A multicenter trial taking place in Germany seeks to quantify the quality of life for patients with metastatic pancreatic cancer undergoing a combination of nab-paclitaxel and gemcitabine.
Gerrit zur Hausen, MD
A multicenter trial taking place in Germany seeks to quantify the quality of life for patients with metastatic pancreatic cancer undergoing a combination of nab-paclitaxel (Abraxane) and gemcitabine (Gemzar).
The study, labeled QoliXane, has enrolled about 350 patients and data from the study are currently being collected. In an interview withTargeted Oncology, Gerrit zur Hausen, MD, clinical trial manager, epidemiologist, Krankenhaus Nordwest GmbH, discusses the importance of uncovering the quality of life for these patients, how interventional therapies play a role in their quality of life, and the management of toxicities that may arise from these drugs.
TARGETED ONCOLOGY:Can you tell us about your recent abstract?
We are currently conducting a large-scale, multicenter observational study in Germany named QoliXane. The study focuses on patients with metastatic pancreatic cancer undergoing first-line therapy with nab-paclitaxel and gemcitabine. Basically what we're doing is assessing quality of life and course of therapy data, as well as collecting available tumor tissues for accompanying translational research projects.
In the current interim analysis, we focused on those patients who entered the study with a high baseline bilirubin level.
TARGETED ONCOLOGY:What do you think is the real importance of having a trial like this is?
On the one hand, it's very important to assess quality of life under these therapies. It's of no use to have a therapy that exceeds overall survival at the cost of quality of life. So it's really important to close that information gap that still exists. On the other hand, with regard to the patients with high bilirubin levels, it's very interesting because these high levels are a common result of the disease for these patients. We have very limited data on the treatment of those patients, because usually they are not enrolled into clinical trials. So this is also an information gap that we can close at this point.
TARGETED ONCOLOGY:Can you tell us a little bit about the results of the trial?
We found that about 9% to 10% of the patients enrolled in the study entered the study with a high baseline bilirubin level, and surprisingly the majority of them, or 70% of them, started therapy at a normal dose, and the remaining 30% started at a lower dose level. What we found on the other hand was that little more than half of those patients also received a secondary intervention like stenting or bile duct anastomosis. Generally we see that the bilirubin levels drop considerably and in statistically significant way during the course of the therapy, and they lower down to the normal levels by the start of the third cycle.
So the treatment of those patients seems to be feasible in general. However, it’s important to look at the toxicity symptoms. We found in those patients that about 70% of them experienced at least one grade 3 or grade 4 toxicity during the course of therapy. Most of them were up to fever and leukopenia, and this is something that doctors really need to take a look at for those patients.
TARGETED ONCOLOGY:What are the optimal managements of those toxicities?
Toxicity management is generally case-dependent and should be evaluated by the treating physician with care. So if a patient has a bilirubin level between 1.5 and maybe up to 4, it seems quite feasible to start with the therapy and see how the patient reacts. When it comes to higher levels, one must look and see if secondary intervention is needed and if toxicities occur. But most of those patients that we saw so far clearly had a benefit of the therapy and clearly reacted with decreasing bilirubin levels.
TARGETED ONCOLOGY:What are some next steps that you think you'll take after this study?