A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer

Okuma, Yusuke; Hosomi, Yukio; Takahashi, Satoshi; Nakahara, Yoshiaki; Watanabe, Kageaki; Nagamata, Makoto; Takagi, Yusuke; Mikura, Sunao

doi:10.1007/s00280-016-3092-9

Cited by 11 publications

(7 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Certainly, more information concerning nanotoxicity and biodistribution may come from the data obtained from aged patients treated with nanomaterials. [63][64][65] In a recent review of patients with lung cancer treated with nanoparticles, Herrera et al 66 included data related to the safety and tolerability of nanomaterials, while highlighting the underrepresentation of elderly patients in the clinical trials. Despite all the age-dependent effects observed in the present study, it is important to remember that the investigated elderly animals did not present any histological alterations or the clinical characteristics of old mice, thus evidencing they were in good health.…”

Section: Discussionmentioning

confidence: 99%

<p>The influence of female mice age on biodistribution and biocompatibility of citrate-coated magnetic nanoparticles</p>

Pinheiro

Fascineli

Farias

et al. 2019

IJN

View full text Add to dashboard Cite

Background: Magnetic nanoparticles (MNPs) have been successfully tested for several purposes in medical applications. However, knowledge concerning the effects of nanostructures on elderly organisms is remarkably scarce. Purpose: To fill part of this gap, this work aimed to investigate biocompatibility and biodistribution aspects of magnetic nanoparticles coated with citrate (NpCit) in both elderly and young healthy mice. Methods: NpCit (2.4 mg iron) was administered intraperitoneally, and its toxicity was evaluated for 28 days through clinical, biochemical, hematological, and histopathological examinations. In addition, its biodistribution was evaluated by spectrometric (inductively coupled plasma optical emission spectrometry) and histological methods. Results: NpCit presented age-dependent effects, inducing very slight and temporary biochemical and hematological changes in young animals. These changes were even weaker than the effects of the aging process, especially those related to the hematological data, tumor necrosis factor alpha, and nitric oxide levels. On the other hand, NpCit showed a distinct set of results in the elderly group, sometimes reinforcing (decrease of lymphocytes and increase of monocytes) and sometimes opposing (erythrocyte parameters and cytokine levels) the aging changes. Leukocyte changes were still observed on the 28th day after treatment in the elderly group. Slight evidence of a decrease in liver and immune functions was detected in elderly mice treated or not treated with NpCit. It was noted that tissue damage or clinical changes related to aging or to the NpCit treatment were not observed. As detected for aging, the pattern of iron biodistribution was significantly different after NpCit administration: extra iron was detected until the 28th day, but in different organs of elderly (liver and kidneys) and young (spleen, liver, and lungs) mice. Conclusion: Taken together, the data show NpCit to be a stable and reasonably biocompatible sample, especially for young mice, and thus appropriate for biomedical applications. The data showed important differences after NpCit treatment related to the animals' age, and this emphasizes the need for further studies in older animals to appropriately extend the benefits of nanotechnology to the elderly population.

show abstract

Section: Discussionmentioning

confidence: 99%

<p>The influence of female mice age on biodistribution and biocompatibility of citrate-coated magnetic nanoparticles</p>

Pinheiro

Fascineli

Farias

et al. 2019

IJN

View full text Add to dashboard Cite

show abstract

“…The development of the coronavirus disease 2019 (COVID‐19) vaccines has highlighted the need to assess potential vaccines and therapeutics in different age groups, and indeed clinical trials often involve age‐related studies of therapeutic efficacy and safety. [ 182,183 ] Age‐related studies involving NPs have largely focused on toxicity studies of NPs, including ZnO, silver, copper, aluminum, and TiO 2 ( Figure ). [ 184–186 ] Older animals have generally been shown to be more susceptible to the adverse effects of nanomaterials than younger animals.…”

Section: Organism Levelmentioning

confidence: 99%

A Focus on “Bio” in Bio–Nanoscience: The Impact of Biological Factors on Nanomaterial Interactions

