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Clinical Trial
. 2019 Jan;24(1):60-67.
doi: 10.1007/s10147-018-1336-x. Epub 2018 Aug 14.

Phase II feasibility study of preoperative concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil and elective lymph node irradiation for clinical stage II/III esophageal squamous cell carcinoma

Jun Hashimoto  1 , Ken Kato  2 , Yoshinori Ito  3 , Takashi Kojima  4 , Tetsuo Akimoto  5 , Hiroyuki Daiko  6 , Yasuo Hamamoto  7 , Hisayuki Matsushita  8 , Susumu Katano  9 , Hiroki Hara  10 , Yoichi Tanaka  11 , Yoshihiro Saito  12 , Kengo Nagashima  13 , Hiroyasu Igaki  14
Affiliations
Clinical Trial

Phase II feasibility study of preoperative concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil and elective lymph node irradiation for clinical stage II/III esophageal squamous cell carcinoma

Jun Hashimoto et al. Int J Clin Oncol. 2019 Jan.

Abstract

Background: Preoperative chemoradiotherapy (CRT) is a standard treatment for stage II/III esophageal cancer. Preoperative chemotherapy is also considered a standard treatment for stage II/III esophageal squamous cell carcinoma (ESCC) in patients who undergo radical lymph node dissection. We conducted a feasibility study of preoperative CRT with cisplatin plus 5-fluorouracil (CF) and elective lymph node irradiation followed by esophagectomy with radical lymph node dissection in patients with stage II/III ESCC.

Methods: Patients with clinical stage II/III, excluding T4, ESCC (International Union Against Cancer TNM classification system, 6th edition) were eligible. Chemotherapy comprised two courses of CF infusion repeated after 4-weeks. Radiation therapy was concurrently administered to the primary tumor, metastatic lymph nodes, and regional lymph nodes at a dose of 41.4 Gy. After the completion of CRT, transthoracic esophagectomy with 2-3 fields lymphadenectomy was performed. The primary endpoint was the completion rate of protocol treatment with R0 resection.

Results: Thirty-one eligible patients were enrolled. During CRT, the most common grade 3 or 4 toxicities were leukopenia (65%), neutropenia (65%), anemia (13%), thrombocytopenia (13%), febrile neutropenia (13%), anorexia (16%), esophagitis (16%) and hyponatremia (16%). Thirty patients (96.8%) underwent surgery. One patient received palliative chemotherapy because of appearance of lung metastasis during CRT. The completion rate of protocol treatment was 93.5% (29/31). There was one treatment-related death after surgery. Pathological complete response was achieved in 42% (13/30).

Conclusion: Preoperative CRT with CF and elective lymph node irradiation showed an acceptable toxicity and promising activity especially in ESCC.

Keywords: Clinical trial; Elective lymph node irradiation; Esophageal cancer; Phase II; Preoperative chemoradiotherapy.

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References

    1. J Clin Oncol. 2001 Jan 15;19(2):305-13 - PubMed
    1. J Clin Oncol. 2005 Apr 1;23(10):2310-7 - PubMed
    1. Br J Cancer. 2006 May 22;94(10):1389-94 - PubMed
    1. J Clin Oncol. 2008 Mar 1;26(7):1086-92 - PubMed
    1. J Clin Oncol. 2009 Feb 20;27(6):851-6 - PubMed

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