Accessing a Novel Cancer Therapy

Cancer immunotherapy is a type of cancer treatment that enlists the power of an individual’s immune system to fight cancer by stimulating, or boosting, the natural defenses of the immune system to find and attack cancer cells. Since it is an active area of investigation, many clinical trials are underway to test this promising new approach to treating cancer, including in Malaysia. As with any clinical study, people who are asked to participate in research studies testing new cancer treatments must be informed in an understandable way about the possible benefits and harms of the research, among other things.

This case involved a 52-year-old woman with metastatic breast cancer that was diagnosed 6 years ago and who has received three courses of treatment to date. Her latest computed tomography (CT) scan showed that her cancer had progressed and spread to other organs, including bone and both lungs. Hearing reports about it in the news, friends and relatives suggested that this patient should try one of the newest cancer drugs on the market (an immunotherapy drug). The existing, approved immunotherapy drug is very expensive: at least $10,000 USD per 3-week cycle. This patient does not have the means to afford this treatment, as she is from a lower-income family and does not have medical insurance. The patient’s doctor, an oncologist working in a Malaysian government hospital, recently became the principal investigator of an industry-sponsored clinical trial testing the efficacy and safety of a new immunotherapy treatment for breast cancer. Knowing of the patient’s interest, the doctor contacted the patient by phone about participating in the study. The doctor told the patient that all treatment costs during the clinical trial would be fully covered by the company sponsoring the trial and that the patient would be reimbursed for any incidental costs, such as travel, and to compensate for taking time off to attend the study’s clinic. Without a second thought, the patient agreed to participate in the clinical trial.

During the patient’s appointment at the study clinic to receive the experimental immunotherapy, the patient spoke with other patients who had also joined the clinical trial, and they discussed reasons for joining the study. It quickly became evident that none had read the patient consent information sheet, but rather they had considered a doctor’s recommendation to be sufficient, thinking the doctor had a patient’s best interest in mind. Some patients did not understand the language in which the information sheet was written. However, all patients shared that they had been offered time to consider participation in the trial, and some approached family members for advice. Some friends and family members consulted online sources and social media to learn more about the experimental therapy and offered their opinions about participation.