Metastatic Breast Cancer Patients May Not Benefit
from Surgery, Radiation after Chemotherapy
Study found there was a 7 percent excess death rate
in those who received treatment with radiotherapy and surgery
Dec. 11, 2013 - After a response to initial
chemotherapy, treatment with radiotherapy and surgical removal of the
breast tumor and nearby lymph nodes do not provide any additional
benefit to patients with metastatic breast cancer, according to results
of a clinical trial presented at the 2013 San Antonio Breast Cancer
"There is a small percentage, about 5 to 20 percent
of breast cancer patients, who present with metastatic breast cancer
when they see their doctors for the first time, and across the globe,
the thought is that the local tumor in such events does not require any
surgery or radiation - known as loco-regional treatment (LRT) - after
chemotherapy, unless there is bleeding or ulceration," said Rajendra
Badwe, M.D., director of the Tata Memorial Hospital in Mumbai, India.
"However, there are conflicting results from retrospective analyses, and
hence, there was a need for a randomized trial.
"We found that there was no difference in overall
survival between those who received LRT and those who did not receive
LRT," explained Badwe. "Indeed, there was a 7 percent excess death rate
in those who received LRT. This finding was not statistically
significant; nevertheless, it aligns with previous preclinical findings
that suggest surgical removal of the primary tumor bestows a growth
advantage on metastases.
"I'm sure a lot of oncologists who believe in
conventional wisdom and don't provide loco-regional treatment will feel
a lot more comfortable looking at these results," said Badwe. "As for
those who have changed practice based on the retrospective study
history, they would have to rethink."
Badwe and colleagues conducted a prospective,
randomized, controlled trial, to which they recruited 350 women between
2005 and 2013. Eligible patients had metastatic breast cancer and an
objective tumor response to six cycles of chemotherapy. Patients were
randomized to two arms: 173 women received LRT (LRT arm) and 177 women
received no LRT (no-LRT arm). Both arms were matched for age, clinical
tumor size, hormone receptor and HER2 receptor status, and status of
Patients in the LRT arm underwent partial or
complete surgical removal of their breasts and surgical removal of
axillary lymph nodes, followed by radiotherapy. Patients in the no-LRT
arm did not receive any surgery or radiotherapy. Patients from both arms
whose breast cancers were hormone-related received standard hormone
therapy. The primary endpoint of the study was overall survival. Nine
patients from the LRT arm and three patients from no-LRT arm could not
adhere to trial protocol.
During the median follow-up period of 17 months,
the investigators recorded 218 deaths, 111 from the LRT arm and 107 from
the no-LRT arm.
They found that the median overall survival in the
LRT and no-LRT arms were 18.8 months and 20.5 months, respectively.
Overall survival after two years of follow-up was 40 percent in the LRT
arm and 43.3 percent in the no-LRT arm. No difference in overall
survival between the two arms emerged, even after adjusting for age,
hormone receptor and HER2 receptor status, site of disease spread, and
number of tumors in organs other than the indicated breast.
This clinical trial was funded by Tata Memorial
Center and the Department of Atomic Energy Clinical Trial Center in
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