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Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using
Ivo A Olivotto1, Timothy J Whelan, Sameer Parpia
1Ivo A. Olivotto, Tanya Berrang, Pauline T. Truong, Alan Nichol, Melanie Reed, and Wayne Beckham, British Columbia Cancer Agency; Ivo A. Olivotto, Tanya Berrang, and Pauline T. Truong, University of British Columbia; Wayne Beckham, University of Victoria, Victoria; Alan Nichol, University of British Columbia, Vancouver; Melanie Reed, University of British Columbia, Kelowna, British Columbia; Timothy J. Whelan, Do-Hoon Kim, Iwa Kong, and Mark N. Levine, Juravinski Cancer Centre; Timothy J. Whelan, Sameer Parpia, Do-Hoon Kim, Iwa Kong, Brandy Cochrane, Mark N. Levine, and Jim A. Julian, McMaster University; Timothy J. Whelan, Sameer Parpia, Brandy Cochrane, Mark N. Levine, and Jim A. Julian, Ontario Clinical Oncology Group, Hamilton; Anthony Fyles, Princess Margaret Hospital, University of Toronto, Toronto; Francisco Perera, London Regional Cancer Centre, University of Western Ontario, London, Ontario; Isabelle Roy, Hôpital Notre-Dame, University of Montreal, Montreal; Isabelle Germain, Hôtel-Dieu de Quebec, Laval University, Quebec City, Quebec; Mohamed Akra, Cancer Care Manitoba, University of Manitoba, Winnipeg, Manitoba; and Theresa Trotter, Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada.
Purpose:
To report interim cosmetic and toxicity results of a multicenter randomized trial comparing accelerated partial-breast irradiation (APBI) using three-dimensional conformal external beam radiation therapy (3D-CRT) with whole-breast irradiation (WBI).
Patients And Methods:
Women age > 40 years with invasive or in situ breast cancer ≤ 3 cm were randomly assigned after breast-conserving surgery to 3D-CRT APBI (38.5 Gy in 10 fractions twice daily) or WBI (42.5 Gy in 16 or 50 Gy in 25 daily fractions ± boost irradiation). The primary outcome was ipsilateral breast tumor recurrence (IBTR). Secondary outcomes were cosmesis and toxicity. Adverse cosmesis was defined as a fair or poor global cosmetic score. After a planned interim cosmetic analysis, the data, safety, and monitoring committee recommended release of results. There have been too few IBTR events to trigger an efficacy analysis.
Results:
Between 2006 and 2011, 2,135 women were randomly assigned to 3D-CRT APBI or WBI. Median follow-up was 36 months. Adverse cosmesis at 3 years was increased among those treated with APBI compared with WBI as assessed by trained nurses (29% v 17%; P < .001), by patients (26% v 18%; P = .0022), and by physicians reviewing digital photographs (35% v 17%; P < .001). Grade 3 toxicities were rare in both treatment arms (1.4% v 0%), but grade 1 and 2 toxicities were increased among those who received APBI compared with WBI (P < .001).
Conclusion:
3D-CRT APBI increased rates of adverse cosmesis and late radiation toxicity compared with standard WBI. Clinicians and patients are cautioned against the use of 3D-CRT APBI outside the context of a controlled trial.
