Treatment of advanced ovarian cancer results in a high objective response rate (> 70% to 80%), but disease recurs in most patients. Some studies have been done to understand the role of maintenance therapy after conventional adjuvant chemotherapy. Maintenance therapy must balance prevention of disease recurrence with cumulative toxic effects and reduction in quality of life. The effects of maintenance therapy with chemotherapy (e.g. paclitaxel maintenance) or antiangiogenetic agents (e.g. bevacizumab or pazopanib) have been studied, but results have been conflicting and without significant benefit in overall survival. We have performed this study to assess the role of maintenance tamoxifen post adjuvant chemotherapy in patients with advanced ovarian cancer.
In this prospective study, done in a tertiary care centre in northern India, patients with advanced ovarian cancer (stage III and IV), post conventional adjuvant chemotherapy, were randomly enrolled from Sep 2012 to April 2015. Tamoxifen maintenance was given at a dose of 20 mg twice a day for entire follow up period. The progression free survival (PFS) was analyzed.
In total 100 patients were enrolled: 50 patients were given tamoxifen and 50 patients were put on post adjuvant treatment surveillance. The median age was 51.0 years (31-69 years). Median follow up of these patients was 14 months (6-22 months). Median increase in PFS was 6.3 months (95% CI: 4.52-6.14 months) in patients treated with maintenance tamoxifen and there were no grade 3/4 side effects seen in this group.
Maintenance tamoxifen prolongs PFS by 6.3 months when compared to no treatment after conventional adjuvant chemotherapy. Further studies should be planned for comparison of maintenance tamoxifen with maintenance chemotherapy (e.g. paclitaxel maintenance) or antiangiogenetic agents.
Clinical trial identification
Legal entity responsible for the study
Rajiv Gandhi Cancer Institute and Research Center
All authors have declared no conflicts of interest.