Background: The PARP inhibitor olaparib (Lynparza® ) has shown significant efficacy as maintenance therapy for patients (pts) with PSR OC, especially pts with BRCA mutations, as capsules (Ledermann et al Lancet Oncol 2014) and tablets (Pujade‐Lauraine et al Lancet Oncol 2017). Olaparib capsules have shown long‐term benefit, with pts staying on treatment for ≥5 years (yrs; Gourley et al ASCO 2017). We analysed the longabstracts term tolerability of olaparib tablets in the SOLO2 trial (ENGOT‐Ov21; NCT01874353). Methods: In SOLO2, pts with BRCA‐mutated PSR OC in response to platinum received maintenance olaparib tablets (300 mg bid) or placebo until disease progression. Adverse events (AEs) were graded by CTCAE v4.0. Results: At the primary data cut‐off (DCO; 19 Sep 2016), of 195 pts treated with olaparib, 62 (32%) had received olaparib for ≥1‐<2 yrs (Group 1) and 59 (30%) for ≥2 yrs (Group 2), vs 12/99 (12%) and 9/99 (9%), respectively, who received placebo. Most AEs that began after ≥1 yr (Group 1) or≥2 yrs (Group 2) were grade 1‐2, with few serious AEs (Table). The most common AEs with onset during the second yr of olaparib treatment were anaemia (19%), nausea (18%), and vomiting (15%). The most common AEs with onset after≥2 yrs were diarrhoea (8%), abdominal pain (5%), and upper abdominal pain (5%). Four pts in Group 1 discontinued olaparib because of AEs (acute myeloid leukaemia, decreased neutrophil count, muscular weakness, disturbance in attention and depression; all n=1) vs no pts in Group 2. Conclusions: AEs reported during long‐term olaparib maintenance therapy were mostly low grade, non‐serious and associated with a low rate of treatment discontinuation. Common AEs were consistent with the known safety profile. Olaparib tablets are suitable for long‐term maintenance therapy for PSR OC pts, without cumulative toxicity and with few late‐onset AEs.
CITATION STYLE
Korach, J., Freyer, G., Banerjee, S., Asher, R., Cosin, J., Oza, A. M., … Pujade-Lauraine, E. (2018). Long-term tolerability of olaparib tablets as maintenance therapy for platinum-sensitive relapsed ovarian cancer (PSR OC): Phase III SOLO2 trial. Annals of Oncology, 29, viii340–viii341. https://doi.org/10.1093/annonc/mdy285.160
Mendeley helps you to discover research relevant for your work.