VYLOY Clinical Trial Quiz
48 Questions
4 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to Lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What was the initial dose of VYLOY administered in GLOW?

  • 600 mg/m2
  • 1000 mg/m2
  • 800 mg/m2 (correct)
  • 200 mg/m2

What percentage of patients experienced serious adverse reactions while on VYLOY?

  • 8%
  • 55%
  • 19%
  • 47% (correct)

Which of the following was the most common serious adverse reaction among patients treated with VYLOY?

  • Diarrhea
  • Nausea
  • Pneumonia
  • Vomiting (correct)

What proportion of patients had to permanently discontinue VYLOY due to adverse reactions?

<p>19% (A)</p> Signup and view all the answers

Which adverse reaction led to the highest percentage of dose interruptions of VYLOY?

<p>Nausea (C)</p> Signup and view all the answers

What was the median duration of exposure to VYLOY in combination with CAPOX?

<p>4.4 months (C)</p> Signup and view all the answers

What fatal adverse reaction occurred most frequently among patients receiving VYLOY?

<p>Sepsis (C)</p> Signup and view all the answers

Which of the following was NOT listed as an adverse reaction leading to discontinuation of VYLOY?

<p>Pulmonary embolism (B)</p> Signup and view all the answers

What percentage of patients in the VYLOY with mFOLFOX6 group experienced progression-free survival events?

<p>51.6% (A)</p> Signup and view all the answers

Which of the following represents the median overall survival for the placebo group in combination with mFOLFOX6?

<p>15.5 months (C)</p> Signup and view all the answers

What was the hazard ratio for overall survival comparing VYLOY with mFOLFOX6 to placebo with mFOLFOX6?

<p>0.750 (C)</p> Signup and view all the answers

What was the complete response rate for the VYLOY with mFOLFOX6 group?

<p>14% (C)</p> Signup and view all the answers

What percentage of patients in the placebo group experienced events during the progression-free survival endpoint?

<p>59.2% (B)</p> Signup and view all the answers

What was the median duration of response for patients receiving VYLOY?

<p>10.3 months (C)</p> Signup and view all the answers

What was the one-sided p-value indicating the significance of progression-free survival improvement in VYLOY group?

<p>0.0066 (A)</p> Signup and view all the answers

How many patients achieved a partial response in the VYLOY group?

<p>100 (D)</p> Signup and view all the answers

What is the primary indication for VYLOY?

<p>First-line treatment for HER2-negative gastric or GEJ adenocarcinoma (D)</p> Signup and view all the answers

What is the defining characteristic for selecting patients for VYLOY treatment?

<p>Presence of claudin 18.2 positive tumors (B)</p> Signup and view all the answers

What is the initial recommended dosage for VYLOY?

<p>800 mg/m2 intravenously (C)</p> Signup and view all the answers

What should be the state of nausea and/or vomiting before administering VYLOY?

<p>Resolved to Grade ≤1 (D)</p> Signup and view all the answers

How often should subsequent doses of VYLOY be administered after the first dose?

<p>Every 2 weeks or every 3 weeks (D)</p> Signup and view all the answers

Which of the following is NOT recommended as a dosage modification for VYLOY?

<p>Increasing the infusion rate (D)</p> Signup and view all the answers

What type of chemotherapy is VYLOY used in combination with?

<p>Fluoropyrimidine- and platinum-containing chemotherapy (B)</p> Signup and view all the answers

How is the CLDN18.2 positivity determined?

<p>By immunohistochemical staining (B)</p> Signup and view all the answers

Which of the following symptoms is NOT considered a serious allergic reaction to VYLOY?

<p>Decreased appetite (D)</p> Signup and view all the answers

What action should be taken if nausea or vomiting worsens after receiving VYLOY?

<p>Consult a healthcare provider immediately (B)</p> Signup and view all the answers

During which treatment cycle is nausea and vomiting reported to occur more frequently?

<p>First treatment cycle (A)</p> Signup and view all the answers

Which of the following side effects is associated with changes in laboratory tests during VYLOY treatment?

<p>Changes in kidney function tests (A)</p> Signup and view all the answers

What is a common preventative measure against severe nausea and vomiting during VYLOY treatment?

<p>Administering medicines before infusion (B)</p> Signup and view all the answers

When experiencing a serious allergic reaction to VYLOY, which symptom indicates a breathing issue?

<p>Throat tightness (D)</p> Signup and view all the answers

Which of the following is NOT listed as a common side effect of VYLOY?

<p>Severe headaches (A)</p> Signup and view all the answers

What might a healthcare provider do if a patient experiences certain side effects during VYLOY treatment?

<p>Completely stop treatment (C)</p> Signup and view all the answers

Which laboratory abnormality was reported in more than 15% of the pooled population?

