Therapeutic options for locally advanced
pancreatic cancer (LAPC) include concurrent chemoradiation,
induction chemotherapy followed by chemoradiation or systemic
therapy alone. The original Gastro-Intestinal Study Group and Eastern Cooperative Oncology Group studies defined
fluorouracil (5-FU) with concurrent
radiation therapy followed by maintenance
5-FU until progression, as the standard
therapy for this subset of patients. Although this combined
therapy has been demonstrated to increase local control and median survival from 8 to 12 months, almost all patients succumb to the disease secondary to either local or distant recurrence. Our earlier studies provided a strong rationale for the use of
capecitabine in combination with concurrent radiation followed by maintenance
capecitabine therapy. To report our clinical experience, we retrospectively evaluated our patients who were treated with maintenance
capecitabine. We reviewed the medical records of patients with LAPC who received treatment with
capecitabine and radiation, followed by a 4-week rest, then
capecitabine alone 1,000 mg twice daily (ECOG performance status 2 or age >70 years) or 1,500 mg twice daily for 14 days every 3 weeks until progressive disease. We treated 43 patients between September 2004 and September 2012. The population consisted of 16 females and 25 males, with a median age of 64 years (range, 38-80 years). Patients received maintenance
capecitabine for median duration of 9 months (range, 3-18 months). The median overall survival (OS) for these patients was 17 months, with two patients still living and receiving
therapy. The 6-month survival rate was 91% (39/43), 1-year survival rate was 72% (31/43) and 2-year OS rate was 26% (11/43). Grade 3 or 4 toxicity was observed rarely:
Hand-foot syndrome (HFS) in two patients,
diarrhea in one patient and
peripheral neuropathy in one patient, and there was no mortality directly related to treatment.
Capecitabine maintenance
therapy following chemoradiation in LAPC offers an effective, tolerable and convenient alternative to
5-FU. To the best of our knowledge, this is the largest study of its kind which has determined the safety and efficacy of
capecitabine maintenance
therapy for patients with LAPC.