PMID- 15850910 OWN - NLM STAT- MEDLINE DCOM- 20050607 LR - 20051227 IS - 0360-3016 (Print) IS - 0360-3016 (Linking) VI - 62 IP - 1 DP - 2005 May 1 TI - Intravaginal brachytherapy alone for intermediate-risk endometrial cancer. PG - 111-7 AB - PURPOSE: Despite the results of the Gynecologic Oncology Group trial No. 99 (GOG#99), some unanswered questions still remain about the role of adjuvant radiotherapy (RT) for intermediate-risk endometrial cancer. First, can intravaginal brachytherapy (IVRT) alone substitute for external beam RT but without added morbidity? Second, is the high-risk (HR) definition from GOG#99 a useful tool to predict pelvic recurrence specifically? The purpose of this study was to try to answer these questions in a group of patients with Stage IB-IIB endometrial carcinoma treated with high-dose-rate (HDR) IVRT alone. METHODS AND MATERIALS: Between November 1987 and December 2002, 382 patients with Stage IB-IIB endometrial carcinoma were treated with simple hysterectomy followed by HDR-IVRT alone at our institution. Comprehensive surgical staging (CSS), defined as pelvic washings and pelvic/paraaortic lymph node sampling, was performed in 20% of patients. The mean age was 60 years (range, 29-92 years). Lymphovascular invasion (LVI) was present in 14% of patients. The median HDR-IVRT dose was 21 Gy (range, 6-21 Gy), given in three fractions. Complications were assessed in terms of late Radiation Therapy Oncology Group (Grade 3 or worse) toxicity of the GI tract, genitourinary GU tract, and vagina. RESULTS: With a median follow-up of 48 months, the 5-year vaginal/pelvic control rate was 95% (95% confidence interval [CI], 93-98%). On multivariate analysis, a poor vaginal/pelvic control rate correlated with age > or =60 years old (relative risk [RR], 3, 95% CI, 1-12; p = 0.01), International Federation of Gynecology and Obstetrics (FIGO) Grade 3 (RR, 9, 95% CI, 2-35; p = 0.03), and LVI (RR, 4, 95% CI, 1-13; p = 0.051). The depth of myometrial invasion and CSS, however, were not significant. With regard to pelvic control specifically, the presence of GOG#99 HR features did not affect the pelvic control rate. The 5-year rate for HR patients was 96% (95% CI, 90-100%) vs. 96% (95% CI, 94-99%) for those without HR disease (p = 0.48). Even when the CSS effect was taken into account, the influence of HR features on pelvic control was still not significant (p = 0.51). In contrast, pelvic control was significantly influenced when patients were grouped according to CSS and stage/grade substages. For those with Stage IB Grade 3-IIB and no CSS, the 5-year pelvic control rate was 86% compared with 97% for those with Stage IB Grade 3-IIB and CSS, 97% for Stage IB, Grade 1-2 without CSS, and 100% for those with Stage IB, Grade 1-2 and CSS (p = 0.027). The 5-year disease-free survival rate was 93% (95% CI, 90-96%). On multivariate analysis, poor disease-free survival correlated with age > or =60 years (RR, 5; 95% CI, 1-18; p = 0.002), FIGO Grade 3 (RR 5, 95% CI 2-17; p = 0.013), and LVI (RR 3, 95% CI 1-8; p = 0.054). Unlike pelvic control, disease-free survival was significantly affected by GOG#99 HR features, with a 5-year rate of 87% (95% CI, 76-99%) vs. 94% (95% CI, 91-97%) for those without HR features (p = 0.027). The 5-year overall and disease-specific survival rate was 93% and 97%, respectively. The overall 5-year actuarial rate of Grade 3 or worse complications was 1% (95% CI, 0-2%). CONCLUSION: Tumor grade, depth of invasion, and the use of CSS were better predictors of pelvic control than the GOG#99 HR factors. IVRT alone seemed to provide adequate tumor control with very low morbidity. Therefore, it seems prudent to consider it for intermediate-risk patients because of its superior therapeutic ratio compared with that for surgery alone or pelvic RT. Additional follow-up, however, with a larger number of patients is needed, especially for those with LVI. FAU - Alektiar, Kaled M AU - Alektiar KM AD - Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. alektiak@mskcc.org FAU - Venkatraman, Ennapadam AU - Venkatraman E FAU - Chi, Dennis S AU - Chi DS FAU - Barakat, Richard R AU - Barakat RR LA - eng PT - Journal Article PL - United States TA - Int J Radiat Oncol Biol Phys JT - International journal of radiation oncology, biology, physics JID - 7603616 SB - IM CIN - Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1275; author reply 1275. PMID: 16253783 MH - Aged MH - Aged, 80 and over MH - Brachytherapy/adverse effects/*methods MH - Carcinoma, Endometrioid/pathology/*radiotherapy/surgery MH - Confidence Intervals MH - Disease-Free Survival MH - Endometrial Neoplasms/pathology/*radiotherapy/surgery MH - Female MH - Humans MH - Middle Aged MH - Multivariate Analysis MH - Neoplasm Recurrence, Local MH - Radiotherapy Dosage MH - Radiotherapy, Adjuvant MH - Risk EDAT- 2005/04/27 09:00 MHDA- 2005/06/09 09:00 CRDT- 2005/04/27 09:00 PHST- 2004/07/21 00:00 [received] PHST- 2004/09/16 00:00 [accepted] PHST- 2005/04/27 09:00 [pubmed] PHST- 2005/06/09 09:00 [medline] PHST- 2005/04/27 09:00 [entrez] AID - S0360-3016(04)02708-7 [pii] AID - 10.1016/j.ijrobp.2004.09.054 [doi] PST - ppublish SO - Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):111-7. doi: 10.1016/j.ijrobp.2004.09.054.