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Safety and efficacy trial of preoperative sequential chemo-radiation therapy for the surgery sparing treatment (SST) in early breast cancer (EBC): Japan Clinical Oncology Group trial (JCOG0306).

10717 Background: The combination of preoperative anthracycline-containing regimen and taxane can obtain a pathological complete response (pCR) rate of around 30% for patients (pts) with EBC. To pursue higher pCR rate with maintaining good systemic control is necessary to put the SST practical in the future. The objective of this trial was to determine whether the addition of radiation therapy (RT) to chemotherapy (CT) could surpass the pCR rate of 50% in pts with EBC.


METHODS
We conducted a safety and efficacy trial of CT (4 courses of doxorubicin and cyclophosphmide (60/600 mg/m2) followed by 12 courses of weekly paclitaxel (80 mg/m2) and RT (whole breast 45Gy + boost 10Gy) sequentially as a primary therapy in pts with stage I-IIIA (5.0 cm ≥ tumor size ≥ 2.0 cm) BC. All pts received mastectomy or lumpectomy 12-16 weeks after completion of RT to maximize the effect of RT. pCR was assessed by the central pathological review board according to the pCR classification adopted by the National Surgical Adjuvant Breast and Bowel Project (NSABP). The study was designed to enroll 104 eligible pts with threshold pCR 35%, expected pCR 50%, alpha 0.05, beta 0.1, and additionally to have the width of 95% confidence interval (CI) within ±10% for sufficient precision of pCR.


RESULTS
Between June 2004 and April 2005, 108 pts were enrolled in this trial. Median age was 50 years (range 23-69). 1 pt had T1, 95 T2, and 3 T3 tumors (2 pts' data are missing and 7 pts' data have not been collected). 58% (59/101) were ER+, 49% (49/101) were PgR+ and 31% (31/101) had HER2 overexpression. Based on the planned interim analysis, the Data Monitoring Committee recommended to terminate the trial for insufficient pCR rate of the first 7 eligible patients (0% (0/7), 95% CI: 0-41.0%). Toxicities were within expected range.


CONCLUSIONS
Preoperative sequential chemo (AC followed by paclitaxel) -radiation therapy is not considered to be promising for accomplishing enough pCR rate. No significant financial relationships to disclose.