Liposomal Doxorubicin in Ovarian, Peritoneal, and Tubal Carcinoma: A Retrospective Comparative Study of Single-Agent Dosages

Rose, Peter G.; Maxson, Jan Hawthorne; Fusco, Nancy; Mossbruger, Kim; Rodriguez, Michael J.

doi:10.1006/gyno.2001.6272

Cited by 100 publications

(52 citation statements)

References 7 publications

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“…For patients with recurrence following first-line platinum-based therapy, pegylated liposomal doxorubicin (PLD) represents an effective nonplatinum second-line therapy [4][5][6][7][8]. All patients will experience disease progression, underscoring the need to improve outcomes.…”

Section: Introductionmentioning

confidence: 99%

ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer

Marth

Vergote

Scambia

et al. 2017

European Journal of Cancer

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Aims: Trebananib, a peptide-Fc fusion protein, inhibits angiogenesis by inhibiting binding of angiopoietin-1/2 to the receptor tyrosine kinase Tie2. This randomized, double-blind, placebocontrolled phase 3 study evaluated whether trebananib plus pegylated liposomal doxorubicin (PLD) improved progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer. Methods:Women with recurrent ovarian cancer (platinum-free interval ≤12 months) were randomized to intravenous PLD 50 mg/m 2 once every 4 weeks plus weekly intravenous trebananib 15 mg/kg or placebo. PFS was the primary endpoint; key secondary endpoints were objective response rate (ORR) and duration of response (DOR). Owing to PLD shortages, enrollment was paused for 13 months; the study was subsequently truncated.Results: Two hundred twenty-three patients were enrolled. Median PFS was 7.6 months (95%CI, 7.2─9.0) in the trebananib arm and 7.2 months (95%CI, 4.8─8.2) in the placebo arm, with a hazard ratio of 0.92 (95%CI, 0.68─1.24). However, because the proportional hazards assumption was not fulfilled, the standard Cox model did not provide a reliable estimate of the hazard ratio. ORR in the trebananib arm was 46% versus 21% in the placebo arm (odds ratio, 3.43; 95%CI, 1.78-6.64). Median DOR was improved (trebananib, 7.4 [95%CI,.6] months; placebo, 3.9 [95%CI, 2.3-6.5] months). Adverse events with a greater incidence in the trebananib arm included localized edema (61% versus 32%), ascites (29% versus 9%), and vomiting (45% versus 33%). Conclusions

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Section: Introductionmentioning

confidence: 99%

ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer

Marth

Vergote

Scambia

et al. 2017

European Journal of Cancer

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“…Inadequate dosage, either per treatment or per total cumulative dose, could be evidenced by the complete absence of grade 4 toxicities. However, in a retrospective study by Rose et al [13], there was no difference in response rates, progression-free survival, or OS in patients treated with 40 or 50 mg/m 2 of single-agent PLD. In that review, 25% of patients who received 50 mg/m 2 required a dose reduction because of toxicity, compared with no dose reductions in patients who received 40 mg/m 2 [13].…”

Section: Discussionmentioning

confidence: 92%

“…However, in a retrospective study by Rose et al [13], there was no difference in response rates, progression-free survival, or OS in patients treated with 40 or 50 mg/m 2 of single-agent PLD. In that review, 25% of patients who received 50 mg/m 2 required a dose reduction because of toxicity, compared with no dose reductions in patients who received 40 mg/m 2 [13]. Based on available data involving phase II studies using four cycles of PLD in recurrent second-line treatment, we chose four treatment cycles during protocol development for consolidation.…”

Section: Discussionmentioning

confidence: 92%

Pegylated Liposomal Doxorubicin Consolidation Therapy after Platinum/Paclitaxel-Based Chemotherapy for Suboptimally Debulked, Advanced-Stage Epithelial Ovarian Cancer Patients

et al. 2006

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Objective. To assess the feasibility of using pegylated liposomal doxorubicin (PLD) as a consolidation therapy in patients with advanced ovarian cancer who have attained a clinically defined complete response to initial platinum/paclitaxel-based chemotherapy.Methods. Patients diagnosed with suboptimally debulked stage IIIC/IV epithelial ovarian cancer who attained a clinically defined complete response at the completion of platinum/paclitaxel-based chemotherapy were eligible for this protocol. Patients were treated with PLD at a dose of 40 mg/m 2 every 28 days for four cycles. A survival analysis was calculated using the KaplanMeier method.Results. Of the 30 patients enrolled, 29 were evaluable. Twenty-three patients (79%) completed all four cycles of consolidation therapy. Palmar-plantar erythrodysesthesia was the most common toxicity. Six patients remained clinically without evidence of disease with a median follow-up of 35 months from the completion of primary chemotherapy. The median progression-free interval was 15 months, and median overall survival time was 31 months, with 47% of patients achieving a 4-year survival.Conclusions. Consolidation therapy with PLD chemotherapy administered to women with advanced epithelial ovarian cancer after initial chemotherapy appears feasible based on its toxicity profile. Considering the tolerability of this agent, further investigation is needed to depict the optimal dose and schedule needed for consolidation therapy.

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“…On the other hand, the impact of changing the dose intensity on clinical outcomes is not clear. Rose et al (20) . partial response in the patients group receiving 50 mg/m 2 .…”

Section: Discussionmentioning

confidence: 99%

Liposomal Doxorubicin-Related Palmar-Plantar Erthrodysesthesia (Hand-And Foot Syndrome): Report Of A Case

Şahin¹,

Terek²,

Özsaran³

et al. 2011

J Turk Soc Obstet Gynecol

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Liposomal Doxorubicin in Ovarian, Peritoneal, and Tubal Carcinoma: A Retrospective Comparative Study of Single-Agent Dosages

Cited by 100 publications

References 7 publications

ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer

ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer

Pegylated Liposomal Doxorubicin Consolidation Therapy after Platinum/Paclitaxel-Based Chemotherapy for Suboptimally Debulked, Advanced-Stage Epithelial Ovarian Cancer Patients

Liposomal Doxorubicin-Related Palmar-Plantar Erthrodysesthesia (Hand-And Foot Syndrome): Report Of A Case

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