Academic Journal
Safety and efficacy of neoadjuvant chemoradiotherapy with moderately hypofractionated intensity‐modulated radiotherapy for resectable pancreatic cancer: A prospective, open‐label, phase II study
| العنوان: | Safety and efficacy of neoadjuvant chemoradiotherapy with moderately hypofractionated intensity‐modulated radiotherapy for resectable pancreatic cancer: A prospective, open‐label, phase II study |
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| المؤلفون: | Masui, Toshihiko, Nagai, Kazuyuki, Anazawa, Takayuki, Kasai, Yosuke, Yogo, Akitada, Yoshimura, Michio, Mizowaki, Takashi, Uza, Norimitsu, Fukuda, Akihisa, Matsumoto, Shigemi, Kanai, Masashi, Isoda, Hiroyoshi, Kawaguchi, Yoshiya, Uemoto, Shinji, Hatano, Etsuro |
| المساهمون: | Japan Society for the Promotion of Science |
| المصدر: | Cancer Medicine ; volume 12, issue 18, page 18611-18621 ; ISSN 2045-7634 2045-7634 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2023 |
| المجموعة: | Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: | Background Resectable pancreatic cancer (RPC) is potentially resectable on admission, and the impact of neoadjuvant therapy on these tumors is controversial. Moreover, the safety and efficacy of neoadjuvant chemoradiotherapy with moderately hypofractionated intensity‐modulated radiation therapy (NACIMRT) for RPC have not been studied. Here, we conducted a phase II study to evaluate the safety and efficacy of hypofractionated NACIMRT for RPC. Methods A total of 54 RPC patients were enrolled and treated according to the study protocol. We used moderately hypofractionated (45 Gy in 15 fractions) IMRT with gemcitabine to shorten the duration of radiotherapy and reduce gastrointestinal toxicity. The primary endpoint was overall survival (OS), and we subsequently analyzed the microscopically margin‐negative resection (R0) rate, disease‐free survival (DFS), and histologic effects and safety of NACIMRT. Results Median OS for the cohort was 40.0 months. Forty‐two patients (77.8%) underwent pancreatectomy after NACIMRT. Median DFS was 20.3 months. The R0 resection rate was 95.2% (40/42) per protocol and 85.2% (46/54) for the cohort. There were no intervention‐related deaths during the study period. Local treatment response, as assessed by the CAP classification, showed no residual tumor in 4.8% of patients. Overall, 23.9% of patients experienced CTCAE grade 3 or 4 during NACIMRT. Adjuvant therapy was initiated in 88% of patients undergoing resection. Postoperative complications grade ≥3b on the Clavien–Dindo scale occurred in 4.8% of patients. CA19‐9 level at enrollment was an independent prognostic factor for OS and DFS. Conclusions This is the first prospective study of hypofractionated IMRT as neoadjuvant therapy for RPC. Hypofractionated NACIMRT for RPC could be safely introduced with a high induction rate of adjuvant chemotherapy, with an overall survival of 40.0 months. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1002/cam4.6470 |
| الاتاحة: | http://dx.doi.org/10.1002/cam4.6470 https://onlinelibrary.wiley.com/doi/pdf/10.1002/cam4.6470 |
| Rights: | http://creativecommons.org/licenses/by/4.0/ |
| رقم الانضمام: | edsbas.516F3393 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/cam4.6470 |
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