A Phase II Study of Weekly Nanoparticle Albumin-Bound Paclitaxel With or Without Trastuzumab in Metastatic Breast Cancer

Mirtsching, B.; Cosgriff, Thomas M.; Harker, Graydon; Keaton, Mark; Chidiac, T.; Min, Myo

doi:10.1016/j.clbc.2011.03.007

Cited by 59 publications

(37 citation statements)

References 42 publications

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“…A phase II trial on 22 patients with c-erb-2 positive breast cancer patients treated nab-paclitaxel 125 mg/m 2 /week plus trastuzumab 4 mg → 2 mg/kg/week as first line therapy reported an overall response rate of 52%. The most commonly observed toxicities were pain, fatigue and sensory neuropathy [15]. A combination of nab-paclitaxel 100 mg/m 2 /w plus carboplatin AUC6 + trastuzumab 4 mg → 2 mg/kg/week was tested as first line in a phase II trial comprising 32 patients with an overall response rate of 62% (95% CI: 46% -79%) and a progression-free survival of 16.6 months (95% CI: 7.5 -26.5 months).…”

Section: Discussionmentioning

confidence: 99%

Impressive Objective Response to Nab-Paclitaxel plus Trastuzumab as Fifth Line Therapy in an Elderly HER-2 Positive Breast Cancer Patient

Valerio¹,

Ancona²,

Marchese³

et al. 2017

JCT

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Background: Agent targeting HER-2 pathway plus chemotherapy has represented a major progress in the management of patients with breast cancer. However, the role of late-line treatment in heavily pretreated patients is still largely unclear. In the last decade, nab-paclitaxel has shown significant activity and good toxicity profile in metastatic breast cancer. Case Presentation: We report the case of a 76-year-old Caucasian woman with metastatic HER-2 positive ductal infiltrating breast carcinoma treated with a combination of weekly nab-paclitaxel and trastuzumab as fifth-line therapy. She had previously received first-line paclitaxel and trastuzumab, second-line vinorelbine and trastuzumab, third-line TDM1 and fourth-line oral capecitabine and lapatinib. Clinical and radiological staging showed progression at bone, skin and soft-tissue. The patient received weekly nab-paclitaxel plus trastuzumab. Massive objective response was clinically and PET documented which lasted 8 months. Tolerance to treatment was fairly good as well as cardiac safety. Conclusion: To the best of our knowledge, this is the first reported case of efficacy of nab-paclitaxel in combination with trastuzumab as fifth-line of treatment in a patient with metastatic HER-2 positive breast cancer.

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Section: Discussionmentioning

confidence: 99%

Impressive Objective Response to Nab-Paclitaxel plus Trastuzumab as Fifth Line Therapy in an Elderly HER-2 Positive Breast Cancer Patient

Valerio¹,

Ancona²,

Marchese³

et al. 2017

JCT

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“…44 In addition, nanoparticle refinement with respect to clinical application in cancer treatment has been demonstrated by loading particles with the drug paclitaxel. 9,10 The following paragraph focuses on the use of nanoparticles as an effective protein or drug delivery system to support bone tissue regeneration. For this purpose, several nondegradable particles, such as silica, lipid, dendrimer, hydroxyapatite, or gold nanoparticles, [43][44][45][46][47][48][49][50] as well as degradable particles made of poly(L-lactide) 51,52 or poly(L-lactideco-glycolide) (PLGA), 11,42,[52][53][54][55][56] have been used.…”

Section: Drug Deliverymentioning

confidence: 99%

“…Specific cell targeting of nanoparticles has been successfully developed for hyperthermia treatment of cancer 8 as well as for drug delivery of paclitaxel. 9,10 Similarly, nanoparticle treatment of systemic bone diseases such as osteoporosis might be feasible in the future. To date, several molecules to target bone have been identified, such as bisphosphonates and their derivatives, [11][12][13] as well as oligopeptides targeting specifically bone-resorption 14 or bone-formation surfaces.…”

