What Is the Main Idea?
Nausea and vomiting are common side effects of chemotherapy, especially in the treatment of breast cancer. A recently approved treatment for these side effects called NEPA has been effective in clinical trials. To observe how this treatment works in real-world settings in breast cancer patients, the authors of a recent paper conducted a study. Here, we look at the results, published under the title “Quality of Life Effects of an Oral Fixed Combination of Netupitant and Palonosetron in Chemotherapy-Induced Nausea and Vomiting Prevention: Real-World Evidence in Patients with Breast Cancer Receiving Anthracycline-Cyclophosphamide-Based Chemotherapy” in the journal Breast Care.
What Else Can You Learn?
From this article, we can understand the safety of the NEPA treatment and its effectiveness in preventing vomiting and nausea. Also, one can learn how these breast cancer patients responded regarding their quality of life with the treatment.
Nausea and Vomiting: Side Effects of Chemotherapy
Since the 1970s, a common treatment for breast cancer involves chemotherapy using a combination of anthracycline and cyclophosphamide, commonly referred to as AC chemotherapy. Unfortunately, this therapy is known to have strong side effects like nausea and vomiting soon after (1–5 days) the treatment. For patients who are already under stress because of cancer and must undergo multiple chemotherapy rounds, these side effects reduce their quality of life even further. These side effects are further pronounced in patients with breast cancer because many of them are women of younger age and usually undergo AC chemotherapy (Osoba et al., Dranitsaris et al.). This can also lead to some patients discontinuing the treatment. Recognizing these issues, guidelines for treating chemotherapy-induced nausea and vomiting have been recommended by various organizations.
Therapy to Reduce the Side Effects
There are multiple drugs that researchers have shown to help prevent vomiting and nausea but each helps only to a certain extent. Additionally, some medications recommended have complex scheduling for administration which could lead to poor adherence.
Interestingly, studies showed that combining different medications helped to reduce vomiting and nausea better than single drugs. One such combination that has been approved and recommended for certain chemotherapy treatments is NEPA (netupitant (300 mg) with palonosetron (0.5 mg)) along with dexamethasone. An important guideline to prevent nausea and vomiting after AC chemotherapy is to administer the NEPA treatment before the chemotherapy begins. Following these recommendations and in line with keeping treatment administration simple, NEPA along with dexamethasone is usually given as a single dose on the day of chemotherapy. The effect of the treatment can last up to 5 days.
Clinical trials, which are done under specific conditions, smaller sample size, and with a control condition to compare, showed positive results in terms of safety and effectiveness in preventing vomiting and nausea with NEPA. Most importantly, compared to the control treatment, significantly more patients who got the NEPA treatment reported that chemotherapy did not impact their daily life. This is a big improvement in helping patients have a better quality of life despite chemotherapy. The next step was to look at how this treatment works outside of controlled trials.
Safety and Effectiveness of NEPA Treatment in Real-World Testing
Since the treatment got approved and is being administered to patients, it was important to check how the NEPA treatment changed the quality of life of patients in real-world settings. The authors conducted the study in 162 centers in Germany with more than 2,000 patients who were undergoing AC chemotherapy and were given NEPA with dexamethasone 1 hour before it. For this study, the authors focused on a subgroup of 1,197 patients who had breast cancer and specifically looked at what happened in the first 3 rounds of the treatment.
With regards to safety, 10% of patients reported some adverse effects related to NEPA treatment. The main issues were constipation and fatigue. More serious side effects were reported in less than 1% of cases, and there were no deaths. Overall, the treatment proved to be safe in real-world settings, too.
Next, the authors looked at the effectiveness of NEPA treatment. With more than 93% of patients not experiencing vomiting across different rounds of chemotherapy, the treatment already proved helpful. However, more patients had nausea, with about 60% of patients reporting to have “no significant nausea” and only approximately 31% patients saying they had no nausea at all. These numbers increased only marginally over chemotherapy rounds. However, due to low vomiting rates, further medications to help with these side effects were required only in 10–15% of the patients. So, rating the treatment overall, more than 84% of both doctors and patients rated this treatment as “good” or “very good”.
What about Effects on Quality of Life?
When it came to affecting their quality of life, 84% reported that vomiting did not affect them and 53% reported nausea not affecting them in daily life. Overall, 64% of the patients felt their quality of life was not affected by nausea or vomiting with the NEPA treatment. Interestingly, for the patients below 60 years, despite the treatment, nausea and vomiting occurred a little more frequently, reducing the effectiveness of NEPA treatment and their quality of life.
NEPA Treatment Helps Reduce Vomiting and Nausea in Real-World Settings
Even though you cannot have a direct comparison to a control condition, real-world testing is important to understand the true effect of a treatment. When compared to previous clinical trials, in this real-world study of NEPA treatment, the patients were affected by vomiting to a similar extent but more patients were affected by nausea. The authors believe that the reason for more nausea-related issues in the real-world test is that in controlled trials, they excluded patients with other comorbidities and those otherwise prone to nausea. Despite this, they believe that the NEPA treatment has been successful in real-world testing when it comes to safety, effectiveness, and improving the quality of life of patients.
Note: Some of the authors of the paper declared that they have received honoraria, travel expenses and support from pharmaceutical companies. It is normal for authors to declare this in case it might be perceived as a conflict of interest. More detail can be found in the Conflict of Interest statement at the end of the referenced paper.