A comparison of overall survival with 40 and 50 mg/m 2 pegylated liposomal doxorubicin treatment in patients with recurrent epithelial ovarian cancer: Propensity score-matched analysis of real-world data

Nakayama, Masahiko; Kobayashi, Hisanori; Takahara, T.; Nishimura, Yukiko; Fukushima, Koji; Yoshizawa, Kazutake

doi:10.1016/j.ygyno.2016.08.331

Cited by 12 publications

(6 citation statements)

References 37 publications

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“…However, equivalent clinical activity with a substantially less severe adverse event profile has been observed when this agent is administered at 40 mg/m 2 on a 4 week schedule [47]. Additional clinical evidence supports the conclusion that a 40 mg/m 2 dose level of PLD is therapeutically equivalent to the higher (and more toxic) dose [48][49][50] and thus is being evaluated in the current trial. For relapsed ovarian cancer patients, approved topotecan dosing is 1.5 mg/m 2 administered on days 1-5 of a 3 week schedule.…”

Section: Background and Rationalesupporting

confidence: 56%

FORWARD I: A Phase III Study of Mirvetuximab Soravtansine Versus Chemotherapy in Platinum-Resistant Ovarian Cancer

Moore

Vergote²,

Oaknin

et al. 2018

Future Oncol.

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Mirvetuximab soravtansine, an antibody-drug conjugate that binds with high affinity to folate receptor-α to provide tumor-directed delivery of the potent microtubule-disrupting agent DM4, has emerged as a promising investigational agent for the treatment of ovarian cancer, particularly in the setting of platinum-resistant disease. Here we describe the rationale and design of FORWARD I (NCT02631876), the first randomized, multicenter Phase III study to compare the safety and efficacy of mirvetuximab soravtansine versus investigator's choice of chemotherapy in women with folate receptor-α-positive, platinumresistant epithelial ovarian, primary peritoneal or fallopian tube cancer. Patients will be randomized in a 2:1 ratio. The primary end point is progression-free survival, and key secondary objectives include comparison of overall response rates, overall survival and duration of response. Ovarian cancer is a leading cause of gynecologic cancer mortality worldwide, responsible for over 150,000 deaths each year [1]. Family history and the presence of penetrant mutations in genes such as BRCA1 and BRCA2 are significant risk factors for the development of ovarian cancer; epidemiological research has also identified a variety of hormonal and reproductive factors that can either increase (e.g., older age at menopause, hormone replacement therapy) or decrease (e.g., parity, lactation, oral contraceptive use) the likelihood of disease (reviewed in [2]). Epithelial ovarian cancer (EOC) accounts for approximately 95% of ovarian cancer malignancies [3,4]. EOC is highly chemosensitive, with the current standard-of-care treatment for newly diagnosed cases involving debulking surgery and adjuvant platinum-and taxane-based combination chemotherapy. Most individuals achieve remission with front-line therapy; unfortunately up to 80% of patients will relapse during or after treatment with eventual drug-resistant disease [5]. Disease recurring within 6 months of platinum-based chemotherapy is classified as platinum-resistant, whereas disease recurring >6 months after therapy is considered platinum sensitive. Patients with platinum-sensitive disease have a high likelihood of responding to additional platinum-based therapy; however, almost all will eventually develop acquired (secondary) platinum resistance [5,6] ovarian cancer typically receive single-agent chemotherapy at relapse. Outcomes for these patients remain poor, with low response rates to further chemotherapy (15-20%), progression-free survival (PFS) of 3-4 months [7][8][9], and a median overall survival rate of less than a year [5]. In addition, this treatment approach is associated with additional, cumulative toxicities and limited tolerability for patients. It has been suggested that natural compounds, such as phytochemicals, may alleviate chemotherapy-induced side effects and therefore may be useful as adjuvants to standard treatment [10]; however, this field remains in its infancy. These measures underscore a critical need for innovative and effective therapeutic stra...

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Section: Background and Rationalesupporting

confidence: 56%

FORWARD I: A Phase III Study of Mirvetuximab Soravtansine Versus Chemotherapy in Platinum-Resistant Ovarian Cancer

Moore

Vergote²,

Oaknin

et al. 2018

Future Oncol.

