Dr. Miriam Koopman of Utrecht University and colleagues suggest that results of ongoing trials may yield a definitive approach, but that meanwhile "caution is warranted" before subjecting mCRC patients - especially those with elevated neutrophils and liver enzymes - to PTR, thereby delaying systemic therapy.
As reported in JAMA Surgery, the current study is a 60-day mortality analysis of a randomized phase 3 trial that included 196 patients enrolled from 2012-2019. Participants had unresectable mCRC, including a primary tumor with few or no symptoms. The median age was 65; about half in the systemic treatment arm were men, versus 62% in the PTR/systemic arm.
Overall, 60-day mortality was 3% in the systemic arm and 11% in the PTR arm. In a per-protocol analysis, percentages were 2% versus 10%. PTR patients with elevated serum levels of lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, and/or neutrophils had a significantly higher 60-day mortality than patients without these characteristics.
LDH levels were elevated in 58 PTR patients, of whom 10 (17%) died. Among 15 patients with elevated neutrophil levels, four (27%) died. Nine of 41 patients (22%) with elevated aspartate aminotransferase levels died, as did seven of 23 patients (30%) with elevated alanine aminotransferase.
Among 39 patients in the PTR arm with two or three high-risk biochemical and/or patient (right-sided tumor) characteristics, five (13%) died within 60 days, as did six (43%) of those with four or five characteristics.
By contrast, none of the 44 patients with one or no unfavorable characteristics died within 60 days.
Dr. Yuman Fong of City of Hope in Duarte, California, author of a related editorial, told Reuters Health by email, "When patients present with CRC accompanied by non-resectable metastases, many are subjected to resections of the primary cancer even if the primary cancer is asymptomatic. Two recent trials tell us this approach is not ideal. The guidelines should change to treatment with oxaliplatin-based chemotherapy first."
"However," he said, "this is not to say that we are advocating a never-surgery approach. Patients treated with oxaliplatin for colorectal cancer can have remarkable responses that result in conversion to resectable metastases. In that setting, surgical resection may lead to improved survival and may even result in a cure."
"Thus, the data indicates that a chemotherapy-first approach will help physicians select patients for safer and more effective surgery," Dr. Fong concluded.
Dr. Paul Oberstein, Director of the Gastrointestinal Medical Oncology Program at NYU Langone's Perlmutter Cancer Center in New York City, commented in an email to Reuters Health, "The biggest concern about this study is that they are reporting an outcome that was not pre-specified prior to the study and which is not the primary outcome of the study. Given this, there is a possibility that this result is not definitive."
"The prevailing practice prior to this report was not to remove primary tumors based on data from other clinical trials," he said. "This (study) does add to the rationale for this recommendation and reinforces the current practice and guidelines. It is preferable to start systemic chemotherapy and not to have surgery in this setting, with exceptions for cases in which the tumor is bleeding, causing obstruction or other local symptoms."
"The final results may shed light on whether there is any potential benefit (to surgery) further on," he added. "In the absence of any evidence to support surgery, we would treat patients with systemic chemotherapy."
Dr. Koopman did not respond to requests for a comment.
The study was funded by the Dutch Cancer Society and Hoffman-LaRoche Ltd. Dr. Koopman and several coauthors have received fees from the company.
SOURCE: https://bit.ly/30kj9Wl and https://bit.ly/3oRkz4R JAMA Surgery, online October 6, 2021.
By Marilynn Larkin
Posted on
Previous Article
« Myocardial injury is common after noncardiac surgery: AHA Next Article
Obstructive sleep apnea tied to brain white-matter hyperintensities »
« Myocardial injury is common after noncardiac surgery: AHA Next Article
Obstructive sleep apnea tied to brain white-matter hyperintensities »
Related Articles
March 12, 2021
Yttrium-90 (Y-90) glass microspheres for HCC
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy
HEAD OFFICE
Laarderhoogtweg 25
1101 EB Amsterdam
The Netherlands
T: +31 85 4012 560
E: publishers@medicom-publishers.com