Comparison of CA-125 and Standard Definitions of Progression of Ovarian Cancer in the Intergroup Trial of Cisplatin and Paclitaxel Versus Cisplatin and Cyclophosphamide

Rustin, G. J. S.; Timmers, Petra; Nelstrop, Ann E.; Shreeves, Gavin; Bentzen, Søren M.; Baron, B.; Piccart, Martine; Bertelsen, K.; Stuart, Gavin; Cassidy, James T.; Eisenhauer, Elizabeth

doi:10.1200/jco.2005.01.2757

Cited by 90 publications

(56 citation statements)

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“…Multiple groups have published direct comparisons of CA125 concentration changes with imaging criteria in trials of paclitaxel, platinum, or cyclophosphamide, alone or in combination, and these trials have shown CA125 to be equal or better to imaging criteria for prognosis. 5,[27][28][29][30] Etoposide, pegylated liposomal doxorubicin, and topotecan have also been shown to be effective in epithelial ovarian cancer on the basis of CA125 criteria. 6,31,32 However, 20% of women with epithelial ovarian cancer do not have elevated CA125 concentrations, which adds to the challenge of using CA125 clinically or in research trials.…”

Section: Discussionmentioning

confidence: 99%

Lack of reliability of CA125 response criteria with anti‐VEGF molecularly targeted therapy

Azad

Annunziata

Steinberg

et al. 2008

Cancer

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BACKGROUNDCA125 is an accepted indicator of epithelial ovarian cancer (EOC) response and is used to monitor patients treated with cytotoxic chemotherapy. It is uncertain how CA125 is affected by molecularly targeted drugs. In this pilot study, the authors analyzed the utility of CA125 to predict disease behavior in patients who were receiving sorafenib, a Raf‐kinase/VEGFR2 inhibitor, and bevacizumab, an anti‐VEGF monoclonal antibody.METHODSFifteen of 42 patients had recurrent EOC. Patients received sorafenib 200 mg orally twice daily or D1‐5 of 7 and bevacizumab 5 mg/kg to 10 mg/kg intravenously every 2 weeks for 28‐day cycles. Computed tomography (CT) scans were performed every 2 cycles for restaging, and CA125 was measured monthly. CA125 concentrations were retrospectively analyzed as a function of clinical behavior.RESULTSFourteen of 15 patients had abnormal CA125 concentrations at study entry (median 1056 U/mL; range, 67 U/mL to 9813 U/mL). Seven (47%) patients had partial response by imaging criteria. Five of these 7 patients had partial response by CA125 criteria (71% sensitivity). Eight (53%) patients would have had partial responses if CA125 criteria were used; only 5 were confirmed by CT (63 % specificity). Imaging and CA125 criteria combined yielded a higher total response rate of 10 of 15 (67%). Three patients with objective partial response by imaging lasting >20, >22, and >24 cycles would have terminated treatment prematurely if CA125 had been used.CONCLUSIONSCA125 changes may not correspond to imaging response criteria for EOC patients who are receiving sorafenib and bevacizumab. Caution is recommended when using CA125 as a response criterion of molecularly targeted agents until prospective studies validate CA125 changes with objective imaging response results. Cancer 2008. © 2008 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Lack of reliability of CA125 response criteria with anti‐VEGF molecularly targeted therapy

Azad

Annunziata

Steinberg

et al. 2008

Cancer

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“…76 Thus, there is uncertainty whether patients diagnosed as having recurrent disease by only CA125 level would have the same diagnosis on radiological scan. In addition, it is also possible that the degree of sensitivity to platinum could differ.…”

Section: Comparability Of Baseline Characteristicsmentioning

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

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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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“…The serum assay utilizes a monoclonal antibody to CA125, the antigenic determinant on a large glycoprotein encoded by the gene MUC16 [16]. Prospective trials involving ovarian cancer patients have validated the use of CA125 for monitoring clinical response to therapy and for the detection of recurrent disease [17]. More recently, the potential utility of CA125 measurement has been evaluated in endometrial cancer patients.…”

Section: Introductionmentioning

confidence: 99%

Serum CA125 predicts extrauterine disease and survival in uterine carcinosarcoma

Huang

Chiu

Gebb

et al. 2007

Gynecologic Oncology

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Objective-The purpose of this study was to determine the clinical utility of CA125 measurement in patients with uterine carcinosarcoma (CS).Methods-Ninety-five consecutive patients treated for CS at a single institution were identified. All 54 patients who underwent preoperative CA125 measurement were included in the study. Data were abstracted from the medical records. Tests of association between preoperative CA125 and previously identified clinicopathologic prognostic factors were performed using Fisher's exact test and Pearson chi-square test. To evaluate relationship of CA125 elevation and survival, a Cox proportional hazard model was used for multivariate analysis, incorporating all of prognostic factors identified by univariate analysis. Conclusion-Preoperative CA125 elevation is a marker of extrauterine disease and deep myometrial invasion in patients with uterine CS. Postoperative CA125 elevation is an independent prognostic factor for poor survival. These findings indicate that CA125 may be a clinically useful serum marker in the management of patients with CS. Results-Preoperative

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Comparison of CA-125 and Standard Definitions of Progression of Ovarian Cancer in the Intergroup Trial of Cisplatin and Paclitaxel Versus Cisplatin and Cyclophosphamide

Abstract: The results of this analysis show that the magnitude of the therapeutic benefit was similar whether CA-125 or standard criteria were used to define progression.

Cited by 90 publications

References 12 publications

Lack of reliability of CA125 response criteria with anti‐VEGF molecularly targeted therapy

Lack of reliability of CA125 response criteria with anti‐VEGF molecularly targeted therapy

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

Serum CA125 predicts extrauterine disease and survival in uterine carcinosarcoma

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