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Adjuvant radiotherapy may benefit patients with lymph node-positive vulvar cancer
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Adjuvant radiotherapy may provide survival benefits for patients with lymph node-positive vulvar cancer, according to study results.
Vulvar cancer is a rare disease, but its incidence has been rising, leading to interest in improving therapy options, according to researchers.
Sven Mahner
The prognosis for patients with vulvar cancer is primarily determined by the status of the lymph nodes. Lymph node-negative patients have substantially better outcomes than node-positive patients.
Sven Mahner, MD, of the department of gynecology and gynecologic oncology at University Medical Center Hamburg-Eppendorf in Germany, and colleagues conducted a large exploratory, multicenter cohort study to try to understand the role of adjuvant therapy — specifically radiotherapy — in node-positive disease.
“Even large gynecologic cancer centers around the world treat only a few patients with vulvar cancer, a rare disease with two to four women diagnosed per 100,000 per year,” Mahner told HemOnc Today.
The AGO-CaRE-1 study included more than 1,600 patients with vulvar cancer treated at 29 German gynecologic cancer centers between 1998 and 2008.
The final analysis included 1,249 patients with primary squamous cell vulvar cancer with surgical groin staging and known lymph node status.
About two-thirds of patients (n=802; 64.2%) had node-negative disease, and about one-third (n=447; 35.8%) had node-negative disease. The majority of node-positive patients had either one (38.5%) or two (22.8%) positive nodes.
There were localized tumors in 90% of the population, and 81.8% underwent complete tumor resection. Most patients (73.6%) had bilateral groin dissection, and the median number of excised groin nodes was 15 (range, 10-19). Only 10.6% of the node-negative patients had a sentinel procedure.
Adjuvant therapy was administered to 54.6% of node-positive patients, and 84.4% received radiotherapy. The radiotherapy dose administered in the node-positive patients had a median of 50.4 Gy (range, 50.4-58.4). Median dose was the same for patients who had radiotherapy directed to the groins and those who had radiotherapy directed to the groins and pelvis.
Median follow-up was 39.4 months (95% CI, 36.8-43.2; range, 11.8-71.4). Overall, 28.8% of patients experienced disease recurrence, and median time to recurrence was 12.6 months.
Nearly four times as many node-positive patients than node-negative patients experienced vulvar recurrence (19.9% vs. 5.6%).
Researchers reported significantly higher rates of 3-year PFS (75.2% vs. 35.2%; P<.001) and 3-year OS (90.2% vs. 56.2; P<.001) among node-negative patients.
The extent of lymph node metastases correlated with PFS and OS.
Researchers reported 3-year PFS rates of 47.6% for patients with one positive node, 27.6% for those with two positive nodes, 33.1% for those with three positive nodes, and 21.2% for those with four or more positive nodes.
Researchers reported 3-year OS rates of 72.8% for patients with one positive node, 50.1% for those with two positive nodes, 44.8% for those with three positive nodes and 33% for those with four or more positive nodes.
Further analysis of node-positive patients showed improved 3-year PFS for those who had received adjuvant radiotherapy compared with those who did not (39.6% vs. 25.9%; HR=0.67; 95% CI, 0.51-0.88).
Overall, researchers observed no significant difference in 3-year OS among those who received adjuvant radiotherapy and those who did not (57.7% vs. 51.4%; HR=0.79; 95% CI, 0.56-1.11). However, subgroup analyses revealed significant 3-year OS benefit with adjuvant radiotherapy among patients with two positive nodes (HR=0.44; 95% CI, 0.25-0.78), three positive nodes (HR=0.37; 95% CI, 0.18-0.74), and four or more positive nodes (HR=0.45; 95% CI, 0.25-0.82).
“Results of the analysis of this unique very large cohort of vulvar cancer patients will hopefully not only help to overcome general concerns regarding adjuvant treatment but also forms the basis for an upcoming prospective randomized comparison of chemoradiation to adjuvant radiotherapy in node-positive vulvar cancer,” Mahner said. – by Anthony SanFilippo
Sven Mahner, MD, can be reached at University Medical Center Hamburg-Eppendorf
Martinistraße 52, D - 20246 Hamburg, Germany; email: mahner@uke.de
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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Dana Chase, MD
In this study of 1,249 retrospectively reviewed vulvar cancer cases, Mahner and colleagues present data from multiple institutions exploring the use of adjuvant therapy in node-positive vulvar cancer. As the authors agree, vulvar cancer often presents in elderly women in whom surgical and adjuvant therapy choices are perhaps more personalized and thus make the treatment choices in this cohort highly variable. This heterogeneity limits the interpretability of the data. Nevertheless, this study confirms prior data indicating that radiation therapy improves outcomes in lymph node-positive disease. In these reported cases, the type of radiation delivered in node-positive disease was variable, without conforming to previous study findings.The benefits of adjuvant radiotherapy were seen in patients with two or more positive lymph nodes, whereas those with only one positive node did not demonstrate as clear a benefit (although the sample size in this group was smaller). At 3 years, only 35% of those who were node positive were progression free and 56% were alive, so advances in adjuvant therapy are needed. Regarding the type of therapy needed, this study adds to existing research calling for the use of adjuvant radiotherapy in advanced disease. However, we still await the results of prospective trials to guide the use of radiation alone vs. chemoradiation, and how the number of lymph nodes involved should be used to guide therapy. With this disease on the rise, hopefully these trials will accrue patients in a timely manner to help guide oncologists toward more uniform and effective therapy.
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