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show abstract

“…PLD therapy is clinically administered at various doses in the range of 30–50 mg/m 2 ; thus, the available evidence should be carefully interpreted because the efficacy and adverse effects may vary. The present study was conducted with a maximum tolerated dose of 50 mg/m 2 , but certain studies have reported similar efficacy and lower toxicity with doses of 40 mg/m 2 [ 16 17 ]. According to the results of this study, the efficacy of PLD monotherapy in platinum-resistant ROC does not appear to be more than expected; therefore, it might be worthwhile to consider a lower dose of treatment that can reduce toxicity without significantly decreasing the efficacy, and a comparative study of the therapeutic effect and side effects of each dose in Asian women is required.…”

Section: Discussionmentioning

confidence: 99%

The efficacy and safety of pegylated liposomal doxorubicin monotherapy and combination therapy with carboplatin in Korean patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer: a single-institution experience

et al. 2017

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ObjectiveThis study aimed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) with or without carboplatin in Korean patients with recurrent ovarian cancer (ROC), fallopian tube, or primary peritoneal cancer.MethodsThis retrospective study included 52 patients with ROC, fallopian tube, or primary peritoneal cancer who received PLD (50 mg/m2) between 1st December 2014 and 31th July 2016.ResultsThe mean number of chemotherapy cycles was 3.8 (range, 2 to 9) in the PLD monotherapy group and 7 (range, 2 to 13) in the PLD combined with carboplatin (PLD-C) group. In overall response rates and clinical beneficial rates, PLD monotherapy group shows 5.0% and 17.5%, and PLD-C group shows 33.3% and 75.0%. The mean progression-free survival (PFS) was 5 and 13 months in the PLD monotherapy and PLD-C groups, respectively. At 6 months after treatment initiation, absence of disease progression was confirmed in 6 (15%) and 10 (83.3%) patients in the PLD monotherapy and PLD-C groups. Hematological adverse events (e.g., neutropenia and thrombocytopenia) were more common in the PLD-C group (P<0.001, P=0.004). The incidence of anemia and non-hematological adverse events, including mucositis, hand-foot syndrome, and allergic reactions, was similar in both groups.ConclusionThis study demonstrated the efficacy and safety of PLD monotherapy and PLD-C combination in Korean patients with ROC. This study would be helpful to consider the degree of worry about side effects and treatment expectations after treatment. Further retrospective studies with larger samples are required to confirm the efficacy of PLD monotherapy in Asian patients with platinum-resistant ROC.

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“…In addition, combination therapy with PLD and bevacizumab shrank the recent recurrent tumor that had appeared following surgical resection and that had increased in size after the third‐line chemotherapy. Both PLD alone and PLD combined with bevacizumab have been effective for recurrent ovarian cancer, with some specific severe adverse effects . No case of HCO, however defined, treated with PLD and bevacizumab has been reported to date.…”

Section: Discussionmentioning

confidence: 99%

Recurrent ovarian undifferentiated carcinoma resembling hepatoid morphology treated with pegylated liposomal doxorubicin and bevacizumab

Ishiguro

Kashima

Yachida

et al. 2017

J of Obstet and Gynaecol

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Hepatoid carcinomas are undifferentiated epithelial carcinomas that are pathologically similar to hepatocellular carcinoma, but occur in a variety of organs. Hepatoid carcinomas, as strictly defined, typically produce α-fetoprotein. In addition, a standard effective chemotherapy regimen for hepatoid carcinoma has yet to be established. We present a case of advanced primary ovarian cancer that was pathologically similar to hepatoid carcinoma without staining for α-fetoprotein or hepatocyte paraffin 1. The primary ovarian, metastatic, and recurrent tumors shared similar pathological characteristics. Fourth-line chemotherapy with pegylated liposomal doxorubicin and bevacizumab was effective in treating the recurrent tumor, even though this disease had recurred three times.

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A comparison of overall survival with 40 and 50 mg/m 2 pegylated liposomal doxorubicin treatment in patients with recurrent epithelial ovarian cancer: Propensity score-matched analysis of real-world data

Abstract: Our study showed that the efficacy of PLD did not differ based on initial dosages, but the risk of adverse events was reduced with PLD40. Considering the balance between patient benefits and risks, our results support the use of PLD40 in clinical practice.

Cited by 12 publications

References 37 publications

FORWARD I: A Phase III Study of Mirvetuximab Soravtansine Versus Chemotherapy in Platinum-Resistant Ovarian Cancer

FORWARD I: A Phase III Study of Mirvetuximab Soravtansine Versus Chemotherapy in Platinum-Resistant Ovarian Cancer

The efficacy and safety of pegylated liposomal doxorubicin monotherapy and combination therapy with carboplatin in Korean patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer: a single-institution experience

Recurrent ovarian undifferentiated carcinoma resembling hepatoid morphology treated with pegylated liposomal doxorubicin and bevacizumab

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