TAEJON, KoreaIn a study from Korea of patients with locally advanced
rectal cancer, preoperative capecitabine (Xeloda) with leucovorin given
concurrently with radiotherapy resulted in primary tumor downstaging and
nodal downstaging, reported Jun-Sang Kim, MD, of Chungnam National
University, Taejon, and colleagues.
In a separate study, German scientists evaluating concurrent capecitabine/radiotherapy
in rectal cancer found the approach feasible and well tolerated with
promising preliminary efficacy results.
Both researchers noted that oral chemotherapy with capecitabine mimics the
pharmacokinetics of continuous fluoro-uracil (5-FU) infusion as a radiation
sensitizer. Continuous infusion 5-FU has been shown to cause tumor
downstaging when given preoperatively in locally advanced rectal cancer
patients and to improve resectability.
The Korean study enrolled 45 patients. The whole pelvis radiotherapy dose
was 45 Gy given in 25 fractions over 5 weeks, followed by a boost dose of 5.4
Gy in three fractions to the primary tumor. Chemotherapy, administered
concurrently, consisted of two 14-day cycles of capecitabine 825 mg/m2 twice
daily and leucovorin 10 mg/m2 twice daily. Each cycle was followed by a 7-day
rest period. Surgery was performed 6 weeks after the completion of chemoradiation.
Of 38 patients who underwent definitive surgery, primary tumor downstaging
occurred in 63% and nodal downstaging in 90%, for an overall downstaging rate
of 84%. The pathologic complete response rate was 31%.
Among 21 patients with distal tumors (located initially 5 cm or less from
the anal verge), 18 underwent surgery. Of these, 13 (72%) received
sphincter-preserving surgery (Int J Radiation Oncology Biol Phys 34:403-408,
Grade 3 toxicities included hand-foot syndrome (7%), fatigue (4%),
diarrhea (4%), and radiation dermatitis (2%). There were no grade 3-4