Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study

Randall, Marcus E.; Filiaci, Virginia L.; Muss, Hyman B.; Spirtos, Nick M.; Mannel, Robert S.; Fowler, Jeffrey; Thigpen, J.T.; Benda, Jo Ann

doi:10.1200/jco.2004.00.7617

Cited by 841 publications

(559 citation statements)

References 46 publications

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“…Therefore VBT could be the adjuvant treatment of choice in this clinical setting. Four randomized trials compared adjuvant platinum based chemotherapy to radiotherapy in high-risk endometrial cancer [22,23,29,30]. The pooled data meta-analyses showed a significant improvement in terms of progression-free survival (HR = 0.80; 95%CI = 0.66-0.97) and overall survival (HR = 0.76, 95% CI = 0.62-0.92) for chemotherapy arm [24].…”

Section: Discussionmentioning

confidence: 99%

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Adjuvant treatment and analysis of failures in patients with high-risk FIGO Stage Ib–II endometrial cancer: An Italian multicenter retrospective study (CTF study)

Gadducci

Cosio

Landoni

et al. 2014

Gynecologic Oncology

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• Adjuvant chemotherapy reduces the risk of distant recurrences in patients with high-risk, early-stage endometrial cancer with negative pelvic nodes.• The sequential administration of adjuvant chemotherapy and radiotherapy achieves excellent local and distant control of disease in this clinical settings. Objectives. The purpose of this retrospective study was to assess the clinical outcome of patients with highrisk, early-stage endometrioid endometrial cancer (stage Ib or II with myometrial invasion N 50%, grade 2-3). a b s t r a c t a r t i c l e i n f oMethods. We assessed 192 patients who underwent hysterectomy, bilateral salpingo-oophorectomy and pelvic lymphadenectomy, had histologically negative pelvic nodes, and had negative CT findings for aortic node involvement.Results. Tumor relapsed in 36 patients after a median time of 21.2 months. The recurrence was vaginal in 7 (19.4%), distant in 16 (44.4%), aortic in 8 (22.2%), and involved multiple sites in 5 (13.9%). There was a trend to a lower vaginal recurrence rate in the 143 patients who received adjuvant radiotherapy (+chemotherapy) compared with the 46 who did not (2.1% versus 8.7%). Distant or aortic recurrences were lower in the 37 patients who received adjuvant chemotherapy (+radiotherapy) than in the 152 who did not (2.7% versus 18.4%, p = 0.02). Of the 29 patients who received sequential adjuvant chemotherapy and radiotherapy, none developed local recurrence and only one had distant recurrence. There was a trend for a better 5-year progression-free survival and overall survival for the patients who received chemotherapy (+ radiotherapy) compared with those who did not (86.0% versus 71.3%, and 92.3% versus 75.6%, respectively).Conclusions. Our data appear to suggest that adjuvant chemotherapy reduces the risk of distant or aortic recurrences and that sequential adjuvant chemotherapy and radiotherapy achieve an excellent local and distant control of disease in these clinical settings.

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Section: Discussionmentioning

confidence: 99%

“…The HR for death was the same if the analysis excluded the trial enrolling carcinosarcomas [30]. However, GOG122 included patients with stage III-IV endometrial cancer with residual disease b 2 cm [29]. The advantage in overall survival for chemotherapy arm was lost if this trial was omitted from the analysis [24].…”

Section: Discussionmentioning

confidence: 99%

Adjuvant treatment and analysis of failures in patients with high-risk FIGO Stage Ib–II endometrial cancer: An Italian multicenter retrospective study (CTF study)

Gadducci

Cosio

Landoni

et al. 2014

Gynecologic Oncology

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“…For patients with advanced stage disease, chemotherapy has been increasingly integrated into first-line therapy. In a randomized trial conducted by the Gynecologic Oncology Group (GOG), doxorubicin and cisplatin chemotherapy produced superior progression-free survival (PFS) and overall survival (OS) compared to whole abdominal irradiation (WAI) [5]. Despite improvements in chemotherapy, the median duration of response for patients with recurrent disease is only 4-8 months, and median survival is generally less than 12 months.…”

Section: Introductionmentioning

confidence: 99%

A phase II trial of thalidomide in patients with refractory endometrial cancer and correlation with angiogenesis biomarkers: A Gynecologic Oncology Group study

