Abstract
Background Anal squamous cell carcinoma (ASCC) is a rare disease accounting for only2.5%ofdigestivecancerintheUSandprobablymorelessofitinJapan.Established standard treatment for non-metastatic ASCC is concurrent chemoradiotherapy (CRT) with5-fluorouracil(5-FU) plusmitomycinC(MMC) andithavebeenreportedthat completeresponse(CR) rateisapproximately80%.5-yeardisease-freesurvival(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. Methods 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 ourhospital.Adverseevent(AE) wasassessedwithCTCAEversion4.0andResponse 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. Results 18 patients were treated in our hospital. Median age was 65 years and 72% were female;clinicalstage(AJCC/UICC)I/II,56%andstageIIIA/IIIB,44%.Medianrelative doseintensitiesofbothdrugswere100%(range50to100%).Although28%ofpatients temporallyinterruptedRTwithamedianinterruptedperiodof2days(2-17days),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%. CRrate, 3-year DFS and 3-year OS ratewere equivalentto previous reports. The most common grade 3/4 AEs were leukopenia (67%) and neutropenia (61%), which are similartothoseofRTOG-9811trial(neutropenia:61%).Althoughoralopioidswas initiatedorincreasedin56%ofpatientsduringCRTforAE,allpatientswererecovered toopioid-free. Therewasnotreatment-relateddeath. Although67% ofanygradeanal pain and 22% ofgrade 3/4 radiation dermatitis were observed, both adverse events were manageable by opioids use. Conclusions Concurrent CRT with 5-FU plus MMC was well tolerable and effective for Japanese patients. Legal entity responsible for the study N/A Funding N/A Disclosure H. Bando: AstraZeneca. T. Yoshino: GlaxoSmithKline Boehringer Ingelheim. All other authors have declared no conflicts of interest.
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