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Avelumab First-Line Maintenance Treatment in Advanced Bladder Cancer: Practical Implementation Steps for Infusion Nurses
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Avelumab First-Line Maintenance Treatment in Advanced Bladder Cancer: Practical Implementation Steps for Infusion Nurses
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Language: EN.
Segment:0 .
DAWN CONWAY: Hi. My name is Dawn Conway. I am an oncology nurse working in the Genitourinary Oncology Group at University of Chicago Medicine, and I specialize in managing patients with urothelial cancer. I would like to discuss our review article entitled: "Avelumab First-Line Maintenance Treatment in Advanced Bladder Cancer: Practical Implementation Steps for Infusion Nurses".
DAWN CONWAY: This article was published in the Journal of Infusion Nursing in May 2022. Bladder cancer is one of the most common cancers. And there are more than 500,000 new cases globally every year. Patients who develop metastatic bladder cancer have a poor prognosis, with a five-year survival rate of 5.5%. Urothelial carcinoma, or UC, is the most common type of bladder cancer, with greater than 90% of UC tumors originating in the bladder.
DAWN CONWAY: Patients with UC tend to be a frail and older population with multiple comorbidities. Although UC is an aggressive disease, UC tumors are sensitive to platinum chemotherapy. Consequently, platinum-containing combination chemotherapy has been the standard of care first-line treatment for eligible patients with locally advanced or metastatic UC with proven benefit for several decades.
DAWN CONWAY: However, the benefits of first-line chemotherapy are limited by short durations of response, and most patients may eventually develop disease progression. Hence, maintenance treatment is needed to extend overall survival in patients with advanced UC. On the left side of Figure 1, you can see the immunogenic effects of first-line platinum- containing chemotherapy.
DAWN CONWAY: A sequential approach with immune checkpoint inhibitor, or ICI, maintenance therapy after first-line platinum-containing chemotherapy can potentially extend the benefits of the chemotherapy and may also enhance the antitumor effects of subsequent ICI treatment. Avelumab is an ICI approved as first-line maintenance treatment for patients with advanced UC that has not progressed on first-line platinum-containing chemotherapy.
DAWN CONWAY: On the right side of Figure 1, we can see how avelumab acts by binding to PD-L1 on tumor cells, preventing it from binding PD-1 receptors on activated T-cells. The blockade of the PD-1 PD-L1 pathway prevents T-cell and activation and restores active antitumor T-cell responses. The figure also shows how the binding of avelumab to PD-L1 may activate natural killer cells to mount anti-cancer effects.
DAWN CONWAY: The approval of avelumab as first-line maintenance treatment for patients with advanced UC was based on data from the phase 3 JAVELIN Bladder 100 trial. As you can see from Figure 2, the trial compared avelumab first-line maintenance plus best supportive care, or BSC, versus BSC alone in patients with locally advanced or metastatic UC who did not have disease progression after 4 to 6 cycles of first-line platinum-containing chemotherapy.
DAWN CONWAY: The survival curve in Figure 3 shows that avelumab maintenance plus BSC significantly improved overall survival compared with BSC alone in the initial analysis. The hazard ratio was 0.69 and the p-value was 0.001. Median overall survival was 21.4 months in the avelumab plus BSC arm versus 14.3 months in the BSC alone arm.
DAWN CONWAY: Results with longer follow up, which confirmed the initial analysis were presented at the ASCO Genitourinary Cancer Symposium in 2022. Treatment-related adverse events, or AEs, occurred more frequently in the avelumab arm than in the BSC alone arm. Treatment-related AEs occurring in at least 10% of avelumab-treated patients were pruritus, hypothyroidism, diarrhea, and infusion-related reaction.
DAWN CONWAY: Discontinuation rates due to AEs were low with avelumab, and the toxicity profile was consistent with that reported in other trials of ICIs. The most common all grade AEs were fatigue, nausea, diarrhea, and increased serum biomarker levels. And these occurred in about 67% of patients. Overall, the data from the JAVELIN Bladder 100 trial show the clear benefit of administering avelumab maintenance therapy directly after 4 to 6 cycles of first-line platinum- containing chemotherapy for patients with complete response, partial response, or stable disease, rather than delaying the start of ICI maintenance until disease progression has occurred.
DAWN CONWAY: Avelumab first-line maintenance is now considered the standard of care treatment for this patient group. Avelumab is also the only category one preferred ICI maintenance treatment in National Comprehensive Cancer Network guidelines for cisplatin eligible and ineligible patients with advanced UC. To be considered for avelumab maintenance, patients need to have responded or had disease stabilization after completing first-line platinum-containing chemotherapy.
