Abstract
Background
The utility of chemotherapy for women who experience a locoregional recurrence after primary treatment of early breast cancer remains an open question. An international collaborative trial is being conducted by the Breast International Group (BIG), the International Breast Cancer Study Group (IBCSG), and the National Surgical Adjuvant Breast and Bowel Project (NSABP) to determine the effectiveness of cytotoxic therapy for these patients, either alone or in addition to selective use of hormonal therapy and trastuzumab.
Methods
The trial population includes women who have had a previous diagnosis of invasive breast cancer treated by mastectomy or breast-conserving surgery, but subsequently develop an isolated local and/or regional ipsilateral invasive recurrence. Excision of all macroscopic tumor without evidence of systemic disease is required for study entry. Patients are randomized to receive chemotherapy or no chemotherapy; type of chemotherapy is not protocol-specified. Radiation, hormonal therapy, and trastuzumab are given as appropriate. The primary endpoint is disease-free survival (DFS). Quality-of-life measurements are collected at baseline, and then at 9 and 12 months. The accrual goal is 977 patients.
Results
This report describes the characteristics of the first 99 patients. Sites of recurrence at study entry were: breast (56%), mastectomy scar/chest wall (35%), and regional lymph nodes (9%). Two-thirds of patients have estrogen-receptor-positive recurrences.
Conclusion
This is the only trial actively investigating the question of “adjuvant” chemotherapy in locally recurrent breast cancer. The case mix of accrual to date indicates a broad representation of this patient population.
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References
Early Breast Cancer Trialists’ Collaborative Group. Favourable and unfavourable effects on long-term survival of radiotherapy for early breast cancer: an overview of the randomised trials. Lancet 2000; 355:1757–70
Brunner KW, Harder F, Greiner R, et al. [Loco-regional recurrence following surgery of breast carcinoma: prognostic factors and therapeutic consequences]. Schweiz Med Wochenschr 1988;118:1976–81. [Article in German]
Schwaibold F, Fowble BL, Solin LJ, et al. The results of radiation therapy for isolated local regional recurrence after mastectomy. Int J Radiat Oncol Biol Phys 1991; 21:299–310.
Halverson KJ, Perez CA, Kuske RR, et al. Survival following locoregional recurrence of breast cancer: univariate and multivariate analysis. Int J Radiat Oncol Biol Phys 1992; 23:285–91.
Willner J, Kiricuta IC, Kolbl O. Locoregional recurrence of breast cancer following mastectomy: always a fatal event? Results of univariate and multivariate analysis. Int J Radiat Oncol Biol Phys 1997; 37:853–63.
Kamby C, Sengelov L. Pattern of dissemination and survival following isolated locoregional recurrence of breast cancer. A prospective study with more than 10 years of follow up. Breast Cancer Res Treat 1997; 45:181–92.
Wallgren A, Bonett M, Gelber R, et al. Risk factors for locoregional recurrence among breast cancer patients: results from International Breast Cancer Study Group Trials I through VII. J Clin Oncol 2003; 21:1205–13.
Voogd AC, van Oost FJ, Rutgers EJ, et al. Long-term prognosis of patients with local recurrence after conservative surgery and radiotherapy for early breast cancer. Eur J Cancer 2005; 41:2637–44.
Wapnir IL, Anderson SJ, Mamounas EP, et al. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in five National Surgical Adjuvant Breast and Bowel Project node-positive adjuvant breast cancer trials. J Clin Oncol 2006;24:2028–37.
Waeber M, Castiglione-Gertsch M, Dietrich D, et al. Adjuvant therapy after excision and radiation of isolated postmastectomy locoregional breast cancer recurrence: definitive results of a phase III randomized trial (SAKK 23/82) comparing tamoxifen with observation. Ann Oncol 2003;14:1215–21.
Stotter A, Atkinson EN, Fairston BA, et al. Survival following locoregional recurrence after breast conservation therapy for cancer. Ann Surg 1990; 212:166–72.
Fowble B, Solin LJ, Schultz DJ, et al. Breast recurrence following conservative surgery and radiation: patterns of failure, prognosis, and pathologic findings from mastectomy specimens with implications for treatment. Int J Radiat Oncol Biol Phys 1990; 19:833–42.
Haffty BG, Fischer D, Beinfield M, et al. Prognosis following local recurrence in the conservatively treated breast cancer patient. Int J Radiat Oncol Biol Phys 1991; 21:293–8.
Abner AL, Recht A, Eberlein T, et al. Prognosis following salvage mastectomy for recurrence in the breast after conservative surgery and radiation therapy for early-stage breast cancer. J Clin Oncol 1993; 11:44–8.
Cajucom CC, Tsangaris TN, Nemoto T, et al. Results of salvage mastectomy for local recurrence after breast-conserving surgery without radiation therapy. Cancer 1993; 71:1774–9.
Leborgne F, Leborgne JH, Ortega B, et al. Breast conservation treatment of early stage breast cancer: patterns of failure. Int J Radiat Oncol Biol Phys 1995; 31:765–75.
Haffty BG, Reiss M, Beinfield M, et al. Ipsilateral breast tumor recurrence as a predictor of distant disease: implications for systemic therapy at the time of local relapse. J Clin Oncol 1996; 14:52–7.
Dalberg K, Mattsson A, Sandelin K, et al. Outcome of treatment for ipsilateral breast tumor recurrence in early-stage breast cancer. Breast Cancer Res Treat 1998; 49:69–78.
Doyle T, Schultz DJ, Peters C, et al. Long-term results of local recurrence after breast conservation treatment for invasive breast cancer. Int J Radiat Oncol Biol Phys 2001;51:74–80.
Borner M, Bacchi M, Goldhirsch A, et al. First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research. J Clin Oncol 1994;12:2071–7.
Fentiman IS, Balkwill FR, Cuzick J, et al. A trial of human alpha interferon as an adjuvant agent in breast cancer after loco-regional recurrence. Eur J Surg Oncol 1987;13:425–8.
Olson CE, Ansfield FJ, Richards MJ, et al. Review of local soft tissue recurrence of breast cancer irradiated with and without actinomycin-D. Cancer 1977; 39:1981–3.
Rauschecker H, Clarke M, Gatzemeier W, et al. Systemic therapy for treating locoregional recurrence in women with breast cancer. Cochrane Database Syst Rev 2007; CD002195
Wapnir I, Aebi S, Geyer CE, et al. A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, NSABP B-37. Clin Breast Cancer 2008; 8:287–92.
Hurny C, van Wegberg B, Bacchi M, et al. Subjective health estimations (SHE) in patients with advanced breast cancer: an adapted utility concept for clinical trials. Br J Cancer 1998; 77:985–91.
Acknowledgements
The authors would like to thank the participating centers, including the Dutch Breast Cancer Trialists’ Group (BOOG), the Spanish Breast Cancer Research Group (GEICAM), the International Breast Cancer Study Group (IBCSG), and the National Surgical Adjuvant Breast and Bowel Project (NSABP). The authors would also like to thank Karen Price, Director of Scientific Administration for the International Breast Cancer Study Group (IBCSG). Supported in part by Public Health Service Grants U10CA-12027, U10CA-69974, U10CA-37377, and U10CA-69651 from the National Cancer Institute, Department of Health and Human Services. The International Breast Cancer Study Group is supported in part by the Swiss Group for Clinical Cancer Research (SAKK), the Frontier Science and Technology Research Foundation, the Cancer Council Australia, the Australian New Zealand Breast Cancer Trials Group, the National Cancer Institute (CA-75362), the Swedish Cancer Society, Cancer Research Switzerland/Oncosuisse, the Cancer Association of South Africa, and the Foundation for Clinical Research of Eastern Switzerland (OSKK).
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Wapnir, I.L., Aebi, S., Gelber, S. et al. Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a Prospective Randomized Trial Evaluating Chemotherapy after Local Therapy for Isolated Locoregional Recurrences of Breast Cancer. Ann Surg Oncol 15, 3227–3231 (2008). https://doi.org/10.1245/s10434-008-0129-2
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DOI: https://doi.org/10.1245/s10434-008-0129-2