By Gene Emery
NEW YORK (Reuters Health) - A large randomized trial is questioning the survival benefit of immediately removing regional lymph nodes if a sentinel node biopsy suggests melanoma metastasis.
In the past, doctors have through it best to remove additional nearby lymph nodes to gauge the degree of spread, despite the risk of complications such as swelling.
The new study, reported online June 7 in The New England Journal of Medicine, suggests that removal of additional nodes may not be necessary. People who avoid the surgery live just as long as those who get it as long as they are periodically checked for spread using ultrasound.
"These results are pretty big," said Dr. Elizabeth Buchbinder, a physician unconnected with the research who is in the melanoma disease group at the Dana-Farber Cancer Institute in Boston. "We've been waiting for these data."
"It means complete dissection is no longer the standard answer," chief author Dr. Mark Faries of the John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, told Reuters Health by phone.
"From a survival standpoint, it's safe not to do the dissection, so that's a more reasonable option for people to choose," he said.
The findings are based on data from 1,934 patients, half of whom went the ultrasound route.
Melanoma-specific survival at three years was identical in both groups - 86% (P=0.42).
The rate of disease-free survival was a bit better, but only barely - 68% with dissection versus 63% with observation (P=0.05).
But that came at a price. Rates of lymphedema were 24.1% with removal but only 6.3% with observation (P<0.001). The swelling was severe in 3% of cases, moderate in 33% and mild in 64%.
Dr. Daniel Coit of New York's Memorial Sloan Kettering Cancer Center called the findings "definitive, unequivocal, and completely consistent" with previous research.
Combined with past studies, he writes in a Journal editorial, "if this aggregate of data is insufficient to extinguish the enthusiasm for immediate completion lymph-node dissection, then it is unclear what more is required."
Taking the additional lymph tissue can help doctors predict whether further treatment is going to be necessary, Dr. Buchbinder told Reuters Health in a telephone interview. Yet "it's not uncommon that even when we say 'This is the standard approach,' some patients decide not to do it because of the side effects."
Instead of doctors saying that node removal is standard practice, the emphasis will probably shift to how the patient feels about risking side effects in exchange for knowing more about whether the cancer cells have spread.
"Now there's going to be a much more complicated discussion," she said.
"It will be an evolution over time, but I think we'll see where more and more that patients will be choosing observation" instead of removal, said Dr. Faries.
The new study, known as MSLT-II, involved 63 centers and was halted early because there was no hint of survival difference.
Patients in the observation group were examined with ultrasound every 4 months for the first two years; every six months in years 3, 4, and 5; and then once a year.
Dr. Faries said that if patients opt for observation, doctors can't be lax about it.
"If patients choose to be observed," he said, "they need to be really observed."
SOURCE: https://bit.ly/2rO0CiJ
N Engl J Med 2017.
(c) Copyright Thomson Reuters 2017. Click For Restrictions - https://about.reuters.com/fulllegal.asp
By Gene Emery
NEW YORK (Reuters Health) - A large randomized trial is questioning the survival benefit of immediately removing regional lymph nodes if a sentinel node biopsy suggests melanoma metastasis.
In the past, doctors have through it best to remove additional nearby lymph nodes to gauge the degree of spread, despite the risk of complications such as swelling.
The new study, reported online June 7 in The New England Journal of Medicine, suggests that removal of additional nodes may not be necessary. People who avoid the surgery live just as long as those who get it as long as they are periodically checked for spread using ultrasound.
"These results are pretty big," said Dr. Elizabeth Buchbinder, a physician unconnected with the research who is in the melanoma disease group at the Dana-Farber Cancer Institute in Boston. "We've been waiting for these data."
"It means complete dissection is no longer the standard answer," chief author Dr. Mark Faries of the John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, told Reuters Health by phone.
"From a survival standpoint, it's safe not to do the dissection, so that's a more reasonable option for people to choose," he said.
The findings are based on data from 1,934 patients, half of whom went the ultrasound route.
Melanoma-specific survival at three years was identical in both groups - 86% (P=0.42).
The rate of disease-free survival was a bit better, but only barely - 68% with dissection versus 63% with observation (P=0.05).
But that came at a price. Rates of lymphedema were 24.1% with removal but only 6.3% with observation (P<0.001). The swelling was severe in 3% of cases, moderate in 33% and mild in 64%.
Dr. Daniel Coit of New York's Memorial Sloan Kettering Cancer Center called the findings "definitive, unequivocal, and completely consistent" with previous research.
