesi Ogni 6 mesi Ogni 6 mesi Ogni 12 mesi Ogni 12 mesi Ogni 12 mesi Visita ginecologica X X X X X E.O. generale X X X X X Colposcopia X X X X X Pap-Test X X X X Rx torace X X X RMN addome-pelvi* X X X X Urinocoltura (+ ev. Abg) X X X CA125 X X X SCC X X X Rettoscopia X X *TAC addome/pelvi qualora RMN controindicata

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