Introduction: We report on the results of the German early access program (EAP) with the third-generation ALK- and ROS1-inhibitor lorlatinib. Patients and Methods: Patients with documented treatment failure of all approved ALK/ROS1-specific therapies or with resistance mutations not covered by approved inhibitors or leptomeningeal carcinomatosis were enrolled and analyzed. Results: In total, 52 patients were included [median age 57 years (range 32–81), 54% female, 62% never smokers, 98% adenocarcinoma]; 71% and 29% were ALK- and ROS1-positive, respectively. G1202R and G2032R resistance mutations prior to treatment with lorlatinib were observed in 10 of 26 evaluable patients (39%), 11 of 39 patients showed TP53 mutations (28%). Thirty-six patients (69%) had active brain metastases (BM) and nine (17%) leptomeningeal carcinomatosis when entering the EAP. Median number of prior specific TKIs was 3 (range 1–4). Median duration of treatment, progression-free survival (PFS), response rate and time to treatment failure were 10.4 months, 8.0 months, 54% and 13.0 months. Calculated 12-, 18- and 24-months survival rates were 65, 54 and 47%, overall survival since primary diagnosis (OS2) reached 79.6 months. TP53 mutations were associated with a substantially reduced PFS (3.7 versus 10.8 month, HR 3.3, p = 0.003) and were also identified as a strong prognostic biomarker (HR for OS2 3.0 p = 0.02). Neither prior treatments with second-generation TKIs nor BM had a significant influence on PFS and OS. Conclusions: Our data from real-life practice demonstrate the efficacy of lorlatinib in mostly heavily pretreated patients, providing a clinically meaningful option for patients with resistance mutations not covered by other targeted therapies and those with BM or leptomeningeal carcinomatosis.

These evaluations largely conclude that epoetin alfa is the better pharmacoeconomic value of the two currently available erythropoietic agents.

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Purpose To retrospectively measure the frequency of medication discrepancies occurring at hospital discharge and to characterize these discrepancies. Methods All consecutive discharges from an adult state psychiatric hospital with a length of stay ≥2 days were retrospectively evaluated for medication discrepancies occurring at the time of discharge. The content of the handwritten discharge plan was compared to the medication administration record from the last day of admission to identify medication discharge discrepancies. The primary endpoint was to determine the number of patients with a medication discharge discrepancy (MDD). Secondary objectives were to characterize the MDD by type of discrepancy and medication class (psychiatric vs nonpsychiatric). Results From October 1, 2008 to December 31, 2008, 205 patients were screened for eligibility; 163 patients were included. Thirty-eight patients (23.3%) had at least 1 MDD, with 10 (26.3%) of these patients having >1 MDD (range, 2-6). Characterization of the MDDs determined that 63.2% of the discrepancies occurred because a scheduled medication was omitted on the discharge plan whereas 36.8% were due to a dosing discrepancy. MDDs occurred at a similar rate for both classes of medications (ie, psychiatric and nonpsychiatric), but omission discrepancies occurred more commonly with nonpsychiatric medications and dosing discrepancies occurred more commonly with psychiatric medications. Conclusions Medication discrepancies occur commonly on hospital discharge. Understanding the frequency and types of MDDs occurring at this interface of care can assist in the development of more effective and targeted medication reconciliation procedures.

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This analysis suggests that COX-2 inhibitors may be cost-effective from the perspective of the VA. However, cost-effectiveness appears to depend less on the specific characteristics of the high-risk target population considered but more on the agent evaluated. Celecoxib appears to be an alternative to traditional NSAIDs in the patient populations studied.

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