Article: Headlines claim drug combination destroys tumor in 11 days—is this too good to be true?

IFLScience published a piece with the exciting headline “Remarkable Breast Cancer Trial Destroys Tumors in Just 11 Days,” based on preliminary trial results presented by Dr. Nigel Bundred, a professor of surgical oncology at The University of Manchester, at the 10th European Breast Cancer Conference.

About the research

The trial results show early promise. The trial looked at 127 women who had newly diagnosed HER2-positive breast cancer and were randomized to receive either a control drug, trastuzumab (know as Herceptin®) only, or trastuzumab in addition to lapatinib (Tykerb®) for eleven days before surgery. The researchers studied breast biopsy tissue taken before the women received their drugs and compared it to the tissue removed at the time of surgery (after they received their drug) to see if the drugs affected cellular growth of the tumor, whether the women had a pathological complete response (no active cancer cells were found) or minimal residual disease (the tumor was smaller than 5mm in diameter).

Among women who were on the combination of Herceptin and Tykerb:

• all of them showed a decrease in cell growth
• 11% had a pathological complete response
• 17% had minimal residual disease

Among women who received only Herceptin:

• None had a pathological complete response
• 3% had minimal residual disease

The researchers stated that the complete results of their study, including details about cell growth in women who received Herceptin only will be available later.

What does this mean for me?

These are promising results for women with HER2-positive breast cancer because as Dr. Judith Bliss, one of the lead researchers of the study said in a press release last March, “These results show that we can get an early indication of pathological response within 11 days, in the absence of chemotherapy in these patients on combination treatment. Most previous trials have only looked at the pathological response after several months of treatment.”

However, these results do not change clinical practice. Presenting results at a conference is often the first step researchers take to share their findings with other researchers. This is a very early step. Researchers who are familiar with the subject area but not directly involved in the work have not yet formally reviewed the findings presented at these conferences. This important process, known as peer review, is a crucial step of the scientific process and every research finding is subjected to this when it is submitted to a scientific publication. Many times, studies presented at conferences are still ongoing, meaning the researchers most likely have more work and experiments to perform.

Despite the headline claiming that the treatment “destroys tumors,” these are preliminary results that do not say anything about whether women will have better long-term survival. Without results that indicate better long-term survival or another later endpoint, healthcare providers cannot skip giving chemotherapy to women just because they received Herceptin and Tykerb. Until the researchers publish their findings with the complete data and long-term survival information from a clinical trial, these findings are far from definitive and clinically actionable.  Even if these results pan out, this treatment is only applicable to people with newly diagnosed HER2-postive breast cancer, which comprise about 10-15% of all breast cancers.

More research will be done on the Herceptin and Tykerb drug combination to help women with HER2-positive breast cancer. While the IFLScience headline and other media articles covering this conference presentation sounded exciting (Tumors destroyed in 11 days!), we need to remember to read beyond the headlines to make sure what is said accurately describes what the researchers found.

Posted 12/6/16

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References:

Lapatinib and trastuzumab shrinks HER2+ breast cancer in 11 days after diagnosis 

Bundred, N, Cameron, D, Armstrong, A, et al., “Effects of perioperative lapatinib and trastuzumab, alone and in combination, in early HER2+ breast cancer - the UK EPHOS-B trial (CRUK/08/00),” Abstract from European Breast Cancer Conference, March 9-11, 2016

Andrews, R, “Remarkable Breast Cancer Trial Destroys Tumors In Just 11 Days,” IFLScience, 11/3/16. 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.