Safety and efficacy evaluation of albumin-bound paclitaxel

Cecco, Sara; Aliberti, Maria; Baldo, Paolo; Giacomin, Elisa; Leone, Roberto

doi:10.1517/14740338.2014.893293

Cited by 34 publications

(28 citation statements)

References 40 publications

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“…It has recently received FDA and EMA approvals for the treatment of certain forms of both cancers [154]. It is also approved in the US for metastatic non-small cell lung cancer [155] (figure 1) and is still under evaluation for several other indications, such as metastatic urothelial tumours [156].…”

Section: Nab-paclitaxelmentioning

confidence: 99%

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Dermatological adverse events with taxane chemotherapy

Sibaud

LeBoeuf

Roché

et al. 2016

European Journal of Dermatology

177

179

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Taxanes (docetaxel and paclitaxel) are among the most commonly prescribed anticancer drugs approved for the treatment of metastatic or locally advanced breast, non-small cell lung, prostate, gastric, head and neck, and ovarian cancers, as well as in the adjuvant setting for operable node-positive breast cancers. Although the true incidence of dermatological adverse events (AEs) in patients receiving taxanes is not known, and has never been prospectively analysed, they clearly represent one of the major AEs associated with these agents. With an increase in the occurrence of cutaneous AEs during treatment with novel targeted and immunological therapies when used in combination with taxanes, a thorough understanding of reactions attributable to this class is imperative. Moreover, identification and management of dermatological AEs is critical for maintaining the quality of life in cancer patients and for minimizing dose modifications of their antineoplastic regimen. This analysis represents a systematic review of the dermatological conditions reported with the use of these drugs, complemented by experience at comprehensive cancer centres. The conditions reported herein include skin, hair, and nail toxicities. Lastly, we describe the dermatological data available for the new, recently FDA-and EMA- approved, solvent-free nab-paclitaxel.

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Section: Nab-paclitaxelmentioning

confidence: 99%

“…Nab-paclitaxel was developed to circumvent the highly hydrophobic properties of taxanes and to improve intratumoural paclitaxel penetration [154, 157]. Since it is devoid of Cremophor EL (the solvent for paclitaxel), several significant AEs, such as hypersensitivity reactions [154, 157], are less likely to be incurred.…”

Section: Nab-paclitaxelmentioning

confidence: 99%

Dermatological adverse events with taxane chemotherapy

Sibaud

LeBoeuf

Roché

et al. 2016

European Journal of Dermatology

177

179

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“…Overall, nab-paclitaxel is associated with more and different side effects than conventional paclitaxel (Table 4). However, the side effects reported could in this case very well originate from the situation in which nab-paclitaxel and conventional paclitaxel are used, in different treatment regimens or for different cancers as their indications are different, 26 which is also reflected by the indicative information from Lareb (Supplementary materials). Regarding efficacy, nab-paclitaxel is reported by the EMA to be more effective than conventional paclitaxelcontaining medicines in patients with metastatic breast cancer whose first treatment had stopped working.…”

mentioning

confidence: 95%

Nanomedicinal products: a survey on specific toxicity and side effects

Brand¹,

Noorlander²,

Giannakou³

et al. 2017

IJN

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Due to their specific properties and pharmacokinetics, nanomedicinal products (NMPs) may present different toxicity and side effects compared to non-nanoformulated, conventional medicines. To facilitate the safety assessment of NMPs, we aimed to gain insight into toxic effects specific for NMPs by systematically analyzing the available toxicity data on approved NMPs in the European Union. In addition, by comparing five sets of products with the same active pharmaceutical ingredient (API) in a conventional formulation versus a nanoformulation, we aimed to identify any side effects specific for the nano aspect of NMPs. The objective was to investigate whether specific toxicity could be related to certain structural types of NMPs and whether a nanoformulation of an API altered the nature of side effects of the product in humans compared to a conventional formulation. The survey of toxicity data did not reveal nanospecific toxicity that could be related to certain types of structures of NMPs, other than those reported previously in relation to accumulation of iron nanoparticles (NPs). However, given the limited data for some of the product groups or toxicological end points in the analysis, conclusions with regard to (a lack of) potential nanomedicine-specific effects need to be considered carefully. Results from the comparison of side effects of five sets of drugs (mainly liposomes and/or cytostatics) confirmed the induction of pseudo-allergic responses associated with specific NMPs in the literature, in addition to the side effects common to both nanoformulations and regular formulations, eg, with liposomal doxorubicin, and possibly liposomal daunorubicin. Based on the available data, immunotoxicological effects of certain NMPs cannot be excluded, and we conclude that this end point requires further attention.

