Most Read Articles
Jairia Dela Cruz, 20 Jan 2018
Empagliflozin appears to be beneficial to type 2 diabetes (T2D) patients with established cardiovascular disease (CVD) and chronic kidney disease (CKD), yielding reductions in CV and all-cause mortality, as well as in heart failure and all-cause hospitalization compared with placebo, according to a study.
13 Feb 2018
Short-term treatment with methotrexate at >0.5 defined daily dose (8.75 mg/week) may help reduce the risk of ischaemic stroke in rheumatoid arthritis (RA) patients, while hydroxychloroquine and sulfasalazine have neutral effects, a retrospective study has found.
28 Dec 2017
Varenicline, while effective for smoking cessation, appears to significantly elevate the risk of cardiovascular hospitalization and emergency department visits, particularly for new users, a recent study shows.
29 Nov 2017
Younger children appear to be more likely to experience behavioural side effects of antiepileptic drugs (AEDs), with the likelihood increasing if children with epilepsy have baseline hyperactivity/impulsivity, a retrospective study has found.

Ramucirumab combined with docetaxel outperforms chemotherapy alone for advanced bladder cancer

Dr. Joseph Delano Fule Robles
15 Sep 2017

Combination therapy with ramucirumab and docetaxel offers a progression-free survival (PFS) advantage over docetaxel alone in patients with advanced or metastatic urothelial carcinoma (UC), according to results of the phase III RANGE trial presented at the European Society of Medical Oncology  (ESMO) 2017 Congress held in Madrid, Spain.

The randomized, double-blind, international, multicentre trial included 530 patients with advanced or metastatic UC who progressed during or after platinum-based chemotherapy. A significant 24.3 percent improvement in PFS was shown in patients who received ramucirumab plus docetaxel vs placebo plus docetaxel (median, 4.07 vs 2.76 months; hazard ratio [HR], 0.757; p=0.0118). [Lancet 2017, doi: http://dx.doi.org/10.1016/S0140-6736(17)32365-6]

Investigator assessment of the PFS outcomes were also consistent among most patient subgroups.

Best overall response rate (24.5 vs 14 percent), complete (4.2 vs 1.4 percent) and partial (20.4 vs 12.7 percent) response rates were also higher among patients who received ramucirumab plus docetaxel vs placebo plus docetaxel.

The frequency of grade ≥3 adverse events were similar between the two groups (ramucirumab group, 60 percent; placebo group, 62 percent). The most common grade 3 adverse events with ramucirumab plus docetaxel were neutropenia (15 percent), febrile neutropenia (10 percent), fatigue (8 percent) and leukopenia (7 percent). In the placebo plus docetaxel group, the most common grade 3 adverse events were neutropenia (14 percent), anaemia (11 percent), fatigue (9 percent) and leukopenia (8 percent).

Mean scores for global quality of life were similar between the two groups, with no significant difference in time to sustained deterioration in global quality of life (non-stratified HR, 0.931; p=0.610).

“Ramucirumab plus docetaxel could become a new treatment option for patients with platinum-refractory advanced UC… The combination therapy did not result in significant additive toxicity or compromise quality of life when compared with placebo plus docetaxel,” said investigator Professor Daniel Petrylak of the Yale University School of Medicine, New Haven, Connecticut, US.  

“The strengths of the study are its ability to meet its primary endpoint, with best ORR reported in a phase III trial in unselected patients along with manageable side effects in this group of complex and frail patients,” commented discussant Dr Yohann Loriot of the Gustave Roussy, University of Paris Saclay, Villejuif, France.

“However, with only 10 percent of patients in the study having received prior immune checkpoint inhibitor [ICI] therapy, the question now is whether ramucirumab plus docetaxel will be active in patients in whom ICIs have no activity or whether ICIs would induce hyperprogression,” argued Loriot.

The overall survival data from this study was not presented due to immaturity. The data are expected to be reported in a separate interim analysis.

The RANGE trial was conducted as a follow-up on the successful phase II study in patients with platinum-refractory advanced or metastatic UC, which showed significant improvement in PFS with ramucirumab plus docetaxel compared with docetaxel alone (median, 5.4 vs 2.8 months; HR, 0.389; p=0.0002).[J Clin Oncol 2016;34:1500-1509]

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Most Read Articles
Jairia Dela Cruz, 20 Jan 2018
Empagliflozin appears to be beneficial to type 2 diabetes (T2D) patients with established cardiovascular disease (CVD) and chronic kidney disease (CKD), yielding reductions in CV and all-cause mortality, as well as in heart failure and all-cause hospitalization compared with placebo, according to a study.
13 Feb 2018
Short-term treatment with methotrexate at >0.5 defined daily dose (8.75 mg/week) may help reduce the risk of ischaemic stroke in rheumatoid arthritis (RA) patients, while hydroxychloroquine and sulfasalazine have neutral effects, a retrospective study has found.
28 Dec 2017
Varenicline, while effective for smoking cessation, appears to significantly elevate the risk of cardiovascular hospitalization and emergency department visits, particularly for new users, a recent study shows.
29 Nov 2017
Younger children appear to be more likely to experience behavioural side effects of antiepileptic drugs (AEDs), with the likelihood increasing if children with epilepsy have baseline hyperactivity/impulsivity, a retrospective study has found.