Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer

References

• Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, et al. Preoperative chemotherapy: Updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol 2008;26:778–85
   PubMed Web of Science ®Google Scholar
• Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, et al. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: Results from NSABP B-28. J Clin Oncol 2005;23:3686–96
   PubMed Web of Science ®Google Scholar
• Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, et al. Randomized trial of dose-dense vs conventionally scheduled and sequential vs concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: First report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol 2003;21:1431–9
   PubMed Web of Science ®Google Scholar
• Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 2005;365:1687–717
   Google Scholar
• Kong G, Anyarambhatla G, Petros WP, Braun RD, Colvin OM, Needham D, et al. Efficacy of liposomes and hyperthermia in a human tumor xenograft model: Importance of triggered drug release. Cancer Res 2000;60:6950–7
   PubMed Web of Science ®Google Scholar
• Needham D, Anyarambhatla G, Kong G, Dewhirst MW. A new temperature-sensitive liposome for use with mild hyperthermia: Characterization and testing in a human tumor xenograft model. Cancer Res 2000;60:1197–201
   PubMed Web of Science ®Google Scholar
• Landon CD, Park J-Y, Needham D, Dewhirst MW. Nanoscale drug delivery and hyperthermia: The materials design and preclinical and clinical testing of low temperature-sensitive liposomes used in combination with mild hyperthermia in the treatment of local cancer. Open Nanomed J 2011;3:24–37
   Google Scholar
• Manzoor AA, Lindner LH, Landon CD, Park JY, Simnick AJ, Dreher MR, et al. Overcoming limitations in nanoparticle drug delivery: Triggered, intravascular release to improve drug penetration into tumors. Cancer Res 2012;72:5566–75
   PubMed Web of Science ®Google Scholar
• Gaber MH. Modulation of doxorubicin resistance in multidrug-resistance cells by targeted liposomes combined with hyperthermia. J Biochem Mol Biol Biophys 2002;6:309–14
   PubMedGoogle Scholar
• Issels RD. Hyperthermia adds to chemotherapy. Eur J Cancer 2008;44:2546–54
   PubMed Web of Science ®Google Scholar
• Dewhirst MW, Vujaskovic Z, Jones E, Thrall D. Re-setting the biologic rationale for thermal therapy. Int J Hyperthermia 2005;21:779–90
   PubMed Web of Science ®Google Scholar
• Clemons M, Danson S, Hamilton T, Goss P. Locoregionally recurrent breast cancer: Incidence, risk factors and survival. Cancer Treat Rev 2001;27:67–82
   PubMed Web of Science ®Google Scholar
• Zagar TM, Oleson JR, Vujaskovic Z, Dewhirst MW, Craciunescu OI, Blackwell KL, et al. Hyperthermia combined with radiation therapy for superficial breast cancer and chest wall recurrence: A review of the randomised data. Int J Hyperthermia 2010;26:612–17
   PubMed Web of Science ®Google Scholar
• Poon RT, Borys N. Lyso-thermosensitive liposomal doxorubicin: A novel approach to enhance efficacy of thermal ablation of liver cancer. Expert Opin Pharmacother 2009;10:333–43
   PubMed Web of Science ®Google Scholar
• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205–16
   PubMed Web of Science ®Google Scholar
• Salvatorelli E, Menna P, Paz OG, Chello M, Covino E, Singer JW, et al. The novel anthracenedione, pixantrone, lacks redox activity and inhibits doxorubicinol formation in human myocardium: Insight to explain the cardiac safety of pixantrone in doxorubicin-treated patients. J Pharmacol Exp Therapeut 2013;344:467–78
   PubMed Web of Science ®Google Scholar
• Dewhirst MW, Phillips TL, Samulski TV, Stauffer P, Shrivastava P, Paliwal B, et al. RTOG quality assurance guidelines for clinical trials using hyperthermia. Int J Radiat Oncol Biol Phys 1990;18:1249–59
   PubMed Web of Science ®Google Scholar
• O’Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) vs conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004;15:440–9
   PubMed Web of Science ®Google Scholar
• Lorusso V, Manzione L, Silvestris N. Role of liposomal anthracyclines in breast cancer. Ann Oncol 2007;18:vi70–3
