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Clinical Trial
. 2015 Mar 1;33(7):709-15.
doi: 10.1200/JCO.2014.57.9029. Epub 2015 Jan 20.

RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation

Beryl McCormick  1 , Kathryn Winter  2 , Clifford Hudis  2 , Henry Mark Kuerer  2 , Eileen Rakovitch  2 , Barbara L Smith  2 , Nour Sneige  2 , Jennifer Moughan  2 , Amit Shah  2 , Isabelle Germain  2 , Alan C Hartford  2 , Afshin Rashtian  2 , Eleanor M Walker  2 , Albert Yuen  2 , Eric A Strom  2 , Jeannette L Wilcox  2 , Laura A Vallow  2 , William Small Jr  2 , Anthony T Pu  2 , Kevin Kerlin  2 , Julia White  2
Affiliations
Clinical Trial

RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation

Beryl McCormick et al. J Clin Oncol. .

Erratum in

  • ERRATA.
    [No authors listed] [No authors listed] J Clin Oncol. 2015 Sep 10;33(26):2934. doi: 10.1200/JCO.2015.64.1290. J Clin Oncol. 2015. PMID: 26355145 Free PMC article. No abstract available.

Abstract

Purpose: The Radiation Therapy Oncology Group 9804 study identified good-risk patients with ductal carcinoma in situ (DCIS), a breast cancer diagnosis found frequently in mammographically detected cancers, to test the benefit of radiotherapy (RT) after breast-conserving surgery compared with observation.

Patients and methods: This prospective randomized trial (1998 to 2006) in women with mammographically detected low- or intermediate-grade DCIS, measuring less than 2.5 cm with margins ≥ 3 mm, compared RT with observation after surgery. The study was designed for 1,790 patients but was closed early because of lower than projected accrual. Six hundred thirty-six patients from the United States and Canada were entered; tamoxifen use (62%) was optional. Ipsilateral local failure (LF) was the primary end point; LF and contralateral failure were estimated using cumulative incidence, and overall and disease-free survival were estimated using the Kaplan-Meier method.

Results: Median follow-up time was 7.17 years (range, 0.01 to 11.33 years). Two LFs occurred in the RT arm, and 19 occurred in the observation arm. At 7 years, the LF rate was 0.9% (95% CI, 0.0% to 2.2%) in the RT arm versus 6.7% (95% CI, 3.2% to 9.6%) in the observation arm (hazard ratio, 0.11; 95% CI, 0.03 to 0.47; P < .001). Grade 1 to 2 acute toxicities occurred in 30% and 76% of patients in the observation and RT arms, respectively; grade 3 or 4 toxicities occurred in 4.0% and 4.2% of patients, respectively. Late RT toxicity was grade 1 in 30%, grade 2 in 4.6%, and grade 3 in 0.7% of patients.

Conclusion: In this good-risk subset of patients with DCIS, with a median follow-up of 7 years, the LF rate was low with observation but was decreased significantly with the addition of RT. Longer follow-up is planned because the timeline for LF in this setting seems protracted.

Trial registration: ClinicalTrials.gov NCT00003857.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
(A) Schema and (B) CONSORT patient flow diagram of the Radiation Therapy Oncology Group (RTOG) 9804 study. (*) Radiation therapy dose consisted of one of the following: 1.8 Gy per fraction for 28 fractions, for a total dose of 50.4 Gy; 2.0 Gy per fraction for 25 fractions, for a total dose of 50.0 Gy; or 2.656 Gy per fraction for 16 fractions, for a total dose of 42.5 Gy. DCIS, ductal carcinoma in situ; LCIS, lobular carcinoma in situ.
Fig 2.
Fig 2.
(A) Local failure in ipsilateral breast for all eligible patients (n = 585). (B) Local failure in ipsilateral breast for all accrued patients with follow-up (n = 629). (C) Disease-free survival (n = 585). (D) Overall survival (n = 585). HR, hazard ratio; RT, radiation therapy.
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Comment in

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