Intensive surveillance with carcinoembryonic antigen (CEA) checking out and CT scans after colorectal cancer resection did now not enhance recurrence-free or overall survival when put next with favorite abdominal ultrasound and chest x-ray monitoring in a fragment 3 trial of nearly 2,000 patients.
On the other hand, amongst patients with colon cancer recurrence, those randomized to intensive surveillance more most frequently had a second surgery with curative intent. Even so, there modified into no overall survival relief versus favorite surveillance in this crew.
In transient, “now not and not utilizing a doubt one of many follow-up modalities resulted in a distinction,” stated investigator Attain Lepage, MD, PhD, of Centre Hospitalier Universitaire de Dijon (France).
Lepage supplied these findings on the European Society for Medical Oncology Virtual Congress 2020.
Lepage stated the look’s outcomes point out pointers that encompass CT and CEA monitoring have to be amended, and the favorite surveillance systems have to be ultrasound and chest x-ray. LePage known as CEA surveillance “ineffective” and stated CT scans have to be performed solely in cases of suspected recurrence.
On the other hand, look discussant Tim Notice, MBBS, DHSc, of the College of Adelaide, famed that every the intensive and favorite arms in this look had abdominal imaging every 3 months, be it ultrasound or CT, so even in the favorite arms, surveillance “modified into serene rather aggressive.”
Thanks to that, the look does now not “point out we have to lower our intensity,” Notice stated.
He added that the look’s principal finding modified into that more intensive surveillance ended in elevated rates of secondary surgery with curative intent, doubtlessly because recurrences hang been caught sooner than they’d hang been with favorite surveillance, when curative surgery modified into serene that you just’d judge of.
Sufferers in the look hang been treated all thru 2009-2015, and that could well perchance additionally just need also made a distinction. “We should always always endure in mind that, in 2020, care is terribly diversified,” Notice stated. This contains elevated surgical interventions and choices for oligometastatic illness, plus systemic therapies such as pembrolizumab. With contemporary treatments, detecting recurrences earlier “could well additionally just properly hang an affect on survival.”
Presumably patients would reside longer with “earlier diagnosis in on the present time’s atmosphere with more packed with life agents and more aggressive surgery and radiotherapy [e.g., stereotactic ablative radiation therapy],” Notice stated in an interview.
Look Crucial points
The trial, dubbed PRODIGE 13, modified into done to bring clarity to the surveillance affirm. Intensive follow-up after curative surgery for colorectal cancer, along side CT and CEA monitoring, is urged by diversified scientific societies, but it and not utilizing a doubt’s based mostly essentially on expert thought. Results of the few clinical trials on the difficulty hang been controversial, Lepage explained.
PRODIGE 13 included 1,995 issues with colorectal cancer. About half of of patients had stage II illness, and the other half of had stage III. Most patients hang been 75 years or youthful at baseline, and there hang been more men in the look than ladies. All patients underwent resection with curative intent and had no proof of residual illness 3 months after surgery. Some patients purchased adjuvant chemotherapy.
Sufferers hang been first randomized to no CEA monitoring or CEA monitoring every 3 months for the first 2 years, then every 6 months for a further 3 years. Contributors in each groups hang been then randomized a second time to both intensive or favorite radiologic surveillance.
Surveillance in the favorite arm consisted of an abdominal ultrasound every 3 months for the first 3 years, then biannually for a further 2 years, plus chest x-rays every 6 months for five years. Intensive surveillance consisted of CT imaging, along side thoracic imaging, alternating with abdominal ultrasound, every 3 months, then biannually for one other 2 years.
At baseline, the surveillance groups hang been properly balanced in regards to demographics, predominant tumor procure 22 situation, and other factors, but stage III illness modified into more prevalent amongst patients randomized to favorite radiologic monitoring without CEA.
Results
The median follow up modified into 6.5 years. There hang been no principal differences between the surveillance groups in regards to five-12 months overall survival (P = .340) or recurrence-free survival (P = .473).
There hang been no principal differences in recurrence-free or overall survival when patients hang been stratified by age, intercourse, stage, CEA at a slice level of 5 mcg/L, and first tumor traits along side procure 22 situation, perineural invasion, and occlusion/perforation.
There hang been 356 recurrences in patients on the initiating treated for colon cancer. CEA surveillance with or without CT scan modified into connected to an elevated incidence of secondary resection with curative intent. The rate of secondary resection modified into 66.3% in the favorite imaging with CEA arm, 59.5% in the CT plus CEA arm, 50.7% with CT imaging but no CEA, and 40.9% with favorite imaging and no CEA (P = .0035).
The rates hang been same amongst the 83 patients with recurrence after preliminary treatment for rectal cancer, but the between-arm differences hang been now not principal. The rate of secondary resection with curative intent modified into 57.9% in the favorite imaging with CEA arm, 47.8% in the CT plus CEA arm, 55% with CT imaging but no CEA, and 42.9% with favorite imaging and no CEA.
The examine is ongoing, and the team expects to file on secondary outcomes and ancillary experiences of circulating tumor DNA, amongst other things, in 2021.
The look is being funded by the Federation Francophone de Cancerologie Digestive. Lepage disclosed ties with Novartis, Amgen, Bayer, Servier, and AAA. Notice disclosed institutional examine funding from Amgen and being an uncompensated adviser to Pierre-Fabre and Merck.
SOURCE: Lepage C et al. ESMO 2020, Abstract 398O.
This article on the initiating appeared on MDedge.com, section of the Medscape Professional Community.
