Chemoradiotherapy for squamous cell carcinoma of the anal canal: Comparison of one versus two cycles mitomycin-C.
OBJECTIVE
Concurrent chemoradiotherapy with 5-fluorouracil (5-FU) and mitomycin-C (MMC) is standard treatment for anal cancer. Randomized clinical trials in Europe have used 1 cycle MMC, while North American studies use 2 cycles. We compared treatment outcomes between patients treated with either 1 or 2 cycles of concurrent MMC.


METHODS
217 consecutive patients were treated definitively with chemoradiation from 2004 to 2012 in an integrated health system. Concurrent chemotherapy regimen depended on individual practice, and consisted of 2 cycles 5-FU (1000 mg/m(2)/day on days 1-4 and 29-32), along with MMC (10-15 mg/m(2)), given on either day 1 alone (n = 154), or days 1 and 29 (n = 63). Outcomes included progression-free (PFS), cancer-specific (CSS), overall (OS), and colostomy-free survival (CFS), as well as toxicity criteria.


RESULTS
Median age 60 years, 70% female, 52% T3-T4, and 40% node-positive. Median follow-up 26 months. At 2 years, outcomes were: PFS 80%, CSS 89%, OS 86%, and CFS 88%. There was no difference in PFS (HR 0.85, 95% CI 0.37-1.92), CSS (HR 0.32, 95% CI 0.07-1.42), OS (HR 0.67, 95% CI 0.25-1.83), or CFS (HR 0.91, 95% CI 0.31-2.67) between the MMC1 and MMC2 groups. Stage and male gender were predictive of worse outcomes. Acute grade ⩾ 2 toxicities were worse in the MMC2 group. There were 3 treatment-related deaths, all in the MMC2 group.


CONCLUSIONS
This study suggests that MMC1 is efficacious and may be an alternative to MMC2 in patients with anal cancer treated with definitive chemoradiation, with the potential for less acute treatment-related toxicity. Randomized trials comparing these two regimens could be considered.
Department of Radiation Oncology, Kaiser Permanente Southern California, Los Angeles Medical Center, United States. Electronic address: ewhite1@gmail.com.
Evan C
EC
White
Department of Radiation Oncology, Kaiser Permanente Southern California, Los Angeles Medical Center, United States.
Kelly
K
Goldman
Department of Radiation Oncology, Kaiser Permanente Southern California, Los Angeles Medical Center, United States.
Alexey
A
Aleshin
Department of Radiation Oncology, Kaiser Permanente Southern California, Los Angeles Medical Center, United States.
Winston W
WW
Lien
Department of Radiation Oncology, Kaiser Permanente Southern California, Los Angeles Medical Center, United States.
Aroor R
AR
Rao
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001005:Anus Neoplasms / Q000473:pathology / Q000628:therapy*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D003125:Colostomy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome
D016685:Mitomycin; D005472:Fluorouracil
Anal cancer; Mitomycin-c; Outcomes; Radiation therapy; Toxicity