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Phase I/II study of stereotactic body radiotherapy boost in patients with cervical cancer ineligible for intracavitary brachytherapy.
Ito, Kei; Nakajima, Yujiro; Ogawa, Hiroaki; Furusawa, Akiko; Murofushi, Keiko Nemoto; Kito, Satoshi; Kino, Nao; Yasugi, Toshiharu; Uno, Takashi; Karasawa, Katsuyuki.
Afiliación
  • Ito K; Division of Radiation Oncology, Department of Radiology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan. keiito600601@gmail.com.
  • Nakajima Y; Division of Radiation Oncology, Department of Radiology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.
  • Ogawa H; Department of Radiological Sciences, Komazawa University, 1-23-1 Komazawa, Setagaya-ku, Tokyo, 154-8525, Japan.
  • Furusawa A; Division of Radiation Oncology, Department of Radiology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.
  • Murofushi KN; Department of Radiation Oncology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.
  • Kito S; Department of Gynecology, Shizuoka Cancer Center Hospital, 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
  • Kino N; Division of Radiation Oncology, Department of Radiology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.
  • Yasugi T; Division of Radiation Oncology, Department of Radiology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.
  • Uno T; Department of Gynecology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.
  • Karasawa K; Department of Gynecology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.
Jpn J Radiol ; 42(8): 909-917, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38625476
ABSTRACT

PURPOSE:

Stereotactic body radiotherapy (SBRT) boost is a promising treatment for cervical cancer patients who are ineligible for intracavitary brachytherapy (ICBT). The aim of this multicenter, single-arm, phase I/II study was to prospectively evaluate the efficacy and toxicity of SBRT boost. MATERIALS AND

METHODS:

ICBT-ineligible patients with untreated cervical cancer were enrolled. Patients underwent whole-pelvic radiotherapy (45 Gy in 25 fractions) with SBRT boost to the primary lesion. In the phase I dose-escalation cohort (3 + 3 design), patients were treated with SBRT boost of 21 or 22.5 Gy in three fractions. Although dose-limiting toxicity was not confirmed, a dose of 21 Gy was selected for the phase II cohort because it was difficult to reproduce the pelvic organs position in two patients during the phase I trial. The primary endpoint was 2-year progression-free survival.

RESULTS:

Twenty-one patients (phase I, n = 3; phase II, n = 18) were enrolled between April 2016 and October 2020; 17 (81%) had clinical stage III-IV (with para-aortic lymph node metastases) disease. The median (range) follow-up was 40 (10-84) months. The initial response was complete response in 20 patients and partial response in one patient. The 2-year locoregional control, progression-free survival, and overall survival rates were 84%, 67%, and 81%, respectively. Grade ≥ 3 toxicity was confirmed in one patient each in the acute (diarrhea) and late (urinary tract obstruction) phases.

CONCLUSION:

These findings suggested that a SBRT boost is more effective than the conventional EBRT boost and can be an important treatment option for ICBT-ineligible patients with cervical cancer. STUDY REGISTRATION This study was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN000036845).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Braquiterapia / Neoplasias del Cuello Uterino / Radiocirugia Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Jpn J Radiol Asunto de la revista: DIAGNOSTICO POR IMAGEM / RADIOLOGIA / RADIOTERAPIA Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Braquiterapia / Neoplasias del Cuello Uterino / Radiocirugia Límite: Adult / Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Jpn J Radiol Asunto de la revista: DIAGNOSTICO POR IMAGEM / RADIOLOGIA / RADIOTERAPIA Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Japón