Trabectedin for the treatment of relapsed ovarian cancer

Papaioannou, Diana; Rafia, Rachid; Stevenson,; Stevens, JW; Evans, Philippa

doi:10.3310/hta15suppl1/08

Cited by 4 publications

(22 citation statements)

References 2 publications

(5 reference statements)

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“…It was not clear within the MS whether the early terminated trial (30-57 72 ) was included within this analysis. The Evidence Review Group (ERG) for TA222 90 commented that 'the manufacturer stated that three trials were included in the mixed-treatment comparison (MTC) analysis: 039 (ten Bokkel Huinink et al; 51 Gore et al…”

Section: Assessment Of Cost-effectivenessmentioning

confidence: 99%

“…Baseline estimates of PFS and OS for PLDH monotherapy were obtained by assuming that survival data for both interventions considered within OVA-301 30 were represented by exponential distributions; however, the ERG considering the evidence submitted in TA222 90 noted that exponential distributions were not the most appropriate fit to the patient-level data.…”

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confidence: 99%

“…Following a clarification request from the ERG for TA222, 90 the manufacturer also included an estimate of the cost of palliative care. Sources of cost data included the BNF for drug costs (BNF 58, Quality-adjusted life-years were estimated by applying health-state utility values to the mean time spent in each health state (i.e.…”

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confidence: 99%

“…The ERG for TA222 90 considered the comparison of trabectedin in combination with PLDH compared with PLDH in people with PPS disease to be the most pertinent decision problem. This was because PLDH was not listed as a comparator of interest in the NICE scope for people with FPS (PFI > 12 months) disease.…”

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confidence: 99%

“…The ERG therefore did not present any results for the FPS population within their report; instead, the ERG focused on results for the PPS population (PFI 6-12 months). The ERG for TA222 90 investigated a number of changes to the model for PPS patients, including amending the parametric distribution used to calculate the mean PFS and OS time for PLDH. The ERG concluded that 'the most plausible ICER for trabectedin in combination with PLDH compared with PLDH alone in women who relapse between 6 to 12 months after initial platinum-based chemotherapy ranges between £46,503 and £54,607' (TA222 ERG report, p.127).…”

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confidence: 99%

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Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation

Edwards¹,

Barton²,

Thurgar³

et al. 2015

Health Technology Assessment

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BackgroundOvarian cancer is the fifth most common cancer in the UK, and the fourth most common cause of cancer death. Of those people successfully treated with first-line chemotherapy, 55–75% will relapse within 2 years. At this time, it is uncertain which chemotherapy regimen is more clinically effective and cost-effective for the treatment of recurrent, advanced ovarian cancer.ObjectivesTo determine the comparative clinical effectiveness and cost-effectiveness of topotecan (Hycamtin®, GlaxoSmithKline), pegylated liposomal doxorubicin hydrochloride (PLDH; Caelyx®, Schering-Plough), paclitaxel (Taxol®, Bristol-Myers Squibb), trabectedin (Yondelis®, PharmaMar) and gemcitabine (Gemzar®, Eli Lilly and Company) for the treatment of advanced, recurrent ovarian cancer.Data sourcesElectronic databases (MEDLINE®, EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) and trial registries were searched, and company submissions were reviewed. Databases were searched from inception to May 2013.MethodsA systematic review of the clinical and economic literature was carried out following standard methodological principles. Double-blind, randomised, placebo-controlled trials, evaluating topotecan, PLDH, paclitaxel, trabectedin and gemcitabine, and economic evaluations were included. A network meta-analysis (NMA) was carried out. A de novo economic model was developed.ResultsFor most outcomes measuring clinical response, two networks were constructed: one evaluating platinum-based regimens and one evaluating non-platinum-based regimens. In people with platinum-sensitive disease, NMA found statistically significant benefits for PLDH plus platinum, and paclitaxel plus platinum for overall survival (OS) compared with platinum monotherapy. PLDH plus platinum significantly prolonged progression-free survival (PFS) compared with paclitaxel plus platinum. Of the non-platinum-based treatments, PLDH monotherapy and trabectedin plus PLDH were found to significantly increase OS, but not PFS, compared with topotecan monotherapy. In people with platinum-resistant/-refractory (PRR) disease, NMA found no statistically significant differences for any treatment compared with alternative regimens in OS and PFS. Economic modelling indicated that, for people with platinum-sensitive disease and receiving platinum-based therapy, the estimated probabilistic incremental cost-effectiveness ratio [ICER; incremental cost per additional quality-adjusted life-year (QALY)] for paclitaxel plus platinum compared with platinum was £24,539. Gemcitabine plus carboplatin was extendedly dominated, and PLDH plus platinum was strictly dominated. For people with platinum-sensitive disease and receiving non-platinum-based therapy, the probabilistic ICERs associated with PLDH compared with paclitaxel, and trabectedin plus PLDH compared with PLDH, were estimated to be £25,931 and £81,353, respectively. Topotecan was strictly dominated. For people with PRR disease, the probabilistic ICER associated with topotecan compared with PLDH was estimated to be £324,188. Paclitaxel was strictly dominated.LimitationsAs platinum- and non-platinum-based treatments were evaluated separately, the comparative clinical effectiveness and cost-effectiveness of these regimens is uncertain in patients with platinum-sensitive disease.ConclusionsFor platinum-sensitive disease, it was not possible to compare the clinical effectiveness and cost-effectiveness of platinum-based therapies with non-platinum-based therapies. For people with platinum-sensitive disease and treated with platinum-based therapies, paclitaxel plus platinum could be considered cost-effective compared with platinum at a threshold of £30,000 per additional QALY. For people with platinum-sensitive disease and treated with non-platinum-based therapies, it is unclear whether PLDH would be considered cost-effective compared with paclitaxel at a threshold of £30,000 per additional QALY; trabectedin plus PLDH is unlikely to be considered cost-effective compared with PLDH. For patients with PRR disease, it is unlikely that topotecan would be considered cost-effective compared with PLDH. Randomised controlled trials comparing platinum with non-platinum-based treatments might help to verify the comparative effectiveness of these regimens.Study registrationThis study is registered as PROSPERO CRD42013003555.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Assessment Of Cost-effectivenessmentioning

