Multicenter retrospective study to evaluate the impact of trabectedin plus pegylated liposomal doxorubicin on the subsequent treatment in women with recurrent, platinum-sensitive ovarian cancer

Romero, Ignacio; Mallol, Pedro; Santaballa, Ana; Campo, J.M. del; Mori, Marta; González-Santiago, Santiago; Casado, Antonio; Vicente, David; Ortega, Eugenia; Herrero, Ana; Guerra, Eva; Barretina-Ginesta, Pilar; Rubio, María Jesús; Martínez, Alejandro; Bover, Isabel; Vidal, Laura; Arcusa, Àngels; Martín, Lola; García, Yolanda; González-Martín, Antonio

doi:10.1097/cad.0000000000000794

Cited by 9 publications

(8 citation statements)

References 37 publications

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“…In contrast, NIMES‐ROC study did not demonstrate a statistically significant difference in PFS and OS during treatment with trabectedin plus PLD neither by BRCA1 / 2 status nor platinum sensitivity. Those outcomes are pretty in line with the data observed in another real‐life national survey of trabectedin plus PLD, which also did not observe significant differences in responses according to platinum sensitivity and BRCA status [16]. In our study, the nonsignificant outcomes by BRCA1 / 2 status could be explained, at least partially, by the high percentage of patients not tested for the BRCA mutation status (i.e., 38.1%).…”

Section: Discussionsupporting

confidence: 92%

“…Patients characteristics at baseline in NIMES-ROC study were in line with those observed in previous noninterventional studies [15][16][17], showing that the analyzed real-life patient population was older (median age: 61 vs. 56 years) and more pretreated (72.5% of patients received at least two prior chemotherapy lines) than patients included in OVA-301 study [11], where the inclusion criteria allowed only one previous line of treatment (Table 1). Despite the difference in patients' characteristics, the overall data observed in our study are consistent with those observed in the subgroup of platinum-sensitive patients from the pivotal, randomized phase III OVA-301 clinical trial [11] and are similar, or even, better than the those observed in previous real-life studies [15][16][17]. The primary endpoint of the NIMES-ROC resulted in a median time for PFS of 9.46 months.…”

Section: Discussionsupporting

confidence: 80%

“…Such observational studies can provide useful insights of the real-world safety, efficacy and management of patients who may be underrepresented in clinical trials due to more restrictive eligibility criteria. In that sense, three previous national studies [15][16][17] about the real-life use of trabectedin plus PLD in patients with platinum-sensitive ROC have reported that this combination confers clinically meaningful long-term benefit to patients with platinum-sensitive ROC, comparable to those reported in clinical trials. So far no prospective, real-life, pan-European, non-interventional study with trabectedin plus PLD had been performed.…”

Section: Introductionmentioning

confidence: 77%

“…In our study, the nonsignificant outcomes by BRCA1 / 2 status could be explained, at least partially, by the high percentage of patients not tested for the BRCA mutation status (i.e., 38.1%). Even though it is recommended to test every new patient with ovarian cancer for genetic mutations, particularly BRCA1 and BRCA2 , the testing rates in the real‐life treatment of ovarian cancer remains suboptimal [15, 16, 22, 23]. Recent results of a large retrospective analysis of real‐life clinical data from 1,921 patients with ovarian cancer showed a trend for increased rates of germline or somatic BRCA testing, with 25% of patients tested in 2011 to 69% in 2018, largely because of the targeted treatment opportunities with PARP inhibitors [22].…”

Section: Discussionmentioning

confidence: 99%

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A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer

