The impact of neoadjuvant chemotherapy and surgery on quality of life (QL) in patients with early stage NSCLC: A prospective analysis of the GINEST project

Abstract

8092 Background: The assessment of the impact of combined modality therapy on QL has rarely been prospectively analyzed. Modest but significant survival gains reported with both neoadjuvant and adjuvant approaches must be viewed in terms of added risks and toxicities associated with multi-modality treatment. Validated QL instruments are available, such as the LCSS (Lung Cancer Symptom Scale), used in this study. Methods: This analysis compares patient-determined QL ratings from baseline (prior to neoadjuvant chemotherapy) with those 6 months post-op. All patients had clinical Stage I or II NSCLC, and participated in one of the two similar randomized protocols of the GINEST Project to receive pre-operatively: three 21-day cycles of gemcitabine plus carboplatin or paclitaxel in the first trial, or gemcitabine plus carboplatin or cisplatin in the second. Patients completed the LCSS at baseline, before each subsequent cycle of chemotherapy, immediately pre-op, and every 3 months post-op. Results: Full QL data over the 9 month evaluation period are available in this ongoing study on 33 patients: M/F = 48%/52%; median: age = 63, PS = 0, complete resections =94%. Pathologic staging: Stage I - 76%, Stage II - 15% Stage III - 9%. Surgical procedure: pneumonectomy = 12%, bilobectomy = 15%, lobectomy = 73%. At 6 mos post-op, 78% of patients rated their QL as stable or improved (95% CI: 64% - 92%). A subgroup (7 of 33 pts) reported worsening of QL (≥ 1 decile), with a mean decrease of 44% in these patients. In this subgroup, an average of 5 of the 9 LCSS parameters also declined; no single symptom was associated with the QL decline. Worsening QL appeared more likely in pts having more than a lobectomy or Stage III extent. It did not appear to correlate with the chemotherapy regimen or baseline QL score. Conclusions: In this evaluation of early stage NSCLC pts 6 months post-op, given neoadjuvant gemcitabine-containing chemotherapy, most pts (78%) reported improved or stable QL. Prospective QL assessments are feasible to carry out in combined modality trials and add information essential for evaluating risk, benefit, and long-term implications. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Lilly Oncology, Bristol-Myers Squibb Eli Lilly Eli Lilly and Company- Advisory Board, Lilly Oncology, Bristol-Myers Squibb, Pfizer, AztraZeneca, Aventis, Amgen Eli Lilly, Aventis, Genentech, Lilly Oncology, Lilly Underwriters US Trial 02099 in breast cancer, Bristol-Myers Squibb, Pfizer, AztraZeneca, Aventis, Amgen Lilly Oncology, Bristol-Myers Squibb