confidence: 99%

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confidence: 99%

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Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation

Edwards¹,

Barton²,

Thurgar³

et al. 2015

Health Technology Assessment

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A Systematic Review of Health State Utility Values for Advanced Ovarian Cancer

et al. 2014

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Objectives: To identify and review methods employed to evaluate medication adherence in studies of oral antineoplastic agents, with particular interest in the opportunities and challenges associated with medication event monitoring systems (MEMS) implemented in observational studies. MethOds: A targeted literature review was conducted to identify studies that have measured adherence with antineoplastic agents. Our review included studies that were published between January 1990 and May 2014. Key data abstracted from each study included patient characteristics, study design and duration, cancer type, treatment, and adherence methodology and results. Based on preliminary results, a second targeted review was conducted to evaluate the literature on the risk of the Hawthorne effect in observational studies utilizing MEMS in any therapeutic area. Results: We identified 69 studies that evaluated adherence to oral chemotherapy; 6 studies were interventional and excluded from further review. Of the remaining 63 studies, 28 (44%) were prospective, 25 (40%) were retrospective, and 10 (16%) were cross-sectional. A total of 15 studies used MEMS to evaluate medication adherence. Among observational studies that utilized MEMS and evaluated the Hawthorne effect (n= 3), mixed results were observed. In two studies, patients reported their behavior was affected by their awareness of being evaluated. This was demonstrated by a significant decrease in adherence between months 1-3 in one study but not measured in the second. The third study showed no change in adherence scores over time and concluded there was no Hawthorne effect. Potential ways to minimize the Hawthorne effect include: study duration > 3 months, blinding patients and physicians to results of MEMS downloads, and use of a patient-completed 'debriefing form' to assess behavior modifications. cOnclusiOns: MEMS have been utilized in observational studies evaluating oral antineoplastic agents. The Hawthorne effect may be present with MEMS caps, but can be minimized and is not prohibitive to study conduct.Objectives: Identifying appropriate utility values to inform cost-effectiveness analysis is a common problem. The aim of this study was to review health-state utility values (HSUVs) for patients with advanced ovarian cancer and make recommendations about their use in the economic evaluation of a targeted maintenance therapy for platinum-sensitive recurrent (PSR) ovarian cancer. MethOds: A systematic search of Embase ® , MEDLINE ® , and MEDLINE ® in Process was conducted in June 2013 for studies reporting direct (standard gamble (SG) or time trade off (TTO)) or indirect (EQ-5D, SF-6D, or HUI-3) utility values for patients with advanced ovarian cancer. HTA agency websites were also searched. Study design, country, HSUV elicitation method, health state (HS) description, and who valued the HS were extracted. Mean (SD) utility scores, or medians (ranges), if means were unavailable, were recorded for each HS. Results: A total of 10 publications were found, representing five pri...

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