She was treated with radiation (60 Gy) and concurrently with three AFTV injections (one course) between October and December 2013, one additional AFTV injection (1/3 course) in September 2015, and then zoledronate (4mg/month) and tamoxifen (20 mg/day) or letrozole (2.5 mg/day).
Eradication of bone-metastatic breast carcinoma had never been successfully achieved in any of our patients, although we have observed in a separate retrospective study that AFTV treatment, added after 2004 on the standardized treatments for breast cancer patients without bone metastasis, increased significantly the number of white blood cells and lymphocytes, CD3+ T cells, percentage of Th1 in CD4+ T cells, and ratio of Th1 and regulatory T cells (Supplementary Table (available here)).
However, following the introduction of AFTV in the comprehensive treatment of advanced breast cancer, we have become aware that at least some of the breast cancer patients with bone metastasis may escape the fateful downhill course as shown in Table 1.
All three of the cCR cases had carried solitary bone metastases, two cases (Case #6 and #20) before treatment with AFTV and one case (Case #17) after treatment with AFTV (Table 1).
In the treatment with AFTV, we did not adopt the common positive criterion, pathological complete response, since it is usually impossible to obtain a biopsy sample from metastatic bone.
The present cohort shown in Table 1 and in Figure 1 revealed longer median OS and higher 5-year survival rate when compared to these two concrete datasets in [2, 19], although results from the present cohort do not necessarily prove the efficacy of AFTV since the present cohort is small and therefore probably includes unnoticed patient selection bias.
The rate of 1-year cCR of 15% suggests that bone-metastatic breast cancer may be partly curable after comprehensive treatments including AFTV. The probable contribution of AFTV to OS should be taken into consideration when planning comprehensive therapeutic courses for the treatment of advanced breast cancer patients with bone metastasis, although a larger scale clinical study is required.
Abbreviations AFTV: Autologous formalin-fixed tumor vaccine cCR: Clinical complete response CEF: Cyclophosphamide, epirubicin, and 5-fluorouracil CT: X-ray computed tomography HCC: Hepatocellular carcinoma MRI: Magnetic resonance imaging PET-CT: Positron-emission tomography combined with CT SPECT-CT: Single-photon emission computed tomography combined with CT SREs: Skeletal-related events.
Fumito Kuranishi treated mainly the patients with AFTV. Yuki Imaoka and Yuusuke Sumi gave the patients additional treatments.
Supplementary Table: peripheral blood cell counts in breast cancer patients before and after the first course of AFTV vaccination.
Ohno, "Long-term survivor of relapsed MFH on the thigh treated with autologous formalin-fixed tumor vaccine (AFTV) combined with limb-sparing surgery and radiotherapy," World Journal of Surgical Oncology, vol.
Ohno, "Eradication of breast cancer with bone metastasis by autologous formalin-fixed tumor vaccine (AFTV) combined with palliative radiation therapy and adjuvant chemotherapy: a case report," World Journal of Surgical Oncology, vol.