PROCLAIM trial secondary analysis: Request for data to determine pre- and mid-treatment neutrophil-to-lymphocyte (NLR) and platelet-to-lymphocyte (PLR) ratios and lymphocyte nadir values to analyze if they are predictive of survival outcome.

PROCLAIM trial secondary analysis: Request for data to determine pre- and mid-treatment neutrophil-to-lymphocyte (NLR) and platelet-to-lymphocyte (PLR) ratios and lymphocyte nadir values to analyze if they are predictive of survival outcome.

Lung cancer ranks as the leading cause of cancer-related death in the United States and globally. In particular, stage III locally advanced non-small-cell lung cancer (NSCLC) continues to be a challenging disease with poor outcomes. Only about 14% of stage IIIA and 5% of stage IIIB lung cancer patients survive five years. Thus, there is a pressing need to establish a predictor for treatment outcome in this subpopulation. There have been steady incremental modifications in surgery, radiotherapy (RT) and systemic therapy in the last two decades. The definitive treatment for stage III NSCLC is usually chemoradiation, with surgery sometimes included either as a part of trimodality therapy or upfront without the knowledge of N2 disease. However, the median progression-free survival among patients who have received chemoradiotherapy is poor (approximately 8 months), and only 15% of patients are alive at 5 years. No major advances in the treatment for patients in this context have been made in many years. At present, there is no established prognostic marker besides standard clinical information for differentiating treatment in stage III NSCLC. During definitive treatment, patients undergo serial blood work to confirm the adequacy of blood count for continuing their treatment. While this blood work contains a wealth of data regularly collected as a part of the treatment protocol, their prognostic potential has not been fully realized. The pre-treatment presence of systemic inflammatory response, as indicated by an increased neutrophil-to-lymphocyte ratio (NLR) and/or platelet-to-lymphocyte ratio (PLR) detected in peripheral blood, has been shown to be predictive of clinical outcomes in various cancers, including gastric cancer, esophageal cancer and colon cancer. Similarly, both increased pre-treatment NLR and a lower lymphocyte nadir value (LNV) during RT for stage I-III NSCLC has been reported to be associated with poorer treatment outcomes, which aligns with the common knowledge that RT can be lympholytic and thus blunt systemic tumor-targeted immune response. Inflammatory markers such as NLR, PLR and LNV are highly repeatable, widely available and inexpensive, making them favorable tools for determining prognosis. We recently reported in a retrospective, single-institution study that markers of systemic inflammation, represented by the pre-treatment NLR >Q75 [4.5] and mid-treatment LNV <Q25 [0.25], are adverse prognostic indicators in stage III NSCLC patients undergoing combined modality therapy. Our study's findings were promising, but the investigation was limited by the small sample size and an inability to validate our result. We were also unable to assess the impact of different chemotherapy regimens on these markers. By requesting secondary analysis of the PROCLAIM data, we hope to validate our findings using a prospective database with high-quality data that can overcome our prior study limitations, such as by providing a large sample size and detailed treatment information, including different chemotherapy drugs utilized, radiation dose and planning treatment volume, baseline blood work, weekly blood tests during treatment, and survival endpoints (overall survival [OS], progression-free survival [PFS]).

[{ "PostingID": 4200, "Title": "LILLY-H3E-MC-JMIG", "Description": "Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell Histology" }]