Oxaliplatin length of therapy

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months).

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months).

The 3-year DFS rates were 74.6% in the 3-month group and 75.5% in the 6-month group.

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months).

Neurotoxicity of grade 2 or higher was lower in the 3-month group (16.6% for patients who received FOLFOX and 14.2% for patients who received CAPOX) than in the 6-month group (47.7% for patients who received FOLFOX and 44.9% for patients who received CAPOX). Moreover, all other toxicities were substantially lower with 3 months of treatment than with 6 months.

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months).

A subgroup analyses observed:

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months). › A subgroup analyses observed:

Among patients receiving FOLFOX, 6 months of therapy was superior to 3 months of therapy (HR, 1.16; 95% CI, 1.06–1.26; P = .001)

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months). › A subgroup analyses observed:

Among patients receiving CAPOX, 3 months of therapy was like 6 months of therapy (HRDFS, 0.95; 95% CI, 0.85–1.06) and met the prespecified margin for noninferiority.

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months). › A subgroup analyses observed:

Among patients with N1 tumors (<4 positive nodes), the HR was 1.07 (0.97–1.17), and among those patients with N2 tumors (≥4 positive nodes), the HR was 1.07 (0.96–1.19).

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months). › A subgroup analyses observed:

Among patients with T4 tumors, a therapy duration of 3 months was inferior to a duration of 6 months (HR, 1.16; 95% CI, 1.03–1.31).

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months). › A subgroup analyses observed:

Among patients with low-risk tumors (T1–3, N1), 3 months of therapy was noninferior to 6 months of therapy (HR, 1.01; 95% CI, 0.90–1.12) with a 3-year DFS rate of 83.1% for patients who received 3 months of therapy and 83.3% for patients who received 6 months of therapy.

The International Duration Evaluation of Adjuvant Therapy (IDEA) collaboration consisted of six separate randomized trials with regimens of 6 months versus 3 months of adjuvant oxaliplatin-based chemotherapy. The IDEA study was a prospective, preplanned pooled analysis of these concurrently conducted studies to evaluate the noninferiority of adjuvant therapy of either FOLFOX or CAPOX administered for 3 months versus 6 months. Noninferiority could be claimed if the upper limit of the two-sided 95% CI of the HR did not exceed 1.12.[30] From 2007 through 2015, 13,025 patients with stage III colon cancer were enrolled in six concurrent phase III trials. Of these patients, 12,834 patients met the criteria for intention-to-treat analysis. At a median follow-up of 41.8 months, noninferiority of 3 months versus 6 months was not confirmed in the modified intention-to-treat population (HR, 1.07; 95% CI, 1.00–1.15, P = .11 for noninferiority of 3 months). › A subgroup analyses observed:

Among patients with high-risk tumors (T4 or N2), 6 months of therapy was superior to 3 months of therapy (HR, 1.12; 95% CI, 1.03–1.23; P = .01).