LBA22 Neoadjuvant chemotherapy with oxaliplatin and capecitabine versus chemoradiation with capecitabine for locally advanced rectal cancer with uninvolved mesorectal fascia (CONVERT): Initial results of a multicenter randomised, open-label, phase III trial

Xz, Wang; Yf, Li; Sun, Yang; Yang, C-K.; Zg, Wu; Zhang, R.; Wang, W.; Li, Yongjun; Zhuang, Y-Z.; Lei, Jian; Wan, X-B.; Ren, Yameng; Cheng, Yong; Wl, Li; Zq, Wang; Pan, ZZ; Yh, Gao; Zeng, Zhifan; Ds, Wan

doi:10.1016/j.annonc.2021.08.2096

Cited by 7 publications

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“…Generally, the pCR rate of patients with LARC who receive nCT is <10% 23 . Despite the CONVERT trial's suggestion that nCT alone can achieve an 11% pCR rate, patients enrolled in the nCT arm had a low burden 24 . Another phase II trial treated patients with mFOLFOXIRI for five cycles as a neoadjuvant regimen 25 .…”

Section: Discussionmentioning

confidence: 99%

Identification of patients with locally advanced rectal cancer eligible for neoadjuvant chemotherapy alone: Results of a retrospective study

Han

Wang

et al. 2023

Cancer Medicine

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Background and Objectives Neoadjuvant chemotherapy (nCT) appears in a few clinical studies as an alternative to neoadjuvant chemoradiation (nCRT) in selected patients with locally advanced rectal cancer (LARC). We aimed to compare the clinical outcomes of nCT with or without nCRT in patients with LARC and to identify patients who may be suitable for nCT alone. Materials and Methods A total of 155 patients with LARC who received neoadjuvant treatment (NT) were retrospectively analysed from January 2016 to June 2021. The patients were divided into two groups: nCRT (n = 101) and nCT (n = 54). More patients with locally advanced disease (cT4, cN+ and magnetic resonance imaging‐detected mesorectal fascia [mrMRF] positive [+]) were found in the nCRT group. Patients in the nCRT group received a dose of 50 Gy/25 Fx irradiation with concurrent capecitabine, and the median number of nCT cycles was two. In the nCT group, the median number of cycles was four. Results The median follow‐up duration was 30 months. The pathologic complete response (pCR) rate in the nCRT group was significantly higher than that in the nCT group (17.5% vs. 5.6%, p = 0.047). A significant difference was observed in the locoregional recurrence rate (LRR); 6.9% in the nCRT group and 16.7% in the nCT group (p = 0.011). Among patients with initial mrMRF (+) status, the LRR in the nCRT group was significantly lower than that in the nCT group (6.1% vs. 20%, p = 0.007), but not in patients with initial mrMRF negative (−) (10.5% in each group, p = 0.647). Compared with the nCT group, a lower LRR was observed in patients in the nCRT group with initial mrMRF (+) converted to mrMRF (−) after NT (5.3% vs. 23%, p = 0.009). No significant difference was observed between the two groups regarding acute toxicity and overall and progression‐free survivals. Multivariate analysis showed that nCRT and ypN stage were independent prognostic factors for the development of LRR. Conclusion Patients with initial mrMRF (−) may be suitable for nCT alone. However, patients with initial mrMRF (+) converted to mrMRF (−) after nCT are still at high risk of LRR, and radiotherapy is recommended. Prospective studies are required to confirm these findings.

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Section: Discussionmentioning

confidence: 99%

Identification of patients with locally advanced rectal cancer eligible for neoadjuvant chemotherapy alone: Results of a retrospective study

Han

Wang

et al. 2023

Cancer Medicine

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“…Only limited data from the randomized phase II study, FOWARC, 10 suggested it may lead to similar outcomes as chemoradiation. In the CONVERT study, presented by Pei-Rong Ding et al., 11 663 patients with locally advanced rectal cancer with uninvolved mesorectal fascia-negative were randomized to four neoadjuvant cycles of CapeOx (nCT) or chemoradiation with concurrent capecitabine (nCRT). The early outcomes for both arms were similar, although nCRT was superior in the degree of tumour regression calculated as TRG 0-1 (38.6% for nCRT versus 24.0% for nCT; P < 0.001) with similar pathological complete responses rates (13.8% for nCRT and 11.0% for nCT; not significant).…”

