(CHICAGO, IL) — Maintenance erlotinib after first-line chemotherapy in women with ovarian cancer did not improve progression-free (PFS) or overall survival (OS), according to results of a trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.
All 835 patients enrolled in the GCIG and EORTC-GCG randomized, phase 3 trial, conducted among 125 institutions in 10 countries, had high-risk FIGO stage I or stage II-IV epithelial ovarian, peritoneal, or fallopian tube cancer and had undergone first-line platinum-based therapy (6 to 9 cycles) with no signs of progression at the end of chemotherapy, noted Ignace B. Vergote, MD, PhD, of University Hospital Leuven, Leuven, Belgium.
Between October 2005 and February 2008, these patients were randomly assigned to maintenance erlotinib 150mg/day for 2 years (n=420) or observation (n=415). They were not selected for EGFR expression. Primary endpoint was PFS by RECIST in combination with GCIG CA125 criteria.
Stratifications factors were FIGO stage, institution, age, and response to and type of first-line chemotherapy. A total of 300 patients (71%) in the erlotinib arm and 302 (73%) in the observation arm had complete responses to first-line chemotherapy; 105 (25%) and 99 (24%) had partial responses and 15 (4%) and 14 (3%) had stable disease, respectively. Immunohistochemistry (IHC) and FISH for EGFR, and EGFR mutation analyses were performed in 318 patients.
Median follow-up was 51 months. Median PFS was 12.7 months in the erlotinib arm and 12.4 months in the observation arm (HR 1.05; P=0.525). Median OS was 51 months in the erlotinib arm and 59 months in the observation arm (HR 0.99; P=0.903).
A total of 25% of patients stopped erlotinib due to unacceptable adverse events; of these, 67% was due to rash.
The investigators concluded that maintenance erlotinib after first line chemotherapy in patients with ovarian, peritoneal, or fallopian tube cancer did not increase PFS nor OS.