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Laparoscopic ‘noninferior’ to open approach for rectal cancer

Key clinical point: Laparoscopic resection is noninferior to open surgery in preventing locoregional recurrence of rectal cancer and improving survival.

Major finding: At 3-year follow-up, the rate of locoregional recurrence was identical between the laparoscopic- and the open-surgery groups, at 5% each.

Data source: An industry-sponsored multicenter open-label noninferiority trial comparing laparoscopic to open resection of rectal cancer in 1,044 patients followed for 3 years.

Disclosures: The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.


 

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Laparoscopic resection of rectal cancer is noninferior to open surgery in preventing locoregional recurrence and in improving overall and disease-free survival, according to a report published online April 1 in the New England Journal of Medicine.

The laparoscopic approach has increasingly replaced open surgery in recent years, primarily because it offers short-term advantages such as less pain, reduced blood loss, and a shorter recovery time. But no large randomized trials have established that long-term outcomes with laparoscopic resection, including survival, are at least noninferior to those with open surgery, said Dr. Hendrik Jaap Bonjer of VU University Medical Center, Amsterdam, and his associates.

They now report the 3-year outcomes of the Colorectal Cancer Laparoscopic or Open Resection (COLOR) II trial, an industry-sponsored noninferiority study performed at 30 medical centers in eight countries in Europe, North America, and Asia. The trial involved 1,044 patients who had solitary, noninvasive adenocarcinomas of the rectum within 15 cm of the anal verge. A total of 699 of the study participants were randomly assigned to laparoscopic and 345 to open surgery.

At 3-year follow-up, the rate of locoregional recurrence was identical between the two study groups, at 5% each. In addition, rates of disease-free survival slightly favored the laparoscopic approach (74.8%) over the open approach (70.8%), as did rates of overall survival (86.7% and 83.6%, respectively) and rates of distant metastases (19.1% and 22.1%, respectively). Patients with stage III disease appeared to benefit the most from laparoscopic surgery, with disease-free survival of 64.9% vs. 52.0%, the investigators said (N. Engl. J. Med. 2015 April 1 [doi:10.1056/NEJMoa1414882]). These findings support the idea that the reduced surgical trauma associated with laparoscopic techniques may decrease tumor recurrence, perhaps by attenuating stress responses and preserving immune function, they noted.

“In our study, laparoscopic surgery in patients with cancer in the lower third of the rectum was associated with a lower rate of involved circumferential resection margin and a lower locoregional recurrence rate than was open surgery. During laparoscopic surgery, narrow spaces such as the lower pelvis are better visualized than in open surgery, owing to the use of a laparoscope, which projects a magnified and well-illuminated image of the operative field on the monitors. A clear view is of paramount importance to accomplish a resection of the cancer with sufficient margins,” Dr. Bonjer and his associates added.

The trial was funded by Ethicon Endo-Surgery Europe, a subsidiary of Johnson & Johnson; the Swedish Cancer Society; the Health and Medical Care Committee of Region Vastra Gotaland; Sahlgrenska University Hospital; Erasmus University Medical Center; Dahousie University; and VU University Medical Center. Dr. Bonjer reported having no disclosures; two of his associates reported ties to AbbVie, Merck Sharp & Dohme, Takeda, Johnson & Johnson, Covidien, Olympus Medical, and Applied Medical.

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