61P - Can total neoadjuvant therapy in locally advanced rectal cancer replace standard treatment protocol?

Background

Total neoadjuvant therapy is a combination of radiotherapy and chemotherapy for treatment of locally advanced rectal cancer, in any sequence, though RAPIDO and PRODIGE -23 have focused on this treatment protocol, in India there is no such trial done now.

Methods

Study design: Prospective interventional single-arm feasibility study. Study duration: August 2020 to May 2021. Study setting: Department of Radiotherapy in collaboration with Department of Surgical Oncology, Department of General Surgery of King George’s Medical University in Lucknow, India. Sample size 30. Sampling technique: All patients who attended radiotherapy opd during this study duration. Selection criteria: ECOG 0-1 patients with locally advanced stage I-III adenocarcinoma of middle or lower rectum. Study course: Patients received short course radiotherapy (SCRT) (25 Gray in 5 fractions over one week ) followed by six cycles of chemotherapy (Inj. oxaliplatin 130 mg / m2 on day one and Tab. capecitabine 1000 mg/m2 bid for 14 days- q3weekly). After completion of chemotherapy, all patients were sent for surgical evaluation. Objectives were to study immediate surgical outcomes in terms of pathological complete response (pCR), R0 resection rate, circumferential resection positive rate.

Results

Among the 30 recruited subjects, 6 (20%) were male and 24 (80%) were female, presentation is bleeding per rectum followed by pain and altered bowel habits. 60% were vegetarian in diet. All patients were histo-pathologically proven adenocarcinoma among 20% were signet ring types. 40% of the patients were well differentiated adenocarcinoma. 70% were T3 stage, and node positive disease. 63% of the patients had lower rectal disease. 83% had mesorectal fascia involvement. 50% had raised CEA (>5ng/ml ). 75% completed 6 cycles of chemotherapy along with 70% grade I neuropathy. 20% had grade 3 diarrhoea. 25 patients got operated. The surgical outcomes are described in the table. Table: 61P

Conclusions

Intensification of this therapy has potential to increase proportion of patients who achieve complete clinical response (cCR) and could be a candidate for wait and watch.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.