Ten patients were randomized and completed all study parameters and were included in this analysis. All five patients in the bootcamp group completed > 80% of the advised exercise sessions, all patients in the control arm received chemotherapy and underwent the required blood draws. Mean age for all patients at the time of diagnosis was 55 years, and mean tumor size was 4.97 cm (). The majority of patients found their tumors on breast self exam, and most patients had an invasive ductal carcinoma on pathology (). Five patients (3 controls and 2 study) did not meet standard indications for genetic testing, and it was therefore not offered. Four patients (1 control, 3 study) were tested and found to be negative for BRCA1/2 mutations, 1 patient in the control group was diagnosed as a BRCA2 mutation carrier. Nine patients received AC + T, one patient in the control arm received taxotere, carboplatin and trastuzumab. All neoadjuvant chemotherapy was completed in 4–6 months after diagnosis, bootcamp was given during this entire time. There were no statistically significant differences between groups in regards to tumor size, age, BMI, tumor grade, C- peptide levels, or initial Ki-67 (). All patients had axillary nodal metastases and subsequently underwent completion axillary lymph node dissection (ALND). Seven patients were diagnosed with the axillary metastases via ultrasound guided percutaneous needle biopsy prior to starting neoadjuvant chemotherapy, 6 patients underwent core needle biopsy, and 1 underwent fine needle aspiration. The additional 3 patients had initial clinically and sonographically negative axillas, and therefore underwent sentinel node biopsy at the completion of neoadjvuant chemotherapy. All 3 were found to have axillary nodal metastases and underwent ALND ().
At the time of surgical intervention, along with their ALND, 6 patients underwent total mastectomy, and 4 underwent partial mastectomy. There were a median of 8.6 positive nodes at ALND (range = 1–16) in the bootcamp group versus 2.4 positive nodes (range = 0–8) in the control group. Final pathologic tumor size was equivalent between the two groups (). Residual cancer burden (RCB)31
was Class III in three patients (2 in the bootcamp group and 1 in the control), Class II in six patients (3 bootcamp, 3 control) and Class I in one control patient.
Analysis after intervention.
For bootcamp patients, mean Ki-67 level after neoadjuvant chemotherapy was 7.2% (7.2% ± 2.8%) versus 29.2% (29.2% ± 12.0%) in the control group ( and ). Fasting C-peptide levels decreased in both groups, and there was no statistically significant difference between the two groups after neoadjuvant chemotherapy (). BMI in the control group was 35.8 (35.8 ± 2.7), versus 28.0 (28.0 ± 1.0) in the bootcamp group after neoadjuvant chemotherapy, which was a statistically significant difference (P = 0.03, ). BMI change and C-peptide change, when evaluated for each individual patient, was also greater in the bootcamp group ( and ), although this was not statistically significant (). Mean BMI change in the control group was 0.79 ± 0.69 versus 2.54 ± 1.47 in the bootcamp group (P = 0.32) Initial IGF-1 was collected for 3 patients in the bootcamp group, mean initial IGF-1 was 130.7 and increased to 160 at the conclusion of neoadjuvant chemotherapy. The control group had 3 patients with a mean initial IGF-1 of 187.7 and the follow-up IGF-1 was 171.0. The change in IGF-1 between the two groups was not statistically significant (P = 0.31). At a median follow-up of 21.6 months, there has been no local or systemic recurrence in either group. All patients continue to take adjuvant hormonal therapy. Multivariate analysis was attempted to ascertain factors predicting a Ki-67 of <12% after chemotherapy, no significant factors were identified, likely due to the small sample size in this pilot study.