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Lymphadenectomy in women with advanced ovarian cancer and normal lymph nodes does not appear to improve overall or progression-free survival, according to a randomized trial of 647 women with newly-diagnosed advanced ovarian cancer who were undergoing macroscopically complete resection.
The women were randomized during the resection to either undergo systematic pelvic and para-aortic lymphadenectomy or no lymphadenectomy. The study excluded women with obvious node involvement.
The median overall survival rates were similar between the two groups; 65.5 months in the lymphadenectomy group and 69.2 months in the no-lymphadenectomy group (HR 1.06, P = .65). There was also no significant difference between the two groups in median progression-free survival, which was 25.5 months in both.
While overall quality of life was similar between the two groups, there were some significant points of difference. Patients who underwent lymphadenectomy experienced significantly longer surgical times, and greater median blood loss, which in turn led to a higher rate of blood transfusions and higher rate of postoperative admission to intensive care.
The 60-day mortality rates were also significantly higher among the lymphadenectomy group – 3.1% vs. 0.9% (P = .049) – as was the rate of repeat laparotomies for complications (12.4% vs. 6.5%, P = .01), mainly due to bowel leakage or fistula.
While systematic pelvic and para-aortic lymphadenectomy is often used in patients with advanced ovarian cancer, there is limited evidence in its favor from randomized clinical trials, wrote Philipp Harter, MD, of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte, Germany, and his coauthors. The report is in the New England Journal of Medicine
“In this trial, patients with advanced ovarian cancer who underwent macroscopically complete resection did not benefit from systematic lymphadenectomy,” the authors wrote. “In contrast, lymphadenectomy resulted in treatment burden and harm to patients.”
The research group also tried to account for the level of surgical experience in each of the 52 centers involved in the study, and found no difference in treatment outcomes between high-recruiting centers and low-recruiting centers. All the centers also had to demonstrate their proficiency with the lymphadenectomy procedure before participating in the study.
“Accordingly, the quality of surgery and the numbers of resected lymph nodes were higher than in previous gynecologic oncologic clinical trials analyzing this issue,” they wrote.
The study was supported by the Deutsche Forschungsgemeinschaft and the Austrian Science Fund. Six authors declared a range of fees and support from the pharmaceutical industry.
SOURCE: Harter P et al. N Engl J Med. 2019 Feb 27 doi: 10.1056/NEJMoa1808424.
Pelvic and aortic lymph nodes can often contain microscopic ovarian cancer metastases even when they appear normal, so there has been some debate as to whether these should be systematically removed during primary surgery to eliminate this potential sanctuary for cancer cells.
While a number of previous studies have suggested a survival benefit, there were concerns about potential confounders that may have influenced those findings. This study avoids many of the criticisms leveled at previous trials; for example, by ensuring surgical center quality, by excluding women with obvious node involvement, and by conducting the lymphadenectomy only after complete macroscopic resection.
The findings are consistent with the notion that the most frequent cause of ovarian cancer-related illness and death is the inability to control intra-abdominal disease.
Dr. Eric L. Eisenhauer is from Massachusetts General Hospital in Boston and Dr. Dennis S. Chi is from Memorial Sloan Kettering Cancer Center in New York. These comments are adapted from their accompanying editorial (N Engl J Med. 2019 Feb 27. doi: 10.1056/NEJMe1900044). Both authors declared financial and other support, including advisory board positions, from private industry.
Pelvic and aortic lymph nodes can often contain microscopic ovarian cancer metastases even when they appear normal, so there has been some debate as to whether these should be systematically removed during primary surgery to eliminate this potential sanctuary for cancer cells.
While a number of previous studies have suggested a survival benefit, there were concerns about potential confounders that may have influenced those findings. This study avoids many of the criticisms leveled at previous trials; for example, by ensuring surgical center quality, by excluding women with obvious node involvement, and by conducting the lymphadenectomy only after complete macroscopic resection.
The findings are consistent with the notion that the most frequent cause of ovarian cancer-related illness and death is the inability to control intra-abdominal disease.
Dr. Eric L. Eisenhauer is from Massachusetts General Hospital in Boston and Dr. Dennis S. Chi is from Memorial Sloan Kettering Cancer Center in New York. These comments are adapted from their accompanying editorial (N Engl J Med. 2019 Feb 27. doi: 10.1056/NEJMe1900044). Both authors declared financial and other support, including advisory board positions, from private industry.
Pelvic and aortic lymph nodes can often contain microscopic ovarian cancer metastases even when they appear normal, so there has been some debate as to whether these should be systematically removed during primary surgery to eliminate this potential sanctuary for cancer cells.
While a number of previous studies have suggested a survival benefit, there were concerns about potential confounders that may have influenced those findings. This study avoids many of the criticisms leveled at previous trials; for example, by ensuring surgical center quality, by excluding women with obvious node involvement, and by conducting the lymphadenectomy only after complete macroscopic resection.
The findings are consistent with the notion that the most frequent cause of ovarian cancer-related illness and death is the inability to control intra-abdominal disease.
Dr. Eric L. Eisenhauer is from Massachusetts General Hospital in Boston and Dr. Dennis S. Chi is from Memorial Sloan Kettering Cancer Center in New York. These comments are adapted from their accompanying editorial (N Engl J Med. 2019 Feb 27. doi: 10.1056/NEJMe1900044). Both authors declared financial and other support, including advisory board positions, from private industry.
