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Medscape
08-07-2025
- Health
- Medscape
Real-World Data: Adjuvant Therapy for BRAF-Mutated Melanoma
This transcript has been edited for clarity. Hello, everybody. My name is Teresa Amaral. Welcome back to this Medscape Oncology series on melanoma. Today, we'll finalize a discussion about real-world data on adjuvant therapy in patients with BRAF -mutated melanoma. We discussed the visual comparison between immunotherapy and targeted therapy using real-world data. We also discussed the benefit in terms of relapse-free survival and distant metastasis-free survival in this adjuvant setting when we compared the two therapies, showing that visual comparison seems to show a better benefit for patients receiving targeted therapy compared to immunotherapy. We looked into the differences in terms of quality of life and the toxicity profile for both therapies. Now, we will look into the last aspect that we need to discuss with our patients, which is what we do when the patients have a relapse. Obviously, it is different whether the patients have a relapse under adjuvant therapy or off adjuvant therapy. Patients who have a recurrence under adjuvant targeted therapy seem to benefit from programmed cell death protein 1 (PD-1) therapy afterward in a similar way as patients who had PD-1 monotherapy in stage IV and were treatment naive. Patients with recurrence under adjuvant PD-1 therapy do not seem to benefit from continuing PD-1 therapy, but they might benefit from other immunotherapies, such as ipilimumab or the combination of ipilimumab plus PD-1. We have other real-world data, which we've discussed in the episodes before, on where to go in terms of immunotherapy judgment setting. Even if we have a prolongation in terms of relapse-free survival or metastasis-free survival, when we look into overall survival data from real-world studies, we don't see a benefit in either of the two cohorts, one before introducing adjuvant therapy and another after introducing adjuvant therapy. This is also something that we need to discuss with our patients when we propose adjuvant therapy. The paper I mentioned before is an indirect comparison, and of course, it needs to be read as so. There are real-world data that have been analyzed, but obviously, we cannot change the data and how they were analyzed. When we look into the relapse-free survival events, we need to consider that these events are dependent on the timing when the imaging evaluation was performed. If you have an imaging evaluation that was performed a little bit earlier, you might detect relapse-free survival earlier as compared to an imaging evaluation that was performed later. The criteria for including these studies in this analysis was the same, but inclusion criteria may vary in the different trials, which might lead to a bias. Another aspect that is important to retain from this analysis is that we included both patients with BRAF wild-type and BRAF -mutated melanoma, because we could not separate these as we didn't have access to raw data. We also included all patients despite the BRAF mutation subtype. We didn't know if the patients were BRAF V600E or K, although the majority were reported as having BRAF V600E. We also were not able to analyze the data based on the substage — so stage IIIA to IIID. We included all the patients as stage III, but not the substage. Although the median follow-up time is long, it might not be long enough to capture all the events in the adjuvant setting. We probably need an update of this work in the near future. We were unable to exclude a couple of patients that were stage IV with no evidence of disease that were included in the different publications because we didn't have access to the raw data. We didn't perform any statistical comparison because of the differences in terms of the publications that we selected. The comparison was visually performed based on the formula that I mentioned in the first episode of this series. We have some advantages from this analysis. One is the number of patients, where more than 3600 patients were included. We included analyses that started around 2018, which means that, for the majority of the patients, they would have had access to PD-1 therapies or PD-1-based therapies as in the modern era if they had progressive disease or a recurrence. We don't know if this is the case for all the patients included in the analysis. Finally, grouping all the analyses and doing this digitalization using this visual comparison is obviously, I would say, an advantage. Another advantage is the fact that we used weighted average calculations to produce these Kaplan-Meier curves, showing that there is a concordance among the different works that we selected for this analysis. In conclusion, I would say that, based on this real-world analysis, targeted therapy seems to have a better outcome when we look into relapse-free survival and distant metastasis-free survival in stage III. Targeted therapy has a different profile from immunotherapy, and this needs to be discussed with the patients, especially when we look into long-term toxicity. Also, the impact in terms of quality of life between these two therapies seems to be different, and this needs to be taken into consideration when we discuss this with our patients. With that, I'll finish this three-episode series. I look forward to your comments and to our next series together. Enjoy your day.
Medscape
28-05-2025
- Business
- Medscape
Understanding Gaps in OS Data for Melanoma Adjuvant Therapy
This transcript has been edited for clarity. Welcome back, everybody. My name is Teresa Amaral, and it's a real pleasure to have you here for this melanoma series on Medscape. We have talked in the last two episodes about the current status of adjuvant therapy and its benefit in patients with stage III melanoma, and in the last episode we discussed the absence of overall survival (OS) benefit. You may question why it is important to have this discussion in terms of the absence of OS benefit or the absence of data on the OS benefit. This absence of data might have three consequences, and I'm going to go through them with you. The first one is associated with reimbursement. The fact that we will need to wait until 2028, most likely, to evaluate the OS benefit from adjuvant therapy compared to placebo in stage III might lead to some discussions in terms of the reimbursement and might lead some agencies to consider whether they would like to continue reimbursing this therapy or not in this setting. Second, in some countries, the absence of OS data is leading to discussions on whether they will fund this therapy or not until there is clear proof that there is an OS benefit. The third point is related to the fact that we don't knowthe patient's individual benefit. We also know that, depending on the stage, we might need to treat more patients to actually have one patient to prevent a recurrence. For example, we know that in patients in stage IIB, we will have to treat between five and nine patients in stage IIB to prevent a recurrence. In patients with stage IIC, we need to treat between four and seven patients to prevent a recurrence. All of these cost-effectiveness analyses are being done by the healthcare agencies, and this obviously needs to be taken into consideration when we are discussing these types of therapiesthat have a benefit in terms of relapse-free survival and distant metastasis-free survival but lack data in terms of OS benefit. Another point is that, despite the fact that all the guidelines have been supporting the use of this therapy in stage III and stage IV — namely the ESMO guidelines and the ASCO guidelines— there is some uncertainty in terms of the OS benefit. This may lead to some difficult discussions and a lack of clear direction in terms of whatpatients should do when they need to make a decision on receiving adjuvant therapy or not. The patients and their treating physicians may struggle with treatment choices due to this uncertainty and the fact that they don't know if there will be a long-term survival impact for this particular patient or not. Here, we come to the first discussion that we had a couple of sessions before, which is the absence of prognostic and predictive biomarkers in this setting. Besides that, we really don't know the impact of these adjuvant treatments in terms of long-term benefitwhen we talk about OS, which might lead to reduced use of these therapies in stage III and stage II. This decline in terms of use of these adjuvant therapies has already been seen in some countries, like in Denmark.
