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Taipei Veterans General Hospital Practice Guideline for Cervical Cancer (2008)

Taipei Veterans General Hospital Practice Guideline for Cervical Cancer (2008). 吳 華 席 Huahsi Wu 台北榮總 婦產部. Clinical practice guidelines (CPG).

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Taipei Veterans General Hospital Practice Guideline for Cervical Cancer (2008)

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  1. Taipei Veterans General HospitalPractice Guideline for Cervical Cancer(2008) 吳 華 席 Huahsi Wu 台北榮總 婦產部

  2. Clinical practice guidelines (CPG) •CPG are ‘systematically developed statements to assist practitioners and consumer decisions about appropriate health care for specific clinical circumstances’. •They are tools used by healthcare professionals to assist in clinical decision making and to improve healthcare for consumers. [Ref:New Zealand Guidelines Group (NZGG). Handbook for the preparation of explicit evidence-based clinical practice guidelines, 2001.p4]

  3. 臨床指引 (guideline) • 形成明確易使用的標準 • (To make evidence based standards explicit and accessible) • 較容易作客觀的決定 • (To make decision making easier and more objective) • 可教育病人或醫護人員目前的最佳治療方式 • (To educate patients and professionals about current best practice) • 增進醫療的成本效應 • (To improve the cost effectiveness of health services) • 當作管控的工具 • (To serve as a tool for external control)

  4. Clinical Practical Guidelines Development Process

  5. Taipei Veterans General HospitalPractice Guideline for Cervical Cancer • FIGO early stage (IA to IIA, selected IIB) • FIGO easrly stage inoperable patients • and advanced stage • Incidental cervical cancer (post simple hysterectomy) • Persistent/Recurrent cervical cancer • Chemotherapy

  6. ( I ) FIGO early stage ( IA to IIA, selective IIB)

  7. Post-operative Adjuvant Therapy (FIGO early stage) Prognostic Risk Factors: - High Risk: LN (+) / Parametrial margin (+) / Vaginal cut end margin (+). - Intermediate Risk: Bulky tumor size ( > 4 cm ) / LVSI (+) / DSI (+) - Others Age / Diploidy / Differentiation / Histological Type

  8. ( II ) FIGO early stage inoperable patients and advanced stage ( 5 year survival rate: IIB-IVA: 20-60%, IVB: < 20 %)

  9. (III) Incidental Cervical Cancer( Post Simple Hysterectomy )

  10. (III) Incidental Cervical Cancer( Post Simple Hysterectomy ) Re-op include the following: • Radical parametrectomy + Upper vaginectomy + PLND ± PALNS • Image study consistent with the following: • No parametrium invasion • No pelvic side wall invasion • No rectal or bladder invasion - -

  11. (IV) Treatment Strategies for Persistent / Recurrent Cervical Cancer Factors to Consider: • Site of recurrence or metastases • Pelvic: central, side wall, combined • Extra-pelvic: intra-abdominal organs, Distant lymph nodes, Distant disseminated metastasis • Prior therapy • Surgery → Radiotherapy • Radiotherapy → Surgery • Status of patient's performance • Palliative or Curative treatment

  12. (IV-1) Cervical Cancer withCentral Recurrence • Prior Surgery • Surgical intervention if no contraindication • Radiotherapy if surgical intervention not possible • Prior Radiotherapy • Surgical intervention if no contraindication • Radiotherapy indicated if recurrence outside of previously treated field • Palliative radiotherapy or palliative chemotherapy • Surgical Intervention • If previous surgery is only total abdominal hysterectomy • Radical parametrectomy + PLND + PALNS • If previous surgery is radical hysterectomy + PLND + PALNS • Exenteration can be considered ( Total / Anterior / Posterior ).

  13. Exenterative surgery should NOT be used as a palliative treatment, except in the presence of malignant fistulas in the pelvis. Final intraoperative assessment: The final decision to proceed with exenteration will not be made until the abdomen has been opened and assessment of the pelvic side-wall and posterior abdominal wall has been made, utilizing frozen section where necessary Contra-indications: * TRIAD: 1. Unilateral uropathy, non-functional kidney, or ureteric obstruction 2. Unilateral leg edema 3. Sciatic leg pain ** Pelvic Exenteration

  14. (IV-2) Cervical Cancer withPelvic Side Wall Recurrence • Prior Surgery • Radiotherapy recommended • Prior Radiotherapy • Surgical intervention if no contraindication • LEER procedure: laterally extended endopelvic resection • CORT procedure: combined operative and radio-therapeutic treatment • Indication: • Histological confirmed, unifocal pelvic side-wall recurrence • Free from tumor dissemination • Tumor limited to a maximal diameter of < 5 cm • Medical condition compatible with major surgery. • Willingness to accept urinary or fecal diversion • Palliative chemotherapy if surgical intervention not possible • Radiotherapy indicated if recurrence outside of previously treated field • Palliative radiotherapy or palliative chemotherapy

