According to the results of a Phase II clinical trial published in the Journal of Thoracic Oncology, the combination of Gemzar® (gemcitabine) and Paraplatin® (carboplatin) does not result in better treatment outcomes than Gemzar alone in patients with advanced non–small cell lung cancer and a limited ability to carry out usual daily activities (a performance status of 2).
Lung cancer remains the leading cause of cancer deaths in the United States. Non–small cell lung cancer (NSCLC) accounts for approximately 75–80% of all lung cancers. Advanced NSCLC refers to cancer that has spread from the lung to other sites in the body.
Performance status refers to a patient’s ability to carry out activities of daily living. The commonly-used Eastern Cooperative Oncology Group (ECOG) measure of performance status ranges from 0 to 4; 0 indicates a patient who is fully active and able to carry out all pre-disease activities without restriction, and 4 refers to a patient who is completely disabled. The current study focused on individuals with a performance status of 2, which is defined as “Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.”
To evaluate the role of combination versus single-agent chemotherapy in patients with advanced NSCLC and a performance status of 2, researchers in Greece conducted a Phase II clinical trial. The study enrolled 90 patients with Stage IIIB or Stage IV NSCLC. Roughly half the patients received Gemzar plus Paraplatin, and half received Gemzar alone.
- 4% of patients treated with Gemzar alone experienced a partial disappearance of detectable cancer compared with 14% of patients treated with Gemzar plus Paraplatin. The difference in response rate between study groups did not meet the criteria for statistical significance, indicating that it could have occurred by chance alone.
- Median survival was 4.8 months among patients treated with Gemzar alone compared with 6.7 months among patients treated with Gemzar plus Paraplatin. Again, the difference between study groups did not meet the criteria for statistical significance.
- There were no significant differences between study groups in lung cancer symptoms or general feeling (very good, good, poor).
- Patients treated with Gemzar plus Paraplatin were more likely than patients treated with Gemzar alone to develop neutropenia (low white blood cell levels) and thrombocytopenia (low platelet levels).
The researchers conclude that in this population of patients with advanced NSCLC, treatment with the combination of Gemzar and Paraplatin did not significantly improve outcomes, and increased the frequency of side effects, compared with treatment with Gemzar alone.
 Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity and response criteria of the eastern cooperative oncology group. Am J Clin Oncol. 5:649-655, 1982.
Kosmidis PA, Dimopoulos M-A, Syrigos K et al. Gemcitabine versus gemcitabine-carboplatin for patients with advanced non-small cell lung cancer and a performance status of 2: a prospective randomized Phase II study of the hellenic Cooperative Oncology Group. Journal of Thoracic Oncology. 2007;2:135-140.
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