Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study.
BACKGROUND
Preoperative radiotherapy has been shown to decrease the local recurrence rate of patients with locally advanced rectal cancer. Capecitabine and oxaliplatin are both active anticancer agents in the treatment of patients with advanced colorectal cancer and have radiosensitizing properties. Therefore, these drugs would be expected to improve effectiveness of preoperative radiotherapy in terms of local control and prevention of distant metastases.


METHODS
Forty patients with rectal cancer (T3-T4 and/or N+) received radiotherapy (1.8 Gy, 5 days a week over 5 weeks, total dose 45 Gy, 3D conformational technique) in combination with intravenous oxaliplatin 50 mg/m2 once weekly for 5 weeks and oral capecitabine 825 mg/m2 twice daily on each day of radiation. Surgery was performed 6-8 weeks after completion of radiotherapy. The main end points were safety and efficacy as assessed by the pathological complete response (pCR).


RESULTS
The most frequent grade 3/4 adverse event was diarrhea, occurring in 30% of patients. pCR was found in five (14%) patients. According to Dworak's classification, good regression was found in six (18%) additional patients.


CONCLUSIONS
Combination of preoperative radiotherapy with capecitabine and oxaliplatin is feasible for downstaging rectal cancer.
Machiels
J-P
JP
Clinique des Pathologies Tumorales du Colon et du Rectum, Centre du Cancer, Université Catholique de Louvain, Brussels, Belgium. jean-pascal.machiels@onco.ucl.ac.be
Duck
L
L
Honhon
B
B
Coster
B
B
Coche
J-C
JC
Scalliet
P
P
Humblet
Y
Y
Aydin
S
S
Kerger
J
J
Remouchamps
V
V
Canon
J-L
JL
Van Maele
P
P
Gilbeau
L
L
Laurent
S
S
Kirkove
C
C
Octave-Prignot
M
M
Baurain
J-F
JF
Kartheuser
A
A
Sempoux
C
C
D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D007275:Injections, Intravenous; D008113:Liver Neoplasms / Q000556:secondary / Q000628:therapy; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011300:Preoperative Care; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil