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Less Radical Surgery for Patients with Early-Stage Cervical Cancer

Less Radical Surgery for Patients with Early-Stage Cervical Cancer. Dr Marie Plante NCIC CTG, Cervix Working Group . GCIG meeting Belgrade, Oct 10-11, 2009. Less Radical Surgery. Rationale Trial proposal Areas of controversies. Less radical surgery.

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Less Radical Surgery for Patients with Early-Stage Cervical Cancer

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  1. Less Radical Surgery for Patients with Early-Stage Cervical Cancer Dr Marie Plante NCIC CTG, Cervix Working Group GCIG meeting Belgrade, Oct 10-11, 2009

  2. Less Radical Surgery • Rationale • Trial proposal • Areas of controversies

  3. Less radical surgery • Morbidity of the radical hysterectomy and nodes comes from • Lymphadenectomy • Lymphocele/lymphoedema, nerve/vessel injury • Parametrectomy • Damage to autonomic nerve fibers a/w bladder, bowel and sexual dysfunction • Late urological/rectal dysfunctions: 20-30% Magrina 1995, Sood 2002, Benedetti-Panici 2005

  4. Less Radical Surgery • In low risk disease • Stage Ib1 • < 2 cm • LVSI - • Rate of lymph node metastasis: < 5% Kinney WK. Gynecol Oncol 57:3-6, 1995

  5. Less Radical Surgery • Review of 1063 cases of stage IA2 • Rate of lymph node mets: < 5% • 12% in ptes with LVSI + • 1.3% in ptes with LVSI - • Recurrence rate: 3.6% Van Meurs H et al. Int J Gynecol Cancer 19: 21, 2009

  6. Less Radical Surgery • Review of 1565 cases of IA1/IA2adenoca • Rate LN mets: 1.5% • Recurrence rate: 2.4% • Cone alone appears to be safe • PLND may be avoided in LVSI - patients Bisseling K and Quinn M. Gynecol Oncol 107: 424, 2007

  7. Less radical surgery • Parametrial invasion (PI) • Retrospective study of 842 ptes • Risk of PI was 0.6% if • Tumor size < 2 cm • Negative pelvic nodes • Depth of stromal invasion < 10 mm Covens et al. Gynecol Oncol 2002; 84: 145

  8. Less radical surgery • Parametrial invasion • Retrospective review of 594 ptes • PI in node + and node - ptes : 48 vs 6% • PI was found in 0.4% if • Node negative ptes • No LVSI • Tumors < 2 cm Wright JD et al. Cancer 2007; 110: 1281

  9. Less radical surgery • Parametrial invasion • Literature review of ptes with low-risk pathological characteristics: • Tumor size < 2 cm • Stromal invasion < 10 mm • Negative pelvic nodes • No LVSI • Risk of PI was 0.63% (5/799) Stegeman et al. Gynecol Oncol 2007; 105: 475

  10. Less radical surgery • Hard to justify the morbidity of a radical hysterectomy and parametrectomy in very low risk patients • Risk of PI < 1% • Lymphadenectomy probably still justified although LN mets low < 5% • Could possibly be omitted in IA2/LVSI -

  11. Less radical surgery • Sentinel node mapping • Particularly effective in small lesions (< 2 cm) • Detection rate: 100% • False negative rate: 0% • Could reduce the radicality/morbidity of the PLND in this low risk group Rob L et al. Gynecol Oncol 98: 281, 2005

  12. Less radical surgery • Relationship between SN vs PI status • 158 ptesIA2/IB1 • If SN +: risk of PI 28% • If SN - : risk of PI 0% if • Tumor < 2 cm • Stromal invasion < 50% Strnad P et al. Gynecol Oncol 2008; 109: 280

  13. Less radical surgery • Pilot study : n=60 • Procedure • Laparoscopic SLN followed by PNLD in SN- ptes on FS and simple vaginal hysterectomy • Selection criteria • IA1/VSI (3), IA2 (11), IB1 < 2 cm and SI < 50% (46) • Diagnosis by leep/cone (75%) or cx biopsy (25%) • MRI after to identify residual disease • LVSI not excluded Pluta M et al. Gynecol Oncol 2009; 113: 181

