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An international team of scientists, including doctors from the Champalimaud Clinical Center in Lisbon, has just published results in the prestigious journal The Lancet Oncology, suggesting that the majority of rectal cancer patients may be able to replace aggressive colorectal surgery with chemoradiotherapy in the not too distant future and several years of close monitoring. All of this with a very low likelihood of their tumor growing back locally or later developing distant metastases if they survived the first few years after treatment with no evidence of tumor recurrence.

Specifically, the team showed that nearly 70% of around 800 rectal cancer patients who had undergone a non-invasive alternative treatment to surgery, known as the “watch-and-wait” protocol, from 1991 to 2015 – remained free anew Tumors and metastases in the following years could then be subject to less strict medical monitoring and possibly even abolish additional oncological treatment.

For many years, the only treatment available for patients with rectal cancer was radical surgery, often ending with a permanent colostomy, which meant the patient had to be provided with a stool collection bag connected by an incision in the intestine for life the belly.

The watch-and-wait approach to rectal cancer was developed about 20 years ago by the Brazilian surgeon Angelita Habr-Gama at the University of São Paulo, who led the new study along with colleagues from Brazil, the UK, the Netherlands and Portugal.

It therefore happens that patients with low grade rectal cancer (i.e., whose tumor is very close to the anus) need to undergo radio and chemotherapy to reduce the tumor before surgery and avoid potentially serious postoperative complications. What Habr-Gama observed was that in some of these patients, analysis (biopsy) of the tissue taken during surgery often showed absolutely no trace of cancer cells. This led her to wonder whether rectal surgery had actually been necessary in these cases with her cohort of possible complications and lifelong effects on the patients’ quality of life.

The watch-and-wait approach has been increasingly used since the mid-2000s when surgeons in the Netherlands (also co-authors of the new study) decided to propose it to their eligible patients.

The protocol consists of performing a series of diagnostic tests eight to 10 weeks after the chemoradiotherapy course before deciding whether surgery is necessary. To make this decision, three exams are performed: a digital rectal exam, an endoscopy, and a magnetic resonance imaging. And if the patient’s clinical response is “complete” – that is, if the tumor is not detectable in any of these exams – the patient has the option to enter the watch-and-wait protocol.

A large amount of data has already been compiled in the International Watch-and-Wait database, an extensive register of rectal cancer patients from 47 centers in 15 countries whose initial radiochemotherapeutic treatment resulted in a “complete clinical response”. This is the repository that was now used for the study.

Critics of the protocol have claimed there are at least two disadvantages. The first is that subsequent local tumor regrowth (estimated to be one in four patients) could prove harmful to the patient as it delays potentially life-saving surgery. The second doubt is that if the cancer is not removed immediately, it may have time to metastasize. “This strategy carries a potential risk of local tumor recurrence or regrowth,” agrees Laura Fernández, who currently works at the Champalimaud Foundation and is the first author of this study. “It is estimated that one in four patients who achieve a full clinical response will experience local regrowth, especially in the early years of follow-up,” she adds. “That’s why patients are put on a very strict monitoring program after chemoradiotherapy.”

In an article published in February 2020 in the journal Annals of Surgery, digestive surgeon Nuno Figueiredo, who is also co-author of this new study and directs the Champalimaud Surgical Center, and colleagues along with the same Dutch team showed that waiting time was the result for patients with local regrowth not affected. In particular, the end result was the same as what they would have received if the operation had been done right away. Although this study was not designed to address the problem of metastatic spread, based on the medical literature, the authors observed that 25% of rectal cancer patients who underwent surgery continue to develop metastases, only 8.2% of patients who developed an operation to do the watch-and-wait protocol.

Could a healthy year be enough to loosen surveillance?

In the new study, the team wanted to try to answer: How intense should the follow-up be and how long should it take to ensure the safety and effectiveness of the watch-and-wait approach? “Our research area needs real-world data to support what kind of active monitoring is required and how long these patients should be observed,” Fernández emphasizes. And despite our knowledge that one in four patients will develop regrowth, we still don’t know if that risk will change over time once patients achieve an additional cancer-free year. Now in this article we have provided important information to help doctors advise their rectal cancer patients. “

The analysis led to several conclusions. First: “For patients who survived the first year without relapse, the risks of local regrowth and distant metastases were significantly lower in the two following years, so that such intensive monitoring is no longer necessary after three years,” says Fernández.

Perhaps more surprisingly, she adds, “once patients have achieved and maintained a full clinical response.” [recovery] For a year now, known risk factors for local regrowth (such as the stage of the disease before any treatment and the radiation dose received by the patient) seem to become irrelevant. “

Fernández says this could mean that additional treatment for all patients who have gone through the watch-and-wait protocol and remain free of tumor recurrence after the first year may also become unnecessary. “Our results suggest that achieving full clinical recovery and maintaining it for one year is the most important protective factor in patients with rectal cancer, which puts them at an excellent stage of prognosis,” she concludes.

The “watch-and-wait” strategy could safely replace surgery in more than 20% of rectal cancers

Provided by the Champalimaud Center for the Unknown

Quote: Rectal cancer patients who “watch and wait” may only need a few years of strict follow-up care (2020, December 11th), which will be available on December 12th, 2020 from https://medicalxpress.com/news/2020-12-rectal-cancer- patients were retrieved -years-stringent.html

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