DAWN CONWAY: In the JAVELIN Bladder 100 trial, patients waited 4 to 10 weeks from the last dose of chemotherapy before starting avelumab. This means that patients had time to recover from the effects of first-line chemotherapy, including toxicities. Oncology providers and patients should be aware that there may be an increased risk for disease progression with an interval longer than 10 weeks.
DAWN CONWAY: Data from the JAVELIN Bladder 100 trial showed that avelumab is suitable for patients with a range of demographic, clinical, and disease characteristics. In particular, survival benefits were seen in patients with high-risk disease, such as older patients or those with renal impairment, in patients who receive cisplatin-based or carboplatin-based chemotherapy, and regardless of whether patients had a response or stable disease with first-line chemotherapy.
DAWN CONWAY: The different ways that infusion nurses can provide support for patients with advanced UC receiving avelumab first-line maintenance treatment are summarized in the patient treatment pathway shown in Figure 4. Infusion nurses trained in the administration of cancer therapy will likely begin interacting with patients with first-line chemotherapy is initiated, and may maintain a relationship throughout treatment with avelumab.
DAWN CONWAY: Before the patient starts treatment, infusion nurses may hold a consultation with patients and their caregivers to discuss the time commitment required and to provide detailed instructions and educational materials related to recognizing and reporting potential AEs. Also, because many patients may feel anxious and uncertain about receiving a new treatment, infusion nurses can help them feel as comfortable as possible while they are in the clinic, which may also encourage treatment adherence.
DAWN CONWAY: In addition to administering therapy, infusion nurses proactively assess the patient's tolerance of therapy and monitor and assess for AEs during the course of their treatment. Advanced UC should be treated as a chronic aggressive disease. Patients should be educated on the need for continued avelumab maintenance treatment until disease progression or unacceptable toxicity.
DAWN CONWAY: Avelumab is approved to be administered at a dose of 800 milligrams as an intravenous infusion over 60 minutes every two weeks. There is no fixed duration for treatment. And avelumab first-line maintenance is recommended to be administered until disease progression or unacceptable toxicity, consistent with the JAVELIN Bladder 100 clinical trial and prescribing information.
DAWN CONWAY: Avelumab can potentially cause severe or life-threatening infusion-related reactions. In the JAVELIN Bladder 100 trial, 10% of patients had an infusion-related reaction, with 0.9% having a grade 3 reaction. Patients should receive pre-medication with an antihistamine and acetaminophen before the first four avelumab infusions.
DAWN CONWAY: The pre-medication regimen may be modified based on local treatment standards and guidelines as appropriate, provided it does not include systemic corticosteroids. Pre-medication may also be needed for subsequent infusions, depending on clinical judgment and the presence and severity of prior infusion-related reactions. In the JAVELIN Bladder 100 trial, pre-medication was given 30 to 60 minutes before avelumab infusions.
DAWN CONWAY: Nurses should instruct patients to have someone accompany them for the first infusion visit and potentially for subsequent visits because of the potential for infusion reactions or drowsiness from certain types of pre-medication. Patients should be monitored throughout the infusion process for signs and symptoms of infusion-related reaction, such as fever, chills, flushing, shortness of breath, wheezing, hypotension, back or abdominal pain, or urticaria.
DAWN CONWAY: Infusion-related reactions may occur up to two days after infusion. So it is important to educate patients and caregivers to alert a health care provider if they have any unusual symptoms after leaving the infusion center. As shown in Table 1, one useful tool is the common terminology criteria for AEs grading system, which was developed to standardize AE reporting across different specialties.
DAWN CONWAY: A good understanding of these criteria can help infusion nurses to effectively respond and communicate with the patient's primary oncology team. Immune-related AEs may also occur during avelumab treatment or after treatment has been discontinued. Infusion nurses should monitor patients closely for signs and symptoms of potential immune-related AEs because early recognition and management are critical.
DAWN CONWAY: Patient monitoring should include evaluations of liver enzymes, creatinine, and thyroid function at the initial consultation and throughout treatment. All symptoms and AEs should be documented in the patient's electronic medical record. Overall, infusion nurses are the front line of patient care and play a vital role throughout the treatment journey of patients with advanced UC.
DAWN CONWAY: Infusion nurses may serve as both valuable educational resources and important champions for patients' needs. A thorough understanding of the rationale and benefits of avelumab first-line maintenance, as well as the recognition and management of infusion-related reactions and immune-related AEs, will enable infusion nurses to ensure that patients with advanced UC receive optimal cancer care. This will ensure the safe and appropriate use of avelumab and help eligible patients to derive maximum benefit.
