Objective: The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial. Summary Background Data: Current data on the effect of an extended interval between ...radiochemotherapy (RCT) and resection for rectal cancer on the rate of complete pathological response (pCR = ypT0N0) is controversial. Furthermore, its effect on oncological outcomes is unknown. Methods: The GRECCAR-6 trial was a phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumors of the mid or lower rectum who had received RCT (45–50 Gy with 5-fluorouracil or capecitabine) were included and randomized into a 7- or 11-week waiting period. Primary endpoint was the pCR rate. Secondary endpoints were 3-year overall (OS), disease-free survival (DFS), and recurrence rates. Results: A total of 265 patients from 24 participating centers were enrolled. A total of 253 patients underwent a mesorectal excision. Overall pCR rate was 17% (43/253). Mean follow-up from surgical resection was 32 ± 8 months. Twenty-four deaths occurred with an 89% OS at 3 years. DFS was 68.7% at 3 years (75 recurrences). Three-year local and distant recurrences were 7.9% and 23.8%, respectively. The randomization group had no impact on the 3-year OS ( P = 0.8868) or DFS ( P = 0.9409). Distant ( P = 0.7432) and local ( P = 0.3944) recurrences were also not influenced by the waiting period. DFS was independently influenced by 3 factors: circumferential radial margin (CRM) ≤1 mm hazard ratio (HR) = 2.03; 95% confidence interval (CI), 1.17–3.51, ypT3-T4 (HR = 2.69; 95% CI, 1.19–6.08) and positive lymph nodes (HR = 3.62; 95% CI, 1.89–6.91). Conclusion: Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.
Objective: The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial.Summary background data: Current data on the effect of an extended interval between radiochemotherapy ...(RCT) and resection for rectal cancer on the rate of complete pathological response (pCR = ypT0N0) is controversial. Furthermore, its effect on oncological outcomes is unknown.Methods: The GRECCAR-6 trial was a phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumors of the mid or lower rectum who had received RCT (45-50 Gy with 5-fluorouracil or capecitabine) were included and randomized into a 7- or 11-week waiting period. Primary endpoint was the pCR rate. Secondary endpoints were 3-year overall (OS), disease-free survival (DFS), and recurrence rates.Results: A total of 265 patients from 24 participating centers were enrolled. A total of 253 patients underwent a mesorectal excision. Overall pCR rate was 17% (43/253). Mean follow-up from surgical resection was 32 ± 8 months. Twenty-four deaths occurred with an 89% OS at 3 years. DFS was 68.7% at 3 years (75 recurrences). Three-year local and distant recurrences were 7.9% and 23.8%, respectively. The randomization group had no impact on the 3-year OS (P = 0.8868) or DFS (P = 0.9409). Distant (P = 0.7432) and local (P = 0.3944) recurrences were also not influenced by the waiting period. DFS was independently influenced by 3 factors: circumferential radial margin (CRM) ≤1 mm hazard ratio (HR) = 2.03; 95% confidence interval (CI), 1.17-3.51, ypT3-T4 (HR = 2.69; 95% CI, 1.19-6.08) and positive lymph nodes (HR = 3.62; 95% CI, 1.89-6.91).Conclusion: Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.
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Background: There are controversial data on the impact of a long waiting period between radiochemotherapy (RCT) and resection for rectal cancer on the rate of complete pathological ...response (pCR = ypT0N0). The impact on the oncological prognosis is also unknown. We present the 3 years survival results of the GRECCAR6 trial. Methods: The GRECCAR6 trial was a phase III, multicentre, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumours assessed by radiological examination (MRI and/or endo-ultrasound) of the mid or lower rectum who had received RCT (45-50 Gy with intravenous 5-FU or capecitabine) were included and randomized between 7 weeks or 11 weeks of waiting period. Primary endpoint was the pCR rate. Secondary endpoints were overall, disease-free survival and rate of recurrences. Results: A total of 265 patients from 24 participating centres were enrolled between October 2012 and February 2015. Among them, 253 patients underwent surgery with mesorectal excision. The rate of pCR was 17% (43/253). Mean follow-up from surgical resection was 32±8 months. 25 deaths occurred with a 89% OS at 3 years. DFS was 67.7% at 3 years due to 77 deaths or recurrences. 3-years local and distant recurrences rates were 9.2% and 24.9%, respectively. The group of randomization had no impact on the OS (p = 0.9486) and the DFS (p = 0.8672). Distant (p = 0.8589) and local (p = 0.5780) recurrences were also not influenced by the waiting period. Patients with a pCR had an excellent prognosis with an overall survival of 94.5% versus 87.9% for the remaining patients at 3 years (p = 0.232) and a DFS of 89.6% versus 63.4% (p = 0.0025). On multivariate analysis, DFS was influenced by low rectal tumors (OR=1.74; 1.03; 2.94, p = 0.037), R1 resection (OR = 2.03; 1.18; 3.50, p = 0.011), ypT3-T4 (OR = 2.4; 1.12; 5.19, p = 0.0245) and N+ (OR = 2.85; 1.76; 4.61, p < 0.001). Conclusions: Waiting 4 weeks longer after radiochemotherapy has no influence on the oncological outcomes of T3/T4 rectal cancers. Clinical trial information: NCT01648894.
According to the IDEA trial, 6-month adjuvant chemotherapy should remain the treatment standard in stage III T4 or N2 colon cancer. The relatively poor survival in this high-risk subgroup—a 3-year ...disease-free survival (DFS) rate of 65%—and the potential synergistic efficacy of 5-fluorouracil (5-FU), oxaliplatin, and irinotecan suggest that FOLFIRINOX may be a regimen of particular interest in this setting.
This multicenter international phase 3 trial (ClinicalTrials.gov NCT02967289) being conducted in 49 centers in France and Canada plans to randomize (1:1; minimization method) 640 patients aged 18 to 70 years with Eastern Cooperative Oncology Group performance status ≤ 1. Randomization occurs within 42 days (with treatment initiated within 56 days) after curative-intent R0 surgical resection of a pT4N1 or pT1-4N2 colon adenocarcinoma. Patients will be randomized to receive adjuvant modified FOLFIRINOX (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 180 mg/m2, and 5-FU 2.4 g/m2 over 46 hours) or modified FOLFOX6 (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-FU bolus 400 mg/m2, then 2.4 g/m2 over 46 hours) every 2 weeks for 24 weeks (12 cycles). Patients will be followed for 5 years after the end of adjuvant chemotherapy. A gain of 9% in 3-year DFS (primary end point) is expected (74% in the experimental arm vs. 65% in the control arm; α, 5% 2-sided log-rank test; 1-β, 80%). Secondary end points of this study include 2-year DFS, overall survival, and toxicity.
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