Short-course radiotherapy and subsequent CAPOX pluscamrelizumab followed by delayedsurgery for locally advanced rectalcancer: Short-term results of aphase II trial
Journal of Clinical Oncology
; 39(3 SUPPL), 2021.
Article
in English
| EMBASE | ID: covidwho-1147263
ABSTRACT
Background:
Chemoradiotherapy followed byradical surgery is standard treatment for patients with locally advanced rectal cancer(LARC). Short-course radiotherapy (SCRT), either with immediate or delayed surgery, providessimilar oncological results compared with long-course radiotherapy with delayed surgery.Delayed surgery with the addition of neoadjuvant immunotherapy may bring betterdownstaging effect and minimize the risk of distant relapse. We conducted this single-armphase 2 trial to investigate the efficacy and safety of SCRT combined with subsequentcapecitabine and oxaliplatin (CAPOX) plusCamrelizumab (anti-PD-1 antibody) followed bydelayed surgery in patients with LARC.Methods:
Patients with histologically confirmed T3-4 N0 M0 or T1-4 N+ M0 rectal cancer, previouslyuntreated disease, and ECOG performancestatus of 0-1, received SCRT (5×5 Gy) withsubsequent two 21-day cycles of CAPOX(oxaliplatin 130 mg/m2 ivgtt, d1;capecitabine1000 mg/m2 po bid, d1-14) plus Camrelizumab(200 mg iv drip, d1) after 1 week, followed byradical surgery after 1 week. Adjuvant therapy was decided by the investigator. The primaryendpoint was pathological complete response(pCR) rate, defined as the absence of viabletumor cells in the primary tumor and lymphnodes. The study is ongoing to follow up thesurvival outcomes and obtain the results of nextgeneration sequencing and PD-L1 expression.The data cutoff date was September 8, 2020.Results:
From November 2019 to September2020, a targeted number of patients (n = 29)were enrolled and are expected to complete thesurgery by November 2020. The median age was 57 (range 31-73) years, 55% (16/29) of patients had ECOG performance status of 1, and the median distance from tumor to the anal verge was 5 (range, 1.9-9) cm. At data cutoff, 10 patients had undergone the surgery, with R0 resection rate of 100%. The pCR rate was 60% (6/10), including 56% (5/9) for those with mismatch repair-proficient, and 100% (1/1) for those with mismatch repair-deficient. Of 4 patients without pCR, 2 only received one cycle of CAPOX plus Camrelizumab due to the outbreak of COVID-19 in Wuhan, and 1 had signet-ring cell rectal carcinoma. At data cutoff, 20 patients had received at least one dose of Camrelizumab. Immune-related adverse events (irAEs) were all grade 1-2, and the most common irAE was reactive cutaneous capillary endothelial proliferation in 10 (50%) of 20 patients. Postoperative bleeding and infection occurred in 1 (10%) and 2 (20%) of 10 patients, respectively. No treatment-related death was observed.Conclusions:
SCRT combined with subsequent CAPOX plus Camrelizumab followed by delayed surgery showed promising pCR rate with good tolerance in patients with LARC, regardless of the mismatch repair status, suggesting a candidate strategy for the neoadjuvant therapy.
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Type of study:
Prognostic study
/
Randomized controlled trials
Language:
English
Journal:
Journal of Clinical Oncology
Year:
2021
Document Type:
Article
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