DAWN CONWAY:
Segment:0 .
DAWN CONWAY: Hi. My name is Dawn Conway. I am an oncology nurse working in the Genitourinary Oncology Group at University of Chicago Medicine, and I specialize in managing patients with urothelial cancer. I would like to discuss our review article entitled: "Avelumab First-Line Maintenance Treatment in Advanced Bladder Cancer: Practical Implementation Steps for Infusion Nurses".
DAWN CONWAY: This article was published in the Journal of Infusion Nursing in May 2022. Bladder cancer is one of the most common cancers. And there are more than 500,000 new cases globally every year. Patients who develop metastatic bladder cancer have a poor prognosis, with a five-year survival rate of 5.5%. Urothelial carcinoma, or UC, is the most common type of bladder cancer, with greater than 90% of UC tumors originating in the bladder.
DAWN CONWAY: Patients with UC tend to be a frail and older population with multiple comorbidities. Although UC is an aggressive disease, UC tumors are sensitive to platinum chemotherapy. Consequently, platinum-containing combination chemotherapy has been the standard of care first-line treatment for eligible patients with locally advanced or metastatic UC with proven benefit for several decades.
DAWN CONWAY: However, the benefits of first-line chemotherapy are limited by short durations of response, and most patients may eventually develop disease progression. Hence, maintenance treatment is needed to extend overall survival in patients with advanced UC. On the left side of Figure 1, you can see the immunogenic effects of first-line platinum- containing chemotherapy.
DAWN CONWAY: A sequential approach with immune checkpoint inhibitor, or ICI, maintenance therapy after first-line platinum-containing chemotherapy can potentially extend the benefits of the chemotherapy and may also enhance the antitumor effects of subsequent ICI treatment. Avelumab is an ICI approved as first-line maintenance treatment for patients with advanced UC that has not progressed on first-line platinum-containing chemotherapy.
DAWN CONWAY: On the right side of Figure 1, we can see how avelumab acts by binding to PD-L1 on tumor cells, preventing it from binding PD-1 receptors on activated T-cells. The blockade of the PD-1 PD-L1 pathway prevents T-cell and activation and restores active antitumor T-cell responses. The figure also shows how the binding of avelumab to PD-L1 may activate natural killer cells to mount anti-cancer effects.
DAWN CONWAY: The approval of avelumab as first-line maintenance treatment for patients with advanced UC was based on data from the phase 3 JAVELIN Bladder 100 trial. As you can see from Figure 2, the trial compared avelumab first-line maintenance plus best supportive care, or BSC, versus BSC alone in patients with locally advanced or metastatic UC who did not have disease progression after 4 to 6 cycles of first-line platinum-containing chemotherapy.
DAWN CONWAY: The survival curve in Figure 3 shows that avelumab maintenance plus BSC significantly improved overall survival compared with BSC alone in the initial analysis. The hazard ratio was 0.69 and the p-value was 0.001. Median overall survival was 21.4 months in the avelumab plus BSC arm versus 14.3 months in the BSC alone arm.
DAWN CONWAY: Results with longer follow up, which confirmed the initial analysis were presented at the ASCO Genitourinary Cancer Symposium in 2022. Treatment-related adverse events, or AEs, occurred more frequently in the avelumab arm than in the BSC alone arm. Treatment-related AEs occurring in at least 10% of avelumab-treated patients were pruritus, hypothyroidism, diarrhea, and infusion-related reaction.
DAWN CONWAY: Discontinuation rates due to AEs were low with avelumab, and the toxicity profile was consistent with that reported in other trials of ICIs. The most common all grade AEs were fatigue, nausea, diarrhea, and increased serum biomarker levels. And these occurred in about 67% of patients. Overall, the data from the JAVELIN Bladder 100 trial show the clear benefit of administering avelumab maintenance therapy directly after 4 to 6 cycles of first-line platinum- containing chemotherapy for patients with complete response, partial response, or stable disease, rather than delaying the start of ICI maintenance until disease progression has occurred.
DAWN CONWAY: Avelumab first-line maintenance is now considered the standard of care treatment for this patient group. Avelumab is also the only category one preferred ICI maintenance treatment in National Comprehensive Cancer Network guidelines for cisplatin eligible and ineligible patients with advanced UC. To be considered for avelumab maintenance, patients need to have responded or had disease stabilization after completing first-line platinum-containing chemotherapy.
