CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2013; 34(01): 11-15
DOI: 10.4103/0971-5851.113404

Palliative chemotherapy in head and neck squamous cell cancer - What is best in Indian population? A time without symptoms, treatment toxicity score based study

V Anuradha
Department of Pathology, Osmania Medical College, Hyderabad, Andhra Pradesh, India
B.B. Anand
Department of Surgical Oncology, KMIO, Bangalore, Karnataka, India
A. V. S. Suresh
Department of Medical Oncology, MNJIO and RCC, Hyderabad, Andhra Pradesh, India
Sudha Sinha
Department of Medical Oncology, MNJIO and RCC, Hyderabad, Andhra Pradesh, India
S Chinna Babu
Department of Clinical Research, ClinSync Clinical Research Pvt Ltd, Hyderabad, Andhra Pradesh, India
K Suresh
Department of Clinical Research, ClinSync Clinical Research Pvt Ltd, Hyderabad, Andhra Pradesh, India
› Author Affiliations


Background: Patients with recurrent and metastatic head and neck Squamous Cell Cancer (HNSCC) have poor prognosis with limited treatment options. In view of decimal prognosis, the treatment decision should include quality of life (QOL) issues, cost-effectiveness besides the response rates and survival. Aim: Present retrospective analysis was conducted to evaluate efficacy (disease-free survival), pharmacoeconomics, and toxicity profile of four (4) different regimens, viz. gefitinib alone, gefitinib with methotrexate, methotrexate alone, or 5-FU with cisplatin. Materials and Methods: Case records between 2007 September and 2008 September were analyzed, 68 patients were found suitable for analysis. Patients received gefitinib (250 mg/day), methotrexate as 50 mg intramuscular weekly or a combination of the same or 5-FU 750 mg/m 2 /day for 4 days along with cisplatin 75 mg/m 2 /day on day 1 in 21-day cycle. Results: A total of 68 patients received therapy. Fifty-one patients have clinically meaningful response (stable disease + complete + partial responses) (75%) and had symptomatic improvement. The median progression-free survival was significantly superior in responders (those who achieved partial or complete response) (8.4 months vs. 3.1 months, P=0.001). Methotrexate with gefitinib had maximum median survival and better overall QOL compared to the other treatment regimens. Weekly methotrexate is relatively cost-effective followed by methotrexate with gefitinib and gefitinib alone. 5-FU with cisplatin in our experience does not appear so attractive in view of high complication rates (when given in full doses) and prolonged hospital stay. Conclusion: Based on the results of this retrospective analysis, methotrexate weekly as single agent or in combination with gefitinib appears as an attractive alternative regimen for patients with metastatic HNSCC including those having poor performance status. A prospective study was planned and submitted to the local ethics committee based on above results to validate these results and compare methotrexate and gefitinib arm with 5-FU + cisplatin.

Publication History

Article published online:
20 July 2021

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  • References

  • 1 IARC. GLOBOCAN, 2002. Available from: [Last accessed on 2012 Jan 23]
  • 2 Hotte SJ, Wright JR. Understanding the results of meta-analyses in the treatment of head and neck squamous cell cancer. Hematol Oncol Clin North Am 2008;22:1257-66.
  • 3 Vermorken JB, Specenier P. Optimal treatment for recurrent/metastatic head and neck cancer. Ann Oncol 2010;21:vii 252-61.
  • 4 Rao RR, Konnpal A, Lalit B, Amit D, Sameer K, Shneh R, et al. Survival benefit and efficacy of gefitinib in recurrent metastatic head and neck cancer. Indian J Med Paediatr Oncol 2007:28:5-10.
  • 5 Grandis JR, Tweardy DJ. Elevated levels of transforming growth factor alpha and epidermal growth factor receptor messenger RNA are early markers of carcinogenesis in head and neck cancer. Cancer Res 1993;53:3579-84.
  • 6 Cohen EE, Rosen F, Stadler WM, Recant W, Stenson K, Huo D, et al. Phase II trial of ZD1839 in recurrent or metastatic squamous cell carcinoma of the head and neck. J Clin Oncol 2003;21:1980-7.
  • 7 Wheeler RH, Jones D, Sharma P, Davis RK, Spilker H, Boucher K, et al. Clinical and molecular phase II study of gefitinib in patients (pts) with recurrent squamous cell cancer of the head and neck. Proc Am Soc Clin Oncol 2005;23:507s.
  • 8 Kirby AM, A′Hern RP, D′Ambrosio C, Tanay M, Syrigos KN, Rogers SJ, et al. Gefitinib (ZD1839, Iressa) as palliative treatment in recurrent or metastatic head and neck cancer. Br J Cancer 2006;94:631-6.
  • 9 Thatcher N, Chang A, Parikh P, Rodrigues Pereira J, Ciuleanu T, von Pawel J, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: Results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005;366:1527-37.
  • 10 Vermorken B, Bourhis J, Trigo J, Kies M, Leon X, Mueser M, et al. Baselga Cetuximab (Erbitux® ) in recurrent/metastatic (R and M) squamous cell carcinoma of the head and neck (SCCHN) refractory to first-line platinum-based therapies. Proc Am Soc Clin Oncol 2005;23:501.
  • 11 NCCN guidelines for treatment of head and neck squamous cell carcinoma, 2012 Available from: [Last accessed on 2012 Dec 06]
  • 12 Padhani AR, Ollivier L. The RECIST (Response Evaluation Criteria in Solid Tumors) criteria: Implications for diagnostic radiologists. Br J Radiol 2001;74:983-6.
  • 13 Common toxicity criteria, 2009 Available from: [Last accessed on 2012 Dec 06]
  • 14 Attili SV. Role and impact of "non-conventional/alternative medicines" on quality of life as well as disease free and overall survival in patients with locally advanced and metastatic lung cancer. J Thorac Oncol 2008;3:1-42.
  • 15 Stewart JS, Cohen EE, Licitra L, Van Herpen CM, Khorprasert C, Soulieres D, et al. Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck [corrected]. J Clin Oncol 2009;27:1864-71.