Treatment of ("bulky") stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: A phase III trial of the gynecologic oncology group

Gynecologic Oncology

Volumn 106, Issue 2, 2007, Pages 362-369

  Eddy, Gary L ^a   Bundy, Brian N ^b   Creasman, William T ^c   Spirtos, Nick M ^d   Mannel, Robert S ^e   Hannigan, Edward ^f   O'Connor, Dennis ^g  

^a MERCER UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^d UNIVERSITY OF NEVADA SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

^f UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^g Norton Healthcare   (United States)

Author keywords

GOG 141; Suboptimal stage IB cervical cancer; Survival; Vincristine cisplatin

Indexed keywords

CISPLATIN; VINCRISTINE;

ADJUVANT THERAPY; ADULT; AGE DISTRIBUTION; ALLERGY; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HUMAN; HYDRONEPHROSIS; HYSTERECTOMY; LAPAROTOMY; LIVER DISEASE; LIVER DYSFUNCTION; LIVER FUNCTION; LUNG DISEASE; LYMPHADENECTOMY; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; METABOLIC DISORDER; MULTIPLE CYCLE TREATMENT; NEUROLOGIC DISEASE; NEUROTOXICITY; OVERALL SURVIVAL; PAIN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RACE DIFFERENCE; RADICAL HYSTERECTOMY; RANDOMIZED CONTROLLED TRIAL; SKIN MANIFESTATION; TUMOR VOLUME; UNSPECIFIED SIDE EFFECT; URINARY TRACT INFECTION; UTERINE CERVIX CANCER;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; HYSTERECTOMY; LYMPH NODE EXCISION; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASM STAGING; UTERINE CERVICAL NEOPLASMS; VINCRISTINE;

EID: 34447643259     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2007.04.007     Document Type: Article

References (30)

