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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 03/19/2008

Sentinel Node Dissection Safe in the Treatment of Early Vulvar Cancer

Key Words

Vulvar cancer; surgery; lymphadenectomy; sentinel node dissection. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Removing and examining one or two sentinel nodes in the groin and upper leg is an effective way to detect whether cancer has spread in women with early-stage cancer of the vulva, and also results in fewer adverse side effects, compared with the standard approach of removing many lymph nodes. However, extensive experience performing sentinel node dissection is necessary to prevent very small metastases from being overlooked using this technique.

Source

Journal of Clinical Oncology, February 20, 2008 (see the journal abstract)
(J Clin Oncol. 2008 Feb 20;26(6):884-9.)

Background

Like many other cancers, vulvar cancer usually spreads first to nearby lymph nodes. In the case of the vulva, the nearest lymph nodes are in the groin and upper leg (called the inguinofemoral region). Surgical treatment for vulvar cancer traditionally includes removal of the main tumor and many lymph nodes in the inguinofemoral region, a procedure called inguinofemoral lymphadenectomy.

While inguinofemoral lymphadenectomy provides excellent long-term survival without recurrence of disease, it can have many short-term and long-term side effects, including problems with wound healing, lymphedema, and persistent infections.

For this reason, researchers performed a clinical study to examine whether sentinel lymph node dissection (SLND) can be used safely in women with early-stage vulvar cancer, as it can be in breast cancer. With SLND, surgeons examine only the first few nodes into which the primary tumor drains. If no sign of cancer is found in these sentinel nodes, doctors assume the tumor has not spread and do not remove any further nodes.

The Study

Between March 2000 and June 2006 an international team of researchers led by the University Medical Center Groningen in the Netherlands performed SNLD while surgically removing the primary tumor in 403 women with early-stage vulvar cancer. Each of the 15 participating hospitals had a medical team with significant experience in the technique.

Of the 403 study participants, 127 turned out to have metastatic cells in their sentinel nodes and went on to have a full inguinofemoral lymphadenectomy. Some women with metastases also received radiation therapy. The other 276 women showed no signs of cancer in their sentinel nodes and so received no further treatment.

The investigators were able to follow nearly all the women for an average of 35 months after surgery, checking for short- and long-term complications as well as cancer recurrence in the groin, a major concern because it is often fatal.

The study's principal investigator was Ate G.J. Van der Zee, M.D., Ph.D., from the Department of Obstetrics and Gynecology at the University Medical Center Groningen.

Results

Women who underwent only SLND had significantly fewer short- and long-term complications than women who underwent the additional inguinofemoral lymphadenectomy. Women who received postoperative radiation therapy in addition to inguinofemoral lymphadenectomy were even more likely to have recurrent infections in the affected region.

Among the SLND-only women, 3 percent (8 of 126) suffered a cancer recurrence in the groin, a rate the authors said was comparable to that reported for early-stage vulvar cancer patients treated with lymphadenectomy of any kind. What's more, the three-year disease-specific survival rate was 97 percent for the SLND-only women, meaning that the vast majority of them did not die of vulvar cancer during this period.

Limitations

The authors caution that extensive clinical experience with SLND--for both the surgeon and the team supporting the procedure--is essential for replicating these positive results. Even with each hospital practicing the technique at least 10 times before joining the trial, metastatic cells in four out of eight of the patients who had a relapse in the groin were missed due to errors made in the SLND procedure.

"Implementation of the sentinel node procedure in routine treatment of early-stage vulvar cancer requires quality control at each step of this multidisciplinary procedure," state the authors. "To keep the experience at a high level, an exposure of at least five to 10 patients per year per surgeon should be regarded as a minimum figure."

Comments

"The low groin recurrence rate…and excellent disease-specific survival rate of 97 percent at three years in sentinel node-negative patients suggest that the sentinel node procedure is a safe alternative to inguinofemoral lymphadenectomy for selected vulvar cancer patients," concluded the authors.

"Sentinel lymph node evaluation seems to work well, but [only] in a center with a lot of expertise in that surgery," agrees Edward L. Trimble, M.D., M.P.H., of the National Cancer Institute's Cancer Therapy Evaluation Program.

Related Pages

  • Search for Clinical Trials 1
    NCI's List of Cancer Clinical Trials.
  • Vulvar Cancer Home Page 2
    NCI's gateway for information about vulvar cancer.
  • Sentinel Lymph Node Biopsy 3
    A fact sheet that describes the sentinel lymph node biopsy (SLNB) procedure, its use in determining the extent, or stage, of cancer in the body, and the results of research on the use of SLNB in breast cancer and melanoma.


Glossary Terms

disease-specific survival rate (dih-ZEEZ-speh-SIH-fik ser-VY-vul rayt)
The percentage of people in a study or treatment group who have not died from a specific disease in a defined period of time. The time period usually begins at the time of diagnosis or at the start of treatment and ends at the time of death. Patients who died from causes other than the disease being studied are not counted in this measurement.
lymph node (limf node)
A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.
lymphadenectomy (LIM-fa-deh-NEK-toh-mee)
A surgical procedure in which the lymph nodes are removed and a sample of tissue is checked under a microscope for signs of cancer. For a regional lymphadenectomy, some of the lymph nodes in the tumor area are removed; for a radical lymphadenectomy, most or all of the lymph nodes in the tumor area are removed. Also called lymph node dissection.
lymphedema (LIM-fuh-DEE-muh)
A condition in which extra lymph fluid builds up in tissues and causes swelling. It may occur in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery.
metastasis (meh-TAS-tuh-sis)
The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).
postoperative (post-AH-pruh-tiv)
After surgery.
sentinel lymph node (SEN-tih-nul limf node)
The first lymph node to which cancer is likely to spread from the primary tumor. When cancer spreads, the cancer cells may appear first in the sentinel node before spreading to other lymph nodes.
vulva (VUL-vuh)
The external female genital organs, including the clitoris, vaginal lips, and the opening to the vagina.

Table of Links

1http://www.cancer.gov/clinicaltrials/search
2http://www.cancer.gov/cancertopics/types/vulvar
3http://www.cancer.gov/cancertopics/factsheet/detection/sentinel-node-biopsy