Pre-operative chemoradiotherapy using capecitabine and cetuximab followed by definitive surgery in patients with operable rectal cancer.
BACKGROUND
Achieving a high rate of complete pathological response with pre-operative chemoradiotherapy in rectal cancer is an unmet need. We evaluated the efficacy and toxicity of the combination of cetuximab, capecitabine and radiation therapy in the pre-operative setting of localized rectal cancer.


METHODS
Patients with clinically staged T3, T4 or nodepositive rectal cancer were treated with concurrent capecitabine and radiotherapy with weekly cetuximab starting one week before the start of radiation. This was followed by total mesorectal excision within 6-8 weeks. All patients achieving R0 resection received adjuvant capecitabine for 6 cycles.


RESULTS
Fifteen patients were treated and all underwent surgery. Sphincter preservation was achieved in 11 patients (73.3%) and pathological complete response in two. With a median follow up of 48 months (range 8.4-57.5), 12 patients were relapse-free and 14 were alive with 4-year relapse free survival of 80%. Overall survival was 93%. Significant grade 3 and 4 toxicity was mainly cetuximab-induced skin reactions (33%), radiation-induced skin toxicity (13%) and diarrhea (20%).


CONCLUSIONS
Adding cetuximab to pre-operative concurrent capecitabine and radiotherapy provides modest efficacy with manageable toxicity.
Section of Medical Oncology, Oncology Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia. Electronic address: bazarbashi@gmail.com.
Shouki
S
Bazarbashi
Section of Medical Oncology, Oncology Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia; Department of Clinical Oncology and Nuclear Medicine (SCUCON), Suez Canal University Hospitals, Ismaileya, Egypt.
Ayman
A
Omar
Section of Medical Oncology, Oncology Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Ali
A
Aljubran
Section of Medical Oncology, Oncology Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Ahmad
A
Alzahrani
Section of Colorectal Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Nasser
N
Alsanea
Section of Colorectal Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Alaa
A
Abduljabbar
Section of Colorectal Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Samar
S
Alhomoud
Section of Colorectal Surgery, Department of Surgery, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Luai
L
Ashari
Section of Radiation Oncology, Oncology Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Khalid
K
Balaraj
Section of Medical Oncology, Oncology Center, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Hussein
H
Soudy
Department of Radiology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Mohammad
M
Neimatallah
Section of Anatomic Pathology, Department of pathology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Musa
M
Fagih
D000328:Adult; D000368:Aged; D000069287:Capecitabine / Q000009:adverse effects / Q000627:therapeutic use*; D000068818:Cetuximab / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009367:Neoplasm Staging; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D016019:Survival Analysis; D016896:Treatment Outcome
D000069287:Capecitabine; D000068818:Cetuximab
Capecitabine; Cetuximab; Pre-operative chemoradiotherapy; Rectal cancer