A phase II study of neoadjuvant chemoradiotherapy with oxaliplatin and capecitabine for rectal cancer.

Abstract

PURPOSE:

This study evaluated the efficacy and safety of neoadjuvant chemoradiotherapy with the XELOX regimen in rectal cancer patients.

PATIENTS AND METHODS:

Twenty-five patients with histopathologically confirmed and locally advanced rectal cancer (T3/T4 or N+) were enrolled in the study. Radiotherapy of 5000 cGy was delivered in 25 fractions of 200 cGy five times per week for a total of 5 weeks. During the first, second, fourth and fifth weeks of radiotherapy, the patients also received the following chemotherapy: 50 mg/m2 oxaliplatin on day one and 850 mg/m2 capecitabine bid for 5 days. Surgery was scheduled 5-6 weeks after the completion of the preoperative chemoradiotherapy. Four weeks after the surgery, four more cycles of chemotherapy were administered every 3 weeks. The postoperative chemotherapy consisted of 130 mg/m2 oxaliplatin on day 1 and 1000 mg/m2 capecitabine bid from day 1 to day 14. The end points were the downstage rate, R0 resection rate, and sphincter preservation rate.

RESULTS:

Twenty-five patients received the neoadjuvant chemoradiotherapy. The overall regression rate was 85%, with a Grade 3/4 regression rate of 30% and a pathological complete response rate of 12%. Among the 17 patients with lower rectal cancer, thirteen (76%) were originally indicated for abdominal-perineal resection (APR). However, after the neoadjuvant chemoradiotherapy, the anus could be preserved in nine patients (53%). The most frequent toxicities of the chemoradiotherapy were diarrhea (64%) and hematological toxicity (60%), followed by nausea and vomiting (48%), urinary tract irritation (28%), and anal pain (24%). Grade 3 or 4 adverse events were relatively infrequent and presented as diarrhea (12%), myelosuppression (8%), and elevated transaminase (4%). Six cases also experienced long-term anal exudates after surgery.

CONCLUSIONS:

Neoadjuvant chemoradiotherapy using the XELOX regimen in rectal cancer patients obviously reduced the TNM staging and improved the pathological complete response rate. The therapy was well-tolerated and had mild adverse events and no serious perioperational complications.

• Authors: Lin Zhao, Chunmei Bai, Yajuan Shao, Mei Guan, Ning Jia, Yi Xiao, Huizhong Qiu, Fuquan Zhang, Ti Yang, Guangxi Zhong, Shuchang Chen
• Journal: Cancer letters (Cancer Lett) Vol. 310 Issue 2 Pg. 134-9 (Nov 28 2011) ISSN: 1872-7980 [Electronic] Ireland
• PMID: 21782322 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Capecitabine
• Fluorouracil

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Capecitabine
• Chemotherapy, Adjuvant
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Male
• Middle Aged
• Neoadjuvant Therapy
• Neoplasm Staging
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Oxaliplatin
• Prospective Studies
• Rectal Neoplasms (drug therapy, pathology, radiotherapy, surgery)