The safety and efficacy of LORVIQUA® was evaluated in a single-arm, multicentre Phase I/II study of patients with ALK+ advanced NSCLC who were treatment naive in the advanced setting or had disease progression after at least one previous treatment with a TKI.1-4
In the Phase II portion of the Registrational Study for LORVIQUA®, Patient Reported Outcomes (PROs) were assessed as a secondary endpoint using the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ-C30) and the QLQ-LC13 modular supplement for lung cancer.*†1,5
Of the 184 patients with ALK+ advanced NSCLC who received at least one previous ALK TKI:1,5
Improvements from baseline in more than 25% of patients were seen across a number of key lung cancer symptoms, including fatigue (49%), insomnia (42%), appetite loss (39%), pain (38%), dyspnoea (29%) on the QLQ-C30, and cough (41%), pain in other parts (30%), pain in chest (28%) and dyspnoea (265) on the QLQ-LC13.1
A worsening from baseline was observed in 26% of patients for cognitive functioning on the QLQ-C30 and in 36% of patients for peripheral neuropathy on the QLQ-LC13.1
Outcomes for the primary endpoints of overall and intracranial objective tumour response and key secondary endpoints.
Safety profile of LORVIQUA® in the Phase I/II Study.
*The EORTC QLQ-C30 (Version 3.0) and its lung cancer module, QLQ-LC13 were selected for inclusion in the study as they are validated disease specific questionnaires and are also the two most commonly used patient reported measures in lung cancer clinical studies. The EORTC QLQ-C30 consists of 30 questions which are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social domains); a global quality of life (QOL) scale; 3 symptom scales (fatigue, pain, nausea and vomiting scales); and 6 single items that assess the additional symptoms (dysponea, appetite loss, sleep disturbance, constipation, and diarrhoea) and the perceived financial burden of treatment. The QLQ-LC13 consists of one multi-item scale and 9 single items that assess the specific symptoms (dyspnoea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients receiving chemotherapy. Patients were requested to complete these questionnaires at baseline, Day 1 of each cycle until progression and at end of treatment.1,2
†For functioning (EORTC QLQ-C30 and QLQ-LC13) and global QoL, “improved” was defined as a ≥10-point increase from baseline and “worsening” was defined as a ≥10-point decrease from baseline. “Stable” was defined as a patient who neither improved nor worsened. For symptoms, “improved” was defined as a ≥10-point decrease from baseline and “worsening” was defined as a ≥10-point increase from baseline. “Stable” was defined as a patient who neither improved nor worsened.1,2
‡For each of the EORTC QLQ-C30 functional domains (physical, role, cognitive, emotional, and social) improved scores from baseline were seen in 28.3%, 36.4%, 37.5%, 21.7% and 32.1% of patients respectively and stable scores were seen in 58.7%, 44.0%, 51.6%, 52.7% and 54.3% of patients respectively.1
ALK: Anaplastic Lymphoma Kinase, EORTC: European Organisation for Research and Treatment of Cancer, NSCLC: Non-Small Cell Lung Cancer, PROs: Patient Reported Outcomes, QLQ: Quality of Life Questionnaire, QoL: Quality of Life, TKI: Tyrosine Kinase Inhibitor
References
Use interactive hypothetical Patient case studies to understand the Patient pathway, from diagnosis to treatment, including monitoring Adverse Events
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-UNP-GBR-7812. January 2024