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“…Nab-paclitaxel is a newly developed chemotherapy drug, which is albumin-bound paclitaxel nanoparticles (1). Compared with ordinary paclitaxel, nab-paclitaxel is highly soluble and can easily reach potential target tumor tissue through the bloodstream, exerting its broad-spectrum antitumor activity (2).…”

Section: Introductionmentioning

confidence: 99%

Paralytic ileus due to a novel anticancer drug, nab-paclitaxel: A case report

Jiao

Luo

Qin

et al. 2016

Molecular and Clinical Oncology

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Abstract. Nab-paclitaxel is a recently emerged chemotherapy drug, which is widely used for the treatment of multiple types of cancer. The prospects of this novel drug are very bright as a result of its higher efficacy and lower toxicity compared with paclitaxel. Hence, the side effect, even if rare, require attention in clinical practice. The present study described an unusual case of nab-paclitaxel-associated paralytic ileus. To the best of our knowledge, this is the first report to demonstrate that nab-paclitaxel may lead to acute intestinal obstruction. Since nab-paclitaxel will be used more frequently, this unusual side effect might be encountered by a clinical oncologist and must be treated correctly. This is the first reported case, to the best of our knowledge, of paralytic ileus caused by nab-paclitaxel, which will be widely used as a novel anticancer drug. IntroductionNab-paclitaxel is a newly developed chemotherapy drug, which is albumin-bound paclitaxel nanoparticles (1). Compared with ordinary paclitaxel, nab-paclitaxel is highly soluble and can easily reach potential target tumor tissue through the bloodstream, exerting its broad-spectrum antitumor activity (2). It is now commonly used in breast cancer, pancreatic cancer, lung cancer and gastric cancer (3-6). In clinical practice, the infusion time for nab-paclitaxel is shorter and the incidence of allergic reactions is notably lower compared with ordinary paclitaxel, which significantly potentiates its clinical efficacy (7). However, the safety of this agent remains to be fully understood, and the side effects have rarely been reported. Although there several previous studies focussing on the side effect of this novel drug, and the majority of the mentioned side effects were edema, heart failure, asthenia, neutropenia and neuropathy (8-12), another previous study reported a rare case of capillary leak syndrome and pulmonary hypertension following treatment with nab-paclitaxel (13). However, in consideration of the limited clinical administration and short practice time, certain rare side effects must exist, which may not have been revealed in clinical trails. The present study reported an unusual case of nab-paclitaxel-associated paralytic ileus. Although this case accepted gemcitabine and nab-paclitaxel at the same time, considering well-demonstrated side effects of gemcitabine (14), the present study deduced that the rare paralytic ileus was associated with nab-paclitaxel. This case was accurately diagnosed and recovered well following the effective treatments. The present case provided additional evidence for the probable adverse effect of this novel drug, which may further guide our clinical practice. Case reportA 65-year-old male with pancreatic cancer was admitted to the Department of Medical Oncology, Changzheng Hospital (Shanghai, China). He was diagnosed with pancreatic adenocarcinoma and had undergone a radical surgery 17 months previously (Fig. 1). However, the patient suffered from tumor recurrence and metastasis, according to a recent ...

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Safety and efficacy evaluation of albumin-bound paclitaxel

Cited by 34 publications

References 40 publications

Dermatological adverse events with taxane chemotherapy

Dermatological adverse events with taxane chemotherapy

Nanomedicinal products: a survey on specific toxicity and side effects

Paralytic ileus due to a novel anticancer drug, nab-paclitaxel: A case report

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