CLO19-023: Induction Chemotherapy Followed by Chemoradiation and Trans-Anal Full Thickness Local Excision or Total Mesorectal Resection in Patients With T2-T3/NO-N+ Adenocarcinoma of the Rectum; Preliminary Results of Phase 2 Prospective Clinical Trial

Background: The National Comprehensive Cancer Network (NCCN) Guidelines recently recognized total neoadjuvant therapy (TNT) as an acceptable option in patients with T3 and any N rectal cancer. Previous studies suggested that patients who received chemotherapy prior to conventional preoperative chemoradiation (CRT) and surgery allowed patients to receive more of their planned treatment with a better toxicity profile and increase in pathological response. However, those studies used a long course of FOLFOX or used capecitabine and oxaliplatin as an induction regimen. We are conducting a phase 2 prospective clinical trial to evaluate the use of 6 cycles of FOLFOX as TNT in patients with T2-T3/N0-N+. Patients and Methods: Patients with T2-T3/N0-N+ enrolled on our phase 2 prospective trial were included for this analysis. Patients received 6 cycles of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin), which was administered every 2 weeks. After 3 weeks of recovery period, patients then received conventional CRT with 5FU or capecitabine. All patients got MRI and endorectal ultrasound (ERUS) at baseline, after completing FOLFOX 3-months regimen and after finishing conventional CRT. Patients underwent either full-thickness local excision or total mesorectal resection depending on their tumor response to neoadjuvant therapy. The time interval between completion of radiation therapy and surgery ranged between 7and 12 weeks. Results: A total of 10 patients completed the chemotherapy and CRT treatment regimen. 9 patients proceeded to surgery and the 10th patient is scheduled for surgery. Clinical downstaging by MRI or ERUS was shown in 9 of 10 patients with only 6 cycles of FOLFOX. Complete clinical response was achieved in 6 patients as evident by ERUS/MRI of the pelvis after 3 months of FOLFOX before CRT. Complete pathological response was found in 4 of 9 patients (44%). In addition, 4 other patients had significant albeit not complete pathological response. Conclusions: This study suggests that adding only 6 cycles of neoadjuvant FOLFOX before CRT improved clinical and pathological downstaging of T2-T3/N0-N+ rectal adenocarcinoma and may facilitate organ preservation surgery. This is strategy needs to be investigated in larger phase III trials to validate these findings.

ERECTILE DYSFUNCTION AFTER COLORECTAL SURGERY

Sexual dysfunction following surgery for rectal cancer may be frequent and often severe. The aim of the present study is to evaluate the postoperative incidence of this complication and its severity. The current study is a retrospective study in which consecutive patients with rectal tumors, regardless of location (upper, middle or lower) were enrolled during a 1 year period in the General Surgery Clinic of the Emergency Clinical Hospital Prof. Dr. Agrippa Ionescu, Hospital, Bucharest. The patient files, paraclinical investigations, operative protocols, and histopathological bulletins were reviewed and data regarding age, gender, date of diagnosis, medical treatment administered including neoadjuvant therapy and reinterventions were collected. The IIEF-5 type questionnaires were used to assess sexual function at 6 months. We identified a number of 30 patients with amedian age of 60 years. All the patients were operated via open approach. Total mesorectal resection (TME) was practiced in 18 cases. Mean period follow-up was 10 months. Perioperative mortality was 0. There was no recurrence 1 year after surgery. Ten patients benefited from neoadjuvant radiotherapy. Rate of erectile dysfunction was 80%. The rate of ejaculation dysfunction was 70%. Patients operated for rectal cancer via an open approach showed severe sexual dysfunctions (SD). These complications affect the patient’s quality of life and need a multidisciplinary approach towards a better understanding of this problem by both the medical staff and the patient.