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This may open a whole can of worms, but I had an interesting patient encounter that I believe is worth sharing.
Recently, I saw a patient with history of high grade DCIS. She had lumpectomy and then went to a “major center” for radiation.
She was offered a clinical trial that was 10 fractions of whole breast RT with SIB boost. She said that the trial was presented as an improvement in convenience and she did not get the impression there was any increased risk of side effects, so of course she agreed to it.
She described the experience as being really hard on her in terms of fatigue, early skin reaction, breast swelling and pain. She wanted to discontinue, but was encouraged to finish it out.
Post-RT, her breast swelled considerably and she spent several weeks off work essentially not moving her arm due to the pain. Most acute effects eventually resolved, but she does have marked residual/persistent fibrosis, hyperpigmentation, and tenderness in the treated breast.
She said that when she mentioned the toxicities to her team…
“You know it was funny. You could really tell that they wanted to make the trial successful because they kept down-playing what I was experiencing saying it wasn’t so bad or it wasn’t due to the radiation.”
To me, this encompasses a lot of what is wrong in our field. We have major academic institution (most would say a top 10) that runs a hypofrac trial with no potential for improved oncological outcome (aside from the possibility of academic advancement), no intellectual horsepower required to create or run the trial, but a distinct impression of coercion of patients to force the endpoints to be what they want them to be (non-inferior). This is no different than falsifying medical research in a lab.
Given my own and many of my colleagues’ experience with some of these new hypofrac regimens, this is likely much more common than we all want to believe.
Recently, I saw a patient with history of high grade DCIS. She had lumpectomy and then went to a “major center” for radiation.
She was offered a clinical trial that was 10 fractions of whole breast RT with SIB boost. She said that the trial was presented as an improvement in convenience and she did not get the impression there was any increased risk of side effects, so of course she agreed to it.
She described the experience as being really hard on her in terms of fatigue, early skin reaction, breast swelling and pain. She wanted to discontinue, but was encouraged to finish it out.
Post-RT, her breast swelled considerably and she spent several weeks off work essentially not moving her arm due to the pain. Most acute effects eventually resolved, but she does have marked residual/persistent fibrosis, hyperpigmentation, and tenderness in the treated breast.
She said that when she mentioned the toxicities to her team…
“You know it was funny. You could really tell that they wanted to make the trial successful because they kept down-playing what I was experiencing saying it wasn’t so bad or it wasn’t due to the radiation.”
To me, this encompasses a lot of what is wrong in our field. We have major academic institution (most would say a top 10) that runs a hypofrac trial with no potential for improved oncological outcome (aside from the possibility of academic advancement), no intellectual horsepower required to create or run the trial, but a distinct impression of coercion of patients to force the endpoints to be what they want them to be (non-inferior). This is no different than falsifying medical research in a lab.
Given my own and many of my colleagues’ experience with some of these new hypofrac regimens, this is likely much more common than we all want to believe.