Lymphadenectomy in women with advanced ovarian cancer and normal lymph nodes does not appear to improve overall or progression-free survival, according to a randomized trial of 647 women with newly-diagnosed advanced ovarian cancer who were undergoing macroscopically complete resection.
The women were randomized during the resection to either undergo systematic pelvic and para-aortic lymphadenectomy or no lymphadenectomy. The study excluded women with obvious node involvement.
The median overall survival rates were similar between the two groups; 65.5 months in the lymphadenectomy group and 69.2 months in the no-lymphadenectomy group (HR 1.06, P = .65). There was also no significant difference between the two groups in median progression-free survival, which was 25.5 months in both.
While overall quality of life was similar between the two groups, there were some significant points of difference. Patients who underwent lymphadenectomy experienced significantly longer surgical times, and greater median blood loss, which in turn led to a higher rate of blood transfusions and higher rate of postoperative admission to intensive care.
The 60-day mortality rates were also significantly higher among the lymphadenectomy group – 3.1% vs. 0.9% (P = .049) – as was the rate of repeat laparotomies for complications (12.4% vs. 6.5%, P = .01), mainly due to bowel leakage or fistula.
While systematic pelvic and para-aortic lymphadenectomy is often used in patients with advanced ovarian cancer, there is limited evidence in its favor from randomized clinical trials, wrote Philipp Harter, MD, of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte, Germany, and his coauthors. The report is in the New England Journal of Medicine
“In this trial, patients with advanced ovarian cancer who underwent macroscopically complete resection did not benefit from systematic lymphadenectomy,” the authors wrote. “In contrast, lymphadenectomy resulted in treatment burden and harm to patients.”
The research group also tried to account for the level of surgical experience in each of the 52 centers involved in the study, and found no difference in treatment outcomes between high-recruiting centers and low-recruiting centers. All the centers also had to demonstrate their proficiency with the lymphadenectomy procedure before participating in the study.
“Accordingly, the quality of surgery and the numbers of resected lymph nodes were higher than in previous gynecologic oncologic clinical trials analyzing this issue,” they wrote.
The study was supported by the Deutsche Forschungsgemeinschaft and the Austrian Science Fund. Six authors declared a range of fees and support from the pharmaceutical industry.
SOURCE: Harter P et al. N Engl J Med. 2019 Feb 27 doi: 10.1056/NEJMoa1808424.
Lymphadenectomy in women with advanced ovarian cancer and normal lymph nodes does not appear to improve overall or progression-free survival, according to a randomized trial of 647 women with newly-diagnosed advanced ovarian cancer who were undergoing macroscopically complete resection.
The women were randomized during the resection to either undergo systematic pelvic and para-aortic lymphadenectomy or no lymphadenectomy. The study excluded women with obvious node involvement.
The median overall survival rates were similar between the two groups; 65.5 months in the lymphadenectomy group and 69.2 months in the no-lymphadenectomy group (HR 1.06, P = .65). There was also no significant difference between the two groups in median progression-free survival, which was 25.5 months in both.
While overall quality of life was similar between the two groups, there were some significant points of difference. Patients who underwent lymphadenectomy experienced significantly longer surgical times, and greater median blood loss, which in turn led to a higher rate of blood transfusions and higher rate of postoperative admission to intensive care.
The 60-day mortality rates were also significantly higher among the lymphadenectomy group – 3.1% vs. 0.9% (P = .049) – as was the rate of repeat laparotomies for complications (12.4% vs. 6.5%, P = .01), mainly due to bowel leakage or fistula.
While systematic pelvic and para-aortic lymphadenectomy is often used in patients with advanced ovarian cancer, there is limited evidence in its favor from randomized clinical trials, wrote Philipp Harter, MD, of the department of gynecology and gynecologic oncology at Kliniken Essen-Mitte, Germany, and his coauthors. The report is in the New England Journal of Medicine
“In this trial, patients with advanced ovarian cancer who underwent macroscopically complete resection did not benefit from systematic lymphadenectomy,” the authors wrote. “In contrast, lymphadenectomy resulted in treatment burden and harm to patients.”
The research group also tried to account for the level of surgical experience in each of the 52 centers involved in the study, and found no difference in treatment outcomes between high-recruiting centers and low-recruiting centers. All the centers also had to demonstrate their proficiency with the lymphadenectomy procedure before participating in the study.
“Accordingly, the quality of surgery and the numbers of resected lymph nodes were higher than in previous gynecologic oncologic clinical trials analyzing this issue,” they wrote.
The study was supported by the Deutsche Forschungsgemeinschaft and the Austrian Science Fund. Six authors declared a range of fees and support from the pharmaceutical industry.
SOURCE: Harter P et al. N Engl J Med. 2019 Feb 27 doi: 10.1056/NEJMoa1808424.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: No survival benefits are associated with systematic pelvic and para-aortic lymphadenectomy in advanced ovarian cancer.
Major finding: Median overall and progression-free survival did not improve after systematic pelvic and para-aortic lymphadenectomy in advanced ovarian cancer.
Study details: Randomized controlled trial of 647 women with newly-diagnosed advanced ovarian cancer.
Disclosures: The study was supported by the Deutsche Forschungsgemeinschaft and the Austrian Science Fund. Six authors declared a range of fees and support from the pharmaceutical industry.
Source: Harter P et al. N Eng J Med. 2019 Feb 27. doi: 10.1056/NEJMoa1808424.