[Experts' Opinion] Novel formulations of docetaxel, paclitaxel and doxorubicin in the management of metastatic breast cancer

Rajappa,Senthil; Joshi,Ashish; Doval,Dinesh  C.; Batra,Ullas; Rajendranath,Rejiv; Deo,Avinash; Biswas,Ghanshyam; Bajpai,Peush; Tilak,T. V.S.; Kane,Sriram; Kumar,Kishore; Kumar,Manish; Talele,Avinash  D.; Devde,Prakash; Gupta,Ashutosh; Joshi,Nisarg; Sejpal,Jaykumar; Bunger,Deepak; Khan,Mujtaba

doi:10.3892/ol.2018.9057

[Experts' Opinion] Novel formulations of docetaxel, paclitaxel and doxorubicin in the management of metastatic breast cancer

Authors:
- Senthil Rajappa
- Ashish Joshi
- Dinesh C. Doval
- Ullas Batra
- Rejiv Rajendranath
- Avinash Deo
- Ghanshyam Biswas
- Peush Bajpai
- T. V.S. Tilak
- Sriram Kane
- Kishore Kumar
- Manish Kumar
- Avinash D. Talele
- Prakash Devde
- Ashutosh Gupta
- Nisarg Joshi
- Jaykumar Sejpal
- Deepak Bunger
- Mujtaba Khan
View Affiliations

Affiliations: Department of Medical Oncology, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, Telangana 500034, India, Nanavati Hospital, Mumbai, Maharashtra 400056, India, Rajiv Gandhi Cancer Institute and Research Centre, Delhi 110085, India, Apollo Speciality Hospital, Chennai, Tamil Nadu 600096, India, Fortis SL Raheja Hospital, Mumbai, Maharashtra 400016, India, Sparsh Hospital, Bhubaneswar, Odisha 751007, India, Max Super Speciality Hospital, New Delhi 110017, India, Command Hospital, Bangalore, Karnataka 560007, India, Kane Hematology and Oncology Clinic, Nagpur, Maharashtra 440012, India, Command Hospital, Lucknow, Uttar Pradesh 226002, India, CHL Hospital, Indore, Madhya Pradesh 452008, India, Seth Nandlal Dhoot Hospital, Aurangabad, Maharashtra 431210, India, Government Medical College, Jammu, Jammu and Kashmir 180001, India, Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat 380061, India
Published online on: July 2, 2018 https://doi.org/10.3892/ol.2018.9057
Pages: 3757-3769
Copyright : © Rajappa et al. This is an open access article distributed under the terms of Creative Commons Attribution License [CC BY 4.0].

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

The management of breast cancer with advanced disease or metastasis is a common problem in India and other countries. A panel of 13 oncology experts deliberated on the sidelines of the 35th Indian Cooperative Oncology Network Conference held in Mumbai to formulate an expert opinion recommendation on the novel drug delivery system (NDDS) formulations in the treatment of metastatic breast cancer (MBC). The survey comprised of 39 questions related to limitations of conventional formulations and therapeutic positioning of NDDS formulations of docetaxel, paclitaxel and doxorubicin in the management of MBC. The experts used data from published literature and their practical experience to provide expert opinion and recommendations for use by the community oncologists. The experts opined that the newer NDDS formulations should provide a significant efficacy advantage in terms of overall survival and progression‑free survival, or demonstrate better tolerability when compared with conventional formulations. The newer NDDS formulations of taxanes should be considered in special circumstances such as diabetes, in patients who have had hypersensitivity reactions and in cases where steroids need to be avoided. The novel formulations of doxorubicin should be used in the elderly and in patients with borderline cardiac function.

