A randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5503-5503 ◽  
Author(s):  
T. Hogberg ◽  
P. Rosenberg ◽  
G. Kristensen ◽  
C. F. de Oliveira ◽  
R. de Pont Christensen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Early Stage ◽  
Myometrial Invasion ◽  
Phase Iii ◽  
Absolute Difference ◽  
Carboplatin Auc ◽  
Better Than

5503 Background: Adjuvant therapy for early stage high-risk endometrial cancer remains controversial. Methods: Patients with surgical stage I, II, IIIA (positive peritoneal fluid cytology only), or IIIC (positive pelvic lymph nodes only) were eligible if they, according to departmental guidelines, had a sufficiently high risk for micrometastatic disease to qualify for adjuvant therapy. Most patients had two or more of the risk factors: grade 3, deep myometrial invasion, or DNA non-diploidy, while some patients had only one of these. Patients with serous, clear cell, or anaplastic carcinomas were eligible regardless of risk factors. Patients with para-aortic metastases were not eligible. Lymph node exploration at staging surgery was optional. Pelvic RT ± vaginal brachytherapy was given to a dose =44 Gy. CT was given before or after RT. Before August 2004 CT consisted of four courses of cisplatin =50 mg/m2 + doxorubicin 50 mg/m2 or epirubicin 75 mg/m2 (AP). Thereafter several CT regimens were allowed, of which AP, paclitaxel 175 mg/m2 + epirubicin 60 mg/m2 + carboplatin AUC 5, and paclitaxel 175 mg/m2 + carboplatin AUC 5–6 were used. Progression-free survival (PFS) was the primary end-point. The study was terminated before the aimed goal of 400 patients because of slow recruitment. We decided to make an early analysis since new studies on endometrial cancer are presently discussed. Results: 372 patients were entered between May 1996 and Oct 2006. Of 367 evaluable patients 190 were randomized to RT and 177 to RT+CT. Risk factors were well balanced between the randomization arms. The median follow-up time was 3.5 years. The hazard ratio for PFS was 0.58 in favor of RT+CT (95 % confidence interval (CI) 0.34 - 0.99; p=0.046). This translates to an estimated 7 % absolute difference in 5-year PFS from 75 % (95 % CI 67 % - 82 %) to 82 % (95 % CI 73 % - 88 %). Conclusion: RT+CT was better than RT alone. Next question is if RT+CT is better than CT alone. No significant financial relationships to disclose.

scholarly journals Controversies in the Adjuvant Therapy of Endometrial Cancer

2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Sheng-Mou Hsiao ◽  
Lin-Hung Wei
Keyword(s):  
Risk Factors ◽  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Randomized Trials ◽  
Female Genital Tract ◽  
Myometrial Invasion ◽  
Cell Types ◽  
High Risk Factors ◽  
Grade 3

Endometrial cancer is the most common malignancy of the female genital tract. Surgical treatment includes hysterectomy, bilateral salpingo-oophorectomy, and an appropriate staging procedure. Relapse of endometrial cancer may occur in patients with high risk factors, such as old age, grade 3 cancer, deep myometrial invasion, and papillary serous and clear cell types. In recent years, several randomized trials reported the results of adjuvant therapy for patients with high risk factors. Nonetheless, some controversies still exist. This paper presents and discusses the results of important randomized trials of adjuvant therapy for endometrial cancer with risk factors.