   PubMedGoogle Scholar
• Keller AM, Mennel RG, Georgoulias VA, Nabholtz JM, Erazo A, Lluch A, et al. Randomized phase III trial of pegylated liposomal doxorubicin vs vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 2004;22:3893–901
   PubMed Web of Science ®Google Scholar
• Chia S, Clemons M, Martin LA, Rodgers A, Gelmon K, Pond GR, et al. Pegylated liposomal doxorubicin and trastuzumab in HER-2 overexpressing metastatic breast cancer: A multicenter phase II trial. J Clin Oncol 2006;24:2773–8
   PubMed Web of Science ®Google Scholar
• Coleman RE, Biganzoli L, Canney P, Dirix L, Mauriac L, Chollet P, et al. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer 2006;42:882–7
   PubMed Web of Science ®Google Scholar
• Al-Batran SE, Bischoff J, von Minckwitz G, Atmaca A, Kleeberg U, Meuthen I, et al. The clinical benefit of pegylated liposomal doxorubicin in patients with metastatic breast cancer previously treated with conventional anthracyclines: A multicentre phase II trial. Br J Cancer 2006;94:1615–20
   Google Scholar
• Verma S, Dent S, Chow BJ, Rayson D, Safra T. Metastatic breast cancer: The role of pegylated liposomal doxorubicin after conventional anthracyclines. Cancer Treat Rev 2008;34:391–406
   PubMed Web of Science ®Google Scholar
• Jones EL, Oleson JR, Prosnitz LR, Samulski TV, Vujaskovic Z, Yu D, et al. Randomized trial of hyperthermia and radiation for superficial tumors. J Clin Oncol 2005;23:3079–85
   PubMed Web of Science ®Google Scholar
• Vujaskovic Z, Kim DW, Jones E, Lan L, McCall L, Dewhirst MW, et al. A phase I/II study of neoadjuvant liposomal doxorubicin, paclitaxel, and hyperthermia in locally advanced breast cancer. Int J Hyperthermia 2010;26:514–21
   PubMed Web of Science ®Google Scholar
• Mills JK, Needham D. Lysolipid incorporation in dipalmitoylphosphatidylcholine bilayer membranes enhances the ion permeability and drug release rates at the membrane phase transition. Biochim Biophys Acta 2005;1716:77–96
   PubMed Web of Science ®Google Scholar
• Ponce AM, Viglianti BL, Yu D, Yarmolenko PS, Michelich CR, Woo J, et al. Magnetic resonance imaging of temperature-sensitive liposome release: Drug dose painting and antitumor effects. J Natl Cancer Inst 2007;99:53–63
   PubMed Web of Science ®Google Scholar
• Gasselhuber A, Dreher MR, Rattay F, Wood BJ, Haemmerich D. Comparison of conventional chemotherapy, stealth liposomes and temperature-sensitive liposomes in a mathematical model. PLOS ONE 2012;7:e47453
   PubMed Web of Science ®Google Scholar
• Gasselhuber A, Dreher MR, Partanen A, Yarmolenko PS, Woods D, Wood BJ, et al. Targeted drug delivery by high intensity focused ultrasound mediated hyperthermia combined with temperature-sensitive liposomes: Computational modelling and preliminary in vivo validation. Int J Hyperthermia 2012;28:337–48
   PubMed Web of Science ®Google Scholar
• Arunachalam K, Craciunescu OI, Maccarini PF, Schlorff JL, Markowitz E, Stauffer PR. Progress on thermobrachytherapy surface applicator for superficial tissue disease. Proc SPIE 2009;7181. doi: 10.1117/12.809493
   Google Scholar
• Arunachalam K, Maccarini PF, Craciunescu OI, Schlorff JL, Stauffer PR. Thermal characteristics of thermobrachytherapy surface applicators for treating chest wall recurrence. Phys Med Biol 2010;55:1949–69
   PubMed Web of Science ®Google Scholar
• Stauffer PR, Schlorff JL, Juang T, Neuman JDG, Johnson JE, Maccarini PF, et al. Progress on system for applying simultaneous heat and brachytherapy to large-area surface disease. Proc SPIE 2005;5698:82–96
   Google Scholar
• Taschereau R, Stauffer PR, Hsu IC, Schlorff JL, Milligan AJ, Pouliot J. Radiation dosimetry of a conformal heat-brachytherapy applicator. Technol Cancer Res Treat 2004;3:347–58
   PubMed Web of Science ®Google Scholar
• Krawczyk PM, Eppink B, Essers J, Stap J, Rodermond H, Odijk H, et al. Mild hyperthermia inhibits homologous recombination, induces BRCA2 degradation, and sensitizes cancer cells to poly (ADP-ribose) polymerase-1 inhibition. Proc Natl Acad Sci 2011;108:9851–6
   PubMed Web of Science ®Google Scholar