Evaluating the Necessity of Continuing Experimental Cancer Treatments

Q: Evaluating the Necessity of Continuing Experimental Cancer Treatments

Hello： <br>1. <br>If you join a clinical trial, you must adhere to the trial regulations. <br>I cannot advise you on whether to withdraw from the trial, as this is an agreement between you and the principal investigator, and outsiders cannot know the specific details involved. <b

The necessity of continuing to participate in clinical trials?

Hello Dr.
Chen: The patient's second sister (59 years old) has stage IV breast cancer.
The doctor did not perform surgery due to metastasis, so she is undergoing chemotherapy and concurrent radiation therapy to the brain.
After several sessions, the doctor found that the results were not as expected.
Later, she accepted the attending physician's suggestion to participate in a clinical trial and was assigned to the control group, starting targeted therapy with T-DM1 (trastuzumab emtansine) injections since May 2019.
After each injection, she has to return for follow-up visits, blood tests, light therapy, and CT scans, and then review the reports.
During this period, the doctor has consistently stated that the cancer markers are normal.
However, it is evident that the patient is increasingly unable to walk (she receives bone injections every month), and there is fluid discharge from her ears.
Last month, she suddenly experienced a shadow in her right eye and could not see (one week after the injection).
Now, she is also experiencing frequent nosebleeds, with significant volume.
I have a few questions for Dr.
Chen: 1.
The attending physician (Hematology-Oncology) said that the optic nerve damage is unrelated to the targeted therapy.
The ophthalmologist suggested steroid injections, but the attending physician said that receiving steroids would require terminating the clinical trial.
When I asked him why, he did not provide an explanation...
Could you please clarify, Dr.
Chen? 2.
After nearly a year of treatment, transportation is very difficult in the countryside, and the children's attitudes are becoming increasingly negative, leading to emotional distress for the patient.
However, she has a strong desire to live and is correspondingly very fearful of death.
Should she consider terminating the trial and seeking psychological counseling?

Wu Xiaozhu, 50~59 year old female. Ask Date: 2020/02/28

Dr. Chen Yunfang reply Oncology

Hello:
1.
If you join a clinical trial, you must adhere to the trial regulations.
I cannot advise you on whether to withdraw from the trial, as this is an agreement between you and the principal investigator, and outsiders cannot know the specific details involved.

2.
Psychological counseling cannot cure cancer, but it may help alleviate anxiety related to facing death; however, it may not be very helpful for those who wish to live longer.
Besides clinical trials, you should also discuss with your physician whether there are other treatment opportunities available within the covered medications.

Thank you for your understanding.

Reply Date: 2020/02/28

More Info

When evaluating the necessity of continuing experimental cancer treatments, particularly in the context of a patient with stage IV breast cancer undergoing targeted therapy (TDM1), several factors must be considered.
1. Understanding the Treatment Context: The patient has already undergone chemotherapy and brain radiation, which indicates a significant disease burden and a complex treatment history. The transition to a clinical trial with a targeted therapy suggests that the healthcare team is exploring all possible avenues to manage the disease. However, the fact that the patient is in a control group may mean they are not receiving the active treatment, which could lead to feelings of frustration and helplessness.

2. Monitoring Side Effects and Quality of Life: The reported side effects, such as increasing difficulty in walking, fluid discharge from the ears, sudden vision changes, and frequent nosebleeds, raise concerns about the patient's quality of life and overall well-being. These symptoms could indicate either progression of the disease or adverse effects from the treatment. It is crucial to assess whether the benefits of continuing the experimental treatment outweigh the burdens of these side effects.
3. Communication with Healthcare Providers: The patient's healthcare team, including the hematologist and ophthalmologist, should provide clear explanations regarding the relationship between the treatment and the side effects. The hematologist's assertion that the optic nerve damage is unrelated to the targeted therapy needs to be substantiated with evidence. If the patient requires corticosteroids for the eye condition, the concern about terminating the clinical trial may stem from the potential for corticosteroids to interfere with the study's outcomes. Clinical trials often have strict protocols regarding concomitant medications to ensure the integrity of the data collected.

4. Patient Autonomy and Decision-Making: Given the patient's strong desire to live and her fear of death, it is essential to respect her autonomy in decision-making. If she wishes to continue with the experimental treatment despite the side effects, her wishes should be honored, provided that she is fully informed of the risks and benefits. However, if the treatment is causing significant distress and diminishing her quality of life, it may be time to consider alternative options.

5. Psychological Support: The emotional toll of cancer treatment can be profound. If the patient's family is becoming increasingly negative and the patient is experiencing emotional distress, seeking psychological counseling could be beneficial. A mental health professional can help the patient cope with her fears and anxieties, providing support that complements her medical treatment.

6. Evaluating the Continuation of Treatment: After nearly a year of treatment, it may be prudent to reassess the situation. If the patient's cancer markers remain normal but her physical condition is deteriorating, it may indicate that the treatment is not effectively controlling the disease. A multidisciplinary team approach, involving oncologists, palliative care specialists, and mental health professionals, can provide a comprehensive evaluation of the patient's condition and treatment options.

In conclusion, the decision to continue or discontinue experimental cancer treatments should be made collaboratively between the patient, her family, and her healthcare team. It is essential to weigh the potential benefits of the treatment against the side effects and the patient's quality of life. Open communication, psychological support, and a thorough evaluation of the patient's condition will guide the best course of action moving forward.

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