Literature DB >> 25076790

Subcutaneous Administration of Monoclonal Antibodies in Oncology.

C Jackisch1, V Müller2, C Maintz3, S Hell4, B Ataseven5.   

Abstract

Treatment with monoclonal antibodies (mabs) has become an established component of oncological therapy. The monoclonal antibodies available for this purpose are mainly administered intravenously in individually adapted doses according to body weight over longer treatment times. For other chronic diseases such as, for example, diabetes mellitus, the subcutaneous administration of drugs is an established therapy option. For the subcutaneous administration of larger volumes as needed for mab solutions the extracellular matrix of the subcutaneous tissue represents a problem. The co-formulation with recombinant human hyaluronidase makes the relatively pain-free administration of larger fluid volumes and thus the subcutaneous administration of monoclonal antibodies possible, as illustrated by the development of a subcutaneous formulation of trastuzumab. This constitutes a less invasive, time-optimised and flexible form of administration for patients with HER2-positive breast cancer that, with its fixed dosing possibilities, contributes to therapeutic safety. The example of trastuzumab shows that the subcutaneous administration of monoclonal antibodies can simplify oncological long-term therapy not only for the patients but also for the medical personnel.

Entities:  

Keywords:  breast cancer; monoclonal antibodies; oncology; subcutaneous therapy; trastuzumab

Year:  2014        PMID: 25076790      PMCID: PMC4078128          DOI: 10.1055/s-0034-1368173

Source DB:  PubMed          Journal:  Geburtshilfe Frauenheilkd        ISSN: 0016-5751            Impact factor:   2.915


  22 in total

1.  A recombinant human enzyme for enhanced interstitial transport of therapeutics.

Authors:  L H Bookbinder; A Hofer; M F Haller; M L Zepeda; G-A Keller; J E Lim; T S Edgington; H M Shepard; J S Patton; G I Frost
Journal:  J Control Release       Date:  2006-06-07       Impact factor: 9.776

2.  Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma.

Authors:  David H Henry; Luis Costa; Francois Goldwasser; Vera Hirsh; Vania Hungria; Jana Prausova; Giorgio Vittorio Scagliotti; Harm Sleeboom; Andrew Spencer; Saroj Vadhan-Raj; Roger von Moos; Wolfgang Willenbacher; Penella J Woll; Jianming Wang; Qi Jiang; Susie Jun; Roger Dansey; Howard Yeh
Journal:  J Clin Oncol       Date:  2011-02-22       Impact factor: 44.544

Review 3.  Hyaluronidase.

Authors:  D Watson
Journal:  Br J Anaesth       Date:  1993-09       Impact factor: 9.166

4.  Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer (BCIRG 007 study): two highly active therapeutic regimens.

Authors:  Vicente Valero; John Forbes; Mark D Pegram; Tadeusz Pienkowski; Wolfgang Eiermann; Gunter von Minckwitz; Henri Roche; Miguel Martin; John Crown; John R Mackey; Pierre Fumoleau; Janusz Rolski; Zrinka Mrsic-Krmpotic; Agnieszka Jagiello-Gruszfeld; Alessandro Riva; Marc Buyse; Henry Taupin; Guido Sauter; Michael F Press; Dennis J Slamon
Journal:  J Clin Oncol       Date:  2010-11-29       Impact factor: 44.544

5.  Alemtuzumab by continuous intravenous infusion followed by subcutaneous injection plus rituximab in the treatment of patients with chronic lymphocytic leukemia recurrence.

Authors:  Stefan Faderl; Alessandra Ferrajoli; William Wierda; Susan O'Brien; Susan Lerner; Michael J Keating
Journal:  Cancer       Date:  2010-05-15       Impact factor: 6.860

6.  Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers.

Authors:  M Pegram; S Hsu; G Lewis; R Pietras; M Beryt; M Sliwkowski; D Coombs; D Baly; F Kabbinavar; D Slamon
Journal:  Oncogene       Date:  1999-04-01       Impact factor: 9.867

7.  Denosumab and bone-metastasis-free survival in men with castration-resistant prostate cancer: results of a phase 3, randomised, placebo-controlled trial.

Authors:  Matthew R Smith; Fred Saad; Robert Coleman; Neal Shore; Karim Fizazi; Bertrand Tombal; Kurt Miller; Paul Sieber; Lawrence Karsh; Ronaldo Damião; Teuvo L Tammela; Blair Egerdie; Hendrik Van Poppel; Joseph Chin; Juan Morote; Francisco Gómez-Veiga; Tomasz Borkowski; Zhishen Ye; Amy Kupic; Roger Dansey; Carsten Goessl
Journal:  Lancet       Date:  2011-11-15       Impact factor: 79.321

8.  Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study.

