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Published on: February 12, 2017
Outcomes of patients with advanced non-small cell lung cancer treated in a phase I clinic
Filip Janku1, Apostolia M Tsimberidou, Xuemei Wang
1Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. fjanku@mdanderson.org
Background:
The outcomes of patients with advanced non-small cell lung cancer (NSCLC) treated in phase I clinical trials have not been systematically analyzed.
Methods:
We reviewed the records of consecutive patients with advanced/metastatic NSCLC who were treated in the Phase I Clinical Trials Program at MD Anderson from August 2004 to May 2009.
Results:
Eighty-five patients (51 men, 34 women) treated on various phase I protocols were identified. The median age was 62 years (range, 30-85). The median number of previous systemic therapies was two (range, 0-5). A partial response was observed in eight patients (9.5%) and stable disease lasting >4 months was observed in 16 patients (19%). The median overall survival time was 10.6 months and median progression-free survival (PFS) time was 2.8 months, which was 0.6 months shorter than the median PFS of 3.4 months following prior second-line therapy. Factors predicting longer survival in the univariate analysis were an Eastern Cooperative Oncology Group performance status (PS) score of 0-1, no prior smoking, two or fewer organ systems involved, a hemoglobin level ≥ 12 g/dL, liver metastases, a history of thromboembolism, and a platelets count > 440 × 10(9)/L. In the multivariate analysis, a PS score of 0-1 and history negative for smoking predicted longer survival. Sixty-two (73%) patients had grade ≤ 2 toxicity, and there were no treatment-related deaths.
Conclusion:
Phase I clinical trials were well tolerated by selected patients with advanced NSCLC treated at M.D. Anderson. Nonsmokers and patients with a good PS survived longer. PFS in our population was shorter in smokers/ex-smokers and patients with a PS score of 2. It is reasonable to refer pretreated patients with a good PS to phase I clinical trials.
Insights
Outcomes for advanced non-small cell lung cancer (NSCLC) patients in phase I trials show good tolerability. Nonsmokers and those with good performance status (PS) had longer survival, suggesting phase I trials are suitable for select pretreated patients.
Area of Science:
- Oncology
- Clinical Trials
- Cancer Research
Background:
- Outcomes for advanced non-small cell lung cancer (NSCLC) patients in phase I clinical trials are not well-documented.
- Systematic analysis of these outcomes is needed to inform treatment strategies.
Purpose of the Study:
- To analyze the outcomes of advanced NSCLC patients treated in phase I clinical trials.
- To identify factors predicting survival and toxicity in this patient population.
Main Methods:
- Retrospective review of 85 advanced/metastatic NSCLC patients treated in phase I trials at MD Anderson (August 2004 - May 2009).
- Analysis of overall survival, progression-free survival (PFS), response rates, and toxicity.
- Univariate and multivariate analyses to identify prognostic factors.
Main Results:
- Partial response in 9.5%, stable disease >4 months in 19%. Median overall survival: 10.6 months; median PFS: 2.8 months.
- Good performance status (PS 0-1) and nonsmoking history predicted longer survival.
- Trials were well-tolerated with grade ≤2 toxicity in 73% and no treatment-related deaths.
Conclusions:
- Phase I trials are well-tolerated in selected advanced NSCLC patients.
- Nonsmokers and patients with good PS experience longer survival.
- Referring pretreated patients with good PS to phase I trials is a reasonable strategy.
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