Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an
early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and
5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure
(including salvage surgery), cisplatin-5FU combination is the standard option but complete
response is a rare event and the prognosis remains poor with most patients' death occurring
in the first 12 months. Decision making for physicians in this setting is only based on
retrospective studies or small phase II clinical trials including less than 20 patients.
Hence, no efficient standard of care is currently available for relapsing SCCA patients who
are currently treated with a palliative intent.
Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were
treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer
Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved
a complete response. Three patients underwent surgery of all involved metastatic sites. A
pathological complete response was observed for all of them including in metastases occurring
in irradiated fields, suggesting that taxane-based chemotherapy might be an effective
strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was
published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were
HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV)
HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the
potential restoration of cancer immunosurveillance by this regimen.
Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of
taxane-based chemotherapy in SCCA patients.