Project Patient Voice is intended to be used with a healthcare professional when discussing the potential symptoms related to a cancer and cancer treatment. Do not rely on Project Patient Voice alone to make decisions about medical care. Do not use Project Patient Voice to substitute for advice from your health care professional. Conclusions about patient experiences with symptoms may be limited because not all symptoms may have been captured by the patient-reported questionnaire.
How Was the AURA3 Study Conducted?
AURA3 is a Phase III, open label, randomized study comparing TAGRISSOTM with platinum-based doublet chemotherapy. To be included in AURA3, patients had an abnormal epidermal growth factor receptor (EGFRm+/T790M+) lung cancer that had spread to other parts of the lungs or body (locally advanced or metastatic non-small cell lung cancer - NSCLC) and had previously been treated with an approved EGFR-TKI medicine that had stopped working or did not work. Patients were allocated by a ratio of 2:1 Tagrisso: chemotherapy. For more information on how this study was conducted, refer to the product label.
Which Questionnaire Was Used to Collect Patient-Reported Symptoms?
Patients reported their symptom experiences via the Patient Reported Outcomes – Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. PRO-CTCAE was developed by the National Cancer Institute (NCI) to evaluate symptomatic toxicity in patients in oncology clinical trials. The PRO-CTCAE questionnaire was designed to provide additional information that is complementary to existing safety and tolerability assessments reported by clinicians.
How Were Patient-Reported Symptoms in the AURA3 Study Collected?
Patients reported their symptom experiences just before treatment and each week during treatment, using the PRO-CTCAE questionnaire. PRO-CTCAE data was collected from 102 patients randomized to Tagrisso and 59 patients randomized to chemotherapy for whom PRO-CTCAE was available in their language (English, Spanish, Japanese, and German). Twenty-eight symptoms were selected based on their relevance to known side-effects of treatment with Tagrisso, similar EGFR-TKI agents or chemotherapy. Each symptom is asked as either a frequency, severity, occurrence, or amount question. At each assessment week over the first 24 weeks (approximately 6 months) of treatment, between 71.4% to 89.8% of patients provided data. Three patients did not provide any data at any of these weeks, and for that reason are not included in the analysis.
Which Symptoms Were Reported by Patients While on Treatment?
Table 1 presents the PRO-CTCAE questionnaire results from the AURA3 study. The columns summarize the proportion (percentage) of patients who:
- Column C: had any symptom before starting treatment, by treatment arm
- Column D: reported any worsening of their symptoms compared to before treatment, by treatment arm
- Column E: reported worsening to a score 3 or 4 (on a 0 – 4 scale) compared to before treatment, by treatment arm
|Symptom Attribute Scoring|
|Score||Amount (A)||Frequency (F)||Severity/Intensity (S)||Occurrence (O)|
|0||Not at all||Never||None||No|
|1||A Little Bit||Rarely||Mild||Yes|
|3||Quite a Bit||Frequently||Severe||N/A|
|4||Very Much||Almost Constantly||Very Severe||N/A|
|Column A||Column B||Column C||Column D||Column E|
|Symptom (Attribute)||No. of Patients1||Any symptom before treatment (%)2||Any Worsening on treatment (%)3||Worsening to Score 3 or 4 (%)4|
|Loose or Watery Stools (F)||80||44||31%||39%||70%||61%||19%||16%|
|Numbness or Tingling in Hands or Feet (S)||80||44||24%||30%||59%||50%||3%||7%|
|Pain in the Abdomen (F)||80||44||19%||43%||59%||61%||9%||14%|
|Fatigue, Tiredness or Lack of Energy (S)||80||44||64%||70%||58%||73%||24%||45%|
|Hand-Foot Syndrome (S)||80||44||31%||30%||54%||43%||5%||5%|
|Acne or Pimples on the Face or Chest (S)||80||44||36%||30%||53%||32%||0%||0%|
|Dry Mouth (S)||80||44||43%||43%||50%||68%||11%||20%|
|Mouth and Throat Sores (S)||80||44||21%||18%||48%||66%||9%||11%|
|Arm or Leg Swelling (F)||80||44||15%||20%||46%||45%||10%||16%|
|Itchy Skin (S)||80||44||48%||55%||46%||39%||5%||2%|
|Dry Skin (S)||80||44||73%||77%||44%||34%||6%||2%|
|Blurry Vision (S)||80||44||29%||32%||39%||52%||3%||9%|
|Decreased Appetite (S)||80||44||54%||52%||39%||68%||10%||30%|
|Ridges or Bumps on your Fingernails or Toenails (O)||80||44||30%||34%||38%||30%||N/A||N/A|
|Problems Tasting Food or Drink (S)||80||44||24%||30%||36%||73%||6%||27%|
|Change in Color of your Fingernails or Toenails (O)||80||44||6%||7%||36%||32%||N/A||N/A|
|Skin Cracking at Corners of your Mouth (S)||80||44||14%||2%||34%||48%||5%||5%|
|Bruise Easily (O)||80||44||6%||23%||33%||32%||N/A||N/A|
|Shivering or Shaking Chills (F)||80||44||26%||25%||29%||50%||6%||7%|
|Lose Control of Bowel Movements (F)||80||44||6%||14%||28%||36%||8%||2%|
|Increased Skin Sensitivity to Sunlight (O)||80||44||16%||9%||28%||30%||N/A||N/A|
|Lose any Fingernails or Toenails (O)||80||44||14%||14%||23%||20%||N/A||N/A|
|Hair Loss (A)||80||44||20%||20%||20%||30%||1%||2%|
Attributes: A = Amount; F = Frequency; O = Occurrence; S = Severity/Intensity
Chemo = Chemotherapy; N/A = Not Applicable (For symptoms with Occurrence attribute, worsening to score 3 or 4 is not applicable, as responses are either Yes or No)
 No. of Patients: The number of patients who provided a score before treatment and at least one on-treatment score (between weeks 1-24).
 Any Symptom Before Treatment (%): The percentage of patients whose symptom score before treatment was 1-4.
 Any Worsening (%): The percentage of patients whose symptom score increased during treatment, with respect to their score before treatment.
 Worsening to Score 3 or 4 (%): The percentage of patients whose symptom score increased to 3 or 4 during treatment, with respect to their score before treatment.
The following is an example of how to interpret data for Nausea frequency in Table 1:
- Column C: Before starting treatment, 25% of patients who received Tagrisso reported having nausea (ranging from rarely to almost constantly).
- Column D: After starting treatment, 41% of patients who received Tagrisso reported their nausea had worsened (increased by at least 1 point on a 0 – 4 scale) at any time while on treatment.
- Column E: After starting treatment, 6% of patients who received Tagrisso reported their nausea had worsened to either occurring frequently or almost constantly at any time while on treatment.