Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer
NCT ID: NCT03562533
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
432 participants
OBSERVATIONAL
2018-05-17
2018-12-17
Brief Summary
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Detailed Description
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However, rechallenge with CP has been limited by the risk of cumulative peripheral neuropathy. In addition, grade 2 alopecia (complete hair loss), another ill-tolerated adverse effect for patients facing the distress of relapse, occurs in more than 80% of patients. In order to improve the patient's tolerance on the treatment in this setting, other carboplatin-based combinations, such as gemcitabine and carboplatin, have been explored. This combination significantly improved PFS versus carboplatin alone in phase III trial (HR, 0.72; 95%CI, 0.58 to 0.90; P= .0031). however, OS was not significantly improved (HR, 0.96; 95% CI, 0.75 to 1.23; P = .735); the trial was not powered to detect a survival difference. Grade 3 to 4 hematologic toxicities were significantly more frequent in the combination arm. Thus, a need for other carboplatin combinations remains in PS ROC.
Pegylated liposomal doxorubicin (PLD) is an active drug in ROC as the efficacy has been demonstrated in CALYPSO trial.
CAYPSO is a large randomized phase III showing the noninferiority of the combination of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with CP in patients with PS ROC. In this trial, PFS for the CD arm was statistically superior to the CP arm (hazard ratio, 0.821; 95% CI, 0.72 to 0.94; P = .005); median PFS was 11.3 versus 9.4 months, respectively. Overall severe nonhematologic toxicity (36.8% v 28.4%; P = .01) leading to early discontinuation (15% v 6%; P = .001) occurred more frequently in the CP arm. More frequent grade 2 or greater alopecia (83.6% v 7%), hypersensitivity reactions (18.8% v 5.6%), and sensory neuropathy (26.9% v 4.9%) were observed in the CP arm; more hand-foot syndrome (grade 2 to 3, 12.0% v 2.2%), nausea (35.2% v 24.2%), and mucositis (grade 2-3, 13.9% v 7%) in the CD arm.
Moreover, recent subgroup analysis of CALYPSO trial had reported that CD had a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC (patients with a treatment-free interval of \>6 and ≤12 months). The hazard ratio for PFS was 0.73 (95% CI: 0.58-0.90; P = 0.004 for superiority) in favor of CD.
On the basis of the results of CALYPSO trial, Korea Food \& Drug Administration (KFDA) has approved and reimbursed the use of PLD in patients with PS ROC since August 2014. From then, approximately 700 patients with PS ROC have been treated with PLD in Korea.
The majority of patients enrolled in CALYPSO have 1 prior treatment, however, CD has been used in diverse setting of ROC in Korea. Therefore, the effectiveness and safety of the PLD combination should be still evaluated in the real clinical practice in Korea. To fulfill the gap of knowledge between clinical trials and actual clinical practice, we perform a multicenter, retrospective, observational study of CD therapy in the second line setting of PS ROC.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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pegylated liposomal doxorubicin + carboplatin
carboplatin area under the curve \[AUC\] 5 plus pegylated liposomal doxorubicin (PLD) 30 mg/m2 every 4 weeks
pegylated liposomal doxorubicin (PLD) + carboplatin (CD)
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles
paclitaxel + carboplatin
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks
carboplatin + paclitaxel (CP)
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles
Interventions
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pegylated liposomal doxorubicin (PLD) + carboplatin (CD)
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles
carboplatin + paclitaxel (CP)
carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles
Eligibility Criteria
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Inclusion Criteria
* Recurred \>6 months after surgery and first-line platinum-based chemotherapy regimen
* Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) or CA-125 assessable disease according to Gynecologic Cancer InterGroup (GCIG) criteria or histologic proven diagnosis
* Eastern Cooperative Oncology Group performance status of ≤ 2
Exclusion Criteria
* Had received prior radiotherapy; or, had a previous diagnosis of malignancy within the past 5 years.
* Had bowel obstruction or presence of symptomatic brain metastases
* Patients with severe active infection
* Had history of severe hypersensitivity reactions to compounds chemically related to study products.
18 Years
80 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
National Cancer Center, Korea
OTHER_GOV
Asan Medical Center
OTHER
The Catholic University of Korea
OTHER
Samsung Medical Center
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Ajou University
OTHER
Severance Hospital
OTHER
Konkuk University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Seung Hyuk Shim, MD
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Hospital
Locations
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Konkuk University School of Medicine
Seoul, , South Korea
Countries
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References
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Park SJ, Kim J, Kim HS, Lee JW, Chang HK, Lee KH, Kim DY, Kim S, Chang SJ, Han SS, Park SY, Shim SH. Real world effectiveness and safety of pegylated liposomal doxorubicin in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer: a Korean multicenter retrospective cohort study. J Gynecol Oncol. 2020 Mar;31(2):e15. doi: 10.3802/jgo.2020.31.e15. Epub 2019 Sep 10.
Other Identifiers
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KUH1040075
Identifier Type: -
Identifier Source: org_study_id