Authors:  Xavier Pivot; Joseph Gligorov; Volkmar Müller; Peter Barrett-Lee; Sunil Verma; Ann Knoop; Giuseppe Curigliano; Vladimir Semiglazov; Guillermo López-Vivanco; Valerie Jenkins; Nana Scotto; Stuart Osborne; Lesley Fallowfield
Journal:  Lancet Oncol       Date:  2013-08-19       Impact factor: 41.316

Review 9.  Development of a subcutaneous formulation for trastuzumab - nonclinical and clinical bridging approach to the approved intravenous dosing regimen.

Authors:  B Bittner; W F Richter; F Hourcade-Potelleret; C McIntyre; F Herting; M L Zepeda; J Schmidt
Journal:  Arzneimittelforschung       Date:  2012-08-23

10.  Randomized phase II trial of first-line trastuzumab plus docetaxel and capecitabine compared with trastuzumab plus docetaxel in HER2-positive metastatic breast cancer.

Authors:  Andrew M Wardley; Xavier Pivot; Flavia Morales-Vasquez; Luis M Zetina; Maria de Fátima Dias Gaui; Douglas Otero Reyes; Jacek Jassem; Claire Barton; Peter Button; Veronica Hersberger; Antonio Antón Torres
Journal:  J Clin Oncol       Date:  2009-12-28       Impact factor: 44.544

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  20 in total

1.  Practical considerations for the integration of subcutaneous targeted therapies into the oncology clinic.

Authors:  Angela Boudreau
Journal:  Can Oncol Nurs J       Date:  2019-10-01

2.  Mixed-dimensional multi-scale poroelastic modeling of adipose tissue for subcutaneous injection.

Authors:  Yu Leng; Hao Wang; Mario de Lucio; Hector Gomez
Journal:  Biomech Model Mechanobiol       Date:  2022-09-03

3.  Understanding the Monoclonal Antibody Disposition after Subcutaneous Administration using a Minimal Physiologically based Pharmacokinetic Model.

Authors:  Ninad Varkhede; Laird Forrest
Journal:  J Pharm Pharm Sci       Date:  2018       Impact factor: 2.327

4.  Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial.

Authors:  Rene Westhovens; Piotr Wiland; Marek Zawadzki; Delina Ivanova; Alfredo Berrocal Kasay; Elias Chalouhi El-Khouri; Éva Balázs; Sergii Shevchuk; Larisa Eliseeva; Mykola Stanislavchuk; Roman Yatsyshyn; Paweł Hrycaj; Janusz Jaworski; Vyacheslav Zhdan; Jakub Trefler; Pavel Shesternya; Sang Joon Lee; Sung Hyun Kim; Jee Hye Suh; Seul Gi Lee; Noo Ri Han; Dae Hyun Yoo
Journal:  Rheumatology (Oxford)       Date:  2021-05-14       Impact factor: 7.580

Review 5.  Pharmacokinetics of monoclonal antibodies and Fc-fusion proteins.

Authors:  Liming Liu
Journal:  Protein Cell       Date:  2017-04-19       Impact factor: 14.870

Review 6.  Optimizing the Bioavailability of Subcutaneously Administered Biotherapeutics Through Mechanochemical Drivers.

Authors:  D S Collins; L C Kourtis; N R Thyagarajapuram; R Sirkar; S Kapur; M W Harrison; D J Bryan; G B Jones; J M Wright
Journal:  Pharm Res       Date:  2017-07-13       Impact factor: 4.200

7.  Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development.

Authors:  Meric Ovacik; Kedan Lin
Journal:  Clin Transl Sci       Date:  2018-08-07       Impact factor: 4.689

8.  Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance.

Authors:  Cecile Berteau; Orchidée Filipe-Santos; Tao Wang; Humberto E Rojas; Corinne Granger; Florence Schwarzenbach
Journal:  Med Devices (Auckl)       Date:  2015-11-11

9.  Oral Administration and Detection of a Near-Infrared Molecular Imaging Agent in an Orthotopic Mouse Model for Breast Cancer Screening.

Authors:  Sumit Bhatnagar; Kirti Dhingra Verma; Yongjun Hu; Eshita Khera; Aaron Priluck; David E Smith; Greg M Thurber
Journal:  Mol Pharm       Date:  2018-04-26       Impact factor: 4.939

Review 10.  In Vivo Delivery of Nucleic Acid-Encoded Monoclonal Antibodies.

Authors:  Ami Patel; Mamadou A Bah; David B Weiner
Journal:  BioDrugs       Date:  2020-06       Impact factor: 5.807

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