Most Read Articles
Pearl Toh, 2 days ago
First-line therapy with the BTK* inhibitor ibrutinib plus the anti-CD20 immunotherapy rituximab confers significant survival advantage over the current gold-standard regimen of fludarabine, cyclophosphamide, and rituximab (FCR) for young, fit patients with treatment-naïve chronic lymphocytic leukaemia (CLL), according to the E1912 trial, a large cooperative group study supported by the US National Cancer Institute.
6 days ago
Percutaneous coronary intervention (PCI) displays comparable rates of mortality and serious composite outcomes but a higher rate of target-vessel revascularization at 10 years relative to coronary artery bypass grafting (CABG) in patients with significant left main coronary artery (LMCA) disease, reports a study. On the other hand, CABG delivers lower mortality and serious composite outcome rates compared with PCI with drug-eluting stents after 5 years.
Pearl Toh, 07 Dec 2018
Apixaban slashes the risk of recurrent venous thromboembolism (VTE) by 90 percent in cancer patients compared with the low-molecular-weight heparin (LMWH) dalteparin, with no increase in major bleeding risk, according to the ADAM VTE study presented at ASH 2018.
Yesterday
Rates of major bleeding events are similar across cancer patients taking direct oral anticoagulants (DOAC), low-molecular-weight heparin (LMWH) or vitamin K antagonist (VKA), with gastrointestinal bleeding being the most frequent event, a recent study has shown. In addition, DOAC and LMWH recorded higher rates of venous thromboembolism than earlier studies.

Ribociclib add-on to NSAI + goserelin prolongs PFS in HR+, HER2- advanced breast cancer

Elaine Soliven
03 Dec 2018
Dr Seock-Ah Im

Adding ribociclib, a CDK*4/6 inhibitor, to NSAI** and goserelin improves progression-free survival (PFS) in premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC), according to the MONALEESA-7*** study presented at ESMO Asia 2018.

“Consistent treatment benefit with ribociclib + NSAI + goserelin was observed in Asian and non-Asian patients,” said study lead author Dr Seock-Ah Im from the Department of Internal Medicine at Seoul National University Hospital in Seoul, Republic of Korea.

The phase III, double-blind trial involved 495 premenopausal women with HR+, HER2- ABC (Asian, n=166 and non-Asian, n=329) who were randomized to receive either oral ribociclib (600 mg/day on a 3-week-on, 1-week-off schedule) or placebo, both in addition to NSAI (either letrozole or anastrozole)/tamoxifen (TAM) and goserelin (GOS, 3.6 mg subcutaneously every 4 weeks). [ESMO Asia 2018, abstract 39O]

At data cut-off, PFS was significantly longer in the ribociclib arm compared with the placebo arm, regardless of race (median PFS, not evaluable vs 11 months, hazard ratio [HR], 0.418; log-rank p=0.000113 in Asians and 23.8 vs 16.5 months, HR, 0.603; log-rank p=0.001 in non-Asians).

Similarly, women in the ribociclib group achieved a higher overall response rate than those in the placebo group (Asians, 58.5 percent vs 34.2 percent and non-Asians, 46.5 percent vs 37.4 percent).

The clinical benefit rate was also higher among women who received ribociclib compared with those on placebo (Asians, 86.2 percent vs 63.2 percent and non-Asians, 79.5 percent vs 64.2 percent).

Haematological adverse events (AEs) such as neutropenia of any grade occurred more frequently among Asians than non-Asians treated with ribociclib (84 percent vs 75 percent), although a lower incidence of grade 3 febrile neutropenia was observed in Asians compared with non-Asians (1 vs 3 events).

A lower incidence of non-haematological AEs, such as diarrhoea (17 percent vs 21 percent), fatigue (17 percent vs 27 percent), hot flush (22 percent vs 36 percent), and arthralgia (28 percent vs 36 percent), were also observed among Asians compared with non-Asians who received ribociclib.

Of note, no Asian patients in the ribociclib arm experienced treatment discontinuation due to AEs, while 5 percent of non-Asian patients on ribociclib reported treatment discontinuation.

“Ribociclib + NSAI + goserelin may be a treatment option for Asian premenopausal women with HR+, HER2- ABC ... The safety profile was manageable, irrespective of race, and was consistent with that observed in the full population,” said Im.

 

*CDK: Cyclin-dependent kinase

**NSAI: Non-steroidal aromatase inhibitor

**MONALEESA-7: Study of efficacy and safety in premenopausal women with hormone receptor positive, HER2-negative advanced breast cancer

Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS JPOG - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Pearl Toh, 2 days ago
First-line therapy with the BTK* inhibitor ibrutinib plus the anti-CD20 immunotherapy rituximab confers significant survival advantage over the current gold-standard regimen of fludarabine, cyclophosphamide, and rituximab (FCR) for young, fit patients with treatment-naïve chronic lymphocytic leukaemia (CLL), according to the E1912 trial, a large cooperative group study supported by the US National Cancer Institute.
6 days ago
Percutaneous coronary intervention (PCI) displays comparable rates of mortality and serious composite outcomes but a higher rate of target-vessel revascularization at 10 years relative to coronary artery bypass grafting (CABG) in patients with significant left main coronary artery (LMCA) disease, reports a study. On the other hand, CABG delivers lower mortality and serious composite outcome rates compared with PCI with drug-eluting stents after 5 years.
Pearl Toh, 07 Dec 2018
Apixaban slashes the risk of recurrent venous thromboembolism (VTE) by 90 percent in cancer patients compared with the low-molecular-weight heparin (LMWH) dalteparin, with no increase in major bleeding risk, according to the ADAM VTE study presented at ASH 2018.
Yesterday
Rates of major bleeding events are similar across cancer patients taking direct oral anticoagulants (DOAC), low-molecular-weight heparin (LMWH) or vitamin K antagonist (VKA), with gastrointestinal bleeding being the most frequent event, a recent study has shown. In addition, DOAC and LMWH recorded higher rates of venous thromboembolism than earlier studies.