Adjuvant therapy in lymph node-positive vulvar cancer: the AGO-CaRE-1 study.
Abstract | BACKGROUND: Women with node-positive vulvar cancer have a high risk for disease recurrence. Indication criteria for adjuvant radiotherapy are controversial. This study was designed to further understand the role of adjuvant therapy in node-positive disease. METHODS: Patients with primary squamous-cell vulvar cancer treated at 29 gynecologic cancer centers in Germany from 1998 through 2008 were included in this retrospective exploratory multicenter cohort study. Of 1618 documented patients, 1249 had surgical groin staging and known lymph node status and were further analyzed. All statistical tests were two-sided. RESULTS: Four hundred forty-seven of 1249 patients (35.8%) had lymph node metastases (N+). The majority of N+ patients had one (172 [38.5%]) or two (102 [22.8%]) positive nodes. The three-year progression-free survival (PFS) rate of N+ patients was 35.2%, and the overall survival (OS) rate 56.2% compared with 75.2% and 90.2% in node-negative patients (N-). Two hundred forty-four (54.6%) N+ patients had adjuvant therapy, of which 183 (40.9%) had radiotherapy directed at the groins (+/-other fields). Three-year PFS and OS rates in these patients were better compared with N+ patients without adjuvant treatment (PFS: 39.6% vs 25.9%, hazard ratio [HR] = 0.67, 95% confidence interval [CI[= 0.51 to 0.88, P = .004; OS: 57.7% vs 51.4%, HR = 0.79, 95% CI = 0.56 to 1.11, P = .17). This effect was statistically significant in multivariable analysis adjusted for age, Eastern Cooperative Oncology Group, Union internationale contre le cancer stage, grade, invasion depth, and number of positive nodes (PFS: HR = 0.58, 95% CI = 0.43 to 0.78, P < .001; OS: HR = 0.63, 95% CI = 0.43 to 0.91, P = .01). CONCLUSION:
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Authors | Sven Mahner, Julia Jueckstock, Felix Hilpert, Petra Neuser, Philipp Harter, Nikolaus de Gregorio, Annette Hasenburg, Jalid Sehouli, Annika Habermann, Peter Hillemanns, Sophie Fuerst, Hans-Georg Strauss, Klaus Baumann, Falk Thiel, Alexander Mustea, Werner Meier, Andreas du Bois, Lis-Femke Griebel, Linn Woelber, AGO-CaRE 1 investigators |
Journal | Journal of the National Cancer Institute
(J Natl Cancer Inst)
Vol. 107
Issue 3
(Mar 2015)
ISSN: 1460-2105 [Electronic] United States |
PMID | 25618900
(Publication Type: Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | © The Author 2014. Published by Oxford University Press. |
Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Squamous Cell
(drug therapy, pathology, radiotherapy)
- Chemotherapy, Adjuvant
- Disease-Free Survival
- Female
- Germany
- Groin
- Humans
- Kaplan-Meier Estimate
- Lymph Nodes
(pathology)
- Lymphatic Metastasis
- Middle Aged
- Neoplasm Staging
- Prognosis
- Radiotherapy, Adjuvant
- Retrospective Studies
- Treatment Outcome
- Vulvar Neoplasms
(drug therapy, pathology, radiotherapy)
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