  15. (IV-3 ) Cervical Cancer withCentral and Pelvic Side Wall Recurrence • Prior Surgery • Radiotherapy recommended • Prior Radiotherapy • Palliative chemotherapy • Radiotherapy indicated if recurrence outside of previously treated field • Palliative radiotherapy

  16. (IV-4) Only Distant LN Metastasis( Including para-aortic LN ) • Radiotherapy recommended • Chemotherapy recommended ( see above ) • CCRT recommended ( see above )

  17. (IV-5) Intra-abdominal Organ Metastasis • Chemotherapy recommended ( see above ) • Palliative surgery only for intestinal obstruction

  18. (IV-6) Dissemination • Chemotherapy recommended ( see above )

  19. (V) Chemotherapy for Cx Ca • Cisplatin is regarded as the most active agent in treating patients with cervical cancer and is recommended as first-linechemotherapy drug. • In selective cases with poor renal function ( CCr < 60 ) Carboplatin can be substituted as an alternative drug

  20. Indications for Chemotherapy in Cervical Cancer • Adjuvant chemotherapy for postoperative lymph node metastasis • Neoadjuvant chemotherapy for bulky tumor • Followed by surgery • Followed by radiotherapy • Concurrent chemoradiotherapy • Early bulky tumor followed by surgery • Postoperative with parametrium involvement and lymph node metastasis • Local advanced cancer • Consolidation chemotherapy after concurrent chemoradiotherapy for advanced cancer • Palliative chemotherapy for distant, metastatic, or recurrent cancer • If distant metastasis or recurrence Systemic Chemotherapy ± Palliative Radiotherapy

  21. (V-1) Neoadjuvant Chemotherapy Regimen • Cisplatin Only (qw x 3 course) • Cisplatin 40 mg/m2 • RH performed on 3rd day after completing chemotherapy • POB Regimen (q3wk x 3 course) • Cisplatin 50 mg/m2 + Vincristine 1 mg/m2 + Bleomycin 15 mg/m2 (D1~3) • RH performed within 3 weeks after completing chemotherapy • TP Regimen (q10d x 3 course) • Cisplatin 60 mg/m2 + Palcitaxel 60 mg/m2 (3hrs) • RH performed within 3 weeks after completing chemotherapy

  22. (V-2) CCRT regimen • Cisplatin Only (qw) • Cisplatin 40 mg/m2 • POB Regimen (q3wk ) • Cisplatin 50 mg/m2 + Vincristine 1 mg/m2 + Bleomycin 15 mg/m2 (D1~3)

  23. (V-3) Consolidation Chemotherapy Regimen I+P regimen ( q3w ) • Cisplatin 50 mg/m2 + Ifosfamide 1 gm/m2 (3 days) • Cisplatin 50 mg/m2 + Ifosfamide 5 gm/m2 (24 hours)

  24. (V-4) Chemotherapy Regimen for Disseminated or Recurrent Disease • Squamous cell carcinomas • Non-squamous cell carcinomas

  25. Common used Regimen for Squamous Cell Carcinoma • Cisplatin + Ifosfamide ( q3w ) • Cisplatin 50 mg/m2 + Ifosfamide 5 gm/m2 (24 hours) • Cisplatin + Ifosfamide ( D1~3) + Epirubicin ( q3w ) • Cisplatin 50 mg/m2 + Ifosfamide 1 gm/m2 + Epirubicin 50 mg/m2 • Cisplatin + Ifosfamide (D1~3) + Paclitaxel ( q3w ) • Cisplatin 50 mg/m2 + Ifosfamide 1 gm/m2 + Paclitaxel 175 mg/m2 • Cisplatin + Paclitaxel ( q3w ) • Cisplatin 75 mg/m2 + Paclitaxel 175 mg/m2 • Cisplatin + Topotecan (D1~3) ( q3w ) • Cisplatin 50 mg/m2 + Topotecan 1 mg/m2 • Cisplatin + Vincristine + Bleomycin (D1~3) ( q3w ) • Cisplatin 50 mg/m2 + Vincristine 1 mg/m2 + Bleomycin 15 mg/m2 • Cisplatin + Gemcitabine • Cisplatin 50 mg/m2 (D1) + Gemzar 1000 mg/m2 (D1 / D8) • Cisplatin + Camptothecin • Cisplatin: 75 mg/m2 (D1) + CPT-11: 60mg/m2 (D1 / D8 / D15)

