Pilot study of FMC (5-fluorouracil, mitomycin C, and cisplatin) with radiotherapy for patients with anal cancer.
OBJECTIVE
Concurrent chemoradiotherapy (CRT) is the current standard of treatment for anal squamous carcinoma. However, local or metastatic recurrences remain significant after CRT with 5-fluorouracil (5-FU) and mitomycin C (MMC). Therefore, the present study evaluated the feasibility and efficacy of adding cisplatin to the classic CRT (5-FU, MMC, and radiotherapy).


METHODS
Twenty patients with histologically confirmed squamous cell carcinoma of the anus without metastatic disease were enrolled at Kyungpook National University Medical Center (Daegu, Korea) between January 2005 and December 2014. The CRT comprised of two cycles of 5-FU 750 mg/m2days 1-4, MMC 10 mg/m2day 1, and cisplatin 60 mg/m2day 1 every 4 weeks and radiotherapy (59.6 Gy in 33 daily fractions). The primary endpoint was to determine the feasibility of FMC, while the secondary endpoints were the pathologic complete response (pCR) rate at 8 weeks following the completion of CRT, progression-free survival (PFS), and overall survival (OS).


RESULTS
The treatment was generally well tolerated, and all patients received two cycles of FMC chemotherapy. Among the 20 patients, 17 were assessed for their pathologic response and 12 patients (70.6%) achieved pCR. The most common grade 3 or 4 hematologic toxicity was neutropenia (n = 3), while the most frequent severe non-hematologic toxicity was radiation dermatitis (n = 6, 30%). After a median follow-up duration of 45.5 months, the estimated 5-year PFS and overall survival rates were 88.9 and 88.1%, respectively.


CONCLUSIONS
CRT with two cycles of a FMC regimen was found to be feasible for patients with anal squamous carcinoma. Further study is warranted to evaluate the efficacy of CRT with a FMC regimen.
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Kyungpook National University Cancer Research Institute, 807 Hogukno, buk-gu, Daegu, 702-210, South Korea.
In Hee
http://orcid.org/0000-0002-0139-9768
IH
Lee
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Kyungpook National University Cancer Research Institute, 807 Hogukno, buk-gu, Daegu, 702-210, South Korea.
Soo Jung
SJ
Lee
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Kyungpook National University Cancer Research Institute, 807 Hogukno, buk-gu, Daegu, 702-210, South Korea.
Byung Woog
BW
Kang
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Kyungpook National University Cancer Research Institute, 807 Hogukno, buk-gu, Daegu, 702-210, South Korea.
Yee Soo
YS
Chae
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Kyungpook National University Cancer Research Institute, 807 Hogukno, buk-gu, Daegu, 702-210, South Korea.
Dongwon
D
Baek
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Kyungpook National University Cancer Research Institute, 807 Hogukno, buk-gu, Daegu, 702-210, South Korea.
Soyoon
S
Hwang
Department of Surgery, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, South Korea.
Hye Jin
HJ
Kim
Department of Surgery, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, South Korea.
Su Yeon
SY
Park
Department of Surgery, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, South Korea.
Jun Seok
JS
Park
Department of Surgery, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Daegu, South Korea.
Gyu Seog
GS
Choi
Department of Radiation Oncology, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, South Korea.
Jae Chul
JC
Kim
Department of Oncology/Hematology, Kyungpook National University Medical Center, Kyungpook National University School of Medicine, Kyungpook National University Cancer Research Institute, 807 Hogukno, buk-gu, Daegu, 702-210, South Korea. jkk21c@knu.ac.kr.
Jong Gwang
JG
Kim
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001005:Anus Neoplasms / Q000401:mortality / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D010865:Pilot Projects
D016685:Mitomycin; D002945:Cisplatin; D005472:Fluorouracil
Anal cancer; Chemoradiotherapy; Cisplatin; Feasibility; Squamous cell carcinoma