View Figures

View References

1	World Health Organization: GLOBOCAN 2012: Estimated cancer incidence, Mortality and Prevalence Worldwide in 2012. v1.0.
2	National Cancer Registry Programme (India): Three-Year Report of Population Based Cancer Registries 2012–2014.
3	Nagrani R, Budukh A, Koyande S, Panse NS, Mhatre SS and Badwe R: Rural urban differences in breast cancer in India. Indian J Cancer. 51:277–281. 2014. View Article : Google Scholar : PubMed/NCBI
4	Agarwal G and Ramakant P: Breast cancer care in India: The current scenario and the challenges for the future. Breast Care (Basel). 3:21–27. 2008. View Article : Google Scholar : PubMed/NCBI
5	Lao J, Madani J, Puértolas T, Alvarez M, Hernández A, Pazo-Cid R, Artal A and Torres Antón A: Liposomal doxorubicin in the treatment of breast cancer patients: A review. J Drug Deliv. 2013:4564092013. View Article : Google Scholar : PubMed/NCBI
6	Hortobagyi GN: Treatment of breast cancer. N Engl J Med. 339:974–984. 1998. View Article : Google Scholar : PubMed/NCBI
7	Ellis MJ, Hayes DF and Lippman ME: Treatment of metastatic breast cancerDisease of the breast. Harris JR, Lippman ME, Morrow M, et al: Lippincott Williams & Wilkins; 4th ed. Philadelphia: pp. 7492000
8	Henderson IC: Chemotherapy for metastatic diseaseBreast disease. Harris JR, Hellman S, Henderson IC, et al: J.B. Lippincott Company; 2nd ed. Philadelphia: pp. 604–665. 1991
9	Sánchez-Moreno P, Boulaiz H, Ortega-Vinuesa JL, Peula-García JM and Aránega A: Novel drug delivery system based on docetaxel-loaded nanocapsules as a therapeutic strategy against breast cancer cells. Int J Mol Sci. 13:4906–4919. 2012. View Article : Google Scholar : PubMed/NCBI
10	Norris LB, Qureshi ZP, Bookstaver PB, Raisch DW, Sartor O, Chen H, Chen Fei and Bennett CL: Polysorbate 80 hypersensitivity reactions: A renewed call to action. Commun Oncol. 7:425–428. 2010. View Article : Google Scholar
11	Fumoleau P, Chevallier B, Kerbrat P, Krakowski Y, Misset JL, Maugard-Louboutin C, Dieras V, Azli N, Bougon N, Riva A and Roche H: A multicentre phase II study of the efficacy and safety of docetaxel as first-line treatment of advanced breast cancer: Report of the Clinical Screening Group of the EORTC. Ann Oncol. 7:165–171. 1996. View Article : Google Scholar : PubMed/NCBI
12	ten Tije AJ, Verweij J, Loos WJ and Sparreboom A: Pharmacological effects of formulation vehicles: Implications for cancer chemotherapy. Clin Pharmacokinet. 42:665–685. 2003. View Article : Google Scholar : PubMed/NCBI
13	Gelderblom H, Verweij J, Nooter K and Sparreboom A: Cremophor EL: The drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 37:1590–1598. 2001. View Article : Google Scholar : PubMed/NCBI
14	de Jonge ME, Huitema AD, Schellens JH, Rodenhuis S and Beijnen JH: Population pharmacokinetics of orally administered paclitaxel formulated in Cremophor EL. Br J Clin Pharmacol. 59:325–334. 2005. View Article : Google Scholar : PubMed/NCBI
15	O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, et al: Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 15:440–449. 2004. View Article : Google Scholar : PubMed/NCBI
16	Tzakos AG, Briasoulis E, Thalhammer T, Jäger W and Apostolopoulos V: Novel oncology therapeutics: Targeted drug delivery for cancer. J Drug Deliv. 2013:9183042013. View Article : Google Scholar : PubMed/NCBI
17	Kushwaha SK, Rastogl A, Rai A and Singh S: Novel drug delivery system for anticancer drug: a review. Int J PharmTech Res. 4:pp542–553. 2012.
18	Taxotere Prescribing Information: Sanofi-aventis. U.S. LLC; NJ 08807: Revised. May. 2015
19	Harvey V, Mouridsen H, Semiglazov V, Jakobsen E, Voznyi E, Robinson BA, Groult V, Murawsky M and Cold S: Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol. 24:4963–4970. 2006. View Article : Google Scholar : PubMed/NCBI
20	National Comprehensive Cancer Network (NCCN): Breast Cancer Guidelines. 2017.
21	Mavroudis D, Papakotoulas P, Ardavanis A, Syrigos K, Kakolyris S, Ziras N, Kouroussis C, Malamos N, Polyzos A, Christophyllakis C, et al: Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer. Ann Oncol. 21:48–54. 2010. View Article : Google Scholar : PubMed/NCBI
