Outcomes of patients with advanced non-small cell lung cancer treated in a phase I clinic. Oncologist 2011;16(3):327-35
Date
02/23/2011Pubmed ID
21339262Pubmed Central ID
PMC3228100DOI
10.1634/theoncologist.2010-0308Scopus ID
2-s2.0-79953004809 (requires institutional sign-in at Scopus site) 7 CitationsAbstract
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.
Author List
Janku F, Tsimberidou AM, Wang X, Hong DS, Naing A, Gong J, Garrido-Laguna I, Parsons HA, Zinner RG, Kurzrock RAuthor
Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultAged
Aged, 80 and over
Antineoplastic Agents
Antineoplastic Combined Chemotherapy Protocols
Carcinoma, Non-Small-Cell Lung
Clinical Trials, Phase I as Topic
Disease-Free Survival
Female
Humans
Lung Neoplasms
Male
Middle Aged
Survival Rate
Treatment Outcome
