Cancer LACC Trial Update Pedro T. Ramirez, MD Professor Director - - PowerPoint PPT Presentation

A Phase III Randomized Trial of Laparoscopic or Robotic Radical Hysterectomy vs. Abdominal Radical Hysterectomy in Patients with Early-Stage Cervical Cancer LACC Trial Update

Pedro T. Ramirez, MD

Professor Director of Minimally Invasive Research & Education Department of Gynecologic Oncology & Reproductive Medicine

N=740 International Collaboration

End points: DSF Recurrence rate Overall survival Treatment-related morbidity QOL Lymphatic mapping feasibility Total Sites: 27

y = 0.039x2 + 0.8673x R² = 0.9807

• 60

40 140 240 340 440 540 640 740

Jan-08 Mar-08 May-08 Jul-08 Sep-08 Nov-08 Jan-09 Mar-09 May-09 Jul-09 Sep-09 Nov-09 Jan-10 Mar-10 May-10 Jul-10 Sep-10 Nov-10 Jan-11 Mar-11 May-11 Jul-11 Sep-11 Nov-11 Jan-12 Mar-12 May-12 Jul-12 Sep-12 Nov-12 Jan-13 Mar-13 May-13 Jul-13 Sep-13 Nov-13 Jan-14 Mar-14 May-14 Jul-14 Sep-14 Nov-14 Jan-15 Mar-15 May-15 Jul-15 Sep-15 Nov-15 Jan-16 Mar-16 May-16 Jul-16 Sep-16 Nov-16 Jan-17 Mar-17 May-17 Jul-17 Sep-17 Nov-17 Jan-18 Mar-18 May-18 Jul-18 Sep-18

ConCerv Trial

Kathleen M. Schmeler, MD Associate Professor Department of Gynecologic Oncology & Reproductive Medicine

Inclusion Criteria

• Stage IA2 or IB1 cervical cancer
• Tumor diameter < 2 cm
• No LVSI
• < 10 mm stromal invasion
• Squamous cell histology (any grade) or adenocarcinoma

(grade 1 or 2 only)

• Cone margins and ECC negative for malignancy or

CIN/AIS (one repeat cone/ECC permitted)

• Imaging with PET scan, CT scan of the abdomen and

pelvis, and/or MRI of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment

ConCerv Trial

• Future fertility desired:

Cone biopsy and pelvic node dissection

• Future fertility not desired:

Simple hysterectomy and pelvic node dissection

ConCerv Trial

• Sample size: 100 evaluable patients
• Stopping Rules:

– Residual disease in the hysterectomy specimens of > 3 patients – If > 3 patients develop recurrent disease

ConCerv Trial

• MD Anderson, USA (K. Schmeler)
• IDC, Colombia (G. Rendon)
• INCAN, Mexico (D. Cantu)
• Barretos, Brazil (G. Fontes)
• INEN, Peru (A. Lopez)
• Instituto de Ginecologia, Argentina (M. Riege)
• Hospital Italiano, Argentina (M. Perrotta)
• Royal Women’s, Australia (O. McNally)
• Nebraska Methodist, USA (D. Crotzer)
• Hospital Britanico, Argentina (A. Maya)
• Policlinico Gemelli, Italy (G. Scambia)
• Chulalongkorn University, Thailand (T. Manchana)

ConCerv – Participating Sites

• 119 patients pre-enrolled
• 73 evaluable patients:

– 31 simple hysterectomy + nodes (42.5%) – 25 cone and nodes (34.2%) – 17 cut-through hysterectomy (23.3%) Not evaluable: – 43 ineligible after MD Anderson review – 1 cancelled due to + pregnancy test – 1 declined surgery – 1 patient did not have surgery on protocol due to study hold (amendment was submitted)

ConCerv – Preliminary Results

• 4 patients with positive nodes (5.5%)
• One patient with residual disease at hysterectomy:

– Multiple previous cones for AIS – No changes to inclusion criteria

• Three recurrences:

– Deep stromal invasion and CIN3 at margins (Inclusion criteria changed after first recurrence) – Recurrent pelvic mass 9m after cut-through hyst – Metastatic inguinal lymph node 9m after cut-through hyst (Inclusion criteria changed to exclude cut-through hysterectomy and require baseline imaging to rule out metastatic disease)

ConCerv – Preliminary Results

LACC Contacts Pedro T. Ramirez, MD peramire@mdanderson.org Vanessa Behan vanessa.behan@health.qld.gov.au ConCerv Contacts Kathleen M Schmeler kschmele@mdanderson.org Cindy Melendez cvmelend@mdanderson.org