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

Journal Article · Fri Sep 01 04:00:00 EDT 2006 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2006.04.007· OSTI ID:20850070

Navarro, Matilde ^[1]; Dotor, Emma ^[1]; Rivera, Fernando ^[2]; Sanchez-Rovira, Pedro ^[3]; Vega-Villegas, Maria Eugenia ^[2]; Cervantes, Andres ^[4]; Garcia, Jose Luis ^[5]; Gallen, Manel ^[6]; Aranda, Enrique ^[7]

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1. Institut Catala d'Oncologia, Barcelona (Spain)
2. Hospital Marques de Valdecilla, Santander (Spain)
3. Hospital Ciudad de Jaen, Jaen (Spain)
4. Hospital Clinico Universitario, Valencia (Spain)
5. Hospital Ramon y Cajal, Madrid (Spain)
6. Hospital Nuestra Senora del Mar, Barcelona (Spain)
7. Hospital Reina Sofia, Cordoba (Spain)

Purpose: 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 and Materials: Patients with resectable T3-T4 rectal cancer and Eastern Cooperative Oncology Group performance status <2 were included. CPT-11 (50 mg/m{sup 2} weekly) and 5-FU (225 mg/m{sup 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.

• OSTI ID: 20850070
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 1 Vol. 66; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
ANEMIAS
CARCINOMAS
COMBINED THERAPY
DIARRHEA
DRUGS
INFUSION
PAIN
PATIENTS
PERFORMANCE
RADIATION DOSES
RADIOTHERAPY
RECTUM
TOLERANCE
TOXICITY
URACILS