Characteristics of early-stage endometrial cancer and factors that influence disease recurrence.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17567-e17567
Author(s):  
Su Yun Chung ◽  
Janice Shen ◽  
Nina Kohn ◽  
Jennifer Hernandez ◽  
Marina Frimer ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Adjuvant Therapy ◽  
Tumor Size ◽  
Early Stage ◽  
Univariate Analysis ◽  
Multivariable Analysis ◽  
Myometrial Invasion ◽  
Figo Stage ◽  
Risk Of Recurrence ◽  
Early Stage Endometrial Cancer

e17567 Background: Early-stage endometrial cancer (EEC) with FIGO stage I-II generally has a favorable prognosis and overall survival (OS). However, up to 10% of EEC patients (pts) relapse and risk factors for recurrence remain unclear. We evaluated clinical and histopathologic characteristics of EEC and correlated them with OS and recurrence free survival (RFS) through a single-center retrospective analysis. Methods: We conducted a retrospective chart review on 511 pts with EEC identified by our cancer registry from 1/1/2009 to 12/31/2019. The two main histologic groups were endometrioid adenocarcinomas (E) and other subtypes (O) including carcinosarcoma, undifferentiated, and clear cell carcinomas. Papillary serous histology was excluded. Histopathologic and clinical findings recorded included age, FIGO stage and grade, tumor size, presence of recurrence, adjuvant therapies received, percent of myometrial invasion (MI), and lymphovascular invasion (LVI). OS and RFS were estimated, and each predictor was compared using the log-rank test. The association between OS and each continuous characteristic was examined using the Cox proportional hazards model. Factors significantly associated with OS and RFS in the univariable analysis (p < 0.05) were included in a multivariable analysis to examine the joint effects of those factors on survival. Results: A total of 511 cases were reviewed. The analysis included 501 pts (E = 485, O = 16), of which 47 had recurrent disease (E = 45, O = 2) and 17 had died without recurring (E = 15, O = 2) as of their last follow-up. Overall median age was 63 years. Factors significantly associated with recurrence in the multivariable analysis were FIGO grade, (Hazard Ratios (HR): Grade 2 vs 1: 1.95, 95% CI: 1.06-3.58, p = 0.0320, Grade 3 vs 1: 2.88, 95% CI: 1.50-5.52, p = 0.0015), LVI (HR: 2.03, 95% CI: 1.10-3.75, p = 0.0244), and greater than 50% of MI (HR: 3.15, 95% CI: 1.35-7.36, p = 0.0080). The overall RFS was 92% and 86% at three and five years, respectively. On univariate analysis, among pts with a measurable tumor size (n = 446), larger tumors were not significantly associated with OS (p = 0.65) but was associated with increased recurrence (HR 1.22, 95% CI: 1.10-1.37, for a unit increase, p = 0.0003). On univariate analysis, pts who received adjuvant therapy were more likely to recur (p = 0.0002) with RFS of 86% and 76% at three and five years respectively, versus RFS of 94% and 90%, for those who did not. Conclusions: We confirmed the clinical and histopathologic characteristics that are currently considered to increase risk of recurrence in EEC. On multivariate analysis, risk of recurrence was associated with FIGO grades 2 and 3, presence of LVI, and > 50% MI. A limitation of this study is the lack of molecular analysis. Further molecular stratification may help us identify the subset of pts who are at high risk of recurrence, enabling customized adjuvant therapy in EEC.

Adjuvant therapy for early-stage endometrial cancer: a review

2007 ◽  
Vol 17 (5) ◽  
pp. 949-956 ◽  
Author(s):  
S. Tangjitgamol ◽  
S. Manusirivithaya ◽  
C. Lertbutsayanukul
Keyword(s):  
Radiation Therapy ◽  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Adjuvant Treatment ◽  
Hormonal Therapy ◽  
Early Stage ◽  
Favorable Outcome ◽  
Early Stage Endometrial Cancer

Most patients with endometrial cancer (EMC) present their symptoms early in their course, leading to an overall favorable outcome. However, some patients who are in early-stage diseases may carry some risk features that would hamper their prognoses. For these early-stage diseases with high risk of recurrences, radiation therapy certainly plays a major role as an adjuvant treatment. Despite an excellent local diseases control by radiation, systemic failures are still encountered. To improve the prognoses, other types of adjuvant therapy have been attempted. In this review, various options of adjuvant treatment for this early-stage EMC including radiation therapy, chemotherapy, and hormonal therapy are discussed.

Adjuvant chemotherapy in early-stage endometrioid endometrial cancer with >50% myometrial invasion and negative lymph nodes

2021 ◽  
Vol 31 (4) ◽  
pp. 537-544
Author(s):  
Francesco Multinu ◽  
Simone Garzon ◽  
Amy L Weaver ◽  
Michaela E. McGree ◽  
Enrico Sartori ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Early Stage ◽  
Myometrial Invasion ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Endometrioid Endometrial Cancer ◽  
Negative Lymph Nodes

ObjectiveThe role of adjuvant chemotherapy as an addition or alternative to radiotherapy for early-stage high-risk endometrioid endometrial cancer is controversial. This study aimed to investigate the role of adjuvant chemotherapy in early-stage high-risk endometrioid endometrial cancer.MethodsWe identified patients with stage I or II endometrioid grade 2 or 3 endometrial cancer with myometrial invasion >50% and negative lymph nodes after pelvic with or without para-aortic lymphadenectomy at four institutions (USA and Italy). Associations between chemotherapy and cause-specific and recurrence-free survival were assessed with Cox proportional hazards models. Hematogenous, peritoneal, and lymphatic recurrences were defined as 'non-vaginal'.ResultsWe identified 329 patients of mean (SD) age 66.4 (9.8) years. The median follow-up among those alive was 84 (IQR 44–133) months. The 5-year cause-specific survival was 86.1% (95% CI 82.0% to 90.4%) and the 5-year recurrence-free survival was 82.2% (95% CI 77.9% to 86.8%). Stage II (vs stage IB) was associated with poorer cause-specific and recurrence-free survival. A total of 58 (90.6%) of 64 patients who had chemotherapy had 4–6 cycles of platinum-based regimen. In adjusted analysis, we did not observe a statistically significant improvement in cause-specific survival (HR 0.34; 95% CI 0.11 to 1.03; p=0.06) or non-vaginal recurrence-free survival (HR 0.36; 95% CI 0.12 to 1.08; p=0.07) with adjuvant chemotherapy. Sixteen of 18 lymphatic recurrences (88.9%; 3/5 pelvic, all 13 para-aortic) were observed in the 265 patients who did not receive adjuvant chemotherapy. Among stage II patients, no deaths (100% 5-year recurrence-free survival) were observed in the eight patients who received adjuvant chemotherapy compared with 66% 5-year recurrence-free survival in the 34 patients who did not.ConclusionAlthough we observed that adjuvant chemotherapy was associated with improved oncologic outcomes in early-stage high-risk endometrioid endometrial cancer, the associations did not meet conventional levels of statistical significance. Further research is warranted in this relatively uncommon subgroup of patients.

scholarly journals Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early-Stage Endometrial Cancer

2019 ◽  
Vol 37 (21) ◽  
pp. 1810-1818 ◽  
Author(s):  
Marcus E. Randall ◽  
Virginia Filiaci ◽  
D. Scott McMeekin ◽  
Vivian von Gruenigen ◽  
Helen Huang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Endometrial Cancer ◽  
High Risk ◽  
Confidence Limit ◽  
Clear Cell ◽  
Early Stage ◽  
Stage I ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Pelvic Radiation

