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To Treat or Not to Treat Advanced Non–Small-Cell Lung Cancer Patients With Impaired Performance Status?

Medical Oncology, University of Udine, Italy
Medical Oncology, National Institute for Cancer Research, Genoa, Italy

To the Editor:

The randomized phase II study by Baka et al compared two schedules of single-agent gemcitabine in patients with advanced non–small-cell lung cancer (NSCLC) and impaired Karnofsky performance status (KPS 70%).¹ One hundred seventy-four patients were randomly assigned to receive gemcitabine either 1000 mg/m2 on days 1, 8, and 15 of each 28 day cycle (3w4) or gemcitabine 1500 mg/m2 on days 1 and 8 of each 21-day cycle (2w3), both for up to six cycles. The authors conclude that there was no significant difference between the two schedules in terms of improvement in KPS, primary objective of the study, or quality of life (QoL).

We do not agree with this conclusion. We believe that no conclusions can be drawn from this trial. In fact, only 38% of enrolled patients were assessable for the primary end point (ie, KPS score.) Furthermore, only 22% of enrolled patients were assessable for QoL. No conclusion from a phase II trial having response rate as primary end point would be accepted if more than 60% of patients were not assessable for response. So, why should we accept such a high proportion of not assessable patients when KPS or QoL is the primary end point?

In addition, this trial was based on the hypothesis that chemotherapy is superior to best supportive care (BSC) in NSCLC patients with impaired performance status (PS). American Society of Clinical Oncology guidelines recommend the use of single-agent chemotherapy in NSCLC patients with PS 2.² However, this recommendation is only supported by subgroup analyses of randomized trials. To our knowledge, there is no randomized trial designed specifically for PS 2 patients that compared chemotherapy plus BSC versus BSC. Even the Anderson trial mentioned by Baka et al in the discussion of their paper included patients with KPS of 60% to 90%, not only KPS 70%.³

We believe that dedicated trials in NSCLC patients with PS 2 are still required to define the role of chemotherapy and to identify the most effective regimen(s) in this setting. To meet these goals and avoid inconclusive trials, a careful choice of study end points is mandatory.

Authors' Disclosures of Potential Conflicts of Interest

The authors 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. Pfister DG, Johnson DH, Azzoli CG, et al: 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]

3. Anderson H, Hopwood P, Stephens RJ, et al: Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer—A randomized trial with quality of life as the primary outcome. Br J Cancer 83:447-453, 2000[CrossRef][Medline]

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• In Reply:
  Sofia I. Baka
  JCO 2005 23: 7232 [Full Text]

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