ASCO meeting replete with good, not-so-good, findings, leaving clinicians and patients scratching their heads about whether to change practice protocols. Case in point: My best friend, Bob.

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The News:

The 2018 America Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 1-5 in Chicago, brought together more than 32,000 oncology professionals from around the world to present and discuss the latest research in cancer treatment and patient care. It attracted over 5,000 abstract submissions from researchers, helping to strengthen oncology knowledge worldwide.

Not only were there scores of presentations with promising positive developments, but also some disappointments, one of which exemplifies the burden all of these new developments place on clinicians, in particular, as they try to take the best possible care of their patients. The following was one such disappointment, although an argument can be made that it’s better to eliminate a course of treatment if it makes many patients worse than without it.

The particular paper was entitled: “No OS (overall survival) Benefit from HIPEC in Colorectal Cancer.”

New research suggests that survival rates are similar for people with peritoneal carcinomatosis who receive heated chemotherapy directly into the abdomen during surgery and those who do not receive the chemotherapy, CancerNet reports. Peritoneal carcinomatosis is a type of metastatic colorectal cancer in which there are metastatic tumors on the lining of the abdominal cavity, or peritoneum.

The heated chemotherapy, called hyperthermic intra-peritoneal chemotherapy (HIPEC), plus surgery is a treatment used when all of the tumors can be removed. Previous research has shown that HIPEC plus surgery helps patients live longer when compared with systemic chemotherapy alone and can cure up to 16% of people with this type of disease. Systemic chemotherapy is given through a patient’s bloodstream to reach cancer cells throughout the body.

This clinical trial, called PRODIGE 7, included 265 participants. All participants had stage IV colorectal cancer with peritoneal carcinomatosis and no cancer in other parts of the body. The patients were randomly divided into 2 groups, receiving either surgery plus HIPEC or surgery alone. About 96% of the participants also received systemic chemotherapy before surgery, after surgery, or both. The type of systemic therapy was chosen by each person’s doctor.

The median overall survival was similar for both groups. The median is the midpoint, which means that half of patients lived longer, and half lived for a shorter time. Those who received HIPEC lived for a median of almost 42 months compared with about 41 months for those who did not receive HIPEC. The median time until the cancer came back was about 13 months with HIPEC and about 11 months without HIPEC.

After the first 30 days, participants in both groups experienced a similar number of side effects. However, after 60 days, the number of side effects for those who received HIPEC almost doubled  nearly 13% vs. 24%).

Survival rates were “unexpectedly high” among patients who underwent surgery alone, said lead study author François Quenet, MD, of the Regional Cancer Institute in Montpellier, France.

“Every colorectal cancer patient with an isolated peritoneal carcinomatosis should be considered for surgery,” said Quenet.

Dr. Quenet concluded, “This is the first randomized study assessing the role of this special type of chemotherapy in advanced colorectal cancer, and it shows that it does not provide added benefit over surgery.”

Steve’s Take:

I’ve written before about a close friend I’ll call Bob, who was diagnosed with stage IV (metastatic) gastric cancer and was put on a treatment trajectory of…chemotherapy, surgery, chemo…cure! The institution is one of the top five cancer centers in the US.

After surviving the numerous rounds of insanely harsh chemo, the latest CT scan suggested that Bob undergo what’s called cytoreductive surgery (CRS) with HIPEC. In English, this means Bob’s abdomen would be opened and the surgeon would remove all the cancer he could see, most likely including his entire stomach. Then the abdomen would be rinsed with a heated chemotherapy before closing him up.

This is essentially what was entailed in the treatment in the ASCO report above. Talk about a life-changing event.

Bob’s specific type of gastric cancer is the most unfriendly, with a very poor prognosis–namely, a 2-year survival rate of about 4%. Bob’s tumor profile report from that sector’s leader, Caris Life Sciences, said the profile made Merck’s Keytruda (pembrolizumab) the chief treatment option. But Bob’s oncologist said he believed the chemo/surgery/chemo approach had to fail first before he would consider putting Bob on Merck’s Keytruda.

I have to hand it to Merck that the wild success of Keytruda hasn’t gone to the heads of the C-suite group, or board—yet.

Merck still has a cluster of its Keynote clinical trials of Keytruda underway, even as the anti-PD-1 drug has garnered 10 FDA-approved indications, notes STAT News. But kudos to the company for frankness: The many years of follow-up are showing that for every patient who seems to be cured there are many more who aren’t.

What? Huh? Merck actually admitted that?

According to five-year data from a trio of Keynotes on patients with advanced melanoma, of 655 patients who entered the trial, 412 have died. By two years, half had died. Median survival was better in treatment-naive patients, though: just under 39 months in those who hadn’t received any therapy before starting pembro. The data represent the longest follow-up for pembro so far in any cancer.

Definitely a sobering reminder that even some highly-touted therapies are very far from cures.

Bottom line:

Fifteen percent of matched patients survived three years, while 7% of the non-matched did; 6% and 1%, respectively, made it to 10 years. Median overall survival was 9.3 months and 7.3 months. Lead researcher Dr. Apostolia Tsimberidou of MD Anderson emphasized that the IMPACT patients had previously received many therapies and had “exhausted their options,” and that there are more targeted therapies today.

“Far be it from us to dismiss even two extra months of life, but would it be onco-blasphemy to say molecular targeted therapies have fallen short of the high hopes we had for them?” said Dr. Tsimberidou.

Last thoughts:

I was struck by the calm, stoic objectivity of the HIPEC study author, Dr. Quenet, announcing that the 15-year-old HIPEC routine, “…does not provide added benefit over surgery.”

This made me think about my friend, Bob, and his upcoming decision whether to undergo the removal of his stomach and other involved organs, followed by the rinse of his entire abdomen with the heated chemo. Bob knows that losing his stomach will be a life-altering event. And the HIPEC rinse may not only not work, but he may also have life-threatening complications as a result of it.

His preference–right now, prior to the next CT scan of his abdomen–is to have laparoscopic surgery to remove whatever cancer can be identified without opening him up and then undergo more chemo, since it has in fact slowed the progression of the disease.

He figures if he can get five, who knows, 10 years, where he can live a relatively “normal” life before succumbing? That would be an acceptable tradeoff for seeking a “cure,” with all the surgery and HIPEC and post-op complications.

Meetings like the recent ASCO event are replete with promise for those cancer patients undergoing new treatments that work. But as one wades through the data in the papers, it becomes clear that they don’t work for the vast majority of patients, and in some cases, actually kill a non-insubstantial percentage of them.

Steve's Take: @ASCO should also be debating quality-of-life issues since so many #cancer #medicines have such a dismal success rate. Click To Tweet

Beneath the quandary, though, in each instance whether to take the established medical treatment or just let nature take its course, is the quality-of-life issue. This seemingly should be addressed directly at worldwide meetings like ASCO. But I don’t see it mentioned, as though that’s not the purpose of the plethora of trials and papers wherein most stage IV patients die from the complications of their treatment than the medicines being tested. That seems wrong to me.

So, armed with what I thought was incontrovertible evidence of “bad” medicine, I mentioned to an eminent bioethicist my critical view of this refrain from honest dialogue between patient and clinician and asked, why don’t caregivers tell their patients upfront the whole truth about what likely lies ahead. And he simply replied, “Because they want to preserve hope.”

After Bob decides which option to pick for his condition, I’ll report back, so stay tuned.

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