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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 4/2017

01-10-2017 | Original Article

Comparison of adverse events following injection of original or generic docetaxel for the treatment of breast cancer

Authors: Nao Tagawa, Erika Sugiyama, Masataka Tajima, Yasutsuna Sasaki, Seigo Nakamura, Hiromi Okuyama, Hisanori Shimizu, Vilasinee Hirunpanich Sato, Tadanori Sasaki, Hitoshi Sato

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2017

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Abstract

Purpose

The approval of injectable generic drugs does not require bioequivalence testing. However, although generic products contain the same level of the active compound, the levels and types of additives present can differ from those used in the original product. Since docetaxel is highly lipophilic, polysorbate 80 (PS80), polyethylene glycol (PEG), and ethyl alcohol are employed to solubilize this anticancer agent. This retrospective study compared the safety of five docetaxel products (Taxotere®, Docetaxel Hospira, Docetaxel Sandoz, Docetaxel Sawai, and Docetaxel EE).

Methods

The incidence and severity of adverse events were analyzed using the medical records of operable breast cancer patients (n = 363) treated with docetaxel (75 mg/m2) in Showa University Hospital, Japan, from Jan 2013 to Mar 2016. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0.

Results

Significant product-related differences were observed in the following non-hematological adverse events: injection site reaction (P = 0.0012), hand-foot syndrome (≥grade 3) (P = 0.0003), and oral mucositis (≥grade 3) (P = 0.0080). Multivariate logistic regression analyses of the associations between these adverse events and the total additive administered (g/m2) identified significant negative effects of PS80 and ethyl alcohol.

