Mekinist for endometrial and ovarian serous mixed cancer – pro
Trametinib (Mekinist) improved progression-free survival (PFS) and overall response rates (ORRs) among patients with low-grade ovarian cancer, potentially creating a new standard of care for those with this rare, but deadly subtype of ovarian/peritoneal cancer, according to the findings presented at the European Society for Medical Oncology (ESMO) Congress 2019.
Compared with current standard-of-care therapy, PFS was significantly improved in the trametinib arm (median, 13.0 vs. 7.2 months; HR, 0.48; 95% CI, 2.39-12.21; P<.0001). Similarly, ORR was also significantly improved in the trametinib arm, compared with standard of care (26.2% vs 6.2%; OR, 5.4; 95% CI, 2.76-12.19; P<.0001).
Although there is a very recent report by Gershenson et al that provoked a discussion about the change in the standard of care, the fact remains that Mekinist used alone in that study is just resented, not fully published and discussed and not included in the NCCN guidelines. For this reason, I do not consider it to be medically necessary. the plan requires an FDA indication or NCCN listing to consider it to be medically necessary.
Gershenson GA, Miller A, Brady W, et al. A Randomized Phase II/III Study to Assess the Efficacy of Trametinib in Patients with Recurrent or Progressive Low-Grade Serous Ovarian or Peritoneal Cancer. Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394.