Pre-operative chemoradiotherapy with UFT and Leucovorin in patients with advanced rectal cancer: a phase II study.

Abstract

PURPOSE:

The aim this study was to determine the pathologic complete response (pCR) rate defined as tumor regression grade 1 (TRG1) and toxicity profile of the combination of high-dose pre-operative radiotherapy and simultaneous UFT/leucovorin (LV) in patients with locally advanced rectal cancer.

MATERIALS/METHODS:

Eligibility included biopsy proven rectal adenocarcinoma; T3-T4 N0-N2; performance status < 2 (ECOG) and adequate blood, hepatic and renal function. Treatment consisted of radiotherapy 54 Gy at 1.8 Gy/day and UFT 300 mg/m(2)/day and LV 60 mg/day, given simultaneously daily for 6 weeks. Surgery was performed within 4-6 weeks period after chemoradiotherapy. Patients who did not achieve TGR1 were to receive 4 cycles of adjuvant UFT/LV on days 1-28, every 5 weeks.

RESULTS:

Sixty-eight patients were included. All but one received full dose of radiation and 62 had the total planned pre-operative UFT/LV dose. Grade 3 toxicities were diarrhea 7% and proctitis 3%. Complete resection was achieved in 62 patients (91%). Tumor regression grade 1 (TRG1) was seen in 11 patients (16%). Forty-eight patients received adjuvant UFT/LV. Grade 3 toxicity during adjuvant UFT/LV included diarrhea 12%, asthenia 4%, neutropenia 2%, and hand-foot syndrome 2%. The 3-year disease-free survival was 71%.

CONCLUSIONS:

Simultaneous high-dose pre-operative localized radiation therapy concurrent with UFT/LV is feasible and has a low toxicity profile. This schedule is highly effective and merits further investigation.

• Authors: Jordi Giralt, Josep Tabernero, Begoña Navalpotro, Jaume Capdevila, Eloi Espin, Esther Casado, Anabel Mañes, Stefania Landolfi, Jose Luis Sanchez-Garcia, Ines de Torres, Manel Armengol
• Journal: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Radiother Oncol) Vol. 89 Issue 3 Pg. 263-9 (Dec 2008) ISSN: 0167-8140 [Print] Ireland
• PMID: 18768230 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Tegafur
• Uracil
• Leucovorin

Topics

• Adenocarcinoma (radiotherapy, therapy)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Combined Modality Therapy
• Female
• Humans
• Leucovorin (administration & dosage)
• Male
• Middle Aged
• Rectal Neoplasms (radiotherapy, therapy)
• Tegafur (administration & dosage)
• Treatment Outcome
• Uracil (administration & dosage)