1. Early postoperative complications are not increased in patients with rectal cancer treated with induction Capecitabine plus Oxaliplatin (CAPOX) followed by concomitant chemoradiotherapy and surgery compared with concomitant chemoradiotherapy followed by surgery and adjuvant CAPOX Alfonso García-Fadrique, Concepción Gómez i Gavara, María Caballero Soto, Jorge Campos Máñez, Carlos Fernández Martos, Javier Serra*, Rafael Estevan Estevan Fundación Instituto Valenciano de Oncología. Valencia. Spain. *Corporació Sanitària Parc Taulí. Sabadell
Aim
The optimal therapeutic sequence of the adjuvant chemotherapy component of preoperative chemoradiotherapy (CRT) for patients with locally advanced rectal cancer is controversial. Induction chemotherapy before preoperative CRT may be associated with better efficacy and compliance. The aim was to determine whether two different sequences of multimodal treatment for rectal cancer caused different rates of early postoperative complications.
Arm A: preoperative chemoradiotherapy (CRT) + surgery + postoperative adjuvant chemotherapy
Arm B: induction chemotherapy + CRT + surgery
Patients and Methods
A phase II randomized trial was designed¹. A total of 108 patients with locally advanced rectal cancer were randomly assigned to arm A—preoperative CRT with capecitabine, oxaliplatin, and concurrent radiation followed by surgery and postoperative adjuvant capecitabine and oxaliplatin (CAPOX)— or arm B—induction CAPOX followed by CRT and surgery. Surgical technique include to perform a total mesorectal excision (TME), the choice of surgical procedure (abdominoperineal excision or anterior resection) was at the surgeon’s discretion. Early postoperative complications including wound infection, anastomotic leak, stoma-related problem, reoperation and death were identified
CONSORT diagram. CRT, chemoradiotherapy; CT, chemotherapy
Schema for randomized, Grupo Cáncer de Recto 3, phase II study. Cape, capecitabine; RT, radiation therapy; Oxa, oxaliplatin;
Results
On an intention-to-treat basis, thirty-day postsurgical complications of any grade were seen in 21 patients in arm A and in 27 patients in arm B (45% v 51%; P=0.3; respectively). Complications related to wound healing (20% and 27%; P=0.7; respectively), anastomotic leaks (2% and 4%; P=1.0; respectively) and stoma related (0% and 8%; P=0.1; respectively). Re-operation was required for three patients (7%) in arm A and four patients (8%) in arm B (P=1.0). There were three deaths within the 30-day postoperative period, and all were in arm B (P=0.2). Two were due to anastomotic leaks complicated with nosocomial pneumonia. The third patient had major depression and refused all medical attention.
Conclusion
-Early complications after elective surgery are not related to the time of surgery in these two combined treatments for rectal cancer
-Compared with postoperative adjuvant CAPOX, induction CAPOX before CRT had more favorable compliance and toxicity profiles
1. Phase II, Randomized Study of Concomitant Chemoradiotherapy Followed by Surgery and Adjuvant Capecitabine Plus Oxaliplatin (CAPOX) Compared With Induction CAPOX Followed by Concomitant Chemoradiotherapy and Surgery in Magnetic Resonance Imaging–Defined, Locally Advanced Rectal Cancer: Grupo Cáncer de Recto 3 Study
C. Fernández-Martos et al. J Clin Oncol Feb 10;28(5):859-65