Section: Introductionmentioning

confidence: 99%

Nanoparticles and their potential for application in bone

Tautzenberger¹,

Kovtun²,

Ignatius³

2012

IJN

161

137

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Abstract:Biomaterials are commonly applied in regenerative therapy and tissue engineering in bone, and have been substantially refined in recent years. Thereby, research approaches focus more and more on nanoparticles, which have great potential for a variety of applications. Generally, nanoparticles interact distinctively with bone cells and tissue, depending on their composition, size, and shape. Therefore, detailed analyses of nanoparticle effects on cellular functions have been performed to select the most suitable candidates for supporting bone regeneration. This review will highlight potential nanoparticle applications in bone, focusing on cell labeling as well as drug and gene delivery. Labeling, eg, of mesenchymal stem cells, which display exceptional regenerative potential, makes monitoring and evaluation of cell therapy approaches possible. By including bioactive molecules in nanoparticles, locally and temporally controlled support of tissue regeneration is feasible, eg, to directly influence osteoblast differentiation or excessive osteoclast behavior. In addition, the delivery of genetic material with nanoparticulate carriers offers the possibility of overcoming certain disadvantages of standard protein delivery approaches, such as aggregation in the bloodstream during systemic therapy. Moreover, nanoparticles are already clinically applied in cancer treatment. Thus, corresponding efforts could lead to new therapeutic strategies to improve bone regeneration or to treat bone disorders.

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“…The combination with trastuzumab proves to be a reasonable option, with ORRs and median PFS ranging from 52.4% to 62.5%, and from 16.6 to 18.7 months, respectively. 24,36 Weekly use of nab-paclitaxel/bevacizumab was promising in a Phase II trial; 35 however, a subsequent large Phase III trial reported by Rugo et al did not show any more benefits than a weekly paclitaxel/bevacizumab doublet. 37 In combination with other chemotherapeutic agents, a weekly nab-paclitaxel-based combination has never been reported to be successful in MBC to our knowledge.…”

mentioning

confidence: 99%

“…24,35,36 It remains a question whether we can improve efficacy of weekly nab-paclitaxel by combining other antitumor agents. The combination with trastuzumab proves to be a reasonable option, with ORRs and median PFS ranging from 52.4% to 62.5%, and from 16.6 to 18.7 months, respectively.…”

mentioning

confidence: 99%

Cisplatin improves antitumor activity of weekly nab-paclitaxel in patients with metastatic breast cancer

Sun¹,

Tang²,

Zhang³

et al. 2014

IJN

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Although nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is approved to be given every 3 weeks, weekly use of this drug is becoming a new standard of care in patients with metastatic breast cancer (MBC). This prospective Phase II study was conducted to improve the efficacy of weekly nab-paclitaxel with cisplatin in MBC patients. Seventy-three women with recurrent or MBC were eligible for participation. Nab-paclitaxel was administered weekly at a dose of 125 mg/m 2 on day 1, day 8, and day 15, followed by cisplatin 75 mg/m 2 on day 1, repeated every 28 days with a maximum of 6 cycles. The primary objective was investigator-assessed overall response rate (ORR). A high ORR of 67.1% was obtained, with rates of 80.6% for the first-line patients and 80% for patients not pretreated with taxanes. Among those who had objective responses, a large percentage of patients (83.7%) showed quickly remarkable tumor shrinkage during the first two cycles. The median progression-free and overall survival times were 9.8 and 26.9 months, respectively. For the patients receiving first-, second-, and third-line therapy or beyond, median progression-free survival was 11.7, 7.7, and 7.6 months, respectively ( P =0.005). Molecular subtype was not significantly associated with ORR or disease progression. Grade 4 neutropenia occurred in 46 patients (63.0%), with febrile neutropenia found in 9 patients (12.3%). Grade 3 peripheral neuropathy was an accumulated dose-limiting toxicity occurring in 19 patients (26.0%). Efficacy of weekly nab-paclitaxel can be improved by adding cisplatin. The doublet is highly effective, with quick response, manageable toxicity, and possible equivalence across molecular subtypes in MBC patients.

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A Phase II Study of Weekly Nanoparticle Albumin-Bound Paclitaxel With or Without Trastuzumab in Metastatic Breast Cancer

Cited by 59 publications

References 42 publications

Impressive Objective Response to Nab-Paclitaxel plus Trastuzumab as Fifth Line Therapy in an Elderly HER-2 Positive Breast Cancer Patient

Impressive Objective Response to Nab-Paclitaxel plus Trastuzumab as Fifth Line Therapy in an Elderly HER-2 Positive Breast Cancer Patient

Nanoparticles and their potential for application in bone

Cisplatin improves antitumor activity of weekly nab-paclitaxel in patients with metastatic breast cancer

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