Real-World Effectiveness of PLD in Platinum- Sensitive Recurrent Ovarian Cancer

NCT03562533CompletedOBSERVATIONAL

Summary

This retrospective multicenter study aimed to evaluate the effectiveness of pegylated liposomal doxorubicin (PLD) with carboplatin (CD) compared with carboplatin and paclitaxel (CP) in patients who had disease progression longer than 6 months after first-line platinum+taxane chemotherapy for ovarian cancer in real world clinical practice.

Key Facts

Lead Sponsor

Konkuk University Medical Center

Enrollment

432

Start Date

2018-05-17

Completion Date

2018-12-17

Study Type

OBSERVATIONAL

Official Title

Comparison of Real-World Effectiveness of Pegylated Liposomal Doxorubicin Versus Paclitaxel in Platinum- Sensitive Recurrent Ovarian Cancer

Interventions

pegylated liposomal doxorubicin (PLD) + carboplatin (CD)carboplatin + paclitaxel (CP)

Conditions

Ovarian Carcinoma

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria:

* Previous taxane therapy was required.
* 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 ovarian tumors of low malignant potential (borderline tumors); nonepithelial or mixed epithelial/nonepithelial tumors (eg, mixed Mullerian tumors)
* 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.

Outcome Measures

Primary Outcomes

Overall survival (OS)

OS was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive.

Time frame: 36 months

Secondary Outcomes

Progression free survival (PFS)

PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria.

Time frame: 3years

Incidence of Treatment-Related Adverse Events

Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0.

Time frame: 36 months

Response rate

Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) by Modified RECIST until progression reported. Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.

Time frame: 36 months

Locations

Konkuk University School of Medicine, Seoul, South Korea

Linked Papers

2019-09-10

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

To evaluate the effectiveness and safety of the combination of pegylated liposomal doxorubicin with carboplatin (CD) compared with those of carboplatin and paclitaxel (CP) for platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer in a real-world setting in Korea. We enrolled relevant patients from 9 institutions. All patients received CD or CP as the second- or third-line chemotherapy in routine clinical practice during 2013-2018. The primary endpoints were progression-free survival (PFS) and toxicity. The secondary endpoint included the objective response rate (ORR). Overall, 432 patients (224 and 208 in the CD and CP groups, respectively) were included. With a median follow-up of 18.9 months, the median PFS was not different between the groups (12.7 vs. 13.6 months; hazard ratio, 1.161; 95% confidence interval, 0.923-1.460; p=0.202). The ORR was 74.6% and 80.1% in the CD and CP group, respectively (p=0.556). Age and surgery at relapse were independent prognostic factors. More patients in the CD group significantly experienced a grade 3 to 4 hematologic toxicity and hand-foot syndrome (13.8% vs. 6.3%), whereas grade 2 or more alopecia (6.2% vs. 36.1%), peripheral neuropathy (4.4% vs. 11.4%), and allergic/hypersensitivity reaction (0.4% vs. 8.5%) developed more often in the CP group. The safety and effectiveness of chemotherapy with CD in a real-world setting were consistent with the results from a randomized controlled study. The different toxicity profiles between the 2 chemotherapy (CD and CP) regimens should be considered in the clinical practice. ClinicalTrials.gov Identifier: NCT03562533.

Linked Investigators

Dae-Yeon Kim

Ha Kyun Chang

Hee Seung Kim

Jeong-Won Lee

Jihye Kim

Keun Ho Lee

Sang-Yoon Park

Seung-Hyuk Shim

Seung Su Han

Soo Jin Park

Suk-Joon Chang

Gynecologic Cancer Center Department of Obstetrics and Gynecology, Ajou University School of Medicine

Sunghoon Kim