McMeekin

Sill

Benbrook

et al. 2007

Gynecologic Oncology

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Objectives-A phase II trial was conducted to evaluate the anti-tumor activity and adverse effects of thalidomide in persistent or recurrent endometrial cancer refractory to cytotoxic chemotherapy, and to correlate angiogenesis biomarker expression with clinical outcome.Methods-Consenting patients were treated until progression or intolerable toxicity with an oral starting dose of 200 mg thalidomide/day that was to increase by 200 mg every 2 weeks to a target dose of 1000 mg/day. Vascular endothelial growth factor (VEGF), basic fibroblastic growth factor (bFGF), and soluble endothelial protein C receptor (sEPCR) were analyzed by ELISA in pre and post-treatment specimens.Results-Twenty-four of 27 patients enrolled in the study were eligible, of whom 2 reached the target dose, 8 progressed before achieving the target dose and 14 refused or had toxicity that prohibited escalation. Two patients (8.3%) remained progression-free ≥ 6 months. There were 3 (12.5%) with partial responses, 2 (8.3%) with stable disease, 15 (62.5%) with increasing disease, and 4 (16.7%) who were inevaluable for response. Median progression-free survival and overall survival Précis: Thalidomide has minimal activity in chemo-refractory endometrial cancer as judged by the ability to prolong progression-free survival greater than 6 months.Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…Over the past decade, some clinical trials have incorporated UPSC, and CC while others have excluded these poor histologic subtypes (Keys et al, 2004;Randell et al, 2006). This dichotomy stems from the conflicting data in the current literature regarding prognosis of high-risk endometrial tumours.…”

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Uterine papillary serous and clear cell carcinomas predict for poorer survival compared to grade 3 endometrioid corpus cancers

Cheung²,

et al. 2006

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To compare the survival of women with uterine papillary serous carcinoma (UPSC) and clear cell carcinoma (CC) to those with grade 3 endometrioid uterine carcinoma (G3EC). Demographic, pathologic, treatment, and survival information were obtained from the Surveillance, Epidemiology, and End Results Program from 1988 to 2001. Data were analysed using Kaplan -Meier and Cox proportional hazards regression methods. Of 4180 women, 1473 had UPSC, 391 had CC, and 2316 had G3EC cancers. Uterine papillary serous carcinoma and CC patients were older (median age: 70 years and 68 vs 66 years, respectively; Po0.0001) and more likely to be black compared to G3EC (15 and 12% vs 7%; Po0.0001). A higher proportion of UPSC and CC patients had stage III -IV disease compared to G3EC patients (52 and 36% vs 29%; Po0.0001). Uterine papillary serous carcinoma, CC and G3EC patients represent 10, 3, and 15% of endometrial cancers but account for 39, 8, and 27% of cancer deaths, respectively. The 5-year disease-specific survivals for women with UPSC, CC and G3EC were 55, 68, and 77%, respectively (Po0.0001). The survival differences between UPSC, CC and G3EC persist after controlling for stage I -II (74, 82, and 86%; Po0.0001) and stage III -IV disease (33, 40, and 54; Po0.0001). On multivariate analysis, more favourable histology (G3EC), younger age, and earlier stage were independent predictors of improved survival. Women with UPSC and CC of the uterus have a significantly poorer prognosis compared to those with G3EC. These findings should be considered in the counselling, treating and designing of future trials for these high-risk patients.

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Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study

Abstract: Chemotherapy with AP significantly improved progression-free and overall survival compared with WAI. Nevertheless, further advances in efficacy and reduction in toxicity are clearly needed.

Cited by 841 publications

References 46 publications

Adjuvant treatment and analysis of failures in patients with high-risk FIGO Stage Ib–II endometrial cancer: An Italian multicenter retrospective study (CTF study)

Adjuvant treatment and analysis of failures in patients with high-risk FIGO Stage Ib–II endometrial cancer: An Italian multicenter retrospective study (CTF study)

A phase II trial of thalidomide in patients with refractory endometrial cancer and correlation with angiogenesis biomarkers: A Gynecologic Oncology Group study

Uterine papillary serous and clear cell carcinomas predict for poorer survival compared to grade 3 endometrioid corpus cancers

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