Clinical Benefit for Patients with Non-Small Cell Lung Cancer Enrolled in Phase I Trials

Abstract

Aim: To analyze the clinical features and outcomes of advanced non-small cell lung cancer (NSCLC) patients treated in phase I trials. Patients and Methods: The clinical characteristics, efficacy and toxicity data of 70 pretreated NSCLC patients enrolled in 17 phase I trials between January 2005 and June 2010 were analyzed at our institution. Results: The histological types were: adenocarcinoma (79%), squamous cell carcinoma (13%), and others. Patients received a median number of 3 prior lines of treatment before inclusion. 1 complete response (CR), 11 (16%) partial responses (PRs), and 29 (41%) stable diseases (SDs) were observed (according to Response Evaluation Criteria in Solid Tumors (RECIST)). The median overall survival (OS) time was 18 months and the median progression-free survival (PFS) time was 4.1 months. The median PFS of these patients within their prior therapy line before phase I inclusion was 4.3 months. A performance status score of 0 and the number of prior lines of treatment were significant for OS and PFS in multivariate analysis, respectively. Grade 3/4 toxicities were observed in 20 (27%) patients, and there was 1 treatment-related death. Conclusion: Patients in good general condition and with limited pretreatment derived an improved benefit, suggesting that phase I studies may be a valid option for pretreated NSCLC patients.

Academic Cancer Center Phase I Program Development

“…Sites #2, #6, #7, #10, and #15 are relatively new phase I programs and have benefited from this class of clinical study. Retrospective analyses of patients treated on primarily phase IB studies for gastrointestinal cancer and lung cancer showed response rate (RR) of 4% and 16% and stable disease of 38% and 41%, respectively . Further, in genomically matched patients, phase I trials yielded a RR of 27% .…”

Hyperprogression—Immunotherapy-Related Phenomenon vs Intrinsic Natural History of Cancer—In Reply

“…None of the randomized prospective studies that evaluated a single-agent ICI used a placebo, which seems ethically appropriate, and used docetaxel instead. Moreover, significant clinical benefit for patients with NSCLC treated in phase 1 trials has been reported, and experimental agents in early phase studies might also have a detrimental effect, so we considered a chemotherapy cohort the most appropriate. The “disease-stabilizing effect” of late lines of chemotherapy treatment seems uncertain.…”