Resource utilization by non-small cell lung cancer histology: Results from the randomized, phase III trial of pemetrexed/cisplatin versus gemcitabine/cisplatin
Authors: F. L. Pimentel, J. von Pawel, R. G. Martins, S. Novello, J. Douillard, M. O’Brien, A. M. Liepa, L. Simms
Journal: Journal of Clinical Oncology (2008)

8097 Background: Efficacy results from the phase III trial of pemetrexed/cisplatin (PC) versus gemcitabine/cisplatin (GC) for first-line advanced non-small cell lung cancer (NSCLC) demonstrated non-inferior efficacy in the overall population and superior efficacy in adenocarcinoma and large cell histology groups for PC (Scagliotti et al, Proc IASLC 2007). In the overall population, hematological and non- hematological toxicities, with a few exceptions, favored PC; in addition, some resource utilization also favored PC. Given differences in efficacy by histology, we explore resource utilization and toxicity further. Methods: Patients who received treatment were included in the analysis. At each cycle, adverse events (AEs) were assessed using Common Toxicity Criteria (version 2) and concomitant medications, transfusions and AE-related hospitalizations were recorded. Resource utilization and drug-related grade 3/4 AEs were summarized by histology group and compared between arms with Fisher’s exact test. Results: Of 1725 randomized patients, 1669 patients received treatment. Toxicity results by histology group were generally consistent with the overall population (select data presented in table). Resource utilization data are presented in the table. Results for the non-squamous population (adenocarcinoma + large cell + other) retained statistical significance consistent with the overall population. Conclusions: Although efficacy differed by histology when comparing pemetrexed/cisplatin and gemcitabine/cisplatin, results for toxicity and resource utilization were generally consistent with the overall treated population, favoring pemetrexed/cisplatin. Select grade 3/4 toxicity and resource utilization by histology, comparison between arms All: PC (n=839) vs GC (n=830) Squamous: PC (n=235) vs GC (n=221) Adenocarcinoma: PC (n=425) vs GC (n=396) Large cell: PC (n=76) vs GC (n=75) Other: PC (n=103) vs GC (n=138) Neutropenia 15.1% vs 26.7%; p<0.001 15.7% vs 29.9%; p<0.001 15.5% vs 24.2%; p=0.002 14.5% vs 26.7%; p=0.072 12.6% vs 29.0%; p=0.003 Anemia 5.6% vs 9.9%; p=0.001 7.2% vs 9.0%; p=0.497 4.0% vs 9.6%; p=0.002 3.9% vs 12.0%; p=0.078 9.7% vs 10.9%; p=0.833 Thrombocytopenia 4.1% vs 12.7%; p<0.001 5.1% vs 17.6%; p<0.001 3.1% vs 10.1%; p<0.001 2.6% vs 14.7%; p=0.009 6.8% vs 10.9%; p=0.367 Transfusions 16.4% vs 28.9%; p<0.001 19.1% vs 29.0%; p=0.016 13.4% vs 26.8%; p<0.001 21.1% vs 30.7%; p=0.197 19.4% vs 34.1%; p=0.014 Erythropoietin * 10.4% vs 18.1%; p<0.001 9.8% vs 20.1%; p=0.002 9.2% vs 15.6%; p=0.005 15.8% vs 26.0%; p=0.164 13.2% vs 17.8%; p=0.384 G- CSF * 3.1% vs 6.1%; p=0.004 4.9% vs 8.7%; p=0.103 1.8% vs 5.6%; p=0.005 3.9% vs 3.9%; p=1.000 3.8% vs 4.8%; p=0.765 Antibiotics * 30.0% vs 32.7%; p=0.254 34.0% vs 35.8%; p=0.700 26.4% vs 33.8%; p=0.020 28.9% vs 24.7%; p=0.588 36.8% vs 28.8%; p=0.219 Antiemetics * 86.2% vs 84.6%; p=0.376 84.4% vs 77.7%; p=0.077 86.2% vs 86.6%; p=0.920 88.2% vs 87.0%; p=1.000 88.7% vs 88.4%; p=1.000 Hospitalization due to any AE 32.3% vs 34.8%; p=0.277 35.3% vs 37.1%; p=0.698 30.6% vs 33.6%; p=0.370 30.3% vs 40.0%; p=0.235 34.0% vs 31.9%; p=0.782 * Frequency based on randomized population (n=862 for PC; n=863 for GC) Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly Eli Lilly