et al. 2021

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Purpose The noninterventional, prospective NIMES‐ROC phase IV study (NCT02825420) evaluated trabectedin plus pegylated liposomal doxorubicin (PLD) in real‐life clinical practice. Patients and Methods Eligible participants included adults with platinum‐sensitive recurrent ovarian cancer (PS‐ROC) who had received one or more cycles of trabectedin/PLD before inclusion according to the marketing authorization. The primary endpoint was progression‐free survival (PFS) according to investigator criteria. Results Two hundred eighteen patients from five European countries were evaluated, 72.5% of whom were pretreated with at least two prior chemotherapy lines and received a median of six cycles of trabectedin/PLD (range: 1–24). Median PFS was 9.46 months (95% confidence interval [CI], 7.9–10.9), and median overall survival (OS) was 23.56 months (95% CI, 18.1–34.1). Patients not pretreated with an antiangiogenic drug obtained larger median PFS (p < .007) and OS (p < .048), largely owning to differences between the two populations. Twenty‐four patients (11.0%) had a complete response, and 57 patients (26.1%) achieved a partial response for an objective response rate (ORR) of 37.2%. Fifty‐nine patients (27.1%) had disease stabilization for a disease control rate of 64.2%. No statistically significant difference in PFS, OS, or ORR was observed by BRCA1/2 status and platinum sensitivity. Most common grade 3/4 adverse events (AEs) were neutropenia (30.3%), anemia (6.4%), thrombocytopenia (5.5%), and asthenia (5.0%). No deaths attributed to treatment‐related AEs or unexpected AEs occurred. Conclusion The combination of trabectedin/PLD represents a clinically meaningful and safe option for patients with PS‐ROC regardless of prior treatment with an antiangiogenic drug, being comparable with previously observed outcomes in selected and less pretreated patients from clinical trials. Implications for Practice This noninterventional, prospective study, conducted in 57 reference sites across Europe, consistently confirmed that trabectedin plus pegylated liposomal doxorubicin (PLD) in routine clinical practice represents a clinically meaningful and safe option for women with platinum‐sensitive recurrent ovarian cancer. Although the study population represented a heterogeneous, older, and more pretreated population than those in prospective clinical trials, the combination of trabectedin plus PLD induced comparable clinical benefits, with a similar and manageable safety profile. Overall, these findings show that trabectedin in combination with PLD maintains antitumor activity when administered to heavily pretreated patients in real‐life clinical practice.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 80%

Section: Introductionmentioning

confidence: 77%

Section: Discussionmentioning

confidence: 99%

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A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer

et al. 2021

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“…To study drug delivery, we selected DOX, an anthracycline drug that was first extracted from Streptomyces . DOX has been widely used and studied in the treatment of many cancers, including breast carcinoma, lung cancer, and ovarian cancer . We loaded DOX onto in situ GIOPMPC nanocarriers, as illustrated in Figure a.…”

Section: Results and Discussionmentioning

confidence: 88%

Noncovalent Functionalized Graphene Nanocarriers from Graphite for Treating Thyroid Cancer Cells

Perumal

Gangadaran

Bae

et al. 2021

ACS Biomater. Sci. Eng.

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Here, biocompatible graphene (G) nanocarriers decorated with iron oxide nanoparticles (IONPs) were prepared using 2-(methacryloyloxy)ethyl phosphorylcholine (MPC) and poly(ethylene glycol) monomethacrylate (PEGMA). For this, we report the use of graphite directly instead of graphene oxide or reduced graphene oxide. Graphene nanocarrier (in situ GIOPMPC) was prepared in one-pot by in situ copolymerization of MPC and PEGMA monomers in the presence of IONPs and G. GIOPMCP nanocarriers were prepared by sonication using PMPC-co-PEGMA copolymers in the presence of IONPs and G. The prepared graphene nanocarriers were thoroughly characterized by various techniques. The analyses confirmed the successful preparation of nanocarriers with even distributions of PMPC-co-PEGMA and IONPs on surface G. The IONPs were coordinated through the phosphate groups in PMPC. Excellent dispersibility of the graphene nanocarriers in water enabled drug delivery applications. The prepared nanocarriers did not show significant cytotoxicity to the thyroid cancer cells up to 8 mg/mL (IC 50 : 38.26 mg/mL). Thyroid cancer cells were stably transduced with a bioluminescent reporter to monitor cell cytotoxicity. Doxorubicin (DOX) was loaded onto in situ GIOPMPC nanocarriers at two different concentrations and was successfully delivered to thyroid cancer cells, resulting in strong cytotoxicity. Moreover, signaling mechanistic analyses showed apoptosis activation, inhibition of anti-apoptosis and proliferation, and increased DNA damage in the thyroid cancer cells.

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Trabectedin induces ferroptosis via regulation of HIF-1α/IRP1/TFR1 and Keap1/Nrf2/GPX4 axis in non-small cell lung cancer cells

Cai

Ding

Liu

et al. 2023

Chemico-Biological Interactions

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Multicenter retrospective study to evaluate the impact of trabectedin plus pegylated liposomal doxorubicin on the subsequent treatment in women with recurrent, platinum-sensitive ovarian cancer

Cited by 9 publications

References 37 publications

A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer

A European, Observational, Prospective Trial of Trabectedin Plus Pegylated Liposomal Doxorubicin in Patients with Platinum-Sensitive Ovarian Cancer

Noncovalent Functionalized Graphene Nanocarriers from Graphite for Treating Thyroid Cancer Cells

Trabectedin induces ferroptosis via regulation of HIF-1α/IRP1/TFR1 and Keap1/Nrf2/GPX4 axis in non-small cell lung cancer cells

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