PATIENTS AND METHODS: A total of 657 patients with EGFR-mutated (exon 19 deletions or L858R) locally advanced or metastatic NSCLC after disease progression on osimertinib were randomized 2 : 2 : 1 to receive amivantamab-lazertinib-chemotherapy, chemotherapy, or amivantamab-chemotherapy. The dual primary endpoints were progression-free survival (PFS) of amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy. During the study, hematologic toxicities observed in the amivantamab-lazertinib-chemotherapy arm necessitated a regimen change to start lazertinib after carboplatin completion.
RESULTS: All baseline characteristics were well balanced across the three arms, including by history of brain metastases and prior brain radiation. PFS was significantly longer for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy [hazard ratio (HR) for disease progression or death 0.48 and 0.44, respectively; P < 0.001 for both; median of 6.3 and 8.3 versus 4.2 months, respectively]. Consistent PFS results were seen by investigator assessment (HR for disease progression or death 0.41 and 0.38 for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy, respectively; P < 0.001 for both; median of 8.2 and 8.3 versus 4.2 months, respectively). Objective response rate was significantly higher for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy (64% and 63% versus 36%, respectively; P < 0.001 for both). Median intracranial PFS was 12.5 and 12.8 versus 8.3 months for amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy versus chemotherapy (HR for intracranial disease progression or death 0.55 and 0.58, respectively). Predominant adverse events (AEs) in the amivantamab-containing regimens were hematologic, EGFR-, and MET-related toxicities. Amivantamab-chemotherapy had lower rates of hematologic AEs than amivantamab-lazertinib-chemotherapy.
CONCLUSIONS: Amivantamab-chemotherapy and amivantamab-lazertinib-chemotherapy improved PFS and intracranial PFS versus chemotherapy in a population with limited options after disease progression on osimertinib. Longer follow-up is needed for the modified amivantamab-lazertinib-chemotherapy regimen.
OBJECTIVE: This study aims to design and develop a smartphone app called OASapp to improve medication adherence among older adult stroke survivors and evaluate its usability.
METHODS: OASapp was developed in a three-phase development process. Phase 1 is the exploration phase (including a cross-sectional survey, a systematic review, a search for stroke apps on the app stores of Apple App Store and Google Play Store, and a nominal group technique). In phase 2, a prototype was designed based on the Health Belief Model and Technology Acceptance Model. In phase 3, Alpha and Beta testing was conducted to validate the app.
RESULTS: Twenty-five features for inclusion in the app were collected in round one, and 14 features remained and were ranked by the participants during nominal group technique. OASapp included five core components (medication management, risk factor management, health information, communication, and stroke map). Users of OASapp were satisfied based on reports from Alpha and Beta testing. The mean Usability Metric for User Experience (UMUX) score was 71.4 points (SD 14.6 points).
CONCLUSION: OASapp was successfully developed using comprehensive, robust, and theory-based methods and was found to be highly accepted by users. Further research is needed to establish the clinical efficacy of the app so that it can be utilized to improve clinically relevant outcomes.