Pathologic complete response rate was not improved by increasing the interval between neoadjuvant chemoradiotherapy and surgery from 7 to 11 weeks in patients with rectal cancer, according to the French phase III GRECCAR-6 trial reported by Lefevre et al in the Journal of Clinical Oncology. In fact, a longer wait time may be associated with higher morbidity and more difficult surgical resection.
Study Details
In the open-label trial, 265 patients with cT3/T4 or TxN+ tumors of the middle or lower rectum who had received chemoradiation (45 to 50 Gy with fluorouracil or capecitabine) from 24 centers were randomized between October 2012 and February 2015 to an interval of 7 weeks (n = 133) or 11 weeks (n = 132) before surgery. Most tumors were cT3 (82%). Surgery was not performed after chemoradiation in nine patients (3.4%) due to occurrence of distant metastasis (five patients) or other reasons, and two patients had local resection of the tumor scar.
Outcomes
Pathologic complete response was achieved in 20 patients (15.0%) in the 7-week group vs 23 patients (17.4%) in the 11-week group (P = .5983). The morbidity rate was 32% vs 44.5% (P = .0404), reflecting an increased rate of medical complications in the 11-week group (19.2% vs 32.8%, P = .0137). Quality of mesorectal resection was poorer in the 11-week group (complete mesorectum in 90.0% vs 78.7%, P = .0156).
The investigators concluded: “Waiting 11 weeks after [radiochemotherapy] did not increase the rate of [pathologic complete response] after surgical resection. A longer waiting period may be associated with higher morbidity and more difficult surgical resection.”
The study was supported by the French Ministry of Health.
Jérémie H. Lefevre, MD, of Hôpital Saint Antoine (AP HP), Paris, is the corresponding author of the Journal of Clinical Oncology article.
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