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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results
  • Posted: 01/14/2009

Surgery Alone May Be Best for Early Endometrial Cancer

Adapted from the NCI Cancer Bulletin.

Most uterine cancers are diagnosed at an early stage, while still confined to the body of the uterus. In addition to surgery to remove the uterus and ovaries, some doctors perform lymphadenectomy (lymph node removal), external-beam radiation therapy (EBRT), or both, in the hope of preventing local recurrence. However, a large randomized trial, published online December 16, 2008, in The Lancet, showed no improvement in survival associated with lymphadenectomy or EBRT. (The report appears in the January 10, 2009, print issue; see the journal abstract.)

Investigators leading the international ASTEC study randomly assigned 1,408 women to receive surgery or surgery plus pelvic lymphadenectomy. Women in both groups at intermediate or high risk of recurrence were randomly assigned a second time to receive either EBRT or no EBRT.

In the lymphadenectomy arm of the trial, more women who underwent lymph node removal reported moderate or severe treatment-related side effects than women who had standard surgery. Five-year overall survival was 81 percent in the standard surgery group and 80 percent in the lymphadenectomy group.

Five-year recurrence-free survival was 79 percent in the standard surgery group and 73 percent in the lymphadenectomy group. Similar proportions of women in both groups had received postoperative radiation therapy. These results "show no evidence of benefit in terms of overall or recurrence-free survival for pelvic lymphadenectomy in women with early endometrial cancer. Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside clinical trials," concluded the authors.

To determine the effectiveness of EBRT, the results from the second randomization in the ASTEC trial were combined with those from a Canadian trial (EN.5) for a total of 905 participants. Similar proportions of women in the EBRT or no EBRT arms received brachytherapy, which was part of the standard treatment at several participating hospitals.

Both acute and late toxicity was greater in the EBRT group. No difference in overall survival was seen between the two groups. The five-year recurrence-free survival was 84.7 percent in the EBRT group and 85.3 percent in the control group. EBRT did help prevent local recurrences, but only 35 percent of recurrences were isolated local recurrences. The authors concluded that "adjuvant [EBRT] cannot be recommended as part of routine treatment for women with intermediate-risk or high-risk early-stage endometrial cancer with the aim of improving survival."

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