PURPOSE The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma. PATIENTS AND METHODS A randomized phase III trial was performed in eligible patients with endometrial cancer. Eligible patients had International Federation of Gynecology and Obstetrics (2009) stage I endometrioid histology with Gynecologic Oncology Group protocol 33–based high-intermediate–risk criteria, stage II disease, or stage I to II serous or clear cell tumors. Treatment was randomly assigned between RT (45 to 50.4 Gy over 5 weeks) or VCB followed by intravenous paclitaxel 175 mg/m2 (3 hours) plus carboplatin (area under the curve, 6) every 21 days for three cycles. RESULTS The median age of the 601 patients was 63 years, and 74% had stage I disease. Histologies included endometrioid (71%), serous (15%), and clear cell (5%). With a median follow-up of 53 months, the 60-month RFS was 0.76 (95% CI, 0.70 to 0.81) for RT and 0.76 (95% CI, 0.70 to 0.81) for VCB/C (hazard ratio, 0.92; 90% confidence limit, 0.69 to 1.23). The 60-month overall survival was 0.87 (95% CI, 0.83 to 0.91) for RT and 0.85 (95% CI, 0.81 to 0.90) for VCB/C (hazard ratio, 1.04; 90% confidence limit, 0.71 to 1.52). Vaginal and distant recurrence rates were similar between arms. Pelvic or para-aortic nodal recurrences were more common with VCB/C (9% v 4%). There was no heterogeneity of treatment effect with respect to RFS or overall survival among clinical or pathologic variables evaluated. CONCLUSION Superiority of VCB/C compared with pelvic RT was not demonstrated. Acute toxicity was greater with VCB/C; late toxicity was similar. Pelvic RT alone remains an effective, well-tolerated, and appropriate adjuvant treatment in high-risk early-stage endometrial carcinomas of all histologies.

Lymphovascular Space Invasion and the Treatment of Stage I Endometrioid Endometrial Cancer

2015 ◽  
Vol 25 (1) ◽  
pp. 75-80 ◽  
Author(s):  
Louis J.M. van der Putten ◽  
Yvette P. Geels ◽  
Nicole P.M. Ezendam ◽  
Hans W.H.M. van der Putten ◽  
Marc P.M.L. Snijders ◽  
...  
Keyword(s):  
Risk Factors ◽  
Endometrial Cancer ◽  
Adjuvant Radiotherapy ◽  
Early Stage ◽  
Myometrial Invasion ◽  
Distant Recurrence ◽  
Stage I ◽  
Recurrence Rates ◽  
Endometrioid Endometrial Cancer ◽  
Lymphovascular Space Invasion

ObjectivesTreatment of clinical early-stage endometrioid endometrial cancer (EEC) in The Netherlands consists of primary hysterectomy and bilateral salpingo-oophorectomy. Adjuvant radiotherapy is given when 2 or more the following risk factors are present: 60 years or older, grade 3 histology, and 50% or more myometrial invasion. Lymphovascular space invasion (LVSI) is a predictor of poor prognosis and early distant spread. It is unclear whether adjuvant radiotherapy is sufficient in patients with LVSI-positive EEC.Methods/MaterialsEighty-one patients treated from 1999 until 2011 for stage I LVSI-positive EEC in 11 Dutch hospitals were included. The outcomes of patients with 0 to 1 risk factors were compared with those with 2 to 3 risk factors, and both were compared with the known literature.ResultsEighteen patients presented with recurrent disease, and 12 of those recurrences had a distant component. Overall and distant recurrence rates were 19.2% and 11.5% in patients with 0 to 1 risk factors followed by observation and 25.5% and 17% in patients with 2 to 3 risk factors who received adjuvant radiotherapy. Only 1 patient with grade 1 disease had a recurrence.ConclusionsIn stage I LVSI-positive EEC with 0 to 1 risk factors, observation might not be adequate. Moreover, despite adjuvant radiotherapy, a high overall and distant recurrence rate was observed in patients with 2 to 3 risk factors. The use of systemic treatment in these patients, with the exception of patients with grade 1 disease, should be investigated.

scholarly journals Lymphovascular Space Invasion Portends Poor Prognosis in Low-Risk Endometrial Cancer

2015 ◽  
Vol 25 (7) ◽  
pp. 1292-1299 ◽  
Author(s):  
Ricardo dos Reis ◽  
Jennifer K. Burzawa ◽  
Audrey T. Tsunoda ◽  
Masayoshi Hosaka ◽  
Michael Frumovitz ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Adjuvant Therapy ◽  
Early Stage ◽  
Prognostic Significance ◽  
Myometrial Invasion ◽  
Primary Treatment ◽  
Low Risk ◽  
Fisher Exact Test ◽  
Exact Test ◽  
Lymphovascular Space Invasion