  14. Less radical surgery • Pilot study n=60 • 5 ptes had + SLN (8.3%) • 3 detected on FS: rad hyst / nodes + RT • 2 missed on FS (micromets); one had RT • Median F/U: 47 mo (12-92) • No recurrences Pluta M et al. Gynecol Oncol 2009; 113: 181

  15. Less radical surgery • Pilot study n=60 • « Parametrectomy » • Medial part of the lateral parametrium • Between cervical fascia and obliterated umbilical artery • Resection of parametrial « blue node » with ex-vivo radioactive count and parametrial « blue channels » Pluta M et al. Gynecol Oncol 2009; 113: 181

  16. Parametrial SN Ureter Sup. vesical artery Obturator nerve uterine artery Right parametrial SN Right obturator SN

  17. Less radical surgery • Proposed protocol

  18. Proposed Protocol

  19. Less radical surgery • Study design: randomized trial • Modifiedrad hyst/nodes vs. simple hyst/nodes • Outcome primary endpoint: 1500 ptes (80% power to show a difference of 2% in pelvic relapse, i.e, 2 vs 4%) • Toxicity primary endpoint: 320 ptes *** (favoured) (80% power to show a difference of 10% in acute severe toxicity, i.e, 15 vs 5%) • A prospective cohort • to be compared with similar sized contemporaneous cohort of ptes treated by rad hyst: 160 ptes (least favoured)

  20. Less radical surgery • Study design • Modifiedrad hyst/nodes vs. simple hyst/nodes • Toxicity primary endpoint: 320 ptes (80% power to show a difference of 10% in acute severe toxicity, i.e, 15 vs 5%) • Expected to be primarily bladder complications, with smaller numbers of post-operative and operative events (infection, bleeding, thromboembolic etc.) • Early stopping if relapse in the experimental arm exceeds an agreed upon threshold (e.g. more than 4%, stats pending)

  21. Less radical surgery • Question • Would more limited surgery reduce morbidity without jeopardizing outcome • Objective • Feasibility/safety of less radical surgery • Oncologic outcome and treatment-related morbidity • Inclusion criteria • Stage IA1/LVSI, IA2- IB1 < 2 cm with< 50% SI • Adeno and squamous • All grades • LVSI

  22. Less radical surgery • Primary endpoints • Operative morbidity • Severe toxicity (< 12 months) • Secondary endpoints • SLN detection rate • Rates of PI, positive SLN, positive margins • Relapse (site) and survival • QoL (NCI-CTC version 3)

  23. Less radical surgery • Points of discussion • Imaging requirement • Pelvic MRI ? • Sentinel node mapping • « parametrial node » resection. Is it reproducible ? • Stratification • IA2 vs IB1 • With/without LVSI • Surgical approach (abdominal vs vaginal/laparoscopic/robotic)

  24. Less radical surgery • Points of discussion • Exclusion criteria • IA1 with LVSI • If not doing nodes in stage IA2 and LVSI- • Cone alone for fertility preservation • Can’t really compare morbidity of rad hyst vs. cone • Central pathology review ? • Diagnostic cone/LEEP mandatory to assess depth of stromal invasion and size ? • Do we consider depth of stromal invasion or not

  25. MD Anderson Trial • Prospective multi-institutional trial • MSKCC • Texas (El Paso) • Czech Republic (2 centers) • Colombia • Sample size • 20-100 cases Schmeler Kathleen et al

  26. MD Anderson Trial • Criteria differ • IA1 (VSI) excluded • Grade 3 adenoca excluded • LVSI excluded • Diagnostic cone/ECC with negative margins for cancer or ACIS • If +, 2nd cone allowed • Inclusion of women who wish to preserve fertility • SN and PLND only Schmeler Kathleen et al

  27. MD Anderson Trial • Objectives: • Safety, feasibility, recurrence at 2 years • Nodal involvement and tx-related morbidity • compared to historical data from matched patients treated with rad hyst • QoL (5 questionnaires !)

  28. Prague protocol Pluta M et al. Gynecol Oncol 2009; 113: 181

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