ASCO GI 2021: Pabli Juju monoanti-radiation chemotherapy completes the whole process of new auxiliary treatment of local advanced rectal cancer, failed to improve NAR score (NRG-GI002 study)

BACKGROUND AND METHODS: This is a Phase II clinical study designed to assess the efficacy and safety of total new complementary therapy (TNT) for local advanced rectal cancer. the
study included patients with stage II/III stage localized advanced rectal cancer (LARC) (with one or more of the following characteristics: remote location (cT3-4 from the edge of the anus ≤5cm, any N); tumor size (tumors within 3mm of any cT4 or rectal fascia);
patients in the group were randomly assigned to receive the new auxiliary FOLFOX (4 months) sequential chemotherapy (Capentabin 50.4Gy±Paboli pearl monoantigen resistance (200mg IV QW) ×6 cycles), and the last dose was performed 8-12 weeks after the radiotherapy.
the main endpoint was an improvement in the score of new assisted rectal cancer (NAR).
end points include OS, DFS, toxicity, pathological complete remission (pCR), treatment completion, surgical cut-negative, etc.
results: Between August 2018 and May 2019, 185 patients were randomly assigned to the control group (n-95) or the Pabli-Pearl monoantigroup (n-90).
baseline feature equilibrium is available.
, 137 patients were assessed for NAR (68 and 69 cases, respectively, in the control group and Paboli pearl monoantigen).
control group and the middle NAR score of the Pabli Pearl mono-resistance group were 14.08 and 11.53 (P-0.26), respectively, the pCR was 29.4% and 31.9% (P-0.75), and the clinical total remission (cCR) was 13.6% and 13.95%, respectively.
conclusion: The new auxiliary treatment of Paboliju monoantigen and radiation chemotherapy was safe and had no unanticipated toxicity, but failed to improve the patient's NAR score.
secondary endpoints, including PFS and OS, have not yet been reached.
neoadjuvant radiotherapy, neoadjuvant chemotherapy, and neoadjuvant chemoradiotherapy.
in recent years, the TNT (Total neoadjuvant treatment) model has been adopted clinically, with both chemotherapy and chemotherapy to be performed before surgery as the end of treatment.
's greatest advantage is to improve the clinical full remission rate of patient tumors (clinical complete remission, cCR), so that cCR patients can adopt the observation and waiting strategy to avoid direct surgery, maximize the retention of organ structure and function, thereby improving the patient's retention and quality of life, and increase the intensity and treatment of patients throughout the body and improve the long-term survival of patients.
However, the new view on rectal cancer treatment is that total Neoadjuvant Therapy (TNT mode) is safe throughout the procedure, and while the NRG-GI002 study results do not improve the NAR score, TNT may be an acceptable option for patients with very serious conditions, very large tumors, multiple positive lymph nodes, or those who need to retain rectal sphincter.
important to stress that it is clear that for some low-risk rectal cancer patients, perhaps all three treatments are not needed.
, we are looking at which models can be safely eliminated.
if we start with TNT mode and the patient achieves complete remission (cancer cannot be detected even in ANRI or biopsy), then these patients may have a chance to avoid surgery."
We are waiting for the results of the PROSPECT trial to tell us whether patients can skip radiation therapy and undergo surgery directly after chemotherapy is completed once chemotherapy is started and the tumor is well retracted.
the next year, we should be clear about which rectal cancer patients can be given the best chance of a cure without taking one treatment.
Patients with low- and medium-level rectal cancer below 10 cm of the polar edge of the tumor assessed by MRI, clinical phased T3-4 and/or N-plus patients are advised to have new assisted chemotherapy before surgery, and T1-2N0 has difficulty retaining sphincter, if the patient has strong will to adopt a new assisted chemotherapy treatment strategy.
There are current problems: (1) the accuracy of preoperative imaging assessment needs to be improved, especially T phase, N phase and cyclical cut edge, so CSCO 2019 guidelines recommend the use of structured reports on rectal cancer imaging reports; To improve efficacy, such as the role of oxalipari in the introduction of new complementary therapies, there are clinical studies suggesting that pCR rates can be increased without significant DFS benefits;
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