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Palliation in Incurable Head and Neck Cancers: Chemotherapy?

Department of Head and Neck Surgery and Medical Oncology, Tata Memorial Hospital, Parel, Mumbai, India

To the Editor:

We read with keen interest the recent randomized trial comparing the role of cisplatin plus fluorouracil (CF) versus cisplatin plus paclitaxel (CP) in patients with incurable head and neck cancers. We commend the authors for addressing a much needed and important issue, in a subgroup of patients not amenable to prolonged treatment and long follow-up. However, we have a few concerns regarding the article by Gibson et al.¹

It is well known that phase II trials tend to overestimate response and survival rates and based on these trials, expecting a 15% improvement in overall survival in a palliative setting appears unrealistic. Though an intervention may occasionally demonstrate a dramatic survival benefit, the design of a randomized trial should be aimed at a more modest improvement, in this case, perhaps 5% to 7%. The power of this study to detect such a 7% improvement is less than 50%. Further, the authors themselves report a 9% increment in 1 year overall survival in patients on the CF arm as compared to the CP arm (CF, 41.4% v CP, 32.4%). This clinically important benefit probably did not reach statistical significance due to an inadequate sample size. Moreover, this improvement in survival has not been adequately discussed by the authors. Though not in concordance with their assumption that the CP arm is superior, it nevertheless is an important finding in this subgroup of patients especially when overall survival, and not response, was the primary end point of this study.

The details with regard to previous treatments taken for these patients have not been elaborated upon and it would be interesting to know if all these patients received radiation therapy as part of treatment before accrual. Also, we note that 25 patients accrued to this trial have been designated as newly diagnosed. We assume these patients have not received prior treatment and fall in the subgroup of having previously untreated extensive locoregional disease or distant metastases according to the eligibility criteria. If there indeed was such a subgroup of patients with untreated advanced head and neck cancer with no distant metastases, we wonder why radiation therapy was not factored into their treatment planning according to the National Comprehensive Cancer Network guidelines in patients with advanced cancers with a good performance status.²

Finally, though the authors have alluded to publishing their results on quality of life and pain assessments in a separate article, preliminary results of the same trial presented at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002, show a significant improvement in overall quality of life in the CP arm (P = .04).³ This would be an extremely relevant finding and probably the most important result of this study. We feel that results of trials in patients in a palliative setting with prolonged toxic chemotherapeutic regimens would be relevant if quality-of-life issues were addressed along with response rates and overall survivals. Current evidence does not conclusively prove the superiority of toxic chemotherapeutic agents over best supportive care in palliation of incurable head and neck cancers. We hence agree with the authors that less toxic agents like cetuximab, geftinib, and erlotinib for patients with incurable head and neck cancers need to be explored.

Authors' Disclosures of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

REFERENCES

1. Gibson MK, Li Y, Murphy B, et al: Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): An intergroup trial of the Eastern Cooperative Oncology Group. J Clin Oncol 23:3562-3567, 2005[Abstract/Free Full Text]

2. National Comprehensive Cancer Network Guidelines in Oncology 2005: Library of clinical practice guidelines: Guidelines for treatment by site: Head and neck cancers: Unresectable head and neck cancers ADV 1. http//www.nccn.org/professionals/physician_gls/PDF/head-and-neck.pdf.

3. Wells N, Murphy B, Dietrich M, et al: Quality of Life and pain assessment for head and neck cancer patients on E1395: A comparison of two different cisplatin-based chemotherapy regimens. Proc Am Soc Clin Oncol 21:228a, 2002 (abstr 907)

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Related Reply

• In Reply:
  Michael K. Gibson, Yi Li, Barbara Murphy, Maha H.A. Hussain, Ronald C. Deconti, John Ensley, and Arlene A. Forastiere
  JCO 2005 23: 8129-8130 [Full Text]

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