Nine RCTs were included in the clinical-effectiveness review.
Five trials used both the comparators within their licensed indications. Three trials included women with both platinum-resistant and platinum-sensitive advanced ovarian cancer comparing: pegylated liposomal doxorubicin hydrochloride (PLDH) monotherapy versus topotecan; topotecan versus paclitaxel; or PLDH monotherapy versus paclitaxel. Two trials only included women with platinum-sensitive ovarian cancer comparing: single-agent paclitaxel versus a combination of cyclophosphamide, doxorubicin plus cisplatin (CAP); or paclitaxel plus platinum-based chemotherapy versus conventional platinum-based monotherapy.
Four further trials used one of the treatments outside its licensed indication. They compared oxaliplatin versus paclitaxel, paclitaxel given weekly versus every three weeks, paclitaxel given at 175mg/m2 versus 250mg/m2, or oral versus intravenous topotecan.
For women with platinum-resistant disease, there was a low probability of response to treatment with PLDH, topotecan or paclitaxel monotherapy. There was little difference between these three chemotherapies for overall survival, but they differed considerably in their toxicity profiles. Given the low survival times and response rates in this patient group, the maintenance of quality of life and the control of symptoms and toxicity appeared to be the most important factors. Patient and physician choice should be prioritised and included in decisions about second-line therapy because of the different treatment adverse effects. This group of patients may benefit from being included in further clinical trials of new drugs.
For women with platinum-sensitive disease, there was a considerable range of median survival times observed across the trials. The most favourable survival times and response rates were with paclitaxel and platinum combination therapy. This suggested that treatment with combination therapy may be more beneficial than single-agent chemotherapy. For single-agent chemotherapy, the evidence suggested that PLDH was more effective than topotecan. Evidence from the trial that compared PLDH and paclitaxel suggested that there was no significant difference between the two treatments. The three comparators did differ significantly in their toxicity profiles across the trials. Although treatment with PLDH may be more beneficial than that treatment with topotecan, priority should be placed on patient and physician choice between the potential toxicities associated with each treatment and the patient’s ability and willingness to tolerate them.