The retrospective, uni-institutional, observational study as a PhD project was planned for identification of all possible prognostic and predictive factors in locally advanced NSCLC patients treated by radical chemoradiotherapy. The presented study included patients who underwent sequential chemoradiotherapy in the years 2009–2014 in the largest Polish oncology center. Data of long-term clinical observation were used in the analysis of predictors for progression-free and overall survival (PFS, OS).
Inclusion criteria for sequential rather than concurrent chemoradiotherapy were defined according to local guidelines of National Research Institute of Oncology in Warsaw. Each patient had to have at least one of the following characteristics: (A) older age, which was confirmed as a favorable choice for this group of patients [1 (link)], (B) significant comorbidities, and/or (C) reduced exercise capacity defined below 100 by the Karnofsky Performance Scale (KPS).
Assessment of KPS was mandatory, at least at the start of treatment before chemotherapy and at the end of radiotherapy. KPS deterioration was understood as a decrease of at least 10 points between the first and last assessment.
Radiosensitizing chemotherapy had to be used before radiotherapy; there was a possible choice between (1) cisplatine-based regimen (PN: cisplatin + vinorelbine or PG: cisplatin + gemcitabine or PE cisplatin + etoposide) and (2) carboplatin-based regimen (carboplatin + vinorelbine or carboplatin + paclitaxel). The administered doses of radiation therapy were in the range of 5880 cGy to 6600 cGy.
The toxicity of chemotherapy and radiotherapy was recognized in accordance with the Common Terminology Criteria for Adverse Events (CTCAE).
The primary observation point was overall survival (OS). This was the time from the start of chemotherapy to the moment of death from any cause. The secondary endpoint was progression-free survival (PFS), which was measured from the date of the initiation of chemotherapy to the date of disease progression or death (if no progression was previously observed). The Kaplan–Meier estimator and Cox proportional hazard analysis were used for the evaluation of relationships between baseline KPS and the deterioration of KPS with OS and PFS. The odds ratio was used to assess risk factors for the occurrence of KPS deterioration during chemoradiotherapy.
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