Section: Lower Gastrointestinal Tractmentioning

confidence: 99%

ESMO Congress 2021: highlights from the EORTC gastrointestinal tract cancer group’s perspective

et al. 2022

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“…In the FOWARC study, though the neoadjuvant with mFOLFOX6 alone achieved a postoperative pCR rate of 6.6%, the rates of R0 resection (89.4% vs 90.7%), anal preservation (89.5% vs 84.4%), and 3-year local recurrence (8.3% vs 8.0%) were similar compared to CRT, as well as producing less postoperative complications [ 10 ]. The 2021 ESMO congress CONVERT trial enrolled patients without mesorectal fascia (MRF) invasion based on pelvic magnetic resonance images (MRI) at baseline [ 11 ]. Four cycles of XELOX regimen chemotherapy showed comparable pCR (11% vs 13.8%) and downstaging rates (40.8% vs 45.6%), with capecitabine-based CRT in a neoadjuvant setting.…”

Section: Introductionmentioning

confidence: 99%

Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer to transform effectively EMVI and MRF from positive to negative: results of a long-term single center phase 2 clinical trial

et al. 2023

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Purpose Chemoradiotherapy (CRT) remains the standard treatment for locally advanced rectal cancer (LARC). This phase 2 clinical trial was designed to evaluate the efficacy and safety of neoadjuvant triplet chemotherapy with mFOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan) in LARC. Patients and methods The patients with LARC (the lower edge more than 5 cm from the anal verge) received up to 5 cycles of mFOLFOXIRI. MRI was performed to assess the baseline and postchemotherapy TN stage. Radical resection was performed within 4–6 weeks from the last dose of chemotherapy if the tumor shrank or remained stable. Adjuvant chemotherapy with mFOLFOX6 or XELOX was recommended. Postoperative radiation was planned for R1 resection, ypT4b, ypN2 and a positive CRM. The primary endpoint was the pathological complete response (pCR) rate. Results From February 2016 to March 2019, 50 patients were enrolled. Forty-eight (96%) were clinically node-positive, 28 (56.5%) with MRF invasion and 39 (78.4%) were EMVI positive. The median cycle of neoadjuvant mFOLFOXIRI chemotherapy was 5 (range,1–5). A total of 46/50 (92%) patients underwent total mesorectal excision (TME) surgery, all with R0 resection. The pCR rate was 4.3% (2/46). Twenty-three of 46 (50%) patients with cN + achieved a pathological node-negative status. The proportions of pathologically positive CRM and EMVI were 2.2% and 34.7%, respectively. Adjuvant radiotherapy was given to 14/46 (30.4%) patients. The most common Grade 3 or > toxicities included neutrocytopenia (50%), leukopenia (14%) and diarrhea (12%) during the neoadjuvant chemotherapy period. Clinically meaningful postoperative complications included pneumonia (n = 1), pelvic infection (n = 1) and anastomotic fistula (n = 1). With a median follow-up time of 51.2 months, local recurrences and distant metastases were confirmed in 3 (6.5%) and 9 (19.6%) of cases, respectively. The 3-year disease free survival (DFS) and overall survival (OS)rates were 75.8% and 86.8%. Conclusion Neoadjuvant chemotherapy with mFOLFOXIRI yielded a significant down-staging effect and seemed to be effective in eliminating EMVI and transforming the positive MRF to negative in LARC. The survival results are promising. The long-term follow-up showed promising DFS and OS rates accompanied by a favorable safety profile. Trial registration ClinicalTrials.gov identifier: NCT03443661, 23/02/2018.

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LBA22 Neoadjuvant chemotherapy with oxaliplatin and capecitabine versus chemoradiation with capecitabine for locally advanced rectal cancer with uninvolved mesorectal fascia (CONVERT): Initial results of a multicenter randomised, open-label, phase III trial

Cited by 7 publications

References 0 publications

Identification of patients with locally advanced rectal cancer eligible for neoadjuvant chemotherapy alone: Results of a retrospective study

Identification of patients with locally advanced rectal cancer eligible for neoadjuvant chemotherapy alone: Results of a retrospective study

ESMO Congress 2021: highlights from the EORTC gastrointestinal tract cancer group’s perspective

Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer to transform effectively EMVI and MRF from positive to negative: results of a long-term single center phase 2 clinical trial

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