Pre-operative combined 5-FU, low dose leucovorin, and sequential radiation therapy for unresectable rectal cancer
- Memorial Sloan-Kettering Cancer Center, New York, NY (United States)
The authors performed a Phase 1 trial to determine the maximum tolerated dose of combined pre-operative radiation (5040 cGy) and 2 cycles (bolus daily [times] 5) of 5-FU and low dose LV (20 mg/m2), followed by surgery and 10 cycles of post-operative LV/5-FU in patients with unresectable primary or recurrent rectal cancer. Twelve patients were entered. The initial dose of 5-FU was 325 mg/m2. 5-FU was to be escalated while the LV remained constant at 20 mg/m2. Chemotherapy began on day 1 and radiation on day 8. The post-operative chemotherapy was not dose escalated; 5-FU: 425 mg/m2 and LV: 20 mg/m2. The median follow-up was 14 months (7--16 months). Following pre-operative therapy, the resectability rate with negative margins was 91% and the pathologic complete response rate was 9%. For the combined modality segment (preoperative) the incidence of any grade 3+ toxicity was diarrhea: 17%, dysuria: 8%, mucositis: 8%, and erythema: 8%. The median nadir counts were WBC: 3.1, HGB: 8.8, and PLT: 153000. The maximum tolerated dose of 5-FU for pre-operative combined LV/5-FU/RT was 325 mg/m2 with no escalation possible. Therefore, the recommended dose was less than 325 mg/m2. Since adequate doses of 5-FU to treat systemic disease could not be delivered until at least 3 months (cycle 3) following the start of therapy, the authors do not recommend that this 5-FU, low dose LV, and sequential radiation therapy regimen be used as presently designed. However, given the 91% resectability rate they remain encouraged with this approach. 31 refs., 1 fig., 2 tabs.
- OSTI ID:
- 6523446
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics; (United States), Vol. 25:5; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
Similar Records
A Randomized Phase 2 Study of Neoadjuvant Chemoradiaton Therapy With 5-Fluorouracil/Leucovorin or Irinotecan/S-1 in Patients With Locally Advanced Rectal Cancer
Phase 1/2 Study of the Addition of Cisplatin to Adjuvant Chemotherapy With Image Guided High-Precision Radiation Therapy for Completely Resected Gastric Cancer
Related Subjects
NEOPLASMS
CHEMOTHERAPY
RADIOTHERAPY
RECTUM
CITROVORUM FACTOR
COMBINED THERAPY
DIARRHEA
ERYTHEMA
FLUOROURACILS
SIDE EFFECTS
SURGERY
TOXICITY
ANTIMETABOLITES
AZINES
BODY
DIGESTIVE SYSTEM
DISEASES
DRUGS
GASTROINTESTINAL TRACT
HETEROCYCLIC COMPOUNDS
HYDROXY COMPOUNDS
INTESTINES
LARGE INTESTINE
MEDICINE
NUCLEAR MEDICINE
ORGANIC COMPOUNDS
ORGANIC FLUORINE COMPOUNDS
ORGANIC HALOGEN COMPOUNDS
ORGANIC NITROGEN COMPOUNDS
ORGANS
PYRIMIDINES
RADIOLOGY
SYMPTOMS
THERAPY
URACILS
550603* - Medicine- External Radiation in Therapy- (1980-)