br Proctologist admission br Physical and imaging
- Physical and imaging exams Oncologist: CHT-5-FU/LV
Radiotherapist: RT 54Gy
- Wexner scale
- FIQL questionnaire
surgery or follow-up
Neoadjuvant treatment RT/CHT
- Wexner scale
- FIQL questionnaire
Adjuvant treatment CHT
Fig. 1 – Radiotherapy and chemotherapy scheme.
oncology sector of Hospital Santa Izabel – Santa Casa da Bahia.
The present article describes the partial results of the study.
Table 1 – Toxicity related to chemotherapy (CHT) and radiotherapy (RT).
Material and methods
This was a prospective study from June 2015 to June 2018, in patients with low- or mid-rectum adenocarcinoma and clin-ical stage II or III, treated with RT/CHT (IMRT 54 Gy for six weeks) concomitant with 5-fluorouracil (5-FU) 380 mg/m2 and folinic Sotrastaurin (AEB071) (LV) 20 mg/m2 for five days in the first and fifth weeks and two adjuvant cycles after RT, using 5-FU 400 mg/m2 and LV 20 mg/m2 every 28 days (Fig. 1). After the treatment, clinical examination, rectosigmoidoscopy, pelvic magnetic resonance imaging (MRI), chest and upper abdomen computed tomography (CT), and CEA testing were performed. Resec-tion surgery was performed in those with incomplete clinical response (iCR), while those who presented cPR are followed-up monthly, with rectal examination and other exams. Those with complete clinical response (cCR) are under observation (wait-and-see policy). Manometry and scintigraphic function and quality of life scales are collected before treatment and at 30 and 90 days after the end of treatment. Anorectal function will be assessed through the Wexner fecal incontinence ques-tionnaire and manometry measurements; the quality of life, through the Fecal Incontinence and Quality of Life Question-naire (FIQL).
Until June 2018, 11 patients were recruited; one was excluded from the analysis for presenting severe toxicity, suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency, after the first CHT cycle.
Most patients were male (60%) and the mean age was 45.9 years, ranging from 28 to 59 years. The lesions were located in the mid- and lower rectum, at a mean height of 2.7 cm from the anal border, ranging from 0.5 to 6 cm from the anal border. Most patients (six) had clinical staging IIIB on admission; one patient was classified as stage III and two as stage II.
All ten remaining patients completed the treatment. Two patients presented toxicity grade 3/4 related to chemotherapy and had their doses reduced during treatment. Regarding RT, two patients also presented Grade III toxicity (Table 1).
Toxicity G1 G2 G3 G4
Seven patients (70%) presented iCR and underwent surgi-cal treatment according to the indication of the lesion; cPR was achieved in two cases (28.5%; Fig. 2). Three patients (30%) presented cCR and are being followed-up through clinical examination, CEA dosage, and periodic imaging tests (chest, abdomen, and pelvis CT, positron emission tomography [PET], and retosigmoidoscopy), with no evidence of disease to date. Patients presented improvement of anorectal function and quality of life after the end of treatment.
Of the three patients with cCR, all had CEA normalization and did not present changes to the rectal examination; flexible rectosigmoidoscopy (Fig. 3) and pelvic MRI presented alter-ations compatible with cCR. Two of these patients underwent a PET scan to complement the investigation, and no areas of increase in FDG uptake were identified. The mean follow-up of these patients is of 19 months, ranging from 14 to 27 months.
All patients presented improvement in the quality of life score and in the Wexner scale, without significant alterations in manometric pressure when compared to those observed prior to treatment.
In localized rectum cancer, clinical stage I–III, in which sur-gical resection is considered curative, the survival rate is approximately 60% at 5 years and 50% at 10 years.4 How-ever, even surgical treatment can present high morbimortality. The mortality rate in total mesorectal excision (TME) is of approximately 4%, with a directly proportional increase in age, reaching 11.8% in octogenarian patients.5 Other possible complications of rectal cancer resection are urinary and rec-tal dysfunction, which in some series were observed in 25% of patients treated with radical surgery.6,7
Randomized studies and a meta-analysis by Luigi Zorcolo et al. demonstrated a cPR rate ranged from 10% to 20% and