  26. Common used Regimen for Non-squamous Cell Carcinoma • Cisplatin + Paclitaxel ( q3w ) • Cisplatin 75 mg/m2+ Paclitaxel 175 mg/m2 • Paclitaxel ( q3w ) • Paclitaxel 170 mg/m2 ( 24 hrs ) • Paclitaxel 135 mg/m2 ( 24 hrs ) ( if prior radiotherapy ) • Dose escalation to 200mg/m2 or de-escalation to 110mg/m2 depending on toxicity • Etoposide ( every 28 days ) • Oral Etoposide 50mg/m2/day for 21 days • Oral Etoposide 40mg/m2/day ( if prior radiotherapy ) for 21 days • Dose escalation to 60mg/m2/day depending on toxicity

  27. 參考資料 • GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide. World Health Organization. 2004. • Cervical Cancer, in National Comprehensive Cancer Network ( NCCN) Clinical Practice Guidelines in Oncology, v.1. 2006. http://www.nccn.org. • Benedet JL, Bender H, Jones H, III, et al. FIGO staging classifications and clinical practice guidelines in the management of gynecologic cancers. FIGO Committee on Gynecologic Oncology. International Journal of Gynecology & Obstetrics 2000; 70:209-262 • Cervical Cancer (PDQR): Treatment, Health Professional Version. National Cancer Institute. 2003. • Resbeut M, Fondrinier E, Fervers B, et al. Standards, Options and Recommendations for the management of invasive cervical cancer patients ( non metastatic). Bulletin du Cancer 2003;90:333-346 • Resbeut M, Fondrinier E, Fervers B, et al. Carcinoma of the cervix. Br. J. Cancer 2001;84 Suppl 2:24-30. • Landoni F, Maneo A, Colombo A, et al. Randomised study of radical surgery versus radiotherapy for stage Ib-II2 cervical cancer. Lancet 1997; 350:535-540. • Chang TC, Lai CH, Hong JH, et al. Randomized trial of neoadjuvant cisplatin vincrinstine, bleomycin, and radical hysterectomy versus radiation therapy for bulky stage IB and IIa cervical cancer. J. Clin. Oncol. 2000. Apr; 18(8): 1740-1747. • Neoadjuvant chemotherapy for locally advanced cervical cancer: a systemic review and meta-analysis of individual patient data from 21 randomised trials. European Journal of Cancer 2003; 39:2470-2486. • Whitney CW, Sause W, Bundy BN, et al. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIb- IVa carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J. Clin. Oncol. 1999; 17: 1339-1348. • Keys HM, Bundy Bn, Stehman FB, et al. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N. Engl. J. Med. 1999; 340: 1154-1161. • Morris M, Eifel PJ, Lu J, et al. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high risk cervical cancer, N. Engl. J. Med, 1999; 340: 1137-1143. • Rose PG, Bundy Bn, Watkins EB, et al. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N. Engl. J. Med. 1999; 340:1144-1153 • Green JA, Kirwan JM, Tierney JF, et al. Survival and recurrence after concomitant chemotherapy and radiotherapy for cancer of the uterine cervix: a ystematic review and meta-analysis. Lancet 2001; 358: 781-786. • Neoadjuvant chemotherapy for locally advanced cervical cancer: a systemic review and meta-analysis of individual patient data from 21 randomized trials. European Journal of Cancer 2003; 39: 2470-2486. • Lai CH, Juang KG, Hong JH, et al. Randomized trial of surgical staging( extraperitoneal or laparoscopic) versus clinical staging in locally advanced cervical cancer. Gynecol. Oncol. 2003;89: 160-167. • Haie C, Pejovic MH, Gerbaulet A, et al. Is prophylactic para-aortic irradiation worthwhile in the treatment of advanced cervical carcinoma? Results of a controlled clinical trial of the EORTC radiotherapy group. Radiother. Oncol. 1988;11:101-112. • Rotman M, Pajak TF, Choi K, et al. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIb and bulky Ib and IIa cervical carcinomas. Ten-year treatment results of RTOG 79-20, JAMA 1995; 274: 387-393. • Peters WA, Lui PY, Barrett RJ, et al. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J. Clin. Oncol. 2000; Apr; 18(8): 1606-1613. • Sedlis A, Bundy BN, Rotman MZ, et al. A randomized trial of pelvic radiation therapy versus no further therapy in selected patients with stage IB carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: A Gynecologic Oncology Group Study. Gynecol. Oncol. 1999;73: 177-183. • Bloss JD, Blessing JA, Behrens BC. et al. Randomized trial of cisplatin and ifosfamide with or without bleomycin in squamous cell carcinoma of cervix: A Gynecologic Oncology Group Study. J. Clin. Oncol. 2002; 20(7): 1832-1837. • Moore DH, Blessing JA, McQuellon RP, et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: A Gynecologic Oncology Group Study. J. Clin. Oncol. 2004; 22(15): 3113-3119. • Long III HJ, Bundy BN, Grendys Jr EC, et al. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix. A Gynecologic Oncology Group Study. J. Clin. Oncol. 2005;23(21): 4626-4633.

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