Combined with past studies, he writes in a Journal editorial, "if this aggregate of data is insufficient to extinguish the enthusiasm for immediate completion lymph-node dissection, then it is unclear what more is required."
Taking the additional lymph tissue can help doctors predict whether further treatment is going to be necessary, Dr. Buchbinder told Reuters Health in a telephone interview. Yet "it's not uncommon that even when we say 'This is the standard approach,' some patients decide not to do it because of the side effects."
Instead of doctors saying that node removal is standard practice, the emphasis will probably shift to how the patient feels about risking side effects in exchange for knowing more about whether the cancer cells have spread.
"Now there's going to be a much more complicated discussion," she said.
"It will be an evolution over time, but I think we'll see where more and more that patients will be choosing observation" instead of removal, said Dr. Faries.
The new study, known as MSLT-II, involved 63 centers and was halted early because there was no hint of survival difference.
Patients in the observation group were examined with ultrasound every 4 months for the first two years; every six months in years 3, 4, and 5; and then once a year.
Dr. Faries said that if patients opt for observation, doctors can't be lax about it.
"If patients choose to be observed," he said, "they need to be really observed."
SOURCE: https://bit.ly/2rO0CiJ
N Engl J Med 2017.
(c) Copyright Thomson Reuters 2017. Click For Restrictions - https://about.reuters.com/fulllegal.asp
By Gene Emery
NEW YORK (Reuters Health) - A large randomized trial is questioning the survival benefit of immediately removing regional lymph nodes if a sentinel node biopsy suggests melanoma metastasis.
In the past, doctors have through it best to remove additional nearby lymph nodes to gauge the degree of spread, despite the risk of complications such as swelling.
The new study, reported online June 7 in The New England Journal of Medicine, suggests that removal of additional nodes may not be necessary. People who avoid the surgery live just as long as those who get it as long as they are periodically checked for spread using ultrasound.
"These results are pretty big," said Dr. Elizabeth Buchbinder, a physician unconnected with the research who is in the melanoma disease group at the Dana-Farber Cancer Institute in Boston. "We've been waiting for these data."
"It means complete dissection is no longer the standard answer," chief author Dr. Mark Faries of the John Wayne Cancer Institute at Saint John’s Health Center, Santa Monica, told Reuters Health by phone.
"From a survival standpoint, it's safe not to do the dissection, so that's a more reasonable option for people to choose," he said.
The findings are based on data from 1,934 patients, half of whom went the ultrasound route.
Melanoma-specific survival at three years was identical in both groups - 86% (P=0.42).
The rate of disease-free survival was a bit better, but only barely - 68% with dissection versus 63% with observation (P=0.05).
But that came at a price. Rates of lymphedema were 24.1% with removal but only 6.3% with observation (P<0.001). The swelling was severe in 3% of cases, moderate in 33% and mild in 64%.
Dr. Daniel Coit of New York's Memorial Sloan Kettering Cancer Center called the findings "definitive, unequivocal, and completely consistent" with previous research.
Combined with past studies, he writes in a Journal editorial, "if this aggregate of data is insufficient to extinguish the enthusiasm for immediate completion lymph-node dissection, then it is unclear what more is required."
Taking the additional lymph tissue can help doctors predict whether further treatment is going to be necessary, Dr. Buchbinder told Reuters Health in a telephone interview. Yet "it's not uncommon that even when we say 'This is the standard approach,' some patients decide not to do it because of the side effects."
Instead of doctors saying that node removal is standard practice, the emphasis will probably shift to how the patient feels about risking side effects in exchange for knowing more about whether the cancer cells have spread.
"Now there's going to be a much more complicated discussion," she said.
"It will be an evolution over time, but I think we'll see where more and more that patients will be choosing observation" instead of removal, said Dr. Faries.
The new study, known as MSLT-II, involved 63 centers and was halted early because there was no hint of survival difference.
Patients in the observation group were examined with ultrasound every 4 months for the first two years; every six months in years 3, 4, and 5; and then once a year.
Dr. Faries said that if patients opt for observation, doctors can't be lax about it.
"If patients choose to be observed," he said, "they need to be really observed."
SOURCE: https://bit.ly/2rO0CiJ
N Engl J Med 2017.
(c) Copyright Thomson Reuters 2017. Click For Restrictions - https://about.reuters.com/fulllegal.asp