ObjectiveThe prognostic significance of lymphovascular space invasion (LVSI) in patients with early-stage endometrial cancer is not established. We sought to determine if LVSI status in patients with early-stage low-risk endometrial cancer correlates with recurrence and survival.MethodsThe records of all women who underwent hysterectomy for primary treatment of endometrial cancer from January 2006 through January 2011 at 1 academic institution were reviewed. Patients with grade 1 or 2 endometrioid histology, myometrial invasion less than 50%, and disease confined to the uterus (clinical International Federation of Obstetrics and Gynecology stage IA) were analyzed. Fisher exact test and the Wilcoxon rank-sum test were applied to compare patients with and without LVSI. Recurrence-free survival (RFS) and overall survival (OS) were calculated using the Kaplan-Meier method.ResultsTwo hundred forty patients met the inclusion criteria. Forty (16.7%) had LVSI. Ninety-one patients (37.9%) underwent lymphadenectomy. Median tumor size was 30 mm in patients with and 26 mm in patients without LVSI (P = 0.150). Thirty patients (12.5%) received adjuvant therapy. Site of recurrence did not differ between patients with and without LVSI. Patients with LVSI were more likely to have myometrial invasion (P < 0.001), postoperative pathologic grade 2 disease (P < 0.001), to undergo lymphadenectomy (P = 0.049) and receive adjuvant therapy (P < 0.001). The 5-year cumulative incidence of recurrence was 3.8% in the no-LVSI group and 14.2% in the LVSI group (P = 0.053). The presence of LVSI was significantly associated with worse RFS (P = 0.002) and OS (P = 0.013).ConclusionsPatients with low-risk endometrial cancer and LVSI have worse RFS and OS despite being more likely to undergo lymphadenectomy and adjuvant therapy.

Abnormal cervical cytology: a risk factor for endometrial cancer recurrence

2005 ◽  
Vol 15 (3) ◽  
pp. 517-522 ◽  
Author(s):  
A. K. Brown ◽  
S. Gillis ◽  
C. Deuel ◽  
C. Angel ◽  
C. Glantz ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multivariate Analysis ◽  
Endometrial Cancer ◽  
High Risk ◽  
Cancer Recurrence ◽  
Myometrial Invasion ◽  
Nodal Status ◽  
Cervical Cytology ◽  
Abnormal Cervical Cytology ◽  
Risk Factors For Recurrence

The objective of this study was to evaluate the relationship between cervical cytology, histologic type, and risk of endometrial cancer recurrence. We performed a retrospective study of patients undergoing surgery for endometrial carcinoma. Risk factors for recurrence including histology, tumor grade, nodal status, myometrial invasion, peritoneal washings, stage, and cervical cytology were assessed. Abnormal cervical cytology was defined as the presence of any endometrial cells on Pap smear. Papillary serous and clear cell carcinomas were considered high-risk histologies. Univariate and multivariate analyses of risk factors for recurrence were performed. Thirty-nine (9%) patients developed recurrent endometrial cancer. More patients with abnormal Pap smears recurred (12% versus 4%, P < 0.05). For endometrioid adenocarcinoma, abnormal cervical cytology occurred in 61% and 7% recurred, while with high-risk histologies, 84% had abnormal cervical cytology and 19% recurred (P < 0.05). Other significant predictors of recurrence on univariate analysis were myometrial invasion, nodal status, washings, stage, and histology. On multivariate analysis, only nodal status remained a significant predictor of recurrence. Abnormal cervical cytology is associated with increased risk of endometrial cancer recurrence. Abnormal cervical cytology occurs more frequently in high-risk histologies, which are known to have a higher risk of recurrence. On multivariate analysis, only nodal spread remains a significant predictor of recurrence.

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