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Safety/Efficacy Experience With Ramucirumab in HCC

Insights From: R. Kate Kelley, MD, UCSF Helen Diller Family Comprehensive Cancer Center; Josep Llovet, MD, PhD, Icahn School of Medicine at Mount Sinai; Masatoshi Kudo, MD, PhD, Kindai University; Arndt Vogel, MD, PhD, Hannover Medical School
Published: Tuesday, Jul 16, 2019



Transcript:

Masatoshi Kudo, MD, PhD: Ramucirumab is only an antibody, not a tyrosine kinase inhibitor, not a small-molecule inhibitor. So as an antibody, ramucirumab is a very tolerable agent, and it’s every 2-week intravenous injection. So tolerability is very good. And the dose intensity—as compared with other [TKIs], tyrosine kinase inhibitors—and the tolerability are, I think, the best. So in Japan, there are more elderly patients than other countries, and body weight is small. For such patients, ramucirumab is a very good option as a second-line agent.

Arndt Vogel, MD, PhD: The safety profile and tolerability of ramucirumab in patients with metastatic disease is really good. When we look at the most frequent grade 3 adverse effects, they were mainly hypertension and low sodium levels; this is something that really does not affect the patient. And most other drugs we use in HCC are multi–tyrosine kinase inhibitors. And they are in general more difficult drugs. They have a broader spectrum of adverse effects that really affect the quality of life of patients, which could be fatigue or diarrhea. And for skin reaction, this is something that patients really feel. And there are some patients who do not tolerate TKIs, and therefore it’s good that we now have options with a completely different mode of action with antibodies, either the immune therapy agents or ramucirumab as a target of VEGF receptor.

Masatoshi Kudo, MD, PhD: I experienced around 15 cases in clinical trials, but we cannot differentiate which is the real drug and which is placebo because patient do not complain of any adverse event. And we do not have to reduce the dose or interrupt the dose. This is the first experience for me. The dose intensity in Japanese patients is similar to the ITT global cohort.

With TKIs, the elderly Japanese patients with small body weight complain. And we need to reduce or interrupt the dose, but in case of the ramucirumab, we don’t have to reduce or interrupt the dose. So the data show Japanese ramucirumab data were much better than global data. So I think that this is a very good agent.

Arndt Vogel, MD, PhD: So far we do not really have so much experience with ramucirumab because it’s not yet approved in Germany. So we can use it only on a very individual basis at the moment, and we would expect the approval within the next month, of course. The patient I have treated so far with ramucirumab was very much in line with what we have seen in the clinical trials. He had hypertension, and that’s clearly something that we need to look at, and this is something we really recognized in our patient. I think we really need to explain it to our patient that they measure their blood pressure and that they get very immediately the treatment if they develop hypertension.

But in general, this is something the patients do not feel. Therefore, they do not complain. And this is actually, in terms of management and the treatment, easier compared with the TKIs, for which we really need to explain more the adverse effects and really need to more often discuss specific adverse effects.

Transcript Edited for Clarity
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Transcript:

Masatoshi Kudo, MD, PhD: Ramucirumab is only an antibody, not a tyrosine kinase inhibitor, not a small-molecule inhibitor. So as an antibody, ramucirumab is a very tolerable agent, and it’s every 2-week intravenous injection. So tolerability is very good. And the dose intensity—as compared with other [TKIs], tyrosine kinase inhibitors—and the tolerability are, I think, the best. So in Japan, there are more elderly patients than other countries, and body weight is small. For such patients, ramucirumab is a very good option as a second-line agent.

Arndt Vogel, MD, PhD: The safety profile and tolerability of ramucirumab in patients with metastatic disease is really good. When we look at the most frequent grade 3 adverse effects, they were mainly hypertension and low sodium levels; this is something that really does not affect the patient. And most other drugs we use in HCC are multi–tyrosine kinase inhibitors. And they are in general more difficult drugs. They have a broader spectrum of adverse effects that really affect the quality of life of patients, which could be fatigue or diarrhea. And for skin reaction, this is something that patients really feel. And there are some patients who do not tolerate TKIs, and therefore it’s good that we now have options with a completely different mode of action with antibodies, either the immune therapy agents or ramucirumab as a target of VEGF receptor.

Masatoshi Kudo, MD, PhD: I experienced around 15 cases in clinical trials, but we cannot differentiate which is the real drug and which is placebo because patient do not complain of any adverse event. And we do not have to reduce the dose or interrupt the dose. This is the first experience for me. The dose intensity in Japanese patients is similar to the ITT global cohort.

With TKIs, the elderly Japanese patients with small body weight complain. And we need to reduce or interrupt the dose, but in case of the ramucirumab, we don’t have to reduce or interrupt the dose. So the data show Japanese ramucirumab data were much better than global data. So I think that this is a very good agent.

Arndt Vogel, MD, PhD: So far we do not really have so much experience with ramucirumab because it’s not yet approved in Germany. So we can use it only on a very individual basis at the moment, and we would expect the approval within the next month, of course. The patient I have treated so far with ramucirumab was very much in line with what we have seen in the clinical trials. He had hypertension, and that’s clearly something that we need to look at, and this is something we really recognized in our patient. I think we really need to explain it to our patient that they measure their blood pressure and that they get very immediately the treatment if they develop hypertension.

But in general, this is something the patients do not feel. Therefore, they do not complain. And this is actually, in terms of management and the treatment, easier compared with the TKIs, for which we really need to explain more the adverse effects and really need to more often discuss specific adverse effects.

Transcript Edited for Clarity
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