Cortez‐Jugo

Czuba-Wojnilowicz

Tan

et al. 2021

Adv Healthcare Materials

View full text Add to dashboard Cite

Bio–nanoscience research encompasses studies on the interactions of nanomaterials with biological structures or what is commonly referred to as the biointerface. Fundamental studies on the influence of nanomaterial properties, including size, shape, composition, and charge, on the interaction with the biointerface have been central in bio–nanoscience to assess nanomaterial efficacy and safety for a range of biomedical applications. However, the state of the cells, tissues, or biological models can also influence the behavior of nanomaterials at the biointerface and their intracellular processing. Focusing on the “bio” in bio–nano, this review discusses the impact of biological properties at the cellular, tissue, and whole organism level that influences nanomaterial behavior, including cell type, cell cycle, tumor physiology, and disease states. Understanding how the biological factors can be addressed or exploited to enhance nanomaterial accumulation and uptake can guide the design of better and suitable models to improve the outcomes of materials in nanomedicine.

show abstract

“…In phase II and III trials, nab‐PTX and carboplatin significantly increased the objective response rate (ORR) in comparison with conventional PTX in patients with untreated advanced NSCLC. 11 , 12 , 13 , 14 , 15 Moreover, nab‐PTX monotherapy showed antitumor activity against untreated advanced NSCLC in a phase I/II study. 16 However, its role as third‐line or later‐line chemotherapy for previously treated NSCLC has not been clarified.…”

Section: Introductionmentioning

confidence: 99%

“…Nab‐PTX reduces the risk of anaphylaxes triggered by Cremophor EL compared with conventional PTX. In phase II and III trials, nab‐PTX and carboplatin significantly increased the objective response rate (ORR) in comparison with conventional PTX in patients with untreated advanced NSCLC 11–15 . Moreover, nab‐PTX monotherapy showed antitumor activity against untreated advanced NSCLC in a phase I/II study 16 .…”

Section: Introductionmentioning

confidence: 99%

Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402

Miyauchi

Tanaka

Nakamura³

et al. 2021

Thoracic Cancer

View full text Add to dashboard Cite

Background NJLCG1402 was a phase I/II trial investigating biweekly nanoparticle albumin‐bound paclitaxel (nab‐PTX) in patients with advanced non‐small cell lung cancer (NSCLC). Methods The study included patients aged ≥20 years with previously treated NSCLC. Nab‐PTX (100–150 mg/m2) was administered biweekly in a 28‐day cycle. The phase I portion was performed to determine the recommended phase II dose of nab‐PTX. In the phase II portion, the primary endpoint was the objective response rate. Secondary endpoints were disease control rate, progression‐free survival, overall survival, and safety. Results A total of 15 patients received biweekly nab‐PTX (100–150 mg/m2) and 12 patients in phase II were treated with 150 mg/m2. In the phase I portion, 150 mg/m2 was determined as the recommended dose. Among those treated with 150 mg/m2, the objective response rate was 22%, and the median progression‐free and overall survival was 3.6 and 11.2 months, respectively. Adverse events grade ≥3 were observed in 39% of patients. Conclusions Biweekly nab‐PTX monotherapy was well tolerated and exhibited favorable antitumor activity in patients with previously treated NSCLC.

show abstract

A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer

Abstract: UMIN-CTR identifier: UMIN000010738.

Cited by 11 publications

References 21 publications

<p>The influence of female mice age on biodistribution and biocompatibility of citrate-coated magnetic nanoparticles</p>

<p>The influence of female mice age on biodistribution and biocompatibility of citrate-coated magnetic nanoparticles</p>

A Focus on “Bio” in Bio–Nanoscience: The Impact of Biological Factors on Nanomaterial Interactions

Phase I/II study of biweekly nab‐paclitaxel in patients with platinum‐pretreated non‐small cell lung cancer: NJLCG1402

Contact Info

Product

Resources

About