Conclusions

Injectable docetaxel products had different adverse event profiles, which showed negative associations with the amounts of PS80 and ethyl alcohol present. This finding indicated that there might be additive-related pharmacokinetic and physiochemical differences among these products, suggesting a need for further pre- or post-approval testing of injectable generic products containing noticeable different levels of additives.
Literature
1.
2.
3.
Iusuf D, Hendrikx JJ, van Esch A, Wagenaar E, Rosing H, Beijnen JH, Schinkel AH (2015) Human OATP1B1, OATP1B3 and OATP1A2 can mediate the in vivo uptake and clearance of docetaxel. Int J Cancer 136(1):225–233CrossRefPubMed
4.
Royer I, Monsarrat B, Sonnier M, Wright M, Cresteil T (1996) Metabolism of docetaxel by human Cytochromes P450: interactions with paclitaxel and other antineoplastic drugs. Cancer Res 56(1):58–65PubMed
5.
de Graan AJ, Lancaster CS, Obaidat A, Hagenbuch B, Elens L, Friberg LE, de Bruijn P, Hu S, Gibson AA, Bruun GH, Corydon TJ, Mikkelsen TS, Walker AL, Du G, Loos WJ, van Schaik RH, Baker SD, Mathijssen RH, Sparreboom A (2012) Influence of polymorphic OATP1B-type carriers on the disposition of docetaxel. Clin Cancer Res 18(16):4433–4440CrossRefPubMedPubMedCentral
6.
Lewis LD, Miller AA, Owzar K, Bies RR, Markova S, Jiang C, Kroetz DL, Egorin MJ, McLeod HL, Ratain MJ, Alliance for Clinical Trials in Oncology (2013) The relationship of polymorphisms in ABCC2 and SLCO1B3 with docetaxel pharmacokinetics and neutropenia: CALGB 60805 (Alliance). Pharmacogenet Genom 23(1):29–33CrossRef
7.
Minami H, Kawada K, Sasaki Y, Igarashi T, Saeki T, Tahara M, Itoh K, Fujii H (2006) Pharmacokinetics and pharmacodynamics of protein-unbound docetaxel in cancer patients. Cancer Sci 97(3):235–241CrossRefPubMed
8.
9.
Coors EA, Seybold H, Merk HF, Mahler V (2005) Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions. Ann Allergy Asthma Immunol 95(6):593–599CrossRefPubMed
10.
Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C, Breast Cancer International Research Group001 Investigators (2005) Adjuvant docetaxel for node-positive breast cancer. N Engl J Med 352(22):2302–2313CrossRefPubMed
11.
Fossella F, Pereira JR, von Pawel J, Pluzanska A, Gorbounova V, Kaukel E, Mattson KV, Ramlau R, Szczesna A, Fidias P, Millward M, Belani CP (2003) Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group. J Clin Oncol 21(16):3016–3024CrossRefPubMed
12.
Lee JL, Ryu MH, Chang HM, Kim TW, Yook JH, Oh ST, Kim BS, Lee JS, Kang YK (2005) Efficacy and safety study of docetaxel as salvage chemotherapy in metastatic gastric cancer failing fluoropyrimidine and platinum combination chemotherapy. Cancer Res Treat 37(4):201–207CrossRefPubMedPubMedCentral
13.
Shawky H, Tawfik H, Hewidy M (2014) Weekly dose-dense paclitaxel and carboplatin in recurrent ovarian carcinoma: a phase II trial. J Egypt Natl Cancer Inst 26(3):139–145CrossRef
14.
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA, TAX 327 Investigators (2004) Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 351(15):1502–1512CrossRefPubMed
15.
16.
Engel A, Oswald S, Siegmund W, Keiser M (2012) Pharmaceutical excipients influence the function of human uptake transporting proteins. Mol Pharm 9(9):2577–2581CrossRefPubMed
17.
von Minckwitz G, Raab G, Caputo A, Schütte M, Hilfrich J, Blohmer JU, Gerber B, Costa SD, Merkle E, Eidtmann H, Lampe D, Jackisch C, du Bois A, Kaufmann M (2005) Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol 23(12):2676–2685CrossRef
18.
Roché H, Fumoleau P, Spielmann M, Canon JL, Delozier T, Serin D, Symann M, Kerbrat P, Soulié P, Eichler F, Viens P, Monnier A, Vindevoghel A, Campone M, Goudier MJ, Bonneterre J, Ferrero JM, Martin AL, Genève J, Asselain B (2006) Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial. J Clin Oncol 24(36):5664–5671CrossRefPubMed
19.
Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J, Breast Cancer International Research Group (2011) Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 365(14):1273–1283CrossRefPubMedPubMedCentral
20.
Jones S, Holmes FA, O’Shaughnessy J, Blum JL, Vukelja SJ, McIntyre KJ, Pippen JE, Bordelon JH, Kirby RL, Sandbach J, Hyman WJ, Richards DA, Mennel RG, Boehm KA, Meyer WG, Asmar L, Mackey D, Riedel S, Muss H, Savin MA (2009) Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide: 7-year follow-up of US Oncology Research Trial 9735. J Clin Oncol 27(8):1177–1183CrossRefPubMed
21.
Jones SE, Collea R, Paul D, Sedlacek S, Favret AM, Gore I Jr, Lindquist DL, Holmes FA, Allison MA, Brooks BD, Portillo RM, Vukelja SJ, Steinberg MS, Stokoe C, Crockett MW, Wang Y, Asmar L, Robert NJ, O’Shaughnessy J (2013) Adjuvant docetaxel and cyclophosphamide plus trastuzumab in patients with HER2-amplified early stage breast cancer: a single-group, open-label, phase 2 study. Lancet Oncol 14(13):1121–1128CrossRefPubMed
22.
Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortés J (2013) Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol 24(9):2278–2284CrossRefPubMed
23.
Toi M, Nakamura S, Kuroi K, Iwata H, Ohno S, Masuda N, Kusama M, Yamazaki K, Hisamatsu K, Sato Y, Kashiwaba M, Kaise H, Kurosumi M, Tsuda H, Akiyama F, Ohashi Y, Takatsuka Y, Japan Breast Cancer Research Group (JBCRG) (2008) Phase II study of preoperative sequential FEC and docetaxel predicts of pathological response and disease free survival. Breast Cancer Res Treat 110(3):531–539CrossRefPubMed
24.
Nagore E, Insa A, Sanmartín O (2000) Antineoplastic therapy-induced palmar plantar erythrodysesthesia (‘hand-foot’) syndrome. Incidence, recognition and management. Am J Clin Dermatol 1(4):225–234CrossRefPubMed
25.
Muneoka K, Shirai Y, Kanda J, Sasaki M, Wakai T, Wakabayashi H (2015) Improved response to 5-FU using dose adjustment and elastomeric pump selection based on monitoring of the 5-FU level—a case report. Gan To Kagaku Ryoho 42(10):1215–1218PubMed
26.
Loos WJ, Baker SD, Verweij J, Boonstra JG, Sparreboom A (2003) Clinical pharmacokinetics of unbound docetaxel: role of polysorbate 80 and serum proteins. Clin Pharmacol Ther 74(4):364–371CrossRefPubMed
27.
Joulia JM, Pinguet F, Ychou M, Duffour J, Astre C, Bressolle F (1999) Plasma and salivary pharmacokinetics of 5-fluorouracil (5-FU) in patients with metastatic colorectal cancer receiving 5-FU bolus plus continuous infusion with high-dose folinic acid. Eur J Cancer 35(2):296–301CrossRefPubMed
28.
Metadata
Title
Comparison of adverse events following injection of original or generic docetaxel for the treatment of breast cancer
Authors
Nao Tagawa
Erika Sugiyama
Masataka Tajima
Yasutsuna Sasaki
Seigo Nakamura
Hiromi Okuyama
Hisanori Shimizu
Vilasinee Hirunpanich Sato
Tadanori Sasaki
Hitoshi Sato
Publication date
01-10-2017
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 4/2017
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-017-3425-3

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