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Purpose@#Previous report from the ASCEND-8 trial showed consistent efficacy with less gastrointestinal (GI) toxicity in patients with anaplastic lymphoma kinase-rearranged (ALK+) advanced/metastatic non–small cell lung cancer (NSCLC) treated with ceritinib 450-mg with food compared with 750-mg fasted. In this subgroup analysis, we report outcomes in Asian patients of the ASCEND-8 trial. @*Materials and Methods@#Key efficacy endpoints were blinded independent review committee (BIRC)–assessed overall response rate (ORR) and duration of response (DOR) evaluated per Response Evaluation Criteria in Solid Tumors v1.1. Other efficacy endpoints were investigator-assessed ORR and DOR; BIRC- and investigator-assessed progression-free survival (PFS) and disease control rate; overall survival (OS). Safety was evaluated by frequency and severity of adverse events. @*Results@#At final data cutoff (6 March 2020), 198 treatment-naïve patients were included in efficacy analysis, of which 74 (37%) comprised the Asian subset; 450-mg fed (n=29), 600-mg fed (n=19), and 750-mg fasted (n=26). Baseline characteristics were mostly comparable across study arms. At baseline, more patients in 450-mg fed arm (44.8%) had brain metastases than in 750-mg fasted arm (26.9%). Per BIRC, patients in the 450-mg fed arm had a numerically higher ORR, 24-month DOR rate and 24-month PFS rate than the 750-mg fasted arm. The 36-month OS rate was 93.1% in 450-mg fed arm and 70.9% in 750-mg fasted arm. Any-grade GI toxicity occurred in 82.8% and 96.2% of patients in the 450-mg fed and 750-mg fasted arms, respectively. @*Conclusion@#Asian patients with ALK+ advanced/metastatic NSCLC treated with ceritinib 450-mg fed showed numerically higher efficacy and lower GI toxicity than 750-mg fasted patients.
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PURPOSE: To explore patient and nurse satisfaction, compliance with best practice, technical feasibility and safety of home infusion of a bisphosphonate. METHODS: Prospective 1-year survey of home zoledronic acid therapy (4 mg, 15-min intravenous, every three to four weeks) in patients with bone metastases secondary to a solid malignancy. A physician questionnaire, nurse satisfaction/feasibility questionnaire and patient satisfaction questionnaire were administered. RESULTS: Physician participation rate: 56.5% (87/154); 818 patients included; 381 predominantly community nurses; 763/788 case report forms meeting inclusion criteria. PATIENT CHARACTERISTICS: median age, 68 years (30-95); M/F, 40/60; ECOG-PS 0 or 1, 78.6%; primary tumour site: breast (55.2%), prostate (28.4%), lung (7.2%), other (9.4%). Nurse satisfaction rates: 90.9% (organization of home ZOL therapy); 96.7% (ease of infusion); 97.5% (patient-nurse relationship); 73% (relationship with hospital staff). Patient satisfaction rates: 95.3% overall; 57.6% (quality of the nurse-patient relationship); 68.8% (less travel/waiting); 52.9% (consideration for home environment). Treatment tolerance: 33.63% (discontinuation due to adverse events); 0.6% (osteonecrosis of the jaw); 0.2% fractures. Practitioner compliance with best practice: 76.7% to 83.7% (recommended and/or tolerated dosage), 73% (dental hygiene checks at inclusion; 48 to 56% thereafter); 66% (pre-infusion hydration); often undocumented for calcium/vitamin D supplementation. CONCLUSION: Home zoledronic acid treatment was well tolerated. There was a very high level of both patient and nurse satisfaction with home therapy. However, better compliance with best practice should be encouraged.