22	Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Antón A, Lluch A, et al: Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: The M77001 study group. J Clin Oncol. 23:4265–4274. 2005. View Article : Google Scholar : PubMed/NCBI
23	Esteva FJ, Valero V, Booser D, Guerra LT, Murray JL, Pusztai L, Cristofanilli M, Arun B, Esmaeli B, Fritsche HA, et al: Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol. 20:1800–1808. 2002. View Article : Google Scholar : PubMed/NCBI
24	Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, et al: Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 366:109–119. 2012. View Article : Google Scholar : PubMed/NCBI
25	Miles DW, Chan A, Dirix LY, Cortés J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, et al: Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 28:3239–3247. 2010. View Article : Google Scholar : PubMed/NCBI
26	Glück S, Russell C, O'Shaughnessy J, McKenna EF, Hu S, Odom D and Blum JL: Treatment effect of capecitabine and docetaxel or docetaxel alone by oestrogen receptor status in patients with metastatic breast cancer: Results of an exploratory analysis. Breast. 22:1087–1093. 2013. View Article : Google Scholar : PubMed/NCBI
27	Fan Y, Xu BH, Yuan P, et al: Docetaxel-cisplatin might be superior to docetaxel-capecitabine in the first-line treatment of metastatic triple-negative breast cancer. Ann Oncol. 24:1219–1225. 2013. View Article : Google Scholar : PubMed/NCBI
28	Ashraf M, Sajjad R, Khan M, Shah M, Bhat Y and Wani Z: 156P-Efficacy and safety of a novel nanosomal docetaxel lipid suspension (NDLS) as an anti cancer agent-a retrospective study. Ann Oncol. 27 Suppl 9:i×46–i×51. 2016. View Article : Google Scholar
29	Rivera E, Mejia JA, Arun BK, Adinin RB, Walters RS, Brewster A, Broglio KR, Yin G, Esmaeli B, Hortobagyi GN and Valero V: Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 112:1455–1461. 2008. View Article : Google Scholar : PubMed/NCBI
30	Nuzzo F, Morabito A, Gravina A, Di Rella F, Landi G, Pacilio C, Labonia V, Rossi E, De Maio E, Piccirillo MC, et al: Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: Results of a single-centre randomized phase 3 trial. BMC Cancer. 11:752011. View Article : Google Scholar : PubMed/NCBI
31	Seidman AD, Berry D, Cirrincione C, Harris L, Muss H, Marcom PK, Gipson G, Burstein H, Lake D, Shapiro CL, et al: Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 overexpressors and random assignment to trastuzumab or not in HER-2 nonoverexpressors: Final results of Cancer and Leukemia Group B protocol 9840. J Clin Oncol. 26:1642–1649. 2008. View Article : Google Scholar : PubMed/NCBI
32	Wist EA, Mjaaland I, Løkkevik E and Sommer H: Weekly paclitaxel plus capecitabine versus docetaxel every 3 weeks plus capecitabine in metastatic breast cancer. J Oncol. 2012:8629212012. View Article : Google Scholar : PubMed/NCBI
33	Zhang L and Zhang N: How nanotechnology can enhance docetaxel therapy. Int J Nanomedicine. 8:2927–2941. 2013. View Article : Google Scholar : PubMed/NCBI
34	Ahmad A, Sheikh S, Ali SM, Ahmad MU, Paithankar M, Saptarishi D, Maheshwari K, Kumar K, Singh J, Patel GN, et al: Development of aqueous based formulation of docetaxel: Safety and pharmacokinetics in patients with advanced solid tumors. J Nanomed Nanotechnol. 6:2952015.
35	Ahmad A, Sheikh S, Taran R, Srivastav SP, Prasad K, Rajappa SJ, Kumar V, Gopichand M, Paithankar M, Sharma M, et al: Therapeutic efficacy of a novel nanosomal docetaxel lipid suspension compared with taxotere in locally advanced or metastatic breast cancer patients. Clin Breast Cancer. 14:177–181. 2014. View Article : Google Scholar : PubMed/NCBI
36	Seidman AD, Tiersten A, Hudis C, Gollub M, Barrett S, Yao TJ, Lepore J, Gilewski T, Currie V, Crown J, et al: Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol. 13:2575–2581. 1995. View Article : Google Scholar : PubMed/NCBI
37	Taxol Prescribing Information. Bristol-Myers Squibb Company; Princeton, NJ 08543: Revised. April. 2011
38	Perez EA, Vogel CL, Irwin DH, Kirshner JJ and Patel R: Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 19:4216–4223. 2001. View Article : Google Scholar : PubMed/NCBI
