Combined chemoradiation therapy is currently the standard practice for locally advanced rectal cancer (LARC) with uninvolved mesorectal fascia (MRF). The CONVERT study compares neoadjuvant chemotherapy with CapeOx alone to standard chemoradiotherapy (CRT) with Capecitabine for these patients.
Patients between June 2014 and October 2020 with LARC within 12 cm from the anal verge and uninvolved MRF were randomly assigned to receive 4 cycles of CapeOx chemotherapy alone (nCT arm) or CRT with concurrent Capecitabine (nCRT arm). Primary endpoint is local regional failure free survival.
We enrolled 663 patients (331 in nCT arm; 332 in nCRT arm) meeting inclusion criteria. 86.3% of patients accomplished full dose of neoadjuvant therapy in nCT arm compared to 91.0% in nCRT arm (P= 0.074). 52.8% of patients accomplished full dose of adjuvant chemotherapy in nCT arm compared to 44.1% in nCRT arm (P= 0.065). The pCR rate and good downstaging (ypStage 0 to 1) rate in nCT arm and nCRT arm was 11.0% vs. 13.8% (P= 0.333), and 40.8% vs. 45.6% (P= 0.265), respectively. nCT significantly reduced perioperative distant metastases compared with nCRT (0.7% vs. 3.1%, P= 0.034). Two patients in nCT arm and 5 patients in nCRT arm achieved complete clinical response and were treated with a non-operative approach. Less preventive ileostomy were observed in nCT arm (52.2 vs. 63.6, P= 0.008). The two arms had similar short-term toxicity and postoperative complications. Similar results were observed in subgroup analysis.
nCT achieved similar pCR and good downstaging rate with less peri-operative distance metastasis and preventive colostomy compared to nCRT. This regimen could serve as a potential alternative to CRT in LARC with uninvolved MRF. Long-term follow-up is needed to confirm these results. Table: LBA22
|All patients||P value|
|Age Median(Range)||60.1 (31-77)||60.1 (28-77)||0.852|
|Clinical staging III (%)||67.7||71.8||0.260|
|ypStage 0 to 1 (%)||40.8||45.6||0.265|
|R0 resection (%)||99.6||99.6||0.999|
|Sphincter preservation (%)||94.9||94.3||0.760|
|Preventive diverting ileostomy (%)||52.2||63.6||0.008|
|Peri-operative distant metastasis (%)||0.7||3.1||0.034|
|Any grade 3/4 adverse events(%)||12.3||8.3||0.109|
|Any postoperative complications(%)||17.7||24.1||0.065|
Clinical trial identification
NCT02288195, last update time: 05/09/2021.
We thank Prof. Scott R Steele and Prof. Ji-Bin Li for providing the necessary writing assistance and editorial support during the development of the abstract.
Legal entity responsible for the study
Sun Yat-sen University Clinical Research 5010 Program (grant number 2014013).
All authors have declared no conflicts of interest.