180P - Clinical outcome of anal squamous cell carcinoma treated with chemoradiotherapy with 5-fluorouracil plus mitomycin C

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anticancer Agents
Anal Cancer
Surgical Oncology
Presenter Ayako Doi
Citation Annals of Oncology (2016) 27 (suppl_9): ix53-ix67. 10.1093/annonc/mdw581
Authors A. Doi, H. Bando, A. Kawazoe, S. Fukuoka, Y. Kuboki, K. Shitara, W. Okamoto, T. Kojima, T. Doi, A. Ohtsu, T. Yoshino
  • Gastrointestinal Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP



Anal squamous cell carcinoma (ASCC) is a rare disease accounting for only 2.5% of digestive cancer in the US and probably more less of it in Japan. Established standard treatment for non-metastatic ASCC is concurrent chemoradiotherapy (CRT) with 5-fluorouracil (5-FU) plus mitomycin C (MMC) and it have been reported that complete response (CR) rate is approximately 80%. 5-year disease-free survival (DFS) and overall survival (OS) in RTOG-9811 trial were 68% and 78%, respectively. However there were a few reports regarding the clinical outcome in Japanese patients receiving this CRT regimen.


We retrospectively investigated safety and efficacy in patients with ASCC who received definitive CRT with RTOG-9811 regimen from Apr 2007 to Apr 2015 in our hospital. Adverse event (AE) was assessed with CTCAE version 4.0 and Response was evaluated according to the RECIST version 1.1 criteria. CR was defined as no residual cancer on both CT scan and colonoscopy. DFS and OS were assessed with Kaplan-Meier method.


18 patients were treated in our hospital. Median age was 65 years and 72% were female; clinical stage (AJCC/UICC) I/II, 56% and stage IIIA/IIIB, 44%. Median relative dose intensities of both drugs were 100% (range 50 to 100%). Although 28% of patients temporally interrupted RT with a median interrupted period of 2 days (2-17 days), 94% of patients completed the planned schedule. The main reason for dose modification or RT interruption was neutropenia. The CR rate was 89% and median time to CR from CRT initiation was 17.2 weeks. 3-year DFS rate was 75.9% and 3-year OS rate was 87.2%. CR rate, 3-year DFS and 3-year OS rate were equivalent to previous reports. The most common grade 3/4 AEs were leukopenia (67%) and neutropenia (61%), which are similar to those of RTOG-9811 trial (neutropenia: 61%). Although oral opioids was initiated or increased in 56% of patients during CRT for AE, all patients were recovered to opioid-free. There was no treatment-related death. Although 67% of any grade anal pain and 22% of grade 3/4 radiation dermatitis were observed, both adverse events were manageable by opioids use.


Concurrent CRT with 5-FU plus MMC was well tolerable and effective for Japanese patients.

Clinical trial indentification

Legal entity responsible for the study





H. Bando: AstraZeneca. T. Yoshino: GlaxoSmithKline Boehringer Ingelheim. All other authors have declared no conflicts of interest.