39	Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, et al: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 344:783–792. 2001. View Article : Google Scholar : PubMed/NCBI
40	Datko F, D'Andrea G, Dickler M, Theodoulou M, Goldfarb S, Lake D, Fornier M, Modi S, Sklarin N, Comen E, et al: Abstract P5-18-20: Phase II study of pertuzumab, trastuzumab, and weekly paclitaxel in patients with metastatic HER2-overexpressing metastatic breast cancer. Cancer Res. 72 24 Suppl:Abstract nr P5. 18–20. 2012. View Article : Google Scholar : PubMed/NCBI
41	Delaloge S, Pérol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, et al: Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 27:1725–1732. 2016. View Article : Google Scholar : PubMed/NCBI
42	Hu XC, Zhang J, Xu BH, Cai L, Ragaz J, Wang ZH, Wang BY, Teng YE, Tong ZS, Pan YY, et al: Cisplatin plus gemcitabine versus paclitaxel plus gemcitabine as first-line therapy for metastatic triple-negative breast cancer (CBCSG006): A randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 16:436–446. 2015. View Article : Google Scholar : PubMed/NCBI
43	Saloustros E, Nikolaou M, Kalbakis K, Polyzos A, Christofillakis C, Kentepozidis N, Pistamaltzian N, Kourousis C, Vamvakas L, Georgoulias V and Mavroudis D: Weekly paclitaxel and carboplatin plus bevacizumab as first-line treatment of metastatic triple-negative breast cancer. A Multicenter Phase II Trial by the Hellenic Oncology Research Group. Clin Breast Cancer. 18:88–94. 2018. View Article : Google Scholar : PubMed/NCBI
44	Mauri D, Kamposioras K, Tsali L, Bristianou M, Valachis A, Karathanasi I, Georgiou C and Polyzos NP: Overall survival benefit for weekly vs. three-weekly taxanes regimens in advanced breast cancer: A meta-analysis. Cancer Treat Rev. 36:69–74. 2010. View Article : Google Scholar : PubMed/NCBI
45	Trissel LA: Pharmaceutical properties of paclitaxel and their effects on preparation and administration. Pharmacotherapy. 17:133S–139S. 1997.PubMed/NCBI
46	Abraxane Prescribing Information. Abraxis BioScience, LLC. Revised. September. 2013
47	Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M and O'Shaughnessy J: Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 23:7794–7803. 2005. View Article : Google Scholar : PubMed/NCBI
48	Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A and Bhar P: Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 27:3611–3619. 2009. View Article : Google Scholar : PubMed/NCBI
49	Blum JL, Savin MA, Edelman G, Pippen JE, Robert NJ, Geister BV, Kirby RL, Clawson A and O'Shaughnessy JA: Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer. 7:850–856. 2007. View Article : Google Scholar : PubMed/NCBI
50	Danso MA, Blum JL, Robert NJ, Krekow L, Rotche R, Smith DA, Richards P, Anderson T, Richards DA and O'Shaughnessy J: Phase II trial of weekly nab-paclitaxel in combination with bevacizumab as first-line treatment in metastatic breast cancer. J Clin Oncol. 26 15 Suppl:S10752008. View Article : Google Scholar
51	Conlin AK, Seidman AD, Bach A, Lake D, Dickler M, D'Andrea G, Traina T, Danso M, Brufsky AM, Saleh M, et al: Phase II trial of weekly nanoparticle albumin-bound paclitaxel with carboplatin and trastuzumab as first-line therapy for women with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 10:281–287. 2010. View Article : Google Scholar : PubMed/NCBI
52	Mirtsching B, Cosgriff T, Harker G, Keaton M, Chidiac T and Min M: A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer. 11:121–128. 2011. View Article : Google Scholar : PubMed/NCBI
53	Hamilton E, Kimmick G, Hopkins J, Marcom PK, Rocha G, Welch R, Broadwater G and Blackwell K: Nab-paclitaxel/bevacizumab/carboplatin chemotherapy in first-line triple negative metastatic breast cancer. Clin Breast Cancer. 13:416–420. 2013. View Article : Google Scholar : PubMed/NCBI
54	Jain MM, Gupte SU, Patil SGP, et al: Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: A multicenter, randomized, comparative phase II/III study. Breast Cancer Res Treat. 156:125–134. 2016. View Article : Google Scholar : PubMed/NCBI
