Home
Conference Highlights
View All Conference Highlights
Year in Review / Wrap-Ups
Wrap-Ups
Year in Review
Contact Us
Conference Highlights
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naive ALK-positive non-small cell lung cancer (ALK+ NSCLC): Primary results from the J-ALEX study
ASCO 2016 – Lung Cancer
Alectinib (ALC) showed promising efficacy and tolerability in the phase 1/2 study (AF-001JP).
1,2
Nokihara and colleagues conducted a randomized open-label phase 3 trial (J-ALEX study) to prove superior progression-free survival (PFS) of ALC to crizotinib (CRZ) in ALK-positive non–small-cell lung cancer (NSCLC) patients without prior ALK inhibitor treatment.
3
ALK
-positive NSCLC patients were randomized 1:1 either to receive ALC (300 mg twice daily) or CRZ (250 mg twice daily) and stratified by Eastern Cooperative Oncology Group Performance Status (PS; 0/1 vs 2), treatment line (first vs second), and clinical stage (IIIB/IV vs recurrence). Treatment on both arms was continued until disease progression or unacceptable toxicity. The primary end point was PFS according to a blinded independent review board. Secondary end points included overall survival, objective response rate, and safety. A total of 207 patients were enrolled at 41 centers in Japan; 98%, 73%, and 64% of the patients were PS 0-1, stage IV, and first line, respectively. On an interim analysis, the Independent Data Monitoring Committee recommended the release of study data because the superiority in PFS had been demonstrated. The PFS hazard ratio of the ALC arm to the CRZ arm was 0.34 (99.6826% confidence interval [CI], 0.17-0.70, stratified log-rank
P
<0.0001). Median PFS was not reached (95% CI, 20.3-Not Estimated) in the ALC arm compared with 10.2 months (95% CI, 8.2-12.0) in the CRZ arm. In the ALC arm, constipation was the only adverse event (AE) reported in >30% of patients, whereas in the CRZ arm, nausea (74%), diarrhea (73%), vomiting (59%), visual disturbance (55%), dysgeusia (52%), constipation (46%), alanine aminotransferase elevation (32%), and aspartate aminotransferase elevation (31%) were observed. Grade 3-4 AEs occurred with greater frequency in the CRZ arm (ALC arm, 27%, vs CRZ arm, 51%). There were no treatment-related deaths in either arm. The authors conclude that ALC demonstrated significantly prolonged PFS compared with CRZ and was better tolerated with a favorable AE profile.
Seto T, et al.
Lancet Oncol
. 2013;14:590-598.
Takeuchi K, et al.
Ann Oncol
. 2016;27:185-192.
Nokihara H, et al. ASCO 2016. Abstract 9008.
Related Items
IFCT-1001 CHIVA trial: A phase II study of carboplatin (Ca) plus pemetrexed (P) followed by P maintenance, as first-line therapy for human immunodeficiency virus (HIV)-associated advanced non-squamous non-small-cell lung cancer (NS-NSCLC)
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
A phase II open-label single-arm study of vandetanib in patients with advanced RET-rearranged non-small cell lung cancer (NSCLC): Luret study
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
A randomized, open label, phase II study comparing pemetrexed plus cisplatin followed by pemetrexed versus pemetrexed alone in EGFR mutant NSCLC patients who have failed first-line EGFR TKI: KCSG-LU12-13
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
An open-label phase 2 trial of dabrafenib (D) in combination with trametinib (T) in patients (pts) with previously treated BRAF V600E–mutant advanced non-small cell lung cancer (NSCLC; BRF113928)
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
Avelumab (MSB0010718C; anti-PD-L1) as a first-line treatment for patients with advanced NSCLC from the JAVELIN solid tumor phase 1b trial: Safety, clinical activity, and PD-L1 expression
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
Bayesian randomized trial comparing intensity-modulated radiation therapy versus passively scattered proton therapy for locally advanced non–small-cell lung cancer
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
Cost effectiveness of immune checkpoint inhibitors in NSCLC according to PD-L1 expression
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
E1505: Adjuvant chemotherapy ± bevacizumab for early stage NSCLC—outcomes based on chemotherapy subsets
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
Efficacy and safety of crizotinib in patients (pts) with advanced MET exon 14-altered non-small cell lung cancer (NSCLC)
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
Utilizing Chemotherapy to Treat Lung Cancer
American Society of Clinical Oncology (ASCO)
ASCO 2016 – Lung Cancer
Home
Conference Highlights
View All Conference Highlights
Year in Review / Wrap-Ups
Wrap-Ups
Year in Review
Contact Us