Induction chemotherapy with capecitabine and oxaliplatin followed by chemoradiotherapy before surgery in patients with locally advanced rectal cancer (A phase II study)

Background Locally advanced rectal cancer (LARC) has a high incidence of local and distant relapse even after adequate treatment. The emerging role of neoadjuvant induction chemotherapy may allow initial down staging of the primary tumor, less toxicity profile and early treatment of micrometastatic disease followed by chemoradiation, and optimum local control may be attained, with the hope of increased complete response rates Objectives to identify the effect of induction chemotherapy with oxaliplatin and capecitabine (CapeOx) before concurrent chemoradiation in locally advanced rectal cancer in terms of response and toxicity. Primary end point is assessment of complete pathological response rate. Patient and Methods patients with MRI based criteria of high-risk LARC (T4 tumors, tumors within 2 mm of mesorectal fascia, T3 tumors at or below levators and T2-4N+ve tumors) were included. Patients received 12 weeks of induction capecitabine/oxaliplatin followed by concomitant capecitabine and conventional three dimensional conformal radiotherapy. Surgery was done at least 6 weeks after CCRTH. Results Thirty five patients with LARC were recruited during the period from December 2017 till January 2019. Five patients (20.8%) had a pathological complete response (TRG 0) (ypT0N0). Another three patients (12.5%) had near complete pathological response (TRG 1). While unfortunately 29.2% and 37.5% had partial response and poor response respectively. Conclusion Induction chemotherapy could be a promising option for better response rates either clinical or pathological for high risk LARC patients with acceptable toxicity profile.