55	Ranade AA, Bapsy PP, Nag S, Raghunadharao D, Raina V, Advani SH, Patil S, Maru A, Gangadharan VP, Goswami C, et al: A multicenter phase II randomized study of Cremophor-free polymeric nanoparticle formulation of paclitaxel in women with locally advanced and/or metastatic breast cancer after failure of anthracycline. Asia Pac J Clin Oncol. 9:176–181. 2013. View Article : Google Scholar : PubMed/NCBI
56	Ahmad A, Sheikh S, Ali SM, Paithankar M, Mehta A, Nagarkar R, Krishnan S, Majumdar A, Mukherjee KK, Singh JK, et al: Nanosomal paclitaxel lipid suspension demonstrates higher response rates compared to paclitaxel in patients with metastatic breast cancer. J Cancer Sci Ther. 7:116–120. 2015.
57	Doxorubicin Prescribing Informaiton. Pharmacia & Upjohn Company; Kalamazoo, MI 49001: Revised. May. 2003
58	Rafiyath SM, Rasul M, Lee B, Wei G, Lamba G and Liu D: Comparison of safety and toxicity of liposomal doxorubicin vs. conventional anthracyclines: A meta-analysis. Exp Hematol Oncol. 1:102012. View Article : Google Scholar : PubMed/NCBI
59	Xing M, Yan F, Yu S and Shen P: Efficacy and cardiotoxicity of liposomal doxorubicin-based chemotherapy in advanced breast cancer: a meta-analysis of ten randomized controlled trials. PloS one. 10:e01335692015. View Article : Google Scholar : PubMed/NCBI
60	Cowens JW, Creaven PJ, Greco WR, Brenner DE, Tung Y, Ostro M, Pilkiewicz F, Ginsberg R and Petrelli N: Initial clinical (phase I) trial of TLC D-99 (doxorubicin encapsulated in liposomes). Cancer Res. 53:2796–2802. 1993.PubMed/NCBI
61	Hong RL, Huang CJ, Tseng YL, Pang VF, Chen ST, Liu JJ and Chang FH: Direct comparison of liposomal doxorubicin with or without polyethylene glycol coating in C-26 tumor-bearing mice: Is surface coating with polyethylene glycol beneficial? Clin Cancer Res. 5:3645–3652. 1999.PubMed/NCBI
62	Gabizon A and Martin F: Polyethylene glycol-coated (pegylated) liposomal doxorubicin. Rationale for use in solid tumours. Drugs. 54 Suppl 4:S15–S21. 1997. View Article : Google Scholar
63	Gabizon AA: Pegylated liposomal doxorubicin: Metamorphosis of an old drug into a new form of chemotherapy. Cancer Invest. 19:424–436. 2001. View Article : Google Scholar : PubMed/NCBI
64	Simůnek T, Stérba M, Popelová O, Adamcová M, Hrdina R and Gersl V: Anthracycline-induced cardiotoxicity: overview of studies examining the roles of oxidative stress and free cellular iron. Pharmacol Rep. 61:154–171. 2009. View Article : Google Scholar : PubMed/NCBI
65	Caelyx^® summary of product characteristics. Janssen-Cilag International NV; Beerse, Belgium: Revised. January. 2017
66	Gordon AN, Fleagle JT, Guthrie D, Parkin DE, Gore ME and Lacave AJ: Recurrent epithelial ovarian carcinoma: A randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol. 19:3312–3322. 2001. View Article : Google Scholar : PubMed/NCBI
67	Al-Batran SE, Güntner M, Pauligk C, et al: Anthracycline rechallenge using pegylated liposomal doxorubicin in patients with metastatic breast cancer: A pooled analysis using individual data from four prospective trials. Br J Cancer. 103:1518–1523. 2010. View Article : Google Scholar : PubMed/NCBI
68	Smorenburg CH, De Groot SM, van Leeuwen-Stok AE, et al: A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: Results of the OMEGA study of the Dutch Breast Cancer Research Group BOOG. Ann Oncol. 25:599–605. 2014. View Article : Google Scholar : PubMed/NCBI
69	Chia S, Clemons M, Martin LA, Rodgers A, Gelmon K, Pond GR and Panasci L: Pegylated liposomal doxorubicin and trastuzumab in HER-2 overexpressing metastatic breast cancer: A multicenter phase II trial. J Clin Oncol. 24:2773–2778. 2006. View Article : Google Scholar : PubMed/NCBI
70	Martín M, Sánchez-Rovira P, Muñoz M, et al: Pegylated liposomal doxorubicin in combination with cyclophosphamide and trastuzumab in HER2-positive metastatic breast cancer patients: Efficacy and cardiac safety from the GEICAM/2004-05 study. Ann Oncol. 22:2591–2596. 2011. View Article : Google Scholar : PubMed/NCBI
71	Ali SM, Sheikh S, Ahmad A, Ahmad MU, et al: Bioequivalence study of pegylated doxorubicin hydrochloride liposome (PEGADRIA) and DOXIL^® in ovarian cancer patients: Physicochemical characterization and pre-clinical studies. J Nanomed Nanotechnol. 7:3612016.