Retrospective study on efficacy and safety of nanoparticle paclitaxel and concurrent radiotherapy in patients with advanced head and neck cancer

Pradeep K. Chandrakar, Vikram B. Rathore, Vivek Choudhary


Background: Advanced (Stage III and IV) Squamous Cell Carcinomas of the head and neck (SCCHN) produce severe functional impairment, considerable morbidity, and significant mortality. Over the past 2 decades, organ-sparing efforts using either induction chemotherapy or concurrent chemotherapy and radiotherapy (RT) have become popular and have demonstrated equivalent or superior survival rates compared with surgery and/or RT alone, with a survival rate of approximately 40% at 5 years. Although the addition of chemotherapy to RT enhances toxicity, randomized trials and meta analyses have documented improved survival clearly compared with the results from RT alone. Initially, most combinations included once-daily RT combined with cisplatin either alone or with 5-fluorouracil (5-FU). There was number of toxicities of high grades associated with these drugs, and also difficulty in their administration. We have retrospectively studied nanoparticle paclitaxel with RT on concurrent setting as an alternative.

Methods: We have retrospectively studied  data of patients of advanced SCCHN treated with nanoparticle paclitaxel along with RT. Nanoparticle paclitaxel was administered at a dose of 80 mg/m2 over one hour infusion once weekly along with RT, 60 Gray (Gy) in 30 fractions, five days per week, over 6 weeks.

Results: Total numbers of patient in this study were 28 with median age of 49 years. 78.57% of patient had stage IV disease and 21.43% stage III. Overall response rate was 68% with complete response (CR) in 29% and partial response (PR) in 39%.

Conclusions: The use of nanoparticle paclitaxel along with RT is safe, feasible, efficacious and cost effective. Intensive randomized studies with large sample size are required in this direction.



Advanced SCCHN, Concurrent chemo-radiotherapy, Nanoparticle, Paclitaxel

Full Text:



Kamangar F, Dores GM, Anderson WF. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol. 2006;24(14):2137-50.

Monnerat C, Faivre S, Temam S, et al. End points for new agent induction chemotherapy for locally advanced head and neck cancers. Ann Oncol. 2002;13:995-1006.

Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2007,CA. Cancer J Clin. 2007;57:43-66.

Chabner BA, Amrein PC, Druker BJ, Michaelson MD, Mitsiades CS, Goss PE. Antineoplastic agents. In: Brunton LL, Lazo JS, Parker, KL, editors. Goodman and Gilman′s the pharmacological basis of therapeutics. 11th Ed. New York: McGraw-Hill; 2006; 1352-1354.

Ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles: Implications for cancer chemotherapy. Clin Pharmacokinet. 2003;42:665-85.

Hennenfent KL, Govindan R. Novel formulations of taxanes: A review. Old wine in a new bottle? Ann Oncol. 2006;17:735-49.

Weiss RB, Donehower RC, Wiernik PH, Ohnuma T, Gralla RJ, Trump DL, et al. Hypersensitivity reactions from taxol. J Clin Oncol. 1990;8:1263-8.

Ranade AA, Joshi DA, Phadke GK, Patil PP, Kasbekar RB, Apte TG, Dasare RR, Mengde SD, Parikh P. M., Bhattacharyya GS, Lopes GL. Clinical and economic implications of the use of nanoparticle paclitaxel (Nanoxel) in India. Annals of Oncology. 2013;24(Suppl 5):v6–v12.

Therasse P, et al. New Guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. Jour Natl Cancer Inst. 2000;92(3):205-16.

Patrick T. et al. new guidelines to evaluate the response to treatment in solid tumours. Journal of the National Cancer Institute. 2000;92(3):205-16.

Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events, Version 3.0, DCTD, NCI, NIH, DHHS, March 31, 2003 (, Publish Date: August 9, 2006.

Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, et al. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998;338(25):1798-804.

Staar S, Rudat V, Stuetzer H, Dietz A, Volling P, Schroeder M, et al. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy-results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001;50:1161–71.

Haddad R, O'Neill A, Rabinowits G, Tishler R, Khuri F, Adkins D, et al. Induction chemotherapy followed by concurrent chemo radiotherapy (sequential chemo radiotherapy) versus concurrent chemo radiotherapy alone in locally advanced head and neck cancer (PARADIGM): a randomized phase 3 trial. Lancet Oncol. 2013;14(3):257-64.