The challenge of molecular testing for clinical trials in advanced non-small cell lung cancer patients: Analysis of a prospective database.

OBJECTIVES: Molecular testing has become important in the biomarker program of clinical trials for advanced non-small lung cancer (NSCLC). These tissue samples often have to be analyzed in a central laboratory. We evaluated the turnaround time and possible delay in start of therapy in this process and how often testing resulted in inclusion in a clinical trial. METHODS: We reviewed our prospective database on all molecular testing cases for clinical trial suitability in patients with advanced NSCLC between March 1, 2011 and October 31, 2014. RESULTS: 250 patients were considered for biomarker-driven trials. Twenty-three cases did not have further analysis and 20 patients had failure of central biomarker analysis. Results were obtained for 207 (83%) patients. In 91 of 227 (40%) samples sent, a biomarker of interest was documented. This led to 34 (15%) clinical trial inclusions. The mean waiting time between informed consent and request for tissue sections from the pathology lab and receipt of biomarker result from central lab was 24.4 (SD 13.7) calendar days. CONCLUSION: While molecular biomarker testing is crucial in many NSCLC trials, our results show that waiting times for central laboratory analysis can cause an important delay in treatment initiation, and even ineligibility for the trial(s) under consideration. Start of therapy based on properly validated local testing, with a posteriori central biomarker testing to guarantee the integrity of the trial, would be more rewarding for quite some patients.

Characteristics and outcome of unplanned hospital admissions in patients with lung cancer: a longitudinal tertiary center study. Towards a strategy to reduce the burden.

BACKGROUND: Unplanned hospital admissions (UHAs) are frequent in lung cancer, but literature on this topic is scarce. The aim of this study is to gain insight in the demographics, patterns of referral, causes, presenting symptoms, and final outcome of these UHAs. A strategy to improve quality of care and reduce the number and cost of UHAs was suggested based upon these findings. PATIENTS AND METHODS: In retrospective analysis of all consecutive UHAs in a 6-month period in a tertiary center, demographics, pattern of referral, clinical data, tumor control status, final diagnosis, duration of hospitalization, and outcome were examined. RESULTS: Two hundred seven UHAs were recorded. Male/female ratio was 185/62, mean age 65.5 years, performance status (PS) on admission 0-1 in 32 %, 2 in 37.2 %, and 3-4 in 30.8 % of patients. Patient referral occurred by general practitioner in 33.6 % or specialist in 25.5 % and in 40.9 % on own initiative. UHAs were therapy-related in 23.9 %, cancer-related in 47.4 %, comorbidity-related in 19.4 %, or of unclear nature in 9.3 %. Most frequent causes were infections (21.9 %) and respiratory problems (17.0 %). Mean length of stay was 9.5 days. Final outcome was 10.1 % mortality, 6.9 % hospice care transfers, and 79.4 % home returns (including 18.2 % same day returns). CONCLUSION: UHAs in lung cancer were more cancer- than therapy-related. Majority of patients (2/3) were not seen by their general practitioner. A significant number of same day returns were noted. UHAs in patients with poor PS, uncontrolled cancer and cancer-related events had the worst outcome. This work is a first step in identifying specific characteristics of UHAs in lung cancer patients, which may lead to strategies to reduce the burden of UHAs.

Maintenance therapy for advanced non-small-cell lung cancer: a pilot study on patients' perceptions.

INTRODUCTION: Several randomized trials on maintenance therapy (MT) for metastatic non-small-cell lung cancer (NSCLC) have demonstrated benefit in progression-free survival. More recently, a study with pemetrexed and one with erlotinib also showed significant gains in overall survival (OS). Yet, in this palliative treatment setting, the benefit has to be weighed against the potential burden of treatment, and thus patients' preferences should be taken into account. METHODS: In the absence of data on this topic, we undertook a pilot survey with 10 questions covering the overall patient attitude toward MT, the benefit expected by patients, and the acceptance of side effects or modes of administration. Included patients had stage IV NSCLC and were planned to start first-line platinum-based doublet chemotherapy. The questionnaire was submitted at the start of and after two and four cycles of chemotherapy. RESULTS: Thirty patients were included. Overall, patients had a positive attitude toward MT. At baseline, it was considered worthwhile by 83%, 67%, and 43% of patients for an OS benefit of 6, 3, or 1 month, respectively, with some decrease over time. Effects on symptom control were crucial for about 90% of the patients. There was a slight preference for oral versus intravenous administration. Side effects were accepted by most patients as long as they were mild to moderate. CONCLUSION: Our pilot survey showed that metastatic NSCLC patients in general are in favor of MT. They expect either an OS benefit of at least several months, or better symptom control, in balance with mild-to-moderate side effects.