This article reports on a study and accompanying editorial published in The New England Journal of Medicine. The piece details the results of a Phase 2 trial for the experimental cancer drug Iniparib which was developed to treat triple-negative breast cancer. There were appropriate caveats in the body of the story – “we really don’t know if this is going to end up benefitting patients”…”both excitement and caution are appropriate in interpreting the trial”…”some clear drawbacks should be noted.”
Metastasized triple-negative breast cancer is difficult to treat. If the results of this study hold up in already ongoing larger trials, PARP inhibitors may be a new class of drugs that might be more effective than current therapies. The story deserves credit for showing restraint in covering the results of this study. However, it would have been better if the story had included more key details on costs, harms and potential conflicts of interest.
There was no discussion of the potential cost of the drug. Since the story briefly discusses “a similar drug” it could have at least given the cost of that drug. As it is, cost is unaddressed – a huge vacuum.
The benefits are quantified. Women who received Iniparib plus chemotherapy lived an average of 12.3 months while those receiving chemotherapy alone lived an average of 7.7 months. Tumor volume decreased in 50% of the women receiving Iniparib & 33% of women receiving only chemotherapy.
While the researcher believed the drug was well-tolerated, the article should have included information about demonstrated side effects, even minor ones. The author also should have noted if the study was powered to detect differences since the study cohort was so small.
The evaluation of the evidence was good. The piece included cautionary quotes from the researcher. Quotes from a journal editorial also specified drawbacks of the study.
Three of the four drawbacks listed were not explained in the piece. Explanations would have been helpful especially since the piece termed the chemotherapy regimen “commonly used” but one drawback was “the unconventional chemotherapy regimen.”
There is no disease mongering.
The article does not include information about Dr. O’Shaugnessy’s funding from the drug company for consulting & travel. Observations from other researchers about the study would have provided needed perspective about the results.
Alternative treatments are not mentioned but the piece explains that metastatic triple-negative breast cancer is very difficult to treat & that many currently available treatments are not effective.
The story notes that the drug is experimental & that the results reported are from a Phase 2 trial. Results from a larger Phase 3 trial of 500 women will be available in 2-3 months. Information about whether the drug has FDA approval or whether it is currently used for treating other diseases would have been helpful.
The piece states that Iniparib is from a new class of drugs called PARP inhibitors. It also notes that a similar drug has shown benefits in women with BRCA I or BRCA II mutations.
The piece includes information beyond that available in the press release from Sanofi-Aventis.