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Feasibility of accelerated partial breast irradiation with strut-adjusted volume implant brachytherapy in Japan focusing on dosimetry and acute toxicity: a Japanese multi-institutional prospective study

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Abstract

Background

A Japanese multi-institutional prospective study was initiated to investigate the effectiveness and safety of accelerated partial breast irradiation (APBI) using strut-adjusted volume implant (SAVI) brachytherapy, with subjects registered between 2016 and 2021. Herein, we report the preliminary results on the feasibility of this treatment modality in Japan, focusing on the registration process, dosimetry, and acute toxicities.

Patients and methods

Primary registration was conducted before breast-conserving surgery (BCS) and the eligibility criteria included the following: age ≥ 40 years, tumor unifocal and unicentric, ≤ 3 cm in diameter, cN0M0, proven ductal, mucinous, tubular, medullary, or lobular carcinoma by needle biopsy. Secondary registration was conducted after BCS had been performed leaving a cavity for device implantation and pathological evaluations, and the eligibility criteria were as follows: negative surgical margin, tumor ≤ 3 cm in diameter on gross pathological examination, histologically confirmed ductal, mucinous, tubular medullary, colloid, or lobular carcinoma, pN0, L0V0, no extensive ductal component, no initiation of chemotherapy within 2 weeks of the brachytherapy APBI planning with SAVI was performed for the patients successfully entered in the study by the secondary registration process, and the treatment was administered at the dose of 34 Gy in 10 fractions administered twice daily.

Results

Between 2016 and 2021, 64 women were enrolled in the study through primary registration, of which 19 were excluded from the secondary registration process, and in one, it was deemed impossible to comply with the dose constraints established during treatment planning. After the exclusion of these latter 20 patients, we treated the remaining 44 patients by APBI with SAVI. The dose constraints could be adhered to in all the patients, but re-planning was necessitated in 3 patients because of applicator movement during the treatment period. Grade 2 acute toxicities were observed in 18% of all patients, but more severe acute toxicities than Grade 2 were not observed in any of the patients.

Conclusion

APBI with SAVI brachytherapy is feasible in Japan from the aspects of compliance with dose constraints and frequency of acute toxicities.

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Data availability

All data relevant to the study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank the Working group of APBI with SAVIs in Japan: Yoshikazu Kagami, Yoshinori Ito, Kozo Murakami, Masako Kato, Rei Kobayashi, Satoshi Kubo, Takayuki Iwamoto, Norihisa Katayama, Hitoshi Ikushima, Chisato Tonoiso, Akiko Kubo, Masami Morimoto, Taeko Kawanaka, Yasufumi Shitakubo, Motoharu Sasaki, Nobuyasu Suganuma, Toshinari Yamashita, Tetsuo Nonaka, Yoko Harima, Satoaki Nakamura, Tomio Nakagawa, Kazuya Miyoshi, Hirotoshi Takahashi, Kana Takahashi, Hiroyuki Okamoto, Kazuma Toda, Keiko Nakagawa, Mio Kojima, Koji Sasamori, Mio Mori, Tomoyuki Fujioka, Goshi Oda. Furthermore, we thank Masahiko Oguchi, Tomoyuki Aruga, Satoshi Miyake for their support as members of the Efficacy and Safety Assessment Committee. This study was partially supported by The Japan Agency for Medical Research and Development (AMED, 19ck0106305h0003).

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Authors and Affiliations

  1. Department of Radiation Therapeutics and Oncology, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

    Masahiro Yoshida & Ryo-ichi Yoshimura

  2. Department of Radiology, Toho University Ohashi Medical Center, 2-22-36 Ohashi, Meguro-ku, Tokyo, Japan

    Masahiro Yoshida

  3. Radiology Center, Tokyo Medical and Dental University Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

    Ryoichi Notake

  4. Division of Radiation Oncology, Department of Radiology, Showa University, 1-5-8 Hatanodai Shinagawa-ku, Tokyo, Japan

    Hidenori Shinjo & Kazunori Miyaura

  5. Division of Breast Surgical Oncology, Department of Surgery, Showa University, 1-5-8 Hatanodai Shinagawa-ku, Tokyo, Japan

    Takashi Kuwayama & Seigo Nakamura

  6. Department of Radiology and Radiation Oncology, Tokushima University, 3-18-15 Kuramoto-cho, Tokushima, Japan

    Takashi Kawanaka

  7. Department of Breast and Endocrine Surgery, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan

    Tadahiko Shien

  8. Department of Proton Beam Therapy, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama City, Okayama, Japan

    Kotaro Yoshio

  9. Department of Radiology, Kansai Medical University Medical Center, 10-15 Fumizono-cho, Moriguchi, Osaka, Japan

    Toshiko Shiga

  10. Department of Radiation Oncology, National Hospital Organization Fukuyama Medical Center, 4-14-17 Okinogami-cho, Fukuyama, Hiroshima, Japan

    Yuko Kaneyasu

  11. Department of Breast Surgery, Tokyo Medical and Dental University Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

    Tsuyoshi Nakagawa

  12. Department of Radiology, Dokkyo Medical University Saitama Medical Center, Minamikoshigaya 2-1-50, Koshigaya, Saitama, Japan

    Kazunori Kubota

  13. ShinMatsudo Accuracy Radiation Therapy Center, ShinMatsudo Central General Hospital, Matsudo 1-380, Matsudo City, Chiba, Japan

    Jun Itami

Authors
  1. Masahiro Yoshida
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  2. Ryo-ichi Yoshimura
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  9. Kotaro Yoshio
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  13. Kazunori Kubota
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  14. Seigo Nakamura
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  15. Jun Itami
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Working group of APBI with SAVIs in Japan (WASAVIs)

Corresponding author

Correspondence to Ryo-ichi Yoshimura.

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Conflict of interest

Takashi Kuwayama, Tadahiko Shien, and Ryo-ichi Yoshimura received an honorarium from Konica Minolta as speakers at the seminar.

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Yoshida, M., Yoshimura, Ri., Notake, R. et al. Feasibility of accelerated partial breast irradiation with strut-adjusted volume implant brachytherapy in Japan focusing on dosimetry and acute toxicity: a Japanese multi-institutional prospective study. Breast Cancer 31, 75–83 (2024). https://doi.org/10.1007/s12282-023-01513-x

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