From the Guidelines
For second-line treatment of advanced ovarian cancer with homologous recombination deficiency (HRD), niraparib is the recommended option, as it has been shown to be effective in treating adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 prior chemotherapy regimens and whose cancer is associated with HRD-positive status 1. The dosing for niraparib is typically 200-300mg once daily, weight-based. Key points to consider when prescribing niraparib include:
- Selecting patients for therapy based on an FDA-approved companion diagnostic for niraparib 1
- Monitoring for common side effects such as fatigue, nausea, anemia, and thrombocytopenia, which require regular monitoring of blood counts
- Considering alternative options, including platinum rechallenge, bevacizumab-containing regimens, or clinical trials investigating novel combinations, for patients who cannot tolerate or have progressed on niraparib. It is essential to note that olaparib and rucaparib are also effective options for second-line treatment of advanced ovarian cancer with HRD, but niraparib has been specifically indicated for patients with HRD-positive status who have been treated with 3 prior chemotherapy regimens 1.
From the FDA Drug Label
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. The second line treatment for advanced ovarian cancer is gemcitabine in combination with carboplatin 2, 2.
- Indication: Advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
- Dosage: 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
- Key points:
- Monitor for myelosuppression prior to each cycle and reduce or withhold dose for severe myelosuppression.
- Discontinue Gemcitabine Injection for unexplained dyspnea or other evidence of severe pulmonary toxicity.
- Monitor renal function prior to initiation and during therapy. Discontinue Gemcitabine Injection for HUS or severe renal impairment.
From the Research
Second-Line Treatment for Advanced Ovarian Cancer
- The management of patients with recurrent ovarian cancer is based on their response profile to platinum, with patients with platinum-sensitive disease potentially being rechallenged with platinum-based chemotherapy 3.
- For patients with platinum-resistant disease, single agent chemotherapy (pegylated liposomal doxorubicin, topotecan, gemcitabine or weekly paclitaxel) is the standard of care 4.
- A systematic review and economic evaluation found that for people with platinum-sensitive disease and receiving platinum-based therapy, paclitaxel plus platinum could be considered cost-effective compared with platinum at a threshold of £30,000 per additional quality-adjusted life-year (QALY) 5.
- Gemcitabine is an active and safe agent in the treatment of both platinum-sensitive and resistant recurrent ovarian cancer, but may highlight the need for new randomized studies in heavily pre-treated patients 6.
Treatment Options
- Pegylated liposomal doxorubicin (PLDH) plus platinum and paclitaxel plus platinum have been found to have statistically significant benefits for overall survival (OS) compared with platinum monotherapy in patients with platinum-sensitive disease 5.
- Topotecan, gemcitabine, and trabectedin are also options for second-line treatment, with trabectedin plus PLDH found to significantly increase OS compared with topotecan monotherapy in non-platinum-based treatments 5.
- Bevacizumab is an established option for patients with platinum-sensitive disease, and other biologic agents such as trebananib, pazopanib, and cediranib are being investigated 4.
Economic Evaluation
- The estimated probabilistic incremental cost-effectiveness ratio (ICER) for paclitaxel plus platinum compared with platinum was £24,539, indicating that paclitaxel plus platinum could be considered cost-effective at a threshold of £30,000 per additional QALY 5.
- The ICERs associated with PLDH compared with paclitaxel, and trabectedin plus PLDH compared with PLDH, were estimated to be £25,931 and £81,353, respectively, indicating that trabectedin plus PLDH is unlikely to be considered cost-effective compared with PLDH 5.