Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 2

3563 - BISQUIT: A Randomized Phase II Study of the Administration of Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy for Patients With Squamous Cell Carcinoma of the Anal Canal


29 Sep 2019


Poster Display session 2


Tumour Site

Colon and Rectal Cancer


Rachel Riechelmann


Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246


R.P. Riechelmann1, M. Camandaroba1, C.A. Mello1, V.S. Silva1, V.H.F. de Jesus1, M. Barros1, N. Rodrigues1, M.D. Donadio1, M. Cavichiolli2, V.C.C. Lima1, E. Dias-Neto3, D.N. Nunes3, D. Carraro3, L. De Brot4, S. Aguiar Jr5, M.L.G. Silva6

Author affiliations

  • 1 Medical Oncology, A. C. Camargo Cancer Center, 01509-010 - Sao Paulo/BR
  • 2 Nuclear Medicine, A. C. Camargo Cancer Center, 01509-010 - Sao Paulo/BR
  • 3 Cipe, A. C. Camargo Cancer Center, 01509-010 - Sao Paulo/BR
  • 4 Pathology, A. C. Camargo Cancer Center, 01509-010 - Sao Paulo/BR
  • 5 Pelvis, A. C. Camargo Cancer Center, 01509-010 - Sao Paulo/BR
  • 6 Radiation Oncology, A. C. Camargo Cancer Center, 01509-010 - Sao Paulo/BR


Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 3563


The standard treatment for patients (pts) with localized squamous cell carcinoma of the anal canal (SCCAC) is chemoradiation (ChRT). Yet nearly 30% of patients are not cured and undergo salvage anorectal amputation. SCCAC is mostly a virus-associated tumor and thus potentially immunogenic. In fact, immune checkpoint inhibitors are promising in trials of metastatic SCCAC. Recently, studies have shown that the composition of the intestinal microbiota influences response to immunotherapy in some solid tumors, and the replacement of the intestinal "carcinogenic" by a protective microbiota has led to investigations with prebiotics and probiotics (PreProbiotics). Yet, there are no studies on the use of these agents in SCCAC. Thus we are conducting a randomized phase II study to test the efficacy of PreProbiotics during definitive ChRT aiming to improve the cure rate of pts with localized SCCAC.

Trial design

Randomized open label parallel phase II trial, where eligible pts will be randomized 1:1 to receive PreProbiotics starting one week prior to ChRT and throughout treatment until response evaluation at 6 to 8 weeks post ChRT or conventional ChRT. Eligible pts are ≥ 18 years, with histologically confirmed SCCAC, localized disease (≥ T2N0M0), indication to start definitive ChRT; HIV seropositive pts are eligible. Pts with active infection requiring antibiotics will be excluded. Primary endpoint: complete clinical and radiological response (CR) at 6 to 8 weeks post ChRT. Secondary endpoints: CR at 6 months, progression free survival, colostomy-free survival, metabolic response measured by 18-FDG PET-CT (baseline and at 6-8 weeks), toxicity, incidence of HPV in tumor tissues. All pts will have the following biological samples collected for correlative studies at baseline, 6-8 weeks and 6 months post ChRT: blood samples for circulating tumor DNA, inflammatory cytokines, anal/rectal swabs and feces to evaluate microbiota. Sample size assumptions: the H0 is CR at week 6 - 8 of 70% and H1, 90%; with a type I error of 10%, power of 80% and attrition rate of 10%, the final sample size is 75 patients.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Rachel Riechelmann.


AC Camargo Cancer Center.


All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.