Top

Published in:

01-09-2013 | Original Article

A phase II study of intra-arterial cisplatin with concurrent radiation and erlotinib for locally advanced head and neck cancer

Authors: Krishna Rao, Sini Kalapurakal, Pratima Chalasani, Kathy Robinson, James Malone, Cathy Clausen, Ohad Ronen, Muthuswamy Dhiwakar, Bruce Shevlin, K. Thomas Robbins

Published in: Cancer Chemotherapy and Pharmacology | Issue 3/2013

Abstract

Background

Based on the convenient oral dosing of erlotinib and the promising results of biologic therapy, we undertook a phase II study with 21 patients with locally advanced (T3–4) lesions combining radiation with intra-arterial (IA) cisplatin and oral daily erlotinib for a 7-week therapy.

Methods

Treatment for the primary tumor and upper neck was given to a total dose of 70 Gy. Chemotherapy with IA cisplatin (150 mg/m²) was given on days 1, 8, 15, and 22 concurrently with radiotherapy. During the 7-week treatment period, patients were given erlotinib 150 mg/day.

Results

Overall survival is 63 %, and the relapse/persistent disease rate stands at 36.8 %. A total of 15.2 % of serious adverse event was considered related to erlotinib.

Conclusion

Our study and several others now demonstrate the feasibility of combining anti-epidermal growth factor receptor (EGFR) therapy with chemoradiation, hint at improved survival outcomes with reduced distant metastatic rates, and suggest that maintenance therapy with anti-EGFR agent may be beneficial.

Licitra L, Bergamini C, Mirabile A, Granata R (2011) Targeted therapy in head and neck cancer. Curr Opin Otolaryngol Head Neck Surg 19:132–137PubMedCrossRef

Zhou C, Wu YL, Chen G et al (2011) Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol (8):735–742

Pollack VA, Savage DM, Baker DA et al (1999) Inhibition of epidermal growth factor receptor-associated tyrosine phosphorylation in human carcinomas with CP-358,774: dynamics of receptor inhibition in situ and antitumor effects in athymic mice. J Pharmacol Exp Ther 291:739–748PubMed

Yarden Y, Sliwkowski MX (2001) Untangling the ErbB signalling network. Nat Rev Mol Cell Biol 2:127–137PubMedCrossRef

Soulieres D, Senzer NN, Vokes EE, Hidalgo M, Agarwala SS, Siu LL (2004) Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J Clin Oncol 22:77–85PubMedCrossRef

Robbins KT, Storniolo AM, Kerber C, Seagren S, Berson A, Howell SB (1992) Rapid superselective high-dose cisplatin infusion for advanced head and neck malignancies. Head Neck 14:364–371PubMedCrossRef

Lee YY, Wallace S, Dimery I, Goepfert H (1986) Intraarterial chemotherapy of head and neck tumors. AJNR Am J Neuroradiol 7:343–348PubMed

Wolpert SM, Kwan ES, Heros D, Kasdon DL, Hedges TR III (1988) Selective delivery of chemotherapeutic agents with a new catheter system. Radiology 166:547–549PubMed

Yokoyama J, Ito S, Ohba S, Fujimaki M, Ikeda K (2011) A novel approach to translymphatic chemotherapy targeting sentinel lymph nodes of patients with oral cancer using intra-arterial chemotherapy - preliminary study. Head Neck Oncol 3:42PubMedCrossRef

10.

Therasse P, Arbuck SG, Eisenhauer EA et al (2000) 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. J Natl Cancer Inst 92:205–216PubMedCrossRef

11.

Robbins KT, Kumar P, Wong FS et al (2000) Targeted chemoradiation for advanced head and neck cancer: analysis of 213 patients. Head Neck 22:687–693PubMedCrossRef

12.

Shepherd FA, Rodrigues PJ, Ciuleanu T et al (2005) Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123–132PubMedCrossRef

13.

Richards GJ Jr, Chambers RG (1969) Hydroxyurea: a radiosensitizer in the treatment of neoplasms of the head and neck. Am J Roentgenol Radium Ther Nucl Med 105:555–565PubMedCrossRef

14.

Condit PT (1968) Treatment of carcinoma with radiation therapy and methotrexate. Mo Med 65:832–835PubMed

15.

Vermund H, Kaalhus O, Winther F, Trausjo J, Thorud E, Harang R (1985) Bleomycin and radiation therapy in squamous cell carcinoma of the upper aero-digestive tract: a phase III clinical trial. Int J Radiat Oncol Biol Phys 11:1877–1886PubMedCrossRef

16.