<p>Decreased leucocyte count (A)</p> Signup and view all the answers

What percentage of patients experienced serious adverse reactions while treated with VYLOY in combination with mFOLFOX6?

<p>45% (D)</p> Signup and view all the answers

Which serious adverse reaction occurred in the highest percentage of patients treated with VYLOY?

<p>Vomiting (A)</p> Signup and view all the answers

What was the percentage of patients who experienced permanent discontinuation of VYLOY due to adverse reactions?

<p>20% (C)</p> Signup and view all the answers

Which of the following laboratory abnormalities indicates increased creatinine levels?

<p>Increased creatinine (D)</p> Signup and view all the answers

Which of the following was NOT among the common adverse reactions leading to dose interruption?

<p>Diarrhea (A)</p> Signup and view all the answers

What was the range of median exposure to VYLOY in combination with mFOLFOX6?

<p>1 day to 40.9 months (B)</p> Signup and view all the answers

Which fatal adverse reaction had the highest occurrence percentage among patients treated with VYLOY?

<p>Sepsis (D)</p> Signup and view all the answers

What is included in the stratification factors for the Kaplan-Meier estimate?

<p>Region (D)</p> Signup and view all the answers

How should VYLOY be stored prior to use?

<p>In the original carton refrigerated at 2ºC to 8ºC (D)</p> Signup and view all the answers

What is the risk associated with administering VYLOY?

<p>Anaphylaxis (B)</p> Signup and view all the answers

What should patients be advised to do if they experience severe nausea or vomiting while on VYLOY?

<p>Contact their healthcare provider immediately (D)</p> Signup and view all the answers

What is the recommended action regarding breastfeeding during treatment with VYLOY?

<p>Do not breastfeed during treatment and for 8 months after the last dose (A)</p> Signup and view all the answers

What type of reactions can VYLOY cause that require immediate medical attention?

<p>Infusion-related reactions (A)</p> Signup and view all the answers

In what form is VYLOY supplied for injection?

<p>As a lyophilized powder in single-dose vials (D)</p> Signup and view all the answers

What is the dosage form in which VYLOY is available?

<p>100 mg single-dose vial (A)</p> Signup and view all the answers

Flashcards

What is VYLOY used to treat?

VYLOY is a medication used in combination with other chemotherapy drugs for the treatment of advanced gastric or gastroesophageal junction cancer, specifically in cases where the tumor cells express CLDN18.2.

What is the recommended dosing schedule for VYLOY?

The first dose of VYLOY is 800 mg/m2 given intravenously. Subsequent doses are either 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks, depending on the patient's response and tolerance.

Who is VYLOY recommended for?

VYLOY is only recommended for patients with locally advanced or metastatic HER2-negative gastric or GEJ adenocarcinoma who have CLDN18.2 positive tumors, as this indicates the presence of a specific protein that the drug targets.

How is CLDN18.2 positivity determined?

CLDN18.2 positivity is determined through FDA-approved testing. This involves testing tumor tissue for the presence of the CLDN18.2 protein, which is a key factor in selecting patients for VYLOY treatment.

Signup and view all the flashcards

What is the route of administration for VYLOY?

VYLOY is given intravenously, meaning it is infused directly into the bloodstream. This type of administration allows the drug to reach the target tissues and cancer cells more rapidly and effectively.

Signup and view all the flashcards

What is done before administering VYLOY?

Premedication is essential before administering VYLOY. This involves giving patients a combination of antiemetic medications to prevent nausea and vomiting, common side effects of chemotherapy.

Signup and view all the flashcards

How long is VYLOY treatment typically continued?

VYLOY treatment is typically continued until the patient experiences disease progression, meaning the cancer starts to grow again, or until the side effects become too severe and unacceptable.

Signup and view all the flashcards

How are adverse reactions to VYLOY managed?

VYLOY treatment is adjusted based on the severity of adverse reactions. Dose reduction, infusion rate adjustment, interruption, withholding, or permanent discontinuation may be required to manage potential side effects.

Signup and view all the flashcards

What is neutropenia?

A decrease in the number of neutrophils, a type of white blood cell that fights infection.

Signup and view all the flashcards

What is leukopenia?

A reduction in the overall number of white blood cells in the body.

Signup and view all the flashcards

What is hypoalbuminemia?

A decrease in the protein albumin, which is important for maintaining fluid balance and blood pressure.

Signup and view all the flashcards

What is elevated creatinine?

An increase in creatinine, a waste product from muscle breakdown, which can indicate kidney problems.

Signup and view all the flashcards

What is anemia?

A decrease in the oxygen-carrying protein in red blood cells.

Signup and view all the flashcards

What is hyperglycemia?

