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For decades, transurethral resection of bladder tumor (TURBT) + systemic treatment can prolong the survival of patients with invasive bladder cancer (MIBC) with partial preservation of the muscle layer of the bladder
.
However, due to the lack of prospective studies (a) (except for cisplatin-containing neoadjuvant chemotherapy), there is a lack of strict methods to define clinical complete remission (cCR) and its relationship with long-term prognosis (b), and the "rescue" of cystectomy "Limited understanding of the effects (c), it is difficult to advance this treatment model
.
The CRN GU 16-257 study is a phase II study to explore the efficacy of gemcitabine + cisplatin + nivolumab ± bladder cancer resection for myometrial invasive bladder cancer
.
At this year's ASCO conference, researchers announced preliminary research results
.
Methods: Eligible patients are patients with stage cT2-T4aN0M0 bladder urothelial carcinoma who can receive cisplatin-containing regimen
.
The enrolled patients received 4 cycles of gemcitabine + cisplatin + nivolumab treatment, followed by clinical re-staging, including urine cytology, bladder MRI/CT, cystoscopy, and bladder/prostate urethral biopsy
.
Patients who reach cCR (normal cytology and imaging, cT0/Ta staging) may not undergo cystectomy and receive nivolumab therapy (q2w) and monitor
.
The remaining patients underwent cystectomy
.
The common endpoints are cCR rate and 2-year metastasis-free survival (MFS)
.
The key secondary endpoint is the impact of baseline TURBT (TMB, ERCC2, FANCC, RB1, ATM) genome changes on the prediction of MFS by cCR
.
The ASCO conference announced the common primary endpoint cCR rate and the 1-year interim analysis results
.
Results: From August 2018 to November 2020, 76 patients (79% males, median age 69 years old, cT2 staging 56%, cT3 staging 32%, cT4 staging accounted for 12%), 64 patients (84%) completed 4 cycles of treatment, and 48% (31/64) patients achieved cCR.
The median follow-up time of cCR patients was 13.
7 months (range: 2.
5-24 months) ), 1 cCR patient chose to undergo cystectomy immediately (pTaN0M0), 8 (a total of 31) cCR patients had local recurrence, and 6 patients underwent cystectomy (pT0N0, pTaN0, pTisN0, pT2N0, pT4N1 staged patients, respectively) , 1 case, 1 case, 2 cases, 1 case)
.
TMB≥10 (P=0.
02) and ERCC2 mutation (P=0.
02) were related to cCR or pT0
.
The survival rate results are shown in the table below
.
Table 1 year survival rate analysis conclusion: TURBT + gemcitabine + cisplatin + nivolumab reached the strictly defined cCR in most MIBC patients
.
The 1-year intact bladder survival rate is higher
.
A longer follow-up is still needed
.
Clinical trial information: NCT03558087
.
References: Phase 2 trial of gemcitabine, cisplatin, plus nivolumab with selective bladdersparing in patients with muscle- invasive bladder cancer (MIBC): HCRN GU 16-257.
abstract 4503.
Oral Abstract Session
.
However, due to the lack of prospective studies (a) (except for cisplatin-containing neoadjuvant chemotherapy), there is a lack of strict methods to define clinical complete remission (cCR) and its relationship with long-term prognosis (b), and the "rescue" of cystectomy "Limited understanding of the effects (c), it is difficult to advance this treatment model
.
The CRN GU 16-257 study is a phase II study to explore the efficacy of gemcitabine + cisplatin + nivolumab ± bladder cancer resection for myometrial invasive bladder cancer
.
At this year's ASCO conference, researchers announced preliminary research results
.
Methods: Eligible patients are patients with stage cT2-T4aN0M0 bladder urothelial carcinoma who can receive cisplatin-containing regimen
.
The enrolled patients received 4 cycles of gemcitabine + cisplatin + nivolumab treatment, followed by clinical re-staging, including urine cytology, bladder MRI/CT, cystoscopy, and bladder/prostate urethral biopsy
.
Patients who reach cCR (normal cytology and imaging, cT0/Ta staging) may not undergo cystectomy and receive nivolumab therapy (q2w) and monitor
.
The remaining patients underwent cystectomy
.
The common endpoints are cCR rate and 2-year metastasis-free survival (MFS)
.
The key secondary endpoint is the impact of baseline TURBT (TMB, ERCC2, FANCC, RB1, ATM) genome changes on the prediction of MFS by cCR
.
The ASCO conference announced the common primary endpoint cCR rate and the 1-year interim analysis results
.
Results: From August 2018 to November 2020, 76 patients (79% males, median age 69 years old, cT2 staging 56%, cT3 staging 32%, cT4 staging accounted for 12%), 64 patients (84%) completed 4 cycles of treatment, and 48% (31/64) patients achieved cCR.
The median follow-up time of cCR patients was 13.
7 months (range: 2.
5-24 months) ), 1 cCR patient chose to undergo cystectomy immediately (pTaN0M0), 8 (a total of 31) cCR patients had local recurrence, and 6 patients underwent cystectomy (pT0N0, pTaN0, pTisN0, pT2N0, pT4N1 staged patients, respectively) , 1 case, 1 case, 2 cases, 1 case)
.
TMB≥10 (P=0.
02) and ERCC2 mutation (P=0.
02) were related to cCR or pT0
.
The survival rate results are shown in the table below
.
Table 1 year survival rate analysis conclusion: TURBT + gemcitabine + cisplatin + nivolumab reached the strictly defined cCR in most MIBC patients
.
The 1-year intact bladder survival rate is higher
.
A longer follow-up is still needed
.
Clinical trial information: NCT03558087
.
References: Phase 2 trial of gemcitabine, cisplatin, plus nivolumab with selective bladdersparing in patients with muscle- invasive bladder cancer (MIBC): HCRN GU 16-257.
abstract 4503.
Oral Abstract Session
