B Fisher , J Dignam , N Wolmark , E Mamounas , J Costantino , W Poller…Show Morehttps://doi.org/10.1200/JCO.1918.104.22.1681
N Engl J Med. 1993 Jun 3;328(22):1581-6.
Fisher, Costantino J, Redmond C, Fisher E, Margolese R, Dimitrov N, Wolmark N, Wickerham DL, Deutsch M, Ore L, et al.
BACKGROUND AND METHODS:
👉Women with ductal carcinoma in situ have been treated both by lumpectomy and by lumpectomy followed by radiation therapy, but the benefit of combined therapy is uncertain.
👉A group of 818 women with ductal carcinoma in situ were randomly assigned to undergo lumpectomy or lumpectomy followed by breast irradiation (50 Gy).
👉Sufficient tissue was removed that the margins of the resected specimens were histologically tumor-free.
👉The mean duration of follow-up was 43 months (range, 11 to 86).
👉The principal end point of the study was event-free survival, as defined by the presence of no new ipsilateral or contralateral breast cancers, regional or distant metastases, or other cancers and by no deaths from causes other than cancer.
👉Five-year event-free survival was better in the women who received breast irradiation (84.4%, vs. 73.8% for the women treated by lumpectomy alone; P = 0.001).
👉The improvement was due to a reduction in the occurrence of second ipsilateral breast cancers; the incidence of each of the other events was similar in the two groups.
👉Of 391 women treated by lumpectomy alone, ipsilateral breast cancer developed in 64 (16.4%); it was noninvasive in 32 and invasive in the remaining 32.
👉Of 399 women treated with lumpectomy and breast irradiation, ipsilateral breast cancer developed in 28 (7.0%) (noninvasive in 20 and invasive in 8).
👉The five-year cumulative incidence of second cancers in the ipsilateral breast was reduced by irradiation from 10.4% to 7.5% for noninvasive cancers and from 10.5% to 2.9% for invasive cancers (P = 0.055 and P < 0.001, respectively).
👉Breast irradiation after lumpectomy is more appropriate than lumpectomy alone for women with localized ductal carcinoma in situ.
👉In 1993, findings from a National Surgical Adjuvant Breast and Bowel Project (NSABP) trial to evaluate the worth of radiation therapy after lumpectomy concluded that the combination was more beneficial than lumpectomy alone for localized intraductal carcinoma-in-situ (DCIS). This report extends those findings.
PATIENTS AND METHODS
👉Women (N = 818) with localized DCIS were randomly assigned to lumpectomy or lumpectomy plus radiation (50 Gy).
👉Tissue was removed so that resected specimen margins were histologically tumor-free.
👉Mean follow-up time was 90 months (range, 67 to 130).
👉Size and method of tumor detection were determined by central clinical, mammographic, and pathologic assessment.
👉Life-table estimates of event-free survival and survival, average annual rates of occurrence for specific events, relative risks for event-specific end points, and cumulative probability of specific events comprising event-free survival are presented.
👉The benefit of lumpectomy plus radiation was virtually unchanged between 5 years and 8 years of follow-up and was due to a reduction in invasive and noninvasive ipsilateral breast tumors (IBTs).
👉Incidence of locoregional and distant events remained similar in both treatment groups; deaths were only infrequently related to breast cancer.
👉Incidence of noninvasive IBT was reduced from 13.4% to 8.2% (P = .007), and of invasive IBT, from 13.4% to 3.9% (P < .0001).
👉All cohorts benefited from radiation regardless of clinical or mammographic tumor characteristics.
👉Through 8 years of follow-up, our findings continue to indicate that lumpectomy plus radiation is more beneficial than lumpectomy alone for women with localized, mammographically detected DCIS. When evaluated according to the mammographic characteristics of their DCIS, all groups benefited from radiation.
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