An increase in blood glucose levels, which can indicate diabetes or other metabolic problems.

Signup and view all the flashcards

What is lymphopenia?

A decrease in the number of lymphocytes, a type of white blood cell important for the immune system.

Signup and view all the flashcards

What is thrombocytopenia?

A decrease in the number of platelets, which are essential for blood clotting.

Signup and view all the flashcards

GLOW

A clinical trial that evaluated the safety of VYLOY in patients with advanced stomach or gastroesophageal junction cancer.

Signup and view all the flashcards

Metastatic Cancer

A type of cancer that has spread beyond its original location.

Signup and view all the flashcards

Chemotherapy Regimen

A group of cancer treatments.

Signup and view all the flashcards

Thrombocytopenia

A common adverse reaction to VYLOY treatment, characterized by a decrease in blood platelet count.

Signup and view all the flashcards

Anaphylactic Reaction

A severe adverse reaction to VYLOY treatment involving a sudden decrease in blood pressure, rapid heartbeat, and difficulty breathing.

Signup and view all the flashcards

Infusion-Related Reaction

A type of adverse reaction that occurs during or shortly after receiving an intravenous infusion of VYLOY.

Signup and view all the flashcards

Dose Interruption

When treatment is stopped or the dose is adjusted because of an adverse reaction.

Signup and view all the flashcards

Permanent Discontinuation

When treatment is permanently discontinued due to an adverse reaction.

Signup and view all the flashcards

Progression-Free Survival (PFS)

The time it takes for a cancer to progress, usually measured from the start of treatment to the time the cancer grows or spreads.

Signup and view all the flashcards

Overall Survival (OS)

The time a patient lives with a disease, usually measured from the start of treatment to the patient's death.

Signup and view all the flashcards

Hazard Ratio

A statistical measure that compares the risk of an event (like cancer progression) happening in one group (like the treatment group) compared to another group (like the placebo group). A hazard ratio of less than 1 means the treatment group had a lower risk of the event.

Signup and view all the flashcards

P-value

A statistical test that compares the survival rates of two groups. A p-value less than 0.05 generally indicates a statistically significant difference between the groups.

Signup and view all the flashcards

Objective Response Rate (ORR)

The percentage of patients who experience a tumor shrinkage beyond a certain level. This includes complete response (CR) and partial response (PR), where the tumor disappears or shrinks significantly.

Signup and view all the flashcards

Complete Response Rate (CR)

The percentage of patients who experience a complete disappearance of their tumor.

Signup and view all the flashcards

Partial Response Rate (PR)

The percentage of patients who experience a significant reduction in tumor size, but not a complete disappearance.

Signup and view all the flashcards

Overall Survival (OS)

The time a patient lives with a disease, usually measured from the start of treatment to the patient's death.

Signup and view all the flashcards

Kaplan-Meier Estimate

A statistical method used to estimate the survival probability over time in a population.

Signup and view all the flashcards

Stratification Factors

Factors used to divide the data into subgroups, ensuring that the results are not influenced by these factors.

Signup and view all the flashcards

Stratified Cox Proportional Hazards Model

A statistical model that analyzes the relationship between time to an event and multiple predictor variables, considering the effects of stratification factors.

Signup and view all the flashcards

Stratified Log-Rank Test

A statistical test used to compare the survival curves of two or more groups, taking into account stratification factors.

Signup and view all the flashcards

Confirmed Response

The confirmed response to treatment, indicating a positive outcome after a treatment period.

Signup and view all the flashcards

Clopper-Pearson Method

A method used to calculate the confidence intervals for a population proportion.

Signup and view all the flashcards

Route of Administration for Vyloy

The medication Vyloy (zolbetuximab-clzb) is administered intravenously, meaning it is delivered directly into the bloodstream.

Signup and view all the flashcards

Premedication for Vyloy

Premedication is given before administering Vyloy to help prevent adverse effects like nausea and vomiting.

Signup and view all the flashcards

What are the symptoms of a serious allergic reaction to VYLOY?

Severe allergic reaction to VYLOY characterized by symptoms such as itchy bumps, breathing problems, throat tightness, nausea, vomiting, fever, stomach pain, increased saliva, chills, or back pain.

Signup and view all the flashcards

What are the most common side effects of VYLOY?

Common side effects of VYLOY, which can be severe, and may occur more frequently during the first treatment cycle.

Signup and view all the flashcards

Can you list some specific side effects of VYLOY?

Decreased appetite, diarrhea, tingling or numbness in the arms or legs, stomach pain, constipation, decreased weight, changes in kidney function tests, changes in blood sugar levels, changes in liver function tests, and changes in body salt levels are common side effects of VYLOY.

Signup and view all the flashcards

What is VYLOY used for?

