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A phase II study of preoperative capecitabine and radiation therapy in patients with rectal cancer.

AbstractOBJECTIVES:
The purpose of this study was to evaluate the safety and efficacy of preoperative capecitabine and radiation therapy (RT) in patients with locally advanced rectal cancer (LARC).
METHODS:
Patients with adenocarcinoma of the rectum stage >or=T3 or >or=N1 were treated with capecitabine 1330 mg/m per day in 2 divided doses days 1 to 42 and 50.4 Gy of RT in 28 1.8-Gy fractions. Patients with metastatic disease were eligible provided that operative intervention on primary site was anticipated. Surgery resection occurred 4 to 6 weeks after completion of preoperative therapy.
RESULTS:
Thirty eligible patients were enrolled at two institutions. Median age and performance status were 62 years and 90%, respectively. Twenty-eight patients (93%) completed combined modality therapy and 27 underwent resection, including 17 abdominal-perineal and 9 low anterior resections. Three of 27 (11%) had pathologic complete response (pCR) with an additional 7 (26%) having minimal residual disease. Two patients who were felt to require abdominal perineal resection prior to combined modality therapy (CMT) were able to have sphincter-sparing surgery. No patients had progression during CMT which precluded surgical resection. Treatment was well tolerated with >or=grade 3 toxicities limited to diarrhea (5 patients), hand-foot syndrome (1 patient), dermatitis (1 patient). Twenty-four patients are living, 18 with no evidence of disease.
CONCLUSIONS:
The combination of preoperative capecitabine and RT in patients with LARC has significant antitumor activity, efficacy, and a low toxicity profile.
AuthorsSameer P Desai, Basil F El-Rayes, Edgar Ben-Josef, Joel K Greenson, James A Knol, Emina H Huang, Kent A Griffith, Philip A Philip, Cornelius J McGinn, Mark M Zalupski
JournalAmerican journal of clinical oncology (Am J Clin Oncol) Vol. 30 Issue 4 Pg. 340-5 (Aug 2007) ISSN: 1537-453X [Electronic] United States
PMID17762432 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Antimetabolites, Antineoplastic
  • Deoxycytidine
  • Capecitabine
  • Fluorouracil
Topics
  • Adenocarcinoma (drug therapy, radiotherapy, secondary)
  • Adult
  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic (therapeutic use)
  • Capecitabine
  • Combined Modality Therapy
  • Deoxycytidine (analogs & derivatives, therapeutic use)
  • Disease-Free Survival
  • Female
  • Fluorouracil (analogs & derivatives, therapeutic use)
  • Humans
  • Liver Neoplasms (secondary)
  • Lung Neoplasms (secondary)
  • Male
  • Middle Aged
  • Preoperative Care
  • Rectal Neoplasms (drug therapy, pathology, radiotherapy)
  • Treatment Outcome

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