Preoperative treatment combining capecitabine with radiation therapy in rectal cancer: a GERCOR Phase II Study.
OBJECTIVE
To assess efficacy and tolerability of preoperative capecitabine chemoradiation in rectal cancer.


METHODS
Patients received radiotherapy 45 Gy in 25 fractions over 5 weeks and capecitabine 825 mg/m(2) twice daily throughout radiotherapy. Surgery was performed 5-7 weeks after radiotherapy. The primary endpoint was pathological complete response, secondary endpoints were downstaging and tolerability.


RESULTS
Fifty-one patients were enrolled in a phase II study, median age 62 years (range 35-78). Sixty-three percent of tumours involved the lower third of the rectum, 45% were fixed. The median delivered radiotherapy dose was 44.8 Gy (range 39.6-45.0 Gy) over 33-49 days. The treatment-related grade 3 adverse events were diarrhoea (12%), skin reactions (8%) and asthenia (8%), with no grade 4 toxicity. Fifty patients underwent surgery (29 conservative) and 1 patient refused. The pathological complete response rate was 20% and a further 10% of patients had minimal residual disease. Additional tumour downstaging was seen in 28% of patients and the sphincter preservation rate was 58%.


CONCLUSIONS
Preoperative capecitabine chemoradiation is well tolerated and its efficacy supports further exploration, both as a single agent and as part of new therapeutic strategies.
Dupuis
Olivier
O
Clinique Victor Hugo, Le Mans, France. o.dupuis@centre-jean-bernard.org
Vie
Brigitte
B
Lledo
Gérard
G
Hennequin
Christophe
C
Noirclerc
Monique
M
Bennamoun
Mohamed
M
Jacob
Jacques H
JH
D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000556:secondary / Q000628:therapy*; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011355:Prodrugs / Q000627:therapeutic use; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D015996:Survival Rate
D000964:Antimetabolites, Antineoplastic; D011355:Prodrugs; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil