Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy

Kang, Yoon Koo; Ryu, Min‐Hee; Park, S. H.; Kim, J. G.; Kim, Jin Won; Cho, S. H.; Park, Y. I.; Park, S. R.; Rha, Sun Young; Kang, Myoung Joo; Cho, J. Y.; Kang, Seok Yun; Roh, Sang Young; Ryoo, Baek‐Yeol; Nam, Byung–Ho; Jo, Yeong-Woo; Yoon, Koung Eun; Oh, Sang Cheul

doi:10.1093/annonc/mdy055

Cited by 45 publications

(32 citation statements)

References 19 publications

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“…51 Liporaxel is approved in Korea for the treatment of gastric cancer, with similar efficacy as intravenous paclitaxel, and less neuropathy and no hypersensitivity reactions. 52 In the OPTIMAL phase II study of liporaxel, an ORR of 44.4% was seen in mTNBC. 53 A third oral taxane, tesetaxel, is being evaluated as a single agent for metastatic HER2-negative breast cancer (ClinicalTrials.gov identifier: NCT01221870) and in combination with immunotherapy in TNBC (NCT03952325).…”

Section: Oral Taxanesmentioning

confidence: 99%

Novel Agents for Metastatic Triple-Negative Breast Cancer: Finding the Positive in the Negative

Vidula

Ellisen

Bardia

2021

Journal of the National Comprehensive Cancer Network

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Metastatic triple-negative breast cancer (TNBC) is associated with a poor prognosis, and the development of better therapeutics represents a major unmet clinical need. Although the mainstay of treatment of metastatic TNBC is chemotherapy, advances in genomics and molecular profiling have helped better define subtypes of TNBC with distinct biologic drivers to guide the therapeutic development of targeted therapies, including AKT inhibitors for PI3K/AKT-altered TNBC, checkpoint inhibitors for PD-L1–positive TNBC, and PARP inhibitors for BRCA1/2 mutant TNBC. This progress may ultimately convert TNBC from a disease traditionally defined by the absence of therapeutically actionable receptors to one that is defined by the presence of discrete molecular targets with therapeutic implications. Furthermore, antibody drug conjugates have emerged as an important therapeutic strategy to target genomically complex tumors that lack actionable oncogenes but have overexpressed actionable surface receptors such as trop-2. In this article, we discuss promising novel agents for advanced TNBC, some of which have been incorporated into current clinical practice, and others that will likely change the therapeutic landscape and redefine the TNBC terminology in the near future.

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Section: Oral Taxanesmentioning

confidence: 99%

Novel Agents for Metastatic Triple-Negative Breast Cancer: Finding the Positive in the Negative

Vidula

Ellisen

Bardia

2021

Journal of the National Comprehensive Cancer Network

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“… x In Satoh et al (2015) [62], Satoh et al (2014) [46], Sym et al (2013) [55], Thuss‐Patience et al (2011) [47], Yi et al (2012) [43], Higuchi et al (2014) [44], Fuchs et al (2014) [42], Kim et al (2015) [45], Roy et al (2013) [54], Bang et al (2017a) [69], Kang et al (2018) [51], Thuss‐Patience et al (2017) [66], Van Cutsem et al (2017) [72], Lee et al (2019) [117], and Moehler et al (2016) [118], no information was provided regarding the handling of data from patients with measurable versus nonmeasurable disease. …”

Section: Resultsmentioning

confidence: 99%

“… ae In Bang et al (2015) [48], Wilke et al (2014) [41], Muro et al (2016) [63], Shitara et al (2016) [64], Bang et al (2017a) [69], Kang et al (2018) [51], Kim et al (2015) [45], Shitara et al (2018b) [76], Thuss‐Patience et al (2017) [66], Van Cutsem et al (2017) [72], Lee et al (2019) [117], Fushida et al (2016) [60], Pavlakis et al (2016) [74], and Shitara et al (2014) [59], RECIST version 1.1 criteria were used. …”

Section: Resultsmentioning

confidence: 99%

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Toward a Treatment Sequencing Strategy: A Systematic Review of Treatment Regimens in Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

et al. 2021

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Background. Platinum and fluoropyrimidine combinations typically comprise first-line (1L) therapy in advanced gastric cancer or gastroesophageal junction adenocarcinoma (G/GEA), although controversy exists regarding the use of doublet versus triplet cytotoxic regimens. Historically, second-line (2L) and third-line or later (3L+) therapy has been fragmented. Recent trials have increased the need for optimal treatment sequencing in advanced G/GEA. Materials and Methods. We conducted a systematic search of peer-reviewed manuscripts of randomized clinical trials examining 1L, 2L, and 3L+ therapy for advanced G/GEA published from 2009 through November 19, 2019. When available, overall survival, progression-free survival, time to progression, overall response rate, and toxicity were extracted from each and compared descriptively.Results. In 1L therapy, chemotherapy triplets demonstrated variable efficacy improvements with invariable increased toxicity compared to platinum/fluoropyrimidine doublets. Currently, the only published report of positive outcomes using biologics in 1L is adding trastuzumab in HER2+ advanced G/GEA. In 2L, doublet chemotherapy regimens are not uniformly more efficacious than single-agent taxanes or irinotecan, and ramucirumab has demonstrated improved outcomes as both monotherapy or combination. Conclusion.For advanced G/GEA, review of trial results from 2009-2019 support 1L therapy with platinum and fluoropyrimidine and sequencing with taxanes or irinotecan in combination with biologics as effective 2L options. Escalating to a triplet may add some efficacy at the expense of added toxicity. The Oncologist 2021;9999:• • Implications for Practice: The rapidly changing treatment landscape for advanced gastric cancer includes increasing options for refractory disease. With multiple first-line platinum-based regimens, identification of those with the best benefit-to-risk ratio may provide guidance on treatment sequencing strategies. Herein, we present findings from the published literature of randomized controlled trials that included a first-line platinum/fluoropyrimidine combination and, for second-line trials, patients with platinum/fluoropyrimidine-refractory disease. This guiding summary could be a tool for clinicians to identify the optimal first-line regimen(s) followed by a strategy for subsequent regimens.

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“…It has been only available in injectable dosage form due to the low oral BA (2% of absolute BA in rats) and there have been extensive attempts to develop oral dosage forms for more than three decades [1,102]. Finally, a novel oral formulation, DHP107, was approved in South Korea in 2016, which is an oily liquid composed of monoolein, tricaprylin, polysorbate 80 and 1% PTX and supposed to be mucoadhesive in the GI tract [103,104]. This success has casted a light upon the pharmaceutical research and soon there, would be more oral dosage forms of paclitaxel that can reach clinical application.…”

Section: Paclitaxelmentioning

confidence: 99%

Liposomes for Enhanced Bioavailability of Water-Insoluble Drugs: In Vivo Evidence and Recent Approaches

Lee

2020

Pharmaceutics

188

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It has been known that a considerable number of drugs in clinical use or under development are water-insoluble drugs with poor bioavailability (BA). The liposomal delivery system has drawn attention as one of the noteworthy approaches to increase dissolution and subsequently absorption in the gastrointestinal (GI) tract because of its biocompatibility and ability to encapsulate hydrophobic molecules in the lipid domain. However, there have been several drawbacks, such as structural instability in the GI tract and poor permeability across intestinal epithelia because of its relatively large size. In addition, there have been no liposomal formulations approved for oral use to date, despite the success of parenteral liposomes. Nevertheless, liposomal oral delivery has resurged with the rapid increase of published studies in the last decade. However, it is discouraging that most of this research has been in vitro studies only and there have not been many water-insoluble drugs with in vivo data. The present review focused on the in vivo evidence for the improved BA of water-insoluble drugs using liposomes to resolve doubts raised concerning liposomal oral delivery and attempted to provide insight by highlighting the approaches used for in vivo achievements.Pharmaceutics 2020, 12, 264 2 of 30 However, there have been several drawbacks to be overcome, such as instability in the GI tract and poor permeability across the intestinal epithelia because of liposomes' relatively large size [8]. Moreover, it seemed that liposomal oral delivery was faltering during 1980s due to some disappointing results for insulin [9]. However, liposomal oral delivery resurged with a rapid increase in the number of papers published, as shown in Pubmed search results, mainly due to various advanced modification technologies, even though liposomal oral delivery-related papers account for only 5-6% of the total number of liposomes-related studies (Figure 1). In addition, there was an encouraging meta-analysis report in which phospholipid-based solid formulations were analyzed as being effective for BA enhancement [10]. Although liposomal delivery does not seem to achieve satisfactory improvement of oral BA for peptides and protein drugs yet, it looks more promising for oral delivery of hydrophobic drugs because liposomes can solubilize poorly water-soluble drugs, protect the drug from degradation in the GI tract and enhance permeability through the epithelial cell membrane, consequently increasing oral BA. However, most published papers performed in vitro studies only, thus lacking in vivo pharmacokinetic results. The present review focuses on the in vivo evidence for the improved BA of water-insoluble drugs and highlights the approaches used for in vivo achievements.

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Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy

Abstract: NCT01839773.

Cited by 45 publications

References 19 publications

Novel Agents for Metastatic Triple-Negative Breast Cancer: Finding the Positive in the Negative

Novel Agents for Metastatic Triple-Negative Breast Cancer: Finding the Positive in the Negative

Toward a Treatment Sequencing Strategy: A Systematic Review of Treatment Regimens in Advanced Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Liposomes for Enhanced Bioavailability of Water-Insoluble Drugs: In Vivo Evidence and Recent Approaches

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