Gemcitabine Schedules for Poor Performance Status Lung Cancer Patients
Abstract & Commentary
William B. Ershler, MD, INOVA Fairfax Hospital Cancer Center, Fairfax, VA; Director, Institute for Advanced Studies in Aging, Washington, DC, is Editor for Clinical Oncology Alert
Synopsis: In a randomized, clinical trial of patients with advanced lung cancer and impaired performance status, 2 different schedules of gemcitabine were examined. No statistically significant differences were demonstrated, but there was a trend for one of the schedules to be superior. This study designed to enhance care for patients with poor performance status highlights the poor overall survival for this group, but also demonstrates that chemotherapy can be associated with improved quality of life and physical function.
Source: Baka S, et al. J Clin Oncol. 2005;23:2136-2144.
Advanced lung cancer frequently occurs in patients who have comorbid illness and poor performance status. Baka and colleagues from Manchester, United Kingdom, performed a phase II study comparing 2 different schedules of gemcitabine in patients with impaired physical performance as reflected by a Karnofsky performance status (KP) of ≤ 70. One hundred seventy-four patients with non-small-cell lung cancer with stage IIIb or IV disease and a KP of ≤ 70 were randomly assigned to receive gemcitabine 1,000 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 6 cycles. There was significant early attrition due to disease progression; only 61.5% of patients were alive at 2 months. There was a significant improvement in KP from baseline to pre-cycle 3 in both arms with a trend in favor of the 3w4 regimen for duration and faster onset of improvement. Eight of the 17 quality of life (QOL) variables assessed showed an improvement of more than 10% between baseline and the start of the third cycle of treatment. Response rate, survival, and duration were similar in both arms.
Comment by William B. Ershler, MD
The median age for the development of lung cancer in the United States is approximately 70 years and although many patients in this age group have excellent performance, the likelihood is that a good fraction, if not most, will have significant comorbidities and reduced performance status. Chemotherapy has been shown to modestly improve both QOL and survival in older patients,1,2 but most trials included individuals with better function. Thus, it is gratifying to see this report which included rather than excluded, the more typical patients encountered in community oncology practices. When possible, most oncologists prefer to make treatment choices based upon established evidence. Yet, the bulk of published trials have included patients either younger or more fit than the typical patient encountered in practice. Hopefully, the current report will serve as a prototype for others to establish a much-needed database to assist in this regard.
The gemcitabine experience was a bit discouraging in that close to 40% of the patients did not survive 2 months. However, the improvement in performance was encouraging, and the observation that the 3w4 regimen seemed to be better (earlier and more durable response) is useful information.
References
- The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst. 1999;91:66-72.
- Gridelli C, et al. J Natl Cancer Inst. 2003;95:362-372.
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