Provide names of other journalists involved.
Elizabeth Whittington
List date(s) this work was published or aired.
Published Aug. 17, 2012, emailed to subscribers in a newsletter on Aug. 20.
Provide a brief synopsis of the story or stories, including any significant findings.
HER2-positive breast cancer was considered one of the more aggressive types of the disease until Herceptin was approved in 1998. While Herceptin works in about half of all patients with this subtype, research into targeting malignant cells that overexpress HER2 has accelerated over the past few years. Patients who are newly diagnosed and those who have lived with metastatic disease for several years are excited about the potential combinations and new therapies. We must weigh the benefits of these new therapies with their costs and side effects. While we can present one patient’s story and hope in these new treatments, we must also pair that enthusiasm with fact and evidence. 1. The EMILIA study, which offered new data for T-DM1, found that the drug worked better than the existing standard of treatment, and with significantly fewer side effects — a feat that is uncommon in oncology. 2. The FDA approved Perjeta (pertuzumab) for HER2-positive breast cancer, giving women with metastatic breast cancer another treatment option.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
a. Study results from the EMILIA study, presented at the 2012 ASCO annual meeting. b. Background information on the FDA ruling of T-DM1 in 2010. c. Several scientific journals including 1. The Lancet, 2.18.2012, published an article on the NeoALTTO study results that showed that Herceptin and Tykerb used together have a synergistic effect in early HER2-positive breast cancer. 2. A Journal of Clinical Oncology article in 6.20.2012 issue: The EGF104900 study concluded that the combination of Herceptin and Tykerb was better than each drug alone, but also came with an increase of side effects and cost.
Explain types of human sources used.
a. Debra Tincher, a metastatic breast cancer survivor, who participated in an early phase 1 study of the T-DM1. Tincher is also a board member on the Metastatic Breast Cancer Network, a group advocating for more research, awareness and support for terminal breast cancer. b. Kimberly Blackwell, lead author on the T-DM1 study presented at the 2012 ASCO annual meeting. c. Lorraine Heidke-McCartin, breast cancer patient and advocate for T-DM1 approval. Interviewed for background, but not quoted in the article. d. GSK spokesperson (Robert Perry) on whether or not the company would continue to pursue approval for Tykerb in combination with Herceptin. While study results show that the combination extends survival, it also comes with an increase of side effects and cost.
Results:
From Facebook: Debra Tincher, who was interviewed for the piece: Thank you, Elizabeth Whittington, for your article about recent advances in Metastatic Breast Cancer treatments. It is easy to understand and gives hope. This is an excellent way for you to help educate patients, and provide awareness for the Metastatic Breast Cancer Network as a great resource for those of us with MBC. Katherine Obrien: Yes, thanks Elizabeth! Musa Mayer (author and advocate with AdvancedBC.org) praised the article — that is high cotton! Nicely done, thank you, CURE team.
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
None.
Advice to other journalists planning a similar story or project.
You have to be very careful with anecdotal evidence, especially when dealing with such an emotional charged topic as cancer and potential life-saving treatments. Every cancer therapy has side effects, which should not go unmentioned. The patient story gives the article a human interest angle and a voice, but it should be backed up with facts and data. Although the survivor in this article felt very strongly about the therapy and disagreed with the FDA’s initial rejection of the drug, we wanted to explain why the agency chose to not grant approval at that time. We were able to show the survivor’s point of view, while also explaining about the process of accelerated approval and the guidelines the agency follows.