Lo TC, Wiley AL Jr, Ansfield FJ et al (1976) Combined radiation therapy and 5-fluorouracil for advanced squamous cell carcinoma of the oral cavity and oropharynx: a randomized study. AJR Am J Roentgenol 126:229–235PubMedCrossRef

17.

Al-Sarraf M, Pajak TF, Marcial VA et al (1987) Concurrent radiotherapy and chemotherapy with cisplatin in inoperable squamous cell carcinoma of the head and neck. An RTOG Study Cancer 59:259–265CrossRef

18.

Forastiere AA, Goepfert H, Maor M et al (2003) Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med 349:2091–2098PubMedCrossRef

19.

Blanchard P, Baujat B, Holostenco V et al (2011) Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site. Radiother Oncol 100:33–40PubMedCrossRef

20.

Robbins KT, Storniolo AM, Kerber C et al (1994) Phase I study of highly selective supradose cisplatin infusions for advanced head and neck cancer. J Clin Oncol 12:2113–2120PubMed

21.

Robbins KT, Kumar P, Harris J et al (2005) Supradose intra-arterial cisplatin and concurrent radiation therapy for the treatment of stage IV head and neck squamous cell carcinoma is feasible and efficacious in a multi-institutional setting: results of Radiation Therapy Oncology Group Trial 9615. J Clin Oncol 23:1447–1454PubMedCrossRef

22.

Rasch CR, Hauptmann M, Schornagel J et al (2010) Intra-arterial versus intravenous chemoradiation for advanced head and neck cancer: results of a randomized phase 3 trial. Cancer 116:2159–2165PubMedCrossRef

23.

Rasch C (2006) Intra-arterial vs. intravenous chemoradiation for advanced head and neck cancer, early results of a multi-institutional trial. In: ASTRO 48th Annual Meeting. Abstract Plenary 2. 5–6 Nov 2006

24.

Bonner JA, Harari PM, Giralt J et al (2006) Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 354:567–578PubMedCrossRef

25.

Vermorken JB, Trigo J, Hitt R et al (2007) Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol 25:2171–2177PubMedCrossRef

26.

Vermorken JB, Mesia R, Rivera F et al (2008) Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 359:1116–1127PubMedCrossRef

27.

Argiris A, Heron DE, Smith RP et al (2010) Induction docetaxel, cisplatin, and cetuximab followed by concurrent radiotherapy, cisplatin, and cetuximab and maintenance cetuximab in patients with locally advanced head and neck cancer. J Clin Oncol 28:5294–5300PubMedCrossRef

28.

Ready NE, Rathore R, Johnson TT et al (2012) Weekly paclitaxel and carboplatin induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck. Am J Clin Oncol 35(1):6–12

29.

Cohen EE, Haraf DJ, Kunnavakkam R et al (2010) Epidermal growth factor receptor inhibitor gefitinib added to chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol 28:3336–3343PubMedCrossRef

30.

Merlano M, Russi E, Benasso M et al (2011) Cisplatin-based chemoradiation plus cetuximab in locally advanced head and neck cancer: a phase II clinical study. Ann Oncol 22:712–717PubMedCrossRef

31.

Givens DJ, Karnell LH, Gupta AK et al (2009) Adverse events associated with concurrent chemoradiation therapy in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg 135:1209–1217PubMedCrossRef

32.

Bonner JA, Harari PM, Giralt J et al (2010) Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol 11:21–28PubMedCrossRef

Title: A phase II study of intra-arterial cisplatin with concurrent radiation and erlotinib for locally advanced head and neck cancer
Authors: Krishna Rao
Sini Kalapurakal
Pratima Chalasani
Kathy Robinson
James Malone
Cathy Clausen
Ohad Ronen
Muthuswamy Dhiwakar
Bruce Shevlin
K. Thomas Robbins
Publication date: 01-09-2013
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 3/2013
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-013-2225-7

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 3/2013

Can taxanes provide benefit in patients with CNS tumors and in pediatric patients with tumors? An update on the preclinical development of cabazitaxel

Chemotherapy-induced amenorrhea, menopause-specific quality of life, and endocrine profiles in premenopausal women with breast cancer who received adjuvant anthracycline-based chemotherapy: a prospective cohort study

A randomized controlled trial of gemcitabine plus cisplatin versus gemcitabine alone in the treatment of metastatic pancreatic cancer

Vorinostat in combination with bortezomib in patients with advanced malignancies directly alters transcription of target genes

Pharmacodynamic modeling of cell cycle and apoptotic effects of gemcitabine on pancreatic adenocarcinoma cells

Phase II study of ifosfamide and cisplatin for the treatment of recurrent ovarian cancer

Keynote webinar | Spotlight on antibody–drug conjugates in cancer