A Phase II study of preoperative radiotherapy and concomitant weekly irinotecan in combination with protracted venous infusion 5-fluorouracil, for resectable locally advanced rectal cancer.
OBJECTIVE
The aim of this study was to evaluate the efficacy and tolerance of preoperative chemoradiotherapy (CRT) with irinotecan (CPT-11) and 5-fluorouracil (5-FU) in patients with resectable rectal cancer.


METHODS
Patients with resectable T3-T4 rectal cancer and Eastern Cooperative Oncology Group performance status <2 were included. CPT-11 (50 mg/m(2) weekly) and 5-FU (225 mg/m(2)/day continuous infusion, 5 days/week) were concurrently administered with radiation therapy (RT) (45 Gy, 1.8 Gy/day, 5 days/week), during 5 weeks.


RESULTS
A total of 74 patients were enrolled: mean age, 59 years (20-74 years; SD, 11.7). Planned treatment was delivered to most patients (median relative dose intensity for both drugs was 100%). Grade 3/4 lymphocytopenia occurred in 35 patients (47%), neutropenia in 5 (7%), and anemia in 2 (3%). Main Grade 3 nonhematologic toxicities were diarrhea (14%), asthenia (9%), rectal mucositis (8%), and abdominal pain (8%). Of the 73 resected specimens, 13.7% (95% confidence interval [CI], 6.8-23.7) had a pathologic complete response and 49.3% (95% CI, 37.4-61.3) were downstaged. Additionally, 66.7% (95% CI, 51.1-80.0) of patients with ultrasound staged N1/N2 disease had no pathologic evidence of nodal involvement after CRT.


CONCLUSIONS
This preoperative CRT schedule has been shown to be effective and feasible in a large population of patients with resectable rectal cancer.
Navarro
Matilde
M
Institut Catalá d'Oncología, Barcelona, Spain. mnavarrogarcia@ico.scs.es
Dotor
Emma
E
Rivera
Fernando
F
Sánchez-Rovira
Pedro
P
Vega-Villegas
Maria Eugenia
ME
Cervantes
Andrés
A
García
José Luis
JL
Gallén
Manel
M
Aranda
Enrique
E
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003131:Combined Modality Therapy / Q000379:methods; D003967:Diarrhea / Q000209:etiology; D004334:Drug Administration Schedule; D005242:Fecal Incontinence / Q000209:etiology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006471:Gastrointestinal Hemorrhage / Q000209:etiology; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010198:Pancytopenia / Q000209:etiology; D011879:Radiotherapy Dosage; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery
D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin