A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072

Abstract

Background Cryoablation is a well-established technique to treat fibroadenomas. Pilot studies suggest this could be an effective non-surgical treatment for breast cancer. American College of Surgeons Oncology Group (ACOSOG) Z1072 is a phase II trial exploring the effectiveness of cryoablation in the treatment of breast cancers. Methods The primary endpoint of Z1072 was the rate of complete tumor ablation, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathologic examination of the targeted lesion. A secondary objective was to evaluate the negative predictive value of magnetic resonance imaging (MRI) to determine residual IBC or DCIS. Eligible patients included those with unifocal invasive ductal breast cancer ≤2 cm, with <25 % intraductal component and tumor enhancement on MRI. A total of 19 centers contributed 99 patients, of which 86 patients (87 breast cancers) were evaluable for data analysis. Results Final pathology results, regardless of whether residual IBC/DCIS was in the targeted ablation zone or elsewhere in the breast, showed successful ablation in 66/87 (75.9 %) cancers. The 90 % confidence interval for the estimate of successful cryoablation was 67.1–83.2, with the one-sided lower-sided 90 % CI of 69.0. The negative predictive value of MRI was 81.2 % (90 % CI 71.4–88.8). When multifocal disease outside of the targeted cryoablation zone was not defined as an ablation failure, 80/87 (92 %) of the treated cancers had a successful cryoablation. Conclusion Further studies with modifications on the Z1072 protocol could be considered to evaluate the role for cryoablation as a non-surgical treatment of early-stage breast cancer.

Current Technique and Application of Percutaneous Cryotherapy

“…This requires ultrasound-guided positioning of only one needle. Under these problematic conditions, local tumor control could be achieved in 92 % of cases with the result being significantly better in small tumors up to 1 cm than in larger tumors [49]. Another study showed local control of 76.9 % of breast carcinomas up to 3 cm after 12 months.…”

Minimally invasive ablative techniques in the treatment of breast cancer: a systematic review and meta-analysis

“…A total of 63 articles matched the selection criteria. The 63 articles included 16 feasibility studies [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28], 12 phase I studies [29][30][31][32][33][34][35][36][37][38][39][40], nine phase II studies [41][42][43][44][45][46][47][48][49], three comparative studies [50][51][52], one retrospective study [53], and four randomised controlled trials [54][55][56]. In 18 studies the type of study was not reported [8,[57][58][59][60][61][62][63][64]…”

“…In five studies [21,24,49,59,63], patients withdrew from the study during or after treatment and in another six studies [15,26,44,48,49,72] patients withdrew before the start of the treatment. The overall STROBE score ranged from four to seven (mean…”

The role of imaging in percutaneous laser ablation therapy of small breast cancers

“…MRI has had the greatest success in accomplishing this goal. Post-cryoablation detection of residual tumor by MRI has been reported with a negative predictive value of 92% [7].…”