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Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial.


ABSTRACT:

Objective

To compare neoadjuvant chemotherapy (nCT) with CAPOX alone versus neoadjuvant chemoradiotherapy (nCRT) with capecitabine in locally advanced rectal cancer (LARC) with uninvolved mesorectal fascia (MRF).

Background data

nCRT is associated with higher surgical complications, worse long-term functional outcomes, and questionable survival benefits. Comparatively, nCT alone seems a promising alternative treatment in lower-risk LARC patients with uninvolved MRF.

Methods

Patients between June 2014 and October 2020 with LARC within 12 cm from the anal verge and uninvolved MRF were randomly assigned to nCT group with 4 cycles of CAPOX (Oxaliplatin 130 mg/m2 IV day 1 and Capecitabine 1000 mg/m2 twice daily for 14 d. Repeat every 3 wk) or nCRT group with Capecitabine 825 mg/m² twice daily administered orally and concurrently with radiation therapy (50 Gy/25 fractions) for 5 days per week. The primary end point is local-regional recurrence-free survival. Here we reported the results of secondary end points: histopathologic response, surgical events, and toxicity.

Results

Of the 663 initially enrolled patients, 589 received the allocated treatment (nCT, n=300; nCRT, n=289). Pathologic complete response rate was 11.0% (95% CI, 7.8-15.3%) in the nCT arm and 13.8% (95% CI, 10.1-18.5%) in the nCRT arm ( P =0.33). The downstaging (ypStage 0 to 1) rate was 40.8% (95% CI, 35.1-46.7%) in the nCT arm and 45.6% (95% CI, 39.7-51.7%) in the nCRT arm ( P =0.27). nCT was associated with lower perioperative distant metastases rate (0.7% vs. 3.1%, P =0.03) and preventive ileostomy rate (52.2% vs. 63.6%, P =0.008) compared with nCRT. Four patients in the nCT arm received salvage nCRT because of local disease progression after nCT. Two patients in the nCT arm and 5 in the nCRT arm achieved complete clinical response and were treated with a nonsurgical approach. Similar results were observed in subgroup analysis.

Conclusions

nCT achieved similar pCR and downstaging rates with lower incidence of perioperative distant metastasis and preventive ileostomy compared with nCRT. CAPOX could be an effective alternative to neoadjuvant therapy in LARC with uninvolved MRF. Long-term follow-up is needed to confirm these results.

SUBMITTER: Mei WJ 

PROVIDER: S-EPMC9994847 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial.

Mei Wei-Jian WJ   Wang Xiao-Zhong XZ   Li Yun-Feng YF   Sun Yue-Ming YM   Yang Chun-Kang CK   Lin Jun-Zhong JZ   Wu Zu-Guang ZG   Zhang Rui R   Wang Wei W   Li Yong Y   Zhuang Ye-Zhong YZ   Lei Jian J   Wan Xiang-Bin XB   Ren Ying-Kun YK   Cheng Yong Y   Li Wen-Liang WL   Wang Zi-Qiang ZQ   Xu Dong-Bo DB   Mo Xian-Wei XW   Ju Hai-Xing HX   Ye Sheng-Wei SW   Zhao Jing-Lin JL   Zhang Hong H   Gao Yuan-Hong YH   Zeng Zhi-Fan ZF   Xiao Wei-Wei WW   Zhang Xiao-Peng XP   Zhang Xuan X   Xie E E   Feng Yi-Fei YF   Tang Jing-Hua JH   Wu Xiao-Jun XJ   Chen Gong G   Li Li-Ren LR   Lu Zhen-Hai ZH   Wan De-Sen DS   Bei Jin-Xin JX   Pan Zhi-Zhong ZZ   Ding Pei-Rong PR  

Annals of surgery 20221220 4


<h4>Objective</h4>To compare neoadjuvant chemotherapy (nCT) with CAPOX alone versus neoadjuvant chemoradiotherapy (nCRT) with capecitabine in locally advanced rectal cancer (LARC) with uninvolved mesorectal fascia (MRF).<h4>Background data</h4>nCRT is associated with higher surgical complications, worse long-term functional outcomes, and questionable survival benefits. Comparatively, nCT alone seems a promising alternative treatment in lower-risk LARC patients with uninvolved MRF.<h4>Methods</h4  ...[more]

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