1. Plentyl A.A., and Friedman E.A. Clinical significance of cervical lymphatics. Lymphatics system of the female genitalia (1971), Saunders, Philadelphia 85-115
2. Piver M.S., and Chung W.S. Prognostic significance of cervical lesions size and pelvic node metastases in cervical carcinoma. Obstet. Gynecol. 46 (1975) 507-510
3. Ballon S.C., Berman M.L., Lagasse L.D., et al. Survival after extraperitoneal pelvic and para-aortic lymphadenectomy and radiation therapy in cervical carcinoma. Obstet. Gynecol. 57 (1981) 90-95
4. Gauthier P., Gore I., Shingleton H.M., et al. Identification of histopathologic risk groups in Stage IB squamous carcinoma of the cervix. Obstet. Gynecol. 66 (1985) 569-573
5. Eddy G.L., Manetta A., Alvarez R.D., et al. Neoadjuvant chemotherapy with vincristine and cisplatin followed by radical hysterectomy and pelvic lymphadenectomy for FIGO Stage 1B bulky cervical cancer: a Gynecologic Oncology Group pilot study. Gynecol. Oncol. 57 (1995) 412-416
6. Benedetti-Panici P., Greggi S., Colombo A., et al. Neoadjuvant chemotherapy and radical surgery versus exclusive radiotherapy in locally advanced squamous cell cervical cancer: results from the Italian multicenter randomized study. J. Clin. Oncol. 20 (2001) 179-188
7. Chang T.C., Lai C.H., Hong J.H., et al. Randomized trial of neoadjuvant cisplatin, vincristine, bleomycin and radical hysterectomy versus radiation therapy for bulky Stage IB and IIA cervical cancer. J. Clin. Oncol. 18 (2000) 1740-1747
8. Keys H.M., Bundy B.N., Stehman F.B., et al. Weekly cisplatin during radiation therapy versus irradiation alone each followed by adjuvant hysterectomy in bulky stage IB cervical carcinoma: a randomized trial of the Gynecologic Oncology Group. N. Engl. J. Med. 340 (1999) 1154-1161
9. American Joint Committee on Cancer. Manual for staging of cancer. 4th ed. (1992), JB Lippincott Company, Philadelphia 155-157
10. Delgado G., Bundy B.N., Fowler Jr. W.C., et al. A prospective surgical pathologic study of Stage I squamous carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol. Oncol. 35 (1989) 314-320
11. Piver M.S., Rutledge F., and Smith J.P. Five classes of extended hysterectomy for women with cervical cancer. Obstet. Gynecol. 44 (1974) 265-272
12. Blessing J.A. Design, analysis and interpretation of chemotherapy trials in gynecologic cancer. In: Deppe G. (Ed). Chemotherapy of gynecologic cancer. 2nd ed. (1990), AR Liss, Inc, New York 63-97
13. Schoenfeld D. Sample sizes for the proportional hazards regression model. Biometrics 39 (1983) 499-503
14. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemo. Rep. 50 (1966) 163-170
15. Lan K.K.G., and DeMets D.L. Discrete sequential boundaries for clinical trials. Biometrika 70 (1983) 659-663
16. Kaplan E.L., and Meier P. Nonparametric estimation from incomplete observations. J. Am. Stat. Assoc. 53 (1958) 457-481
17. Cox D.R. Regression model and life tables (with discussion). J. R. Stat. Soc. 34 (1972) 187-220
18. Kalbfleisch J.D., and Prentice R.L. The statistical analysis of failure time data (1980), John Wiley and Sons, Inc, New York
19. Hollander M., and Wolfe D.A. Nonparametric statistical methods. Wiley series in probability (1999), John Wiley and Sons, Inc, New York
20. Sedlis A., Bundy B.N., Rotman M.Z., 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. 73 (1999) 177-183
21. Rotman M., Sedlis A., Piedmonte M.R., Bundy B., Lentz S.S., Muderspach L.I., and Zaino RJ. A phase III randomized trial of postoperative pelvic irradiation in stage IB cervical carcinoma with poor prognostic features: follow-up of a Gynecologic Oncology Group study. Int. J. Radiat. Oncol. Biol. Phys. 65 (2006) 169-176
22. Duenas-Gonzalez A., Lopez-Graniel C., Gonzalez-Enciso A., et al. A phase II study of multimodality treatment for locally advanced cervical cancer: neoadjuvant carboplatin and paclitaxel followed by radical hysterectomy and adjuvant cisplatin chemoradiation. Ann. Oncol. 14 (2003) 1278-1284
23. Buda A., Fossati R., Colombo N., et al. Randomized trial of neoadjuvant chemotherapy comparing paclitaxel, ifosfamide, and cisplatin with ifosfamide and cisplatin followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the SNAP01 (Studio Neo-Adjuvante Portio) Italian Collaborative Study. J. Clin. Oncol. 23 (2005) 4137-4145
24. Yessaian A., Magistris A., Burger R.A., et al. Radical hysterectomy followed by tailored postoperative therapy in the treatment of stage IB2 cervical cancer: feasibility and indications for adjuvant therapy. Gynecol. Oncol. 94 (2004) 61-66
25. Sardi J.E., Sananes C.E., Gioaroli A.A., et al. Neoadjuvant chemotherapy in cervical carcinoma Stage IIB: a randomized controlled trial. Int. J. Gynecol. Cancer 8 (1998) 441-450
26. Neoadjuvant Chemotherapy for Cervical Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy for locally advanced cervical cancer: a systematic review and meta-analysis of individual patient data from 21 randomised trials. Eur. J. Cancer 39 (2003) 2470-2486
27. Benedetti-Panici P., Greggi S., Colombo A., et al. Neoadjuvant chemotherapy and radical surgery versus exclusive radiotherapy in locally advanced squamous cell cervical cancer: results from the Italian multicenter randomized study. J. Clin. Oncol. 20 (2002) 179-188
28. Chang T., Lai C., Hong J., et al. Randomized trial of neoadjuvant cisplatin, vincristine, bleomycin, and radical hysterectomy versus radiation therapy for bulky Stage IB and IIA cervical cancer. J. Clin. Oncol. 18 (2000) 1740-1747
29. Delgado G., Bundy B., Zaino R., et al. Prospective surgical-pathological study of disease-free interval in patients with Stage IB squamous cell carcinoma of the cervix. A Gynecologic Oncology Group study. Gynecol. Oncol. 38 (1990) 352-357
30. Katsumata N., Yoshikawa H., Hirakawa T., et al. Phase III randomized trial of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy (RH) versus RH for bulky stage I/II cervical cancer. J. Clin. Oncol. (2006) [Proc ASCO; 24:18S (abst 5013)]