VYLOY is a medication used in combination with other chemotherapy drugs for the treatment of advanced gastric or gastroesophageal junction cancer, when tumor cells express CLDN18.2.

Signup and view all the flashcards

What is done to prevent nausea and vomiting associated with VYLOY?

Before each VYLOY infusion, your healthcare provider may give you medicine to help prevent nausea and vomiting, common side effects of VYLOY.

Signup and view all the flashcards

What happens to the VYLOY treatment if a patient experiences side effects?

The rate of VYLOY infusion may be slowed, temporarily stopped, or treatment may be completely stopped if a patient experiences certain side effects.

Signup and view all the flashcards

What is important to know about nausea and vomiting during VYLOY treatment?

Severe nausea and vomiting are common during treatment with VYLOY, and they happen more often during the first treatment cycle. Tell your healthcare provider right away if nausea or vomiting does not go away or gets worse.

Signup and view all the flashcards

How can you report side effects of VYLOY?

The FDA (Food and Drug Administration) gathers reports on side effects of medications. You can report side effects to the FDA at 1-800-FDA-1088.

Signup and view all the flashcards

Study Notes

VYLOY (zolbetuximab-clzb) for Injection

  • Indications: First-line treatment for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with claudin (CLDN) 18.2-positive tumors.
  • Mechanism of Action: Claudin 18.2-directed cytolytic antibody. Depletes CLDN18.2-positive cells via antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
  • Dosage: Initial dose 800 mg/m², followed by 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks, intravenously.
  • Administration: IV infusion only, do not administer as an IV push or bolus. Premedicate with antiemetics prior to each infusion for nausea and vomiting prevention.
  • Contraindications: None listed.
  • Warnings and Precautions:
    • Hypersensitivity Reactions: Serious anaphylaxis and infusion-related reactions have occurred. Monitor patients during and for at least 2 hours after infusion. Interrupt, slow, or permanently discontinue infusion based on reaction severity. Premedicate with antihistamines for subsequent infusions after hypersensitivity reactions.
    • Severe Nausea and Vomiting: Premedicate with antiemetics. Interrupt or discontinue based on severity. Manage with antiemetics or fluid replacement.
  • Adverse Reactions: Common adverse reactions in trials include nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia. Common laboratory abnormalities include decreased neutrophil and leucocyte counts, decreased albumin, increased creatinine, and decreased hemoglobin.

Dosage Modifications

  • No dose reduction is recommended for VYLOY.
  • Adverse reactions are managed by adjusting infusion rate, interruption, dose withholding, or permanent discontinuation based on severity, as detailed in Table 1.

Preparation and Dilution

  • Calculate the dose based on body surface area and number of vials needed.
  • Reconstitute each vial by adding 5 mL of Sterile Water for Injection.
  • Slowly swirl until dissolved. Do not shake.
  • Visually inspect for particulate matter and discoloration. Discard vials with visible particles.
  • Store reconstituted vials at room temperature (15°C to 30°C) for up to 5 hours if unused immediately.
  • Transfer reconstituted solution to an infusion bag with 0.9% Sodium Chloride Injection to a concentration of 5 mg/mL.
  • Visual inspection of the diluted solution is required prior to use.
  • Storage of diluted solution is at room temperature (15°C to 30°C) for up to 6 hours or refrigerated (2°C to 8°C) for up to 16 hours. Do not freeze.

Administration

  • Administer VYLOY intravenously only.
  • Do not administer as an intravenous push or bolus.
  • If administering VYLOY with chemotherapy, administer VYLOY first.
  • Use compatible infusion devices and tubing.
  • Follow infusion rates in Table 2.
  • Start infusion slowly (30-60 minutes) and increase as tolerated if no adverse reactions occur.
  • If the infusion time exceeds the recommended storage time, discard the bag and prepare a new infusion bag.

Use in Specific Populations

  • Pregnancy: Not recommended unless benefit outweighs risk.
  • Lactation: Advise patients not to breastfeed during treatment and for 8 months after the last dose.
  • Pediatric: Safety and effectiveness not established.
  • Geriatric: No significant differences in safety or effectiveness observed in patients aged 65 years and older compared to younger patients.
  • Females/Males of Reproductive Potential: Refer to the Full Prescribing Information of any associated chemotherapy for pregnancy testing, contraception, and fertility information.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Quiz Team

Related Documents

VYLOY (zolbetuximab-clzb) for Injection, 2024 PDF

Description

Test your knowledge about the VYLOY clinical trial results. This quiz covers dosages, adverse reactions, and survival rates among patients treated with VYLOY in combination with various chemotherapy regimens. Challenge yourself with questions that assess your understanding of the trial's findings and implications.

Use Quizgecko on...
Browser
Open
Browser
Browser