- Chemotherapy combined with the HER2/neu and EGFR inhibitor lapatinib showed too high a rate of diarrhea to be acceptable for patient safety.
Why this matters
- The study is the first completed phase 2 randomized trial of HER2-directed therapy in operable HER2-positive gastroesophageal adenocarcinoma.
- 46 patients were randomly assigned to receive standard ECX (modified epirubicin, cisplatin, and capecitabine chemotherapy) alone or a modified ECX combined with lapatinib (mECX+L)
- Funding: GlaxoSmithKline; a range of nonindustry sources.
- The researchers examined the first 10 patients in the mECX+L group to determine whether doses could be increased for subsequent patients; 2 of 10 patients had preoperative grade 3 diarrhea, and therefore the dose was maintained.
- No patients in the sECX group had preoperative grade 3 or 4 diarrhea compared with 21% in the mECX group.
- Other adverse events occurring more often in the mECX group were grade 1 or 2 stomatitis (58% vs 29%) and any grade vomiting (58% vs 29%).
- Postoperative complications, including frequency of anastomotic leak, postoperative chemotherapy commencement, and postoperative chemotherapy dose reduction, were similar between the 2 groups.
- Small study population.