Oral capecitabine plus radiation therapy appeared as effective and well tolerated as 5-FU plus radiation therapy and may be considered the new standard of care in patients with gastric cancer, according to study results presented at the 2014 Gastrointestinal Cancers Symposium.
“Doctors should feel reassured that they are not giving less effective therapy if they prescribe capecitabine,” Carmen Joseph Allegra, MD, professor of medicine at the University of Florida in Gainesville, Fla., said in a press release. “Oral capecitabine is certainly far more convenient for patients compared to infusional 5-FU. It means taking pills twice a day, rather than undergoing surgery to place an intravenous port and then wearing a pump on their belt for 5 weeks.”
Carmen Joseph Allegra
The study included 1,608 patients with stage II or III rectal cancer. Researchers randomly assigned patients to one of four arms.
Patients in the first arm received 225 mg/m2 5-FU 5 days a week (n=477), and patients in the second arm received 5-FU plus 50 mg/m2 weekly oxaliplatin (Eloxatin, Sanofi-Aventis; n=329).
Patients in the third arm received 825 mg/m2 capecitabine 5 days a week (n=472), and patients in the fourth arm received capecitabine plus oxaliplatin (n=330).
All patients underwent 5 weeks of radiation therapy in 25 fractions of 4,500 cGy doses plus 540 cGy to 1,080 cGY boost doses in three to six daily fractions before undergoing surgery.
Across all study arms, 84% to 97% received more than 80% of the study’s chemotherapy target dose plus radiation therapy.
Researchers observed no significant differences in local-regional tumor control, DFS or OS across study arms. Three-year local-regional tumor control ranged from 87.4% to 88.2%.
Among patients who underwent R0 resection, recurrence occurred in 2% to 4% of stage II patients and 4% to 11% of stage III patients.
At 5 years, 16% of patients with stage II disease and 26% of patients with stage III disease developed distant metastases.
Patients who received oxaliplatin experienced significantly higher incidence of grade 3 to grade 4 diarrhea (P<.0001).
“Capecitabine with preoperative radiation therapy achieved rates similar to continuous infusion 5-FU for the primary endpoint of local-regional failure, as well as for pathologic complete response and longer-term outcomes including DFS and OS,” Allegra said during a press conference. “Oxaliplatin did not improve outcomes but added significant toxicity…and therefore is not indicated in combination with radiation therapy in the preoperative rectal setting. This study establishes capecitabine as a standard of care in this setting.”
For more information:
Allegra CJ. Abstract #390. Presented at: 2014 Gastrointestinal Cancers Symposium; Jan. 16-18, 2014; San Francisco.
Disclosure: One researcher reports a consultant or advisory role with Sanofi.