1. Phase II study of chemoselection with docetaxel plus cisplatin and 5-fluorouracil induction chemotherapy and subsequent conversion surgery for locally advanced unresectable oesophageal cancer
- Author
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Yushi Nagai, Yasuhiro Tsubosa, Keisho Chin, Yasuo Hamamoto, Kentaro Kawakami, Chika Asami, Tomoya Yokota, Shuichi Hironaka, Takashi Kojima, Takashi Ura, Yasunori Akutsu, Hirofumi Ogawa, Hiroki Hara, Ken Kato, Yoshinori Ito, Yasushi Kojima, Yuko Kitagawa, Hisayuki Matsushita, Takayuki Kii, and Keita Mori
- Subjects
Oncology ,Male ,Cancer Research ,medicine.medical_specialty ,oesophageal cancer ,Esophageal Neoplasms ,Phases of clinical research ,Docetaxel ,chemoselection ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,induction chemotherapy ,Aged ,Cisplatin ,business.industry ,Induction chemotherapy ,Cancer ,Chemoradiotherapy ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Surgery ,Survival Rate ,Fluorouracil ,conversion surgery ,030220 oncology & carcinogenesis ,Clinical Study ,030211 gastroenterology & hepatology ,Female ,Taxoids ,Liver cancer ,business ,multidisciplinary treatment strategy ,medicine.drug - Abstract
Background: The standard treatment for locally advanced unresectable squamous cell carcinoma (SCC) of the oesophagus is chemoradiation with cisplatin and 5-fluorouracil (CF-RT). This multicentre phase II trial assessed the safety and efficacy of chemoselection with docetaxel plus cisplatin and 5-fluorouracil (DCF) induction chemotherapy (ICT) and subsequent conversion surgery (CS) for initially unresectable locally advanced SCC of the oesophagus. Methods: Patients with clinical T4 and/or unresectable supraclavicular lymph node metastasis were eligible. Treatment started with three cycles of DCF-ICT, followed by CS if resectable, or by CF-RT if unresectable. The resectability was re-evaluated at 30–40 Gy of CF-RT, followed by CS if resectable, or by completion of 60 Gy of CF-RT. If resectable after CF-RT, CS was performed. The primary end point was 1-year overall survival (OS). Results: From April 2013 to July 2014, 48 patients were enrolled. CS was performed in 41.7% (n=20), including DCF-CS (n=18), DCF-CF-RT40Gy-CS (n=1), and DCF-CF-RT60Gy-CS (n=1). R0 resection was confirmed in 19 patients (39.6%). Grade ⩾3 postoperative complications included one event each of recurrent laryngeal nerve palsy, lung infection, wound infection, pulmonary fistula, and dysphagia; but no serious postoperative complications were observed in patients undergoing CS. Clinical complete response after CF-RT was confirmed in 4 patients (8.3%). The estimated 1-year OS was 67.9% and lower limit of 80% confidence interval was 59.7%. There was one treatment-related death in patient receiving DCF-CF-RT60Gy. Conclusions: Chemoselection with DCF-ICT followed by CS as a multidisciplinary treatment strategy showed promising signs of tolerability and efficacy in patients with locally advanced unresectable SCC of the oesophagus.
- Published
- 2016