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In Reply:

Medical Oncology Department, Christie Hospital, Manchester, UK

Thank you, Dr Belvedere for your letter regarding our recently published article on randomized phase II trial comparing two schedules of single agent gemcitabine in patients with advanced non–small-cell lung cancer (NSCLC) and impaired Karnofsky Performance Status (KPS < 70). Patients were randomly assigned to receive gemcitabine 1000 mg/m² on days 1, 8, and 15 of each 28 days cycle or gemcitabine 1,500 mg/m² on days 1 and 8 of each 21 days cycle both for up to six cycles.¹

In this trial we have concluded that there was no difference on the symptom improvement and the KPS between the two gemcitabine regimens.

We take the opportunity to focus again on the difficulties of a randomized trial in impaired performance status patients with NSCLC. Although many patients with advanced NSCLC have a performance status (PS) of more than 1, historically, clinical trials have largely excluded these patients. Furthermore the clinical benefit of palliative chemotherapy has been difficult to evaluate in this population because of the short survival.^2-34

The attrition rate in our trial was high due to the short survival, despite the entry criterion of a life expectancy of more than 4 weeks, nevertheless 63% patients completed quality of life (QoL) assessment. Some patients were not keen to fill in QoL forms, some staff were unwilling to burden them with QoL assessments, and the missing data make for the difficulties outlined in the letter of Dr Belvedere.

We agree that interpretation in terms of disease-related symptoms on PS should be cautious. However as both treatment arms were balanced for prognostic factors and number of cycles of treatment given, a comparison is not unreasonable.

There is now some evidence that PS 2 patients can benefit from chemotherapy in terms of symptom palliation and possible survival.^5-9 Nevertheless we agree with Dr Belvedere that prospective randomized trials are required to focus attention on patients with advanced NSCLC and impaired PS, our trial could be regarded as an initial attempt in this direction.

Author's Disclosures of Potential Conflicts of Interest

The author indicated no potential conflicts of interest.

REFERENCES

1. Baka S, Ashcroft L, Anderson H, et al: Randomized phase II study of two gemcitabine schedules for patients with impaired performance status (Karnofsky Performance Status 70) and advanced non–small-cell lung cancer. J Clin Oncol 23:2136-2144, 2005[Abstract/Free Full Text]

2. Govindan R: Management of patients with non–small-cell lung cancer and poor performance status. Curr Treat Options Oncol 4:55-59, 2003[Medline]

3. Sweeney CJ, Zhu J, Sandler AB: Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group study E1594: A phase III trial in patients with metastatic non–small-cell lung carcinoma. Cancer 92:2639-2647, 2001[CrossRef][Medline]

4. Gridelli C: Does chemotherapy have a role as palliative therapy for unfit or elderly patients with non–small-cell lung cancer? Lung Cancer 38:S45-S50, 2002 (suppl 3)

5. Pfister DG, Johnson DH, Azzoli CG: American Society of Clinical Oncology treatment of unresectable non–small-cell lung cancer guideline: Update 2003. J Clin Oncol 22:330-353, 2004[Free Full Text]

6. Eckardt J: Single-agent chemotherapy for non–small-cell lung cancer. Lung Cancer 41:S17-S22, 2003

7. Lilenbaum RC, Herndon J, List M, et al: Single-agent (SA) versus combination chemotherapy (CC) in advanced non–small-cell lung cancer (NSCLC): A CALGB randomized trial of efficacy, quality of life (QOL), and cost-effectiveness. Proc Am Soc Clin Oncol 21:1, 2002 (abstr 2)

8. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: Non–small-cell lung cancer, v. 1. 2004 http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf.

9. Gridelli C, Ardizzoni A, Le Chevalier, et al: Treatment of advanced non–small-cell lung cancer patients with ECOG performance status 2: results of a European Experts Panel. Ann Oncol 15:419-426, 2004[Abstract/Free Full Text]

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Related Correspondence

• To Treat or Not to Treat Advanced Non–Small-Cell Lung Cancer Patients With Impaired Performance Status?
  Ornella Belvedere and Francesco Grossi
  JCO 2005 23: 7231-7232 [Full Text]

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Baka, S. I. Search for Related Content PubMed Articles by Baka, S. I. Related Articles Related Correspondence Social Bookmarking                            What's this?