Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial

Gladieff, L.; Ferrero, Annamaria; Rauglaudre, Gaëtan De; Brown, Chris; Vasey, P.; Reinthaller, Alexander; Pujade-Lauraine, Éric; Reed, Nicholas; Lorusso, Domenica; Siena, Salvatore; Helland, Harald; Elit, Laurie; Mahner, Sven

doi:10.1093/annonc/mdr441

Cited by 55 publications

(59 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Accompanying publications were identified that present results on mature OS data, 56 clinical effectiveness results in the subgroup of patients with PPS ovarian cancer (relapse at between 6 and 12 months since receipt of last cycle of chemotherapy) 57 and QoL. 59 The trial was of a non-inferiority design with the aim of determining whether PLDH (30 mg/m 2 ) plus carboplatin (AUC 5) every 4 weeks was non-inferior to the standard treatment of paclitaxel (175 mg/m 2 ) plus carboplatin every 3 weeks.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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.

show abstract

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…31 reported an analysis of PFS in the subgroup of patients with PPS ovarian cancer. 57 The PPS subgroup comprised 161 patients in the PLDH plus carboplatin group and 183 patients in the paclitaxel plus carboplatin group. Baseline characteristics were similar in the two treatment groups.…”

Section: Fully Platinum Sensitivementioning

confidence: 99%

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

View full text Add to dashboard Cite

show abstract

“…The recent CALYPSO trial demonstrated the efficacy of PLD/carboplatin combination treatments for recurrent platinum-sensitive disease. This combination is currently associated with a more favorable risk-benefit profile than paclitaxel/carboplatin in patients with partially platinumsensitive recurrent ovarian carcinoma (14). A previous study in elderly patients revealed that PLD demonstrated an improved therapeutic index with less toxicity than paclitaxel/carboplatin (15).…”

Section: Discussionmentioning

confidence: 99%

Pegylated liposomal doxorubicin for platinum-resistant or refractory Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of Fallopian tube and peritoneal carcinoma): A single-institutional experience

et al. 2012

View full text Add to dashboard Cite

Abstract. The aim of the present study was to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in patients with Müllerian carcinoma treated at our hospital. Nineteen patients with platinum-resistant Müllerian carcinoma were treated with intravenous PLD 50 mg/m 2 every 4 weeks. Tumor response was assessed by MRI following every 2-3 cycles of treatment. The severity of adverse events was assessed according to the Common Terminology Criteria for Adverse Events (v3.0). The best overall responses in the 19 patients were identified as 5 partial responses (PR), 6 stable diseases (SD) and 8 progressive diseases (PD). Response rate was 26.3%. The proportion of patients with CR, PR or SD was 57.9%. The median time to progression was 188.0 days. The median survival time was 381.0 days. Toxicity grades were identified as one grade III hand-foot syndrome, two grade III neutropenia, one grade IV hand-foot syndrome, one grade IV stomatitis and one grade IV neutropenia. The present study confirmed that PLD is an effective drug when administered as a salvage therapy for the treatment of Müllerian carcinoma and is associated with a reduced toxicity profile compared with current therapeutic options.

show abstract

“…10 In particular, carboplatin/pegylated liposomal doxorubicin (PLD) combination is considered in the clinical practice an alternative choice compared with carboplatin/paclitaxel in this specific setting. [11][12][13][14] Patients with a PFI of 6-12 mo are defined platinumpartially-sensitive and showed an intermediate likelihood of responding to a platinum-based regimen. 14 In this subgroup it has been recently hypothesized, based on preclinical and clinical findings, a potential benefit derived from an "artificial" prolongation of the PFI by the use of a platinum-free regimen (such as trabectedine-PLD combination).…”

Section: Introductionmentioning

confidence: 99%

“…[11][12][13][14] Patients with a PFI of 6-12 mo are defined platinumpartially-sensitive and showed an intermediate likelihood of responding to a platinum-based regimen. 14 In this subgroup it has been recently hypothesized, based on preclinical and clinical findings, a potential benefit derived from an "artificial" prolongation of the PFI by the use of a platinum-free regimen (such as trabectedine-PLD combination). [15][16][17] These trials reported significant advantage in progression free survival (PFS) which did not translate in overall survival (OS) prolongation.…”

Section: Introductionmentioning

confidence: 99%

Pegylated liposomal doxorubicin in the management of ovarian cancer

Staropoli

Ciliberto

Botta

et al. 2014

Cancer Biology & Therapy

View full text Add to dashboard Cite

Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial

Abstract: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.

Cited by 55 publications

References 15 publications

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

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

Pegylated liposomal doxorubicin for platinum-resistant or refractory Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of Fallopian tube and peritoneal carcinoma): A single-institutional experience

Pegylated liposomal doxorubicin in the management of ovarian cancer

Contact Info

Product

Resources

About