BACKGROUND: The assessment of the impact of neoadjuvant therapy on quality of life (QL) has rarely been prospectively planned and evaluated, although validated QL instruments are available-such as the Lung Cancer Symptom Scale (LCSS) used in this study. The modest but significant survival gains reported with neoadjuvant and adjuvant approaches need to be viewed in terms of the added risks and toxicities associated with two or three modalities of treatment. MATERIALS AND METHODS: The objective was to compare patient-determined QL ratings from baseline (prior to neoadjuvant chemotherapy) with those in subsequent months of follow-up. All patients had clinical stage I or II non-small cell lung cancer (NSCLC) and participated in one of two similar randomized protocols. Patients received preoperative chemotherapy (three cycles) of gemcitabine plus carboplatin or paclitaxel in one trial or gemcitabine plus carboplatin or cisplatin in the second. Patients completed the LCSS at baseline, every 3 weeks preoperatively, and every 3 months postoperatively up to 12 months. RESULTS: Full QL data are available for 43 patients with at least one postsurgical evaluation and for 23 patients with evaluation at 1-year postsurgery. In patients with at least one postsurgical evaluation, 84% had an ECOG performance status of 0, 93% had a complete resection, and 67% (95% CI = 52, 81) of patients experienced improved or stable symptoms. A subgroup of patients (14 of 43) reported worsening of QL (33%). These patients experienced a mean worsening of 66% in individual symptom parameters, with an average of seven of nine LCSS symptom parameters declining. CONCLUSIONS: Most patients reported improved or stable QL. Prospectively planned QL assessment is feasible with neoadjuvant trials and adds useful information not otherwise attainable.
RCT Entities:
BACKGROUND: The assessment of the impact of neoadjuvant therapy on quality of life (QL) has rarely been prospectively planned and evaluated, although validated QL instruments are available-such as the Lung Cancer Symptom Scale (LCSS) used in this study. The modest but significant survival gains reported with neoadjuvant and adjuvant approaches need to be viewed in terms of the added risks and toxicities associated with two or three modalities of treatment. MATERIALS AND METHODS: The objective was to compare patient-determined QL ratings from baseline (prior to neoadjuvant chemotherapy) with those in subsequent months of follow-up. All patients had clinical stage I or II non-small cell lung cancer (NSCLC) and participated in one of two similar randomized protocols. Patients received preoperative chemotherapy (three cycles) of gemcitabine plus carboplatin or paclitaxel in one trial or gemcitabine plus carboplatin or cisplatin in the second. Patients completed the LCSS at baseline, every 3 weeks preoperatively, and every 3 months postoperatively up to 12 months. RESULTS: Full QL data are available for 43 patients with at least one postsurgical evaluation and for 23 patients with evaluation at 1-year postsurgery. In patients with at least one postsurgical evaluation, 84% had an ECOG performance status of 0, 93% had a complete resection, and 67% (95% CI = 52, 81) of patients experienced improved or stable symptoms. A subgroup of patients (14 of 43) reported worsening of QL (33%). These patients experienced a mean worsening of 66% in individual symptom parameters, with an average of seven of nine LCSS symptom parameters declining. CONCLUSIONS: Most patients reported improved or stable QL. Prospectively planned QL assessment is feasible with neoadjuvant trials and adds useful information not otherwise attainable.
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