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Guide
The 23rd Annual Meeting of the American Society of Urologic Oncology (SUO) was held
in San Diego (San Diego) from November 30, 2022 to December 2, 2022.
Founded in 1984, SUO hosts the annual meeting as one of the world's most important uro-oncology events, providing a platform for the medical community to discuss malignant urological diseases and promote the development of
uro-oncology.
At this conference, the relevant data of PURE-01 research has attracted widespread attention, and the following is compiled by Yimaitong for readers
.
Image from SUO official
Abstract number: Poster #232
：Three year-survival outcomes after neoadjuvant pembrolizumab and radical cystectomy: final results from the PURE-01 study
The PURE-01 study showed new hope
for survival outcomes in patients with muscle-invasive bladder cancer (MIBC) treated with neoadjuvant pembrolizumab prior to radical cystectomy (RC).
This time, the investigators reported the 3-year survival outcome
of the PURE-01 study.
The intention-to-treat (ITT) population included 155 patients, compared with 125 patients receiving neoadjuvant pembrolizumab and RC therapy (without additional chemotherapy
).
The Reverse Kaplan-Meir method was used to assess median follow-up
.
Event-free survival (EFS) is defined as the time from the first cycle of treatment with pembrolizumab until radiographic disease progression, such as RC, initiation of neoadjuvant chemotherapy (NAC), relapse after RC, or death from any cause.
Other endpoints included recurrence-free survival (RFS) and overall survival (OS).
Multivariate Cox regression analysis (MVA) was used to assess clinical and biomarker predictors
of post-treatment events.
A total of 143 (92.
3%) patients underwent RC, 57 (39.
9%) achieved ypT0ypN0, and 83 (58%) patients achieved pathological descent of ypT1/a/isypN0
.
After a median follow-up of 39 (IQR 30-47) months, the three-year EFS rate in the ITT population was 74.
4% (95% CI 67.
8% to 81.
7%) and OS rate at 36 months was 83.
8% (95% CI 77.
8% to 90.
2%)
.
In the cohort of patients who did not receive additional chemotherapy (n=125), the 3-year RFS rate for patients with ypT0ypN0 was 96.
3% (95% CI 91.
6%-100%); The 3-year RFS rate in ypT1/a/isypN0 patients was 96.
1% (95% CI 89%-100%); The 3-year RFS rate in patients with ypT2-4ypN0 was 74.
9% (955CI 60.
2%-93%); The 3-year RFS rate for ypTanyypN+ patients was 58.
3% (95% CI 36.
2%-94.
1%)
.
According to the analysis results of biomarkers, the EFS rate at 36 months was 89% (95% CI 82.
5%-96%) in CD8+≥10% (n=82) and 78.
2% (68.
4%-89.
4%) in CD8+<10% (n=60) at 36 months<b10>.
The results of MVA analysis showed that higher PD-L1 CPS scores (HR=0.
98, 95%CI 0.
96-0.
99, p=0.
01) were associated with lower event rates.
cT3-4 (HR=2.
55, 95%CI 1.
18-5.
51, p=0.
02) was associated with
a higher event rate.
The 3-year survival data from the PURE-01 study confirmed that neoadjuvant pembrolizumab treatment is effective in prolonging survival in patients with MIBC
.
Corresponding biomarker analysis results facilitate clinical screening of potentially beneficial patients
.
Abstract number: Poster #88
：NEOADJUVANT PEMBROLIZUMAB SHOWS PROMISE AS EFFECTIVE SYSTEMIC THERAPY PRIOR TO RADICAL CYSTECTOMY FOR CISPLATIN-INELIGIBLE MUSCLE-INVASIVE BLADDER CANCER
The need for systemic therapy in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin neoadjuvant chemotherapy remains unmet
.
Pembrolizumab is an anti-PD-1 drug that has been shown to have antitumor activity
in NMIBC and metastatic bladder cancer that do not respond to BCG therapy.
The PURE-01 trial confirmed the initial efficacy
of pembrolizumab for neoadjuvant therapy in patients who are candidates for chemotherapy.
To compare the pathologic remission and survival outcomes
of pembrolizumab neoadjuvant therapy (NAP) with immediate radical cystectomy (IRC) in patients who are not candidates for platinum-containing chemotherapy.
Based on the PURE-01 study, MIBC patients who were not eligible for platinum-containing chemotherapy were identified and compared
to MIBC patients who were not eligible for platinum-containing chemotherapy who received IRC at Murfitt Cancer Center.
The total lifetime (OS) analysis was performed using the Kaplan-Meier method, and the Log-Rank function was used for comparison.
The Cox proportional hazards model was used to determine the effect of
variables on survival.
To further eliminate confounding variables between baseline clinicopathologic features, patients receiving IRC were matched to patients not eligible for platinum-containing chemotherapy in the PURE-01 trial using the nearest neighbor ratio
.
The investigators matched
patients according to ECOG status before bladder resection, glomerular filtration rate (GFR), age, sex, and clinical T stage.
Thirty-nine patients with NAP who were not eligible for platinum-containing chemotherapy were screened from the PURE-01 trial and compared with 313 patients who received IRC who were not eligible for platinum-containing chemotherapy (Figure 1A).
Patients in the NAP group had a longer OS than the IRC group, and the median survival time was 19 months versus not yet reached (p<0.
01).
<b11>
Figure 1 OS comparison of patients in different cohorts
After nearest neighbor matching, 39 patients were screened from the IRC cohort, and their baseline data are shown in Table 1
.
Table 1 Comparison of baseline data for patients matched in the IRC and NAP cohorts
The study found that patients in the NAP group had a higher rate of complete response to final pathology (pT0: 33% vs 13%, p=0.
03); The median OS in the NAP group was significantly longer (not yet vs 21.
0 months, p<0.
01).
<b10> OS rates at 12, 24, and 36 months were 89 versus 57 percent and 64 versus 28 percent
, respectively, in the NAP and IRC groups.
and 33% vs 13% (both p < 0.
01).
<b12>
In addition, patients who received IRC who were not eligible for platinum-containing chemotherapy had worse OS data on the Cox proportional risk model, with a hazard ratio of 2.
0 (95% CI 1.
1 to 3.
89)
compared with patients receiving NAP.
Patients who received NAP who were not candidates for platinum-containing chemotherapy had a higher rate of stage decline and survival advantages
than those who received IRC.
This result is expected to provide new treatment options for patients who are not eligible for platinum-containing chemotherapy in neoadjuvant therapy, and it is expected to perform
in subsequent prospective studies.
References
https://suonet.
org/meetings/upcoming-meetings/abstracts.
aspx
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