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Capecitabine, lapatinib combination ineffective for colorectal adenocarcinoma
A regimen of capecitabine and lapatinib offered no clinical benefit in patients with advanced colorectal adenocarcinoma in a recent study.
In the open-label, nonrandomized phase 2 study, researchers evaluated responses to capecitabine and lapatinib in 29 patients. All participants were either on or had been on a regimen containing fluoroidopyrimidine, oxaliplatin or irinotecan less than 6 months prior to enrollment, and 20 had undergone previous EGFR monocolonal antibody treatment. Patients were assigned 1,250 mg lapatinib once daily and 2,000 mg/m2 capecitabine across two doses daily for 14 days in a 21-day cycle.
No patients exhibited either partial or complete responses to the treatment, and investigators halted enrollment at the first stage after no objective responses occurred among 18 evaluable participants. A disease control rate of 41.4% (95% CI, 23.5-61%) was determined, with 12 patients maintaining stable disease. Researchers noted that treatment benefits could not be determined in patients with K-ras wild type mutations, as too few participants enrolled had the mutation.
All but four participants had died by final analysis, with a median survival rate of 6.8 months (95% CI, 3.5-10.6 months), a 1-year survival rate of 22% (95% CI, 11-48%) and a median progression-free survival rate of 2.1 months (95% CI, 2.0-3.5 months).
Reported adverse effects to the treatment were mild, with common symptoms including fatigue (83%), hand-foot syndrome (69%) and diarrhea (59%). No toxicities were higher than grade 3 severity, which was reported in three patients with hand-foot syndrome and two patients each with diarrhea, fatigue and nausea.
“The combination of capecitabine and lapatinib failed to show any clinical activity in heavily pretreated patients with colorectal adenocarcinoma,” the researchers wrote. “Further studies could be considered to evaluate this combination as an oral alternative therapy to an intravenous monoclonal antibody in patients with K-ras wild type tumors without prior monoclonal antibody therapy.”