Consolidation mFOLFOX6 Chemotherapy After Chemoradiotherapy Improves Survival in Patients With Locally Advanced Rectal Cancer: Final Results of a Multicenter Phase II Trial

Abstract

Adding modified FOLFOX6 after chemoradiotherapy and before total mesorectal excision increases compliance with systemic chemotherapy and disease-free survival in patients with locally advanced rectal cancer. Neoadjuvant consolidation chemotherapy may have benefits beyond increasing pathological complete response rates. See Video Abstract at http://links.lww.com/DCR/A739.

Recent advances in (chemo-)radiation therapy for rectal cancer: a comprehensive review

“…Reported pCR rates ranged from 14 to 37% (weighted average 21%) in the TNT arms compared to 11–25% (weighted average 14%) in the standard chemoradiation arms of the comparative studies, indicating the superiority of the TNT approach. Moreover, the largest randomized trials observed significant benefits in terms of disease-free in the TNT arms mainly attributed to a reduction of distant failures [ 24 , 156 , 160 – 162 ], although using slightly different approaches. The Timing of Rectal Cancer Response to Chemoradiation Consortium in the United States [ 24 , 156 ] performed a sequential cohort phase II study including 259 patients with T3/4 or nodal positive patients.…”

“…The pCR rate significantly increased with the number of consolidation chemotherapy cycles from 18% (none) to 38% (6 cycles) [ 24 ]. Three-year DFS rates were also significantly increased for all TNT arms compared to the standard arm, although it has to be noted that the mean number of total chemotherapy cycles was lower in the standard arm [ 156 ]. The Polish group [ 157 ] conducted a phase III trial randomizing 515 patients with fixed T3 or T4 tumors to long-course chemoradiation (50, 4 Gy with 5-FU, leucovorin and, partly, oxalipatin) or to short-course radiation (5 × 5 Gy) followed by 3 cycles of consolidation chemotherapy with FOLFOX prior to surgery [ 157 ].…”

Efficacy and safety-in analysis of short-course radiation followed by mFOLFOX-6 plus avelumab for locally advanced rectal adenocarcinoma

“…For this reason, the NCCN guidelines accepted total neoadjuvant treatment for locally advanced rectal cancer [4]. A recent phase II trial concluded that giving up to 6 cycles of mFOLFOX6, after chemoradiation and before TME, leads to an increase in pathologic complete response rates [5]. Multiple studies indicate that tumor response to preoperative treatment strongly predicts the disease-free survival of patients [6].…”

Italian society of colorectal surgery recommendations for good clinical practice in colorectal surgery during the novel coronavirus pandemic

“…The first cases of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection, the so-called 2019 novel COronaVIrus Disease (COVID- 19), were first reported in Wuhan, Hubei Province, China in December 2019 [1].…”

“…Based on these considerations and although delays in surgical treatment beyond 2-3 months result in a higher recurrence rate [16], there have been recommendations by societies and experts to delay surgical treatment for stage I and stage II colorectal cancer for up to 6 months [17]. Moreover, neoadjuvant treatments have been recommended for high-risk colon and rectal cancer to defer as long as possible surgical admission [18] with the use of preoperative chemotherapy for colon cancer [17] or of consolidation chemotherapy after either chemoradiation or short-course radiotherapy for rectal cancer [19,20]. However, while temporizing strategies may be useful in case of extreme scarcity of heath care resources or in cases of serious threats to patient safety, the experience which we have matured, especially in northern Italy during the last 2 months, leads us to the following considerations for COVID-19-negative patients with colorectal cancer:…”