Abstract
BackgroundThere is no consensus on the therapeutic approach to ECOG 2 patients with locally advanced non-small-cell lung cancer (LA-NSCLC), despite the sizable percentage of these patients in clinical practice. This study focused on the efficacy, toxicity and the optimal chemotherapy regimen of CCRT in ECOG 2 patients in a phase III trial.MethodsPatients capable of all self-care with bed rest for less than 50% of daytime were classified as ECOG 2 subgroup. A subgroup analysis was performed for ECOG 2 patients recruited in the phase III trial receiving concurrent EP (etoposide + cisplatin)/PC (paclitaxel + carboplatin) chemotherapy with intensity-modulated radiation therapy (IMRT) or three-dimensional conformal external beam radiation therapy (3D-CRT).ResultsA total of 71 ECOG 2 patients were enrolled into the study. Forty-six (64.8%) patients were treated with IMRT technique. The median overall survival (OS) and progression free survival (PFS) for ECOG 2 patients were 16.4 months and 9 months, respectively. No difference was observed in treatment compliance and toxicities between ECOG 2 patients and ECOG 0–1 patients. Within the ECOG 2 group (31 in the EP arm and 40 in the PC arm), median OS and 3-year OS were 15.7 months and 37.5% for the EP arm, and 16.8 months and 7.5% for the PC arm, respectively (p = 0.243). The incidence of grade ≥ 3 radiation pneumonitis was higher in the PC arm (17.5% vs. 0.0%, p = 0.014) with 5 radiation pneumonitis related deaths, while the incidence of grade 3 esophagitis was numerically higher in the EP arm (25.8% vs. 10.0%, p = 0.078).ConclusionsCCRT provided ECOG 2 patients promising outcome with acceptable toxicities. EP might be superior to PC in terms of safety profile in the setting of CCRT for ECOG 2 patients. Prospective randomized studies based on IMRT technique are warranted to validate our findings.Trial registrationClinicalTrials.gov registration number: NCT01494558. (Registered 19 December 2011).
Highlights
There is no consensus on the therapeutic approach to Eastern Cooperative Oncology Group (ECOG) 2 patients with locally advanced non-smallcell lung cancer (LA-Non-small-cell lung cancer (NSCLC)), despite the sizable percentage of these patients in clinical practice
The incidence of grade ≥ 3 radiation pneumonitis was higher in the PC arm (17.5% vs. 0.0%, p = 0.014) with 5 radiation pneumonitis related deaths, while the incidence of grade 3 esophagitis was numerically higher in the Etoposide/ cisplatin (EP) arm (25.8% vs. 10.0%, p = 0.078)
EP might be superior to PC in terms of safety profile in the setting of concurrent chemoradiotherapy (CCRT) for ECOG 2 patients
Summary
There is no consensus on the therapeutic approach to ECOG 2 patients with locally advanced non-smallcell lung cancer (LA-NSCLC), despite the sizable percentage of these patients in clinical practice. A pooled analysis demonstrated that approximately 30% of lung cancer patients had an ECOG score of 2 [6]. Despite a sizable percentage of ECOG 2 patients, no specific treatment guidelines exist for this subgroup and management options in clinical practice range from radiotherapy/chemotherapy alone to combined modality of radiotherapy and chemotherapy. In the clinical trials evaluating CCRT, patients with ECOG score of 2 suggesting slightly poorer treatment tolerance and prognosis have been excluded or underrepresented [7,8,9]. The efficacy and safety of CCRT for ECOG 2 patients with LA-NSCLC remains to be defined
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