Treatment Patterns and Health Outcomes in Platinum-Refractory or Platinum-Resistant Ovarian Cancer: A Retrospective Medical Record Review

Parikh, Rohan C.; Kurosky, Samantha; Udall, Margarita; Chang, Jane; Cappelleri, Joseph C.; Doherty, Jim; Kaye, James A.

doi:10.1097/igc.0000000000001222

Cited by 10 publications

(15 citation statements)

References 14 publications

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“…For platinum-resistant/platinumrefractory relapse, sequential single-agent salvage chemotherapy is superior to multiagent chemotherapy which increases toxicity without clear bene ts; however, no priority sequence of these single agents is recommended [5]. As previously mentioned, PLD is the most common initial therapy in the real world [6]. In this preliminary analysis, though the total sample size was 67 (less than 78), 20 patients had achieved an objective response.…”

Section: Discussionmentioning

confidence: 78%

“…Patients with platinum-refractory or resistant relapse were assessed with a Simon's two-stage design with a two-sided an error of 5% and a power of 80% [15]. Previous studies indicated that objective response rate of PLD monotherapy in patients with platinum-refractory or resistant relapse was 15% − 40.4% [6,16], and we initially expected that the objective response rate of PLD in these patients would be 30%. Therefore, we set P0 to 15%, and P1 to 30% in this study.…”

Section: Methodsmentioning

confidence: 99%

“…The current management and treatment options for platinum-resistant and platinum-refractory recurrent ovarian cancer are limited [5]. A retrospective study described the real-world treatment patterns in these patients from January 2010 to June 2014 in the United States, the United Kingdom, and Canada and found that the most common initial therapy was pegylated liposomal doxorubicin (PLD) monotherapy [6].…”

Section: Introductionmentioning

confidence: 99%

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Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

Yuan

Zhang

Cao

et al. 2020

Preprint

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Abstract Objective To evaluate the efficacy and safety of PLD in treating of in patients with epithelial ovarian, tubal, and peritoneal cancer progression within 12 months after the first-line platinum-based therapy. Methods This was an open-label, single-arm and multicenter clinical trial. ORR was the interim primary objective and DCR, AEs and QOL were the secondary objectives. The impact of factors on the efficacy outcomes, the change trend of CA125 and the artificial platinum-free interval were exploratory endpoints. Results Totally, 115 patients were enrolled in this study and included in the ITT. Moreover, 101 patients were included in the safety analysis. The median follow-up time was 4 months (IQR 2–6). In ITT, the confirmed ORR was 37.4% (95%CI, 28.4%-46.4%), and the DCR was 65.2% (95%CI, 56.4%-74.1%). The previous response status to platinum-based chemotherapy and baseline CA125 levels were statistically correlated with the ORR. The ORR was significantly higher in the patients with a CA125 decrease after the first cycle than in the patients with a CA125 increase. The most common grade 3 or higher AE was hand-foot syndrome (3 [3.0%] of 101 patients). No statistically significant differences existed between the baseline and the postbaseline questionnaires. Conclusions For patients with platinum-resistant and platinum refractory relapse, the use of PLD may be a favorite choice because of the associated satisfactory efficacy, low frequency of AEs and high patient QOL. Moreover, a lower CA125 level at baseline and a reduction in CA125 after the first cycle are predictive factors for a better efficacy.

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Section: Discussionmentioning

confidence: 78%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

Yuan

Zhang

Cao

et al. 2020

Preprint

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“…A larger dose expansion cohort would have more clearly characterized disease response. PPROC comprises a small subset ($10%) of patients with EOC with a dismal survival outcome (14). The scarcity of these patients meant that the PPROC-only cohort failed to recruit and was eventually closed.…”

Section: Discussionmentioning

confidence: 99%

“…13 Novartis Pharma AG, Basel, Switzerland. 14 Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.…”

Section: ) Inhibitors Of the Upstream Kinase Mtorc1 Have Been Shown mentioning

confidence: 99%

Phase IB Dose Escalation and Expansion Study of AKT Inhibitor Afuresertib with Carboplatin and Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer

Blagden

Hamilton

Mileshkin

et al. 2019

Clinical Cancer Research

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Purpose: Preclinically, AKT kinase inhibition restores drug sensitivity in platinum-resistant tumors. Here the pan-AKT kinase inhibitor afuresertib was given in combination with paclitaxel and carboplatin (PC) in patients with recurrent platinum-resistant epithelial ovarian cancer (PROC) and primary platinum-refractory ovarian cancer (PPROC). Patients and Methods: Part I was a combination 3þ3 dose escalation study for recurrent ovarian cancer. Patients received daily continuous oral afuresertib at 50-150 mg/day with intravenous paclitaxel (175 mg/m 2) and carboplatin (AUC5) every 3 weeks for six cycles followed by maintenance afuresertib at 125 mg/day until progression or toxicity. Part II was a single-arm evaluation of the clinical activity of this combination in recurrent PROC (Cohort A) or PPROC (Cohort B). Patients received oral afuresertib at the MTD defined in Part I in combination with PC for six cycles, followed by maintenance afuresertib. Primary endpoints were safety and tolerability of afuresertib in combination with PC (Part I, dose escalation), and investigator-assessed overall response rate (ORR) as per RECIST version 1.1 (Part II). Results: Twenty-nine patients enrolled into Part I, and 30 into Part II. Three dose-limiting toxicities of grade 3 rash were observed, one at 125 mg and two at 150 mg afuresertib. The MTD of afuresertib in combination with PC was therefore identified as 125 mg/day. The most common (!50%) drugrelated adverse events observed in Part I of the study were nausea, diarrhea, vomiting, alopecia, fatigue, and neutropenia and, in Part II, were diarrhea, fatigue, nausea, and alopecia. The Part II ORR in the intention to treat patients was 32% [95% confidence interval (CI), 15.9-52.4] by RECIST 1.1 and 52% (95% CI, 31.3-72.2) by GCIG CA125 criteria. Median progression-free survival was 7.1 months (95% CI, 6.3-9.0 months). Conclusions: Afuresertib plus PC demonstrated efficacy in recurrent PROC with the MTD of afuresertib defined as 125 mg/day.

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Platinum-free interval affects efficacy of following treatment for platinum-refractory or -resistant ovarian cancer

Kobayashi-Kato

Yunokawa

Bun

et al. 2019

Cancer Chemother Pharmacol

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Treatment Patterns and Health Outcomes in Platinum-Refractory or Platinum-Resistant Ovarian Cancer: A Retrospective Medical Record Review

Abstract: Current treatments for PRROC yield limited PFS and frequent hospitalizations reported to be related to toxicities or procedural complications, suggesting a continued unmet need for more effective and tolerable therapeutic strategies for PRROC.

Cited by 10 publications

References 14 publications

Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

Pegylated liposomal doxorubicin in patients with epithelial ovarian cancer

Phase IB Dose Escalation and Expansion Study of AKT Inhibitor Afuresertib with Carboplatin and Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer

Platinum-free interval affects efficacy of following treatment for platinum-refractory or -resistant ovarian cancer

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