Phase III Trial Comparing Paclitaxel Poliglumex (CT-2103, PPX) in Combination with Carboplatin Versus Standard Paclitaxel and Carboplatin in the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer

Langer, Corey J.; O’Byrne, Kenneth J.; Socinski, Mark A.; Михайлов, С. М.; Leśniewski-Kmak, Krzysztof; Šmakal, Martin; Ciuleanu, Tudor-Eliade; Орлов, С. В.; Dediu, Mircea; Heigener, David F.; Eisenfeld, Amy J.; Sandalic, Larissa; Oldham, Fred B.; Singer, Jack W.; Ross, Helen J.

doi:10.1097/jto.0b013e3181753b4b

Cited by 180 publications

(88 citation statements)

References 19 publications

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“…However, the combination of CT-2103 and carboplatin was not superior to PTX and carboplatin in a randomized Phase III trial in patients with lung cancer. 22 Furthermore, PGA-PTX has not been reported to self-assemble into nanoparticles. In our study, a new nanoconjugate platform, PGG-PTX, was designed and synthesized without utilizing diblock copolymers.…”

Section: Resultsmentioning

confidence: 99%

Synthesis, characterization, and biological evaluation of poly(L-γ-glutamyl-glutamine)-paclitaxel nanoconjugate

van¹

2010

IJN

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Abstract:The purpose of this study was to develop a novel, highly water-soluble poly(L-γ-glutamyl-glutamine)-paclitaxel nanoconjugate (PGG-PTX) that would improve the therapeutic index of paclitaxel (PTX). PGG-PTX is a modification of poly(L-glutamic acid)-paclitaxel conjugate (PGA-PTX) in which an additional glutamic acid has been added to each glutamic side chain in the polymer. PGG-PTX has higher water-solubility and faster dissolution than PGA-PTX. Unlike PGA-PTX, PGG-PTX self-assembles into nanoparticles, whose size remains in the range of 12-15 nm over the concentration range from 25 to 2,000 µg/mL in saline. Its critical micellar concentration in saline was found to be ∼25 µg/mL. The potency of PGG-PTX when tested in vitro against the human lung cancer H460 cell line was comparable to other known polymer-PTX conjugates. However, PGG-PTX possesses lower toxicity compared with PGA-PTX in mice. The maximum tolerated dose of PGG-PTX was found to be 350 mg PTX/kg, which is 2.2-fold higher than the maximum tolerated dose of 160 mg PTX/kg reported for the PGA-PTX. This result indicates that PGG-PTX was substantially less toxic in vivo than PGA-PTX.

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Section: Resultsmentioning

confidence: 99%

Synthesis, characterization, and biological evaluation of poly(L-γ-glutamyl-glutamine)-paclitaxel nanoconjugate

van¹

2010

IJN

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“…A recent review indicated a median progression-free survival (PFS) of 8-13 months for patients with EGFRm-positive NSCLC receiving first-line EGFR TKIs 19 . In contrast, median time to progression or PFS for patients receiving platinum-based doublet chemotherapy combinations was 4-6 months [20][21][22][23] . The National Comprehensive Cancer Network (NCCN) guidelines recommend first-line therapy with an approved TKI for treatment of EGFRm-positive NSCLC 4 .…”

Section: Introductionmentioning

confidence: 99%

Healthcare costs in patients with advanced non-small cell lung cancer and disease progression during targeted therapy: a real-world observational study

Skinner

Fernandes

Walker

et al. 2017

Journal of Medical Economics

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Aims: To assess healthcare costs during treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and following disease progression in patients with advanced non-small cell lung cancer (NSCLC). Methods: A retrospective analysis of medical records of US community oncology practices was conducted. Eligible patients had advanced NSCLC (stage IIIB/IV) diagnosed between January 1, 2008 and January 1, 2015, initiated treatment with erlotinib or afatinib (first-line or second-line), and had disease progression. Monthly Medicare-paid costs were evaluated during the TKI therapy period and following progression. Results: The study included 364 patients. The total mean monthly cost during TKI therapy was $20,106 (95% confidence interval [CI] ¼ $16,836-$23,376), of which 47.0% and 42.4% represented hospitalization costs and anti-cancer therapy costs, respectively. Following progression on TKI therapy (data available for 316 patients), total mean monthly cost was $19,274 (95% CI ¼ $15,329-$23,218), and was higher in the 76.3% of patients who received anti-cancer therapy following progression than in the 23.7% of those who did not ($20,490 vs $15,364; p < .001). Among patients who received it, anticancer therapy ($11,198; 95% CI ¼ $7,102-$15,295) represented 54.7% of total mean monthly cost. Among patients who did not receive anti-cancer therapy, hospitalization ($13,829; 95% CI ¼ $4,922-$22,736) represented 90.0% of total mean monthly cost. Impaired performance status and brain metastases were significant predictors of increased cost during TKI therapy. Limitations: The study design may limit the generalizability of findings. Conclusions: Healthcare costs during TKI treatment and following progression appeared to be similar and were largely attributed to hospitalization and anti-cancer therapy. Notably, almost one-quarter of patients did not receive anti-cancer therapy following progression, potentially indicating an unmet need; hospitalization was the largest cost contributor for these patients. Additional effective targeted therapies are needed that could prolong progression-free survival, leading to fewer hospitalizations for EGFR mutation-positive patients.ARTICLE HISTORY

