The Conventional Technique Versus the No-touch Isolation Technique for Primary Tumor Resection in Patients With Colon Cancer (JCOG1006): A Multicenter, Open-label, Randomized, Phase III Trial.

OBJECTIVE: This phase III trial evaluated whether the no touch was superior to the conventional in patients with cT3/T4 colon cancer. BACKGROUND: No touch involves ligating blood vessels that feed the primary tumor to limit cancer cell spreading. However, previous studies did not confirm the efficacy of the no touch. METHODS: This open-label, randomized, phase III trial was conducted at 30 Japanese centers. The eligibility criteria were histologically proven colon cancer; clinical classification of T3-4, N0-2, andM0; and patients aged 20 to 80years. Patients were randomized (1:1) to undergo open surgery with conventional or the no touch. Patients with pathological stage III disease received adjuvant capecitabine chemotherapy. The primary endpoint was disease-free survival (DFS) according to the intention-to-treat principle. RESULTS: Between January 2011 and November 2015, 853 patients were randomized to the conventional group (427 patients) or the no touch group (426 patients). The 3-year DFS were 77.3% [95% confidence interval (CI) 73.1%-81.0%] and 76.2% (95% CI 71.9%-80.0%) in the conventional and no touch groups, respectively. The superiority of no touch was not confirmed: hazard ratio for DFS = 1.029 (95% CI 0.800- 1.324; 1-sided P = 0.59). Operative morbidity was observed in 31 of 427 conventional patients (7%) and 26 of 426 no touch patients (6%). All grade adverse events were similar between the conventional and no touch groups. No in-hospital mortality occurred in either group. CONCLUSION: The present study failed to confirm the superiority of the no touch.

Validity of hepatic resection of colorectal liver metastases in the elderly (75 years and older).

AIM: To evaluate the validity of surgical therapy for colorectal liver metastases in the elderly patients. PATIENTS AND METHODS: Between 1992 and 2004, 401 patients were diagnosed as having liver metastases from colorectal cancer. These comprised 64 patients aged 75 years or older and 337 patients aged less than 75 years. RESULTS: Two hundred and thirty-two patients (57.9%) underwent potentially curative hepatic resection. Postoperative complications occurred in 29.6% of the older patients and in 23.4% of the younger patients. Mortality was 0% in the older group and 0.5% in the younger group. The overall 5-year survival rates of the older and younger group were 33.2% and 47.9%, respectively (p < 0.01). The proportion of patients who died of other diseases was significantly higher in the older (11.1%) than the younger group (2.0%) (p = 0.04). CONCLUSION: Age cannot be regarded as a medical contraindication for hepatic resection of colorectal liver metastases.