Impact of neoadjuvant intensity-modulated radiation therapy on borderline resectable pancreatic cancer with arterial abutment; a prospective, open-label, phase II study in a single institution
Toshihiko Masui,
Kazuyuki Nagai,
Takayuki Anazawa,
Asahi Sato,
Yuichiro Uchida,
Kenzo Nakano,
Akitada Yogo,
Akihiro Kaneda,
Naoto Nakamura,
Michio Yoshimura,
Takashi Mizowaki,
Norimitsu Uza,
Akihisa Fukuda,
Shigemi Matsumoto,
Masashi Kanai,
Hiroyoshi Isoda,
Masaki Mizumoto,
Satoru Seo,
Koichiro Hata,
Kojiro Taura,
Yoshiya Kawaguchi,
Kyoichi Takaori,
Shinji Uemoto,
Etsuro Hatano
Affiliations
Toshihiko Masui
Department of Surgery, Graduate School of Medicine, Kyoto University
Kazuyuki Nagai
Department of Surgery, Graduate School of Medicine, Kyoto University
Takayuki Anazawa
Department of Surgery, Graduate School of Medicine, Kyoto University
Asahi Sato
Department of Surgery, Graduate School of Medicine, Kyoto University
Yuichiro Uchida
Department of Surgery, Graduate School of Medicine, Kyoto University
Kenzo Nakano
Department of Surgery, Graduate School of Medicine, Kyoto University
Akitada Yogo
Department of Surgery, Graduate School of Medicine, Kyoto University
Akihiro Kaneda
Department of Surgery, Graduate School of Medicine, Kyoto University
Naoto Nakamura
Department of Surgery, Graduate School of Medicine, Kyoto University
Michio Yoshimura
Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University
Takashi Mizowaki
Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University
Norimitsu Uza
Department of Gastroenterology and Hepatology, Kyoto University
Akihisa Fukuda
Department of Gastroenterology and Hepatology, Kyoto University
Shigemi Matsumoto
Department of Real World Data Research and Development, Graduate School of Medicine, Kyoto University
Masashi Kanai
Department of Clinical Oncology, Kyoto University
Hiroyoshi Isoda
Department of Diagnostic Imaging and Nuclear Medicine, Kyoto University
Masaki Mizumoto
Department of Surgery, Graduate School of Medicine, Kyoto University
Satoru Seo
Department of Surgery, Graduate School of Medicine, Kyoto University
Koichiro Hata
Department of Surgery, Graduate School of Medicine, Kyoto University
Kojiro Taura
Department of Surgery, Graduate School of Medicine, Kyoto University
Yoshiya Kawaguchi
Department of Surgery, Graduate School of Medicine, Kyoto University
Kyoichi Takaori
Department of Surgery, Graduate School of Medicine, Kyoto University
Shinji Uemoto
Department of Surgery, Graduate School of Medicine, Kyoto University
Etsuro Hatano
Department of Surgery, Graduate School of Medicine, Kyoto University
Abstract Background Borderline resectable pancreatic cancer (BRPC) is a category of pancreatic cancer that is anatomically widely spread, and curative resection is uncommon with upfront surgery. Intensity-modulated radiation therapy (IMRT) is a form of radiation therapy that delivers precise radiation to a tumor while minimizing the dose to surrounding normal tissues. Here, we conducted a phase 2 study to estimate the curability and efficacy of neoadjuvant chemoradiotherapy using IMRT (NACIMRT) for patients with BRPC with arterial abutment (BRPC-A). Methods A total of 49 BRPC-A patients were enrolled in this study and were treated at our hospital according to the study protocol between June 2013 and March 2021. The primary endpoint was microscopically margin-negative resection (R0) rates and we subsequently analyzed safety, histological effect of the treatment as well as survivals among patients with NACIMRT. Results Twenty-nine patients (59.2%) received pancreatectomy after NACIMRT. The R0 rate in resection patients was 93.1% and that in the whole cohort was 55.1%. No mortality was encountered. Local therapeutic effects as assessed by Evans classification showed good therapeutic effect (Grade 1, 3.4%; Grade 2a, 31.0%; Grade 2b, 48.3%; Grade 3, 3.4%; Grade 4, 3.4%). Median disease-free survival was 15.5 months. Median overall survival in the whole cohort was 35.1 months. The only independent prognostic pre-NACIMRT factor identified was serum carbohydrate antigen 19–9 (CA19-9) > 400 U/ml before NACIMRT. Conclusions NACIMRT showed preferable outcome without significant operative morbidity for BRPC-A patients. NACIMRT contributes to good local tumor control, but a high initial serum CA19-9 implies poor prognosis even after neoadjuvant treatment. Trial Registration UMIN-CTR Clinical Trial: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011776 Registration number: UMIN000010113. Date of first registration: 01/03/2013,