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“…They are based on the traditional cytotoxic drugs (e.g. platinates [145,146], doxorubicin [147,148], camptothecin and analogues [149][150][151][152][153][154][155][156][157][158][159], paclitaxel/docetaxel [160][161][162][163][164], methotrexate [165], and irinotecan [166,167]). Xyotax (CT-2103 or OPAXIO), a PGA-paclitaxel conjugate, and NKTR-102, a polymer conjugate of irinotecan, are both currently in phase III clinical trials, being the conjugates closest to approval and market availability [164,[166][167][168].…”

Section: Polymer Therapeuticsmentioning

confidence: 99%

Advanced targeted therapies in cancer: Drug nanocarriers, the future of chemotherapy

Pérez-Herrero

Fernández‐Medarde

2015

European Journal of Pharmaceutics and Biopharmaceutics

1,460

754

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Cancer is the second worldwide cause of death, exceeded only by cardiovascular diseases. It is characterized by uncontrolled cell proliferation and an absence of cell death that, except for hematological cancers, generates an abnormal cell mass or tumor. This primary tumor grows thanks to new vasculatization and, in time, adquires metastatic potential and spreads to other body sites, which causes metastasis and finally death. Cancer is caused by damage or mutations in the genetic material of the cells due to environmental or inherited factors. While surgery and radiotherapy are the primary treatment used for local and non-metastatic cancers, anti-cancer drugs (chemotherapy, hormone and biological therapies) are the choice currently used in metastasic cancers. Chemotherapy is based on the inhibition of the division of rapidly growing cells, which is a characteristic of the cancerous cells, but unfortunately, it also affects normal cells with fast proliferation rates, like the hair follicles, bone marrow and gastrointestinal tract cells, generating the characteristic side effects of chemotherapy. The indiscriminate destruction of normal cells, the toxicity of conventional chemotherapeutic Código de campo cambiado

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Phase III Trial Comparing Paclitaxel Poliglumex (CT-2103, PPX) in Combination with Carboplatin Versus Standard Paclitaxel and Carboplatin in the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer

Abstract: PPX/carboplatin failed to provide superior survival compared with paclitaxel/carboplatin in the first-line treatment of PS 2 patients with NSCLC, but the results with respect to progression-free survival and overall survival were comparable and the PPX regimen was more convenient.

Cited by 180 publications

References 19 publications

Synthesis, characterization, and biological evaluation of poly(L-γ-glutamyl-glutamine)-paclitaxel nanoconjugate

Synthesis, characterization, and biological evaluation of poly(L-γ-glutamyl-glutamine)-paclitaxel nanoconjugate

Healthcare costs in patients with advanced non-small cell lung cancer and disease progression during targeted therapy: a real-world observational study

Advanced targeted therapies in cancer: Drug nanocarriers, the future of chemotherapy

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Phase III Trial Comparing Paclitaxel Poliglumex (CT-2103, PPX) in Combination with Carboplatin Versus Standard Paclitaxel and Carboplatin in the Treatment of PS 2 Patients with Chemotherapy-Naïve Advanced Non-small Cell Lung Cancer

Abstract: PPX/carboplatin failed to provide superior survival compared with paclitaxel/carboplatin in the first-line treatment of PS 2 patients with NSCLC, but the results with respect to progression-free survival and overall survival were comparable and the PPX regimen was more convenient.

Cited by 180 publications

References 19 publications

Synthesis, characterization, and biological evaluation of poly(L-&gamma;-glutamyl-glutamine)-paclitaxel nanoconjugate

Synthesis, characterization, and biological evaluation of poly(L-&gamma;-glutamyl-glutamine)-paclitaxel nanoconjugate

Healthcare costs in patients with advanced non-small cell lung cancer and disease progression during targeted therapy: a real-world observational study

Advanced targeted therapies in cancer: Drug nanocarriers, the future of chemotherapy

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Product

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Synthesis, characterization, and biological evaluation of poly(L-γ-glutamyl-glutamine)-paclitaxel nanoconjugate

Synthesis, characterization, and biological evaluation of poly(L-γ-glutamyl-glutamine)-paclitaxel nanoconjugate