DAWN CONWAY: In the JAVELIN Bladder 100 trial, patients waited 4 to 10 weeks from the last dose of chemotherapy before starting avelumab. This means that patients had time to recover from the effects of first-line chemotherapy, including toxicities. Oncology providers and patients should be aware that there may be an increased risk for disease progression with an interval longer than 10 weeks.
DAWN CONWAY: Data from the JAVELIN Bladder 100 trial showed that avelumab is suitable for patients with a range of demographic, clinical, and disease characteristics. In particular, survival benefits were seen in patients with high-risk disease, such as older patients or those with renal impairment, in patients who receive cisplatin-based or carboplatin-based chemotherapy, and regardless of whether patients had a response or stable disease with first-line chemotherapy.
DAWN CONWAY: The different ways that infusion nurses can provide support for patients with advanced UC receiving avelumab first-line maintenance treatment are summarized in the patient treatment pathway shown in Figure 4. Infusion nurses trained in the administration of cancer therapy will likely begin interacting with patients with first-line chemotherapy is initiated, and may maintain a relationship throughout treatment with avelumab.
DAWN CONWAY: Before the patient starts treatment, infusion nurses may hold a consultation with patients and their caregivers to discuss the time commitment required and to provide detailed instructions and educational materials related to recognizing and reporting potential AEs. Also, because many patients may feel anxious and uncertain about receiving a new treatment, infusion nurses can help them feel as comfortable as possible while they are in the clinic, which may also encourage treatment adherence.
DAWN CONWAY: In addition to administering therapy, infusion nurses proactively assess the patient's tolerance of therapy and monitor and assess for AEs during the course of their treatment. Advanced UC should be treated as a chronic aggressive disease. Patients should be educated on the need for continued avelumab maintenance treatment until disease progression or unacceptable toxicity.
DAWN CONWAY: Avelumab is approved to be administered at a dose of 800 milligrams as an intravenous infusion over 60 minutes every two weeks. There is no fixed duration for treatment. And avelumab first-line maintenance is recommended to be administered until disease progression or unacceptable toxicity, consistent with the JAVELIN Bladder 100 clinical trial and prescribing information.
DAWN CONWAY: Avelumab can potentially cause severe or life-threatening infusion-related reactions. In the JAVELIN Bladder 100 trial, 10% of patients had an infusion-related reaction, with 0.9% having a grade 3 reaction. Patients should receive pre-medication with an antihistamine and acetaminophen before the first four avelumab infusions.
DAWN CONWAY: The pre-medication regimen may be modified based on local treatment standards and guidelines as appropriate, provided it does not include systemic corticosteroids. Pre-medication may also be needed for subsequent infusions, depending on clinical judgment and the presence and severity of prior infusion-related reactions. In the JAVELIN Bladder 100 trial, pre-medication was given 30 to 60 minutes before avelumab infusions.
DAWN CONWAY: Nurses should instruct patients to have someone accompany them for the first infusion visit and potentially for subsequent visits because of the potential for infusion reactions or drowsiness from certain types of pre-medication. Patients should be monitored throughout the infusion process for signs and symptoms of infusion-related reaction, such as fever, chills, flushing, shortness of breath, wheezing, hypotension, back or abdominal pain, or urticaria.
DAWN CONWAY: Infusion-related reactions may occur up to two days after infusion. So it is important to educate patients and caregivers to alert a health care provider if they have any unusual symptoms after leaving the infusion center. As shown in Table 1, one useful tool is the common terminology criteria for AEs grading system, which was developed to standardize AE reporting across different specialties.
DAWN CONWAY: A good understanding of these criteria can help infusion nurses to effectively respond and communicate with the patient's primary oncology team. Immune-related AEs may also occur during avelumab treatment or after treatment has been discontinued. Infusion nurses should monitor patients closely for signs and symptoms of potential immune-related AEs because early recognition and management are critical.
DAWN CONWAY: Patient monitoring should include evaluations of liver enzymes, creatinine, and thyroid function at the initial consultation and throughout treatment. All symptoms and AEs should be documented in the patient's electronic medical record. Overall, infusion nurses are the front line of patient care and play a vital role throughout the treatment journey of patients with advanced UC.
DAWN CONWAY: Infusion nurses may serve as both valuable educational resources and important champions for patients' needs. A thorough understanding of the rationale and benefits of avelumab first-line maintenance, as well as the recognition and management of infusion-related reactions and immune-related AEs, will enable infusion nurses to ensure that patients with advanced UC receive optimal cancer care. This will ensure the safe and appropriate use of avelumab and help eligible patients to derive maximum benefit.
DAWN CONWAY:
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