Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada
Srikala S. Sridhar , Nicholas Power , Rodney H. Breau , Susanna Y. Cheng , Gregory Russell Pond , Peter W. M. Chung , Ur Metser , Mark Norman Levine , Som D. Mukherjee
Background: Muscle invasive bladder cancer (MIBC) is an aggressive local disease where initial staging with conventional CT imaging is often suboptimal. To explore the role of PET-CT in both staging MIBC and assessing response to neoadjuvant chemotherapy (NAC), we conducted a prospective multicentre, randomized trial known as PETMUSE. We report here the first results from the neoadjuvant substudy which assessed interim PET-CT response after 2-3 cycles of NAC and how this correlated with disease free survival (DFS) and overall survival (OS). Methods: Patients with MIBC (T2a-4a, N0-3, M0) based on transurethral resection of their bladder tumor and CT staging were randomized 2:1 to PET-CT or no PET-CT. All PET-CT patients, receiving cisplatin-based NAC underwent a second PET-CT after 2 cycles of gemcitabine and cisplatin (GC) or 3 cycles of dose dense methotrexate, vinblastine, adriamycin, cisplatin (ddMVAC) to assess for interim response. Patients were scored (1-5) by 2 independent reviewers according to the extent of metabolic response on PET-CT. Disease-free survival (DFS) and overall survival (OS) were collected. Results: Between 2016 and 2021, 291 patients were enrolled on PETMUSE of which 46 participated in the neoadjuvant substudy. Median age was 68 (51-86); 36 (78%) were male; 26 were ECOG 0 (57%); 31 (68%) were T2, 13 (28%) were T3/T4; and 35 (76%) were node negative. In terms of NAC regimens: 22 (48%) received GC, 17 (37%) split dose GC, 6 (13%) ddMVAC, and 1 (2%) MVAC. On PET-CT, 23 (50%) had a complete metabolic response, 14 (30%) had a partial metabolic response, 5 (11%) had no change or mixed response and 4 (9%) had progressive disease or new lesion on PET scan. Metabolic response on PET-CT was a statistically significant prognostic factor for both DFS and OS (see Table). Conclusions: In MIBC patients receiving cisplatin-based NAC, metabolic response seen on interim PET-CT was correlated with DFS and OS. PET-CT warrants further study in this setting as a potential early indicator of response to NAC. Clinical trial information: NCT02462239.
Metabolic Response Score | N | Median (95% CI) RFS | 6-month (95% CI) RFS | Univariate Hazard Ratio (95% CI) | Cox Regression p-value |
---|---|---|---|---|---|
1 – complete 2 – partial 3 – other | 23 14 9 | 11.9 (8.5, 16.6) 10.2 (7.5, NR) 8.1 (3.0, NR) | 88.0 (59.4, 96.9) 100 75.0 (12.8, 96.1) | Reference 1.70 (0.62, 4.63) 5.03 (1.35, 18.77) | 0.054 |
Metabolic Response Score | N | Median (95% CI) OS | 6-month (95% CI) OS | Univariate Hazard Ratio (95% CI) | Cox Regression p-value |
---|---|---|---|---|---|
1 – complete 2 – partial 3 – other | 23 14 9 | 15.7 (9.1, NR) 13.7 (8.8, NR) 8.6 (3.0, 8.7) | 93.3 (61.3, 99.0) 100 75.0 (12.8, 96.1) | Reference 1.04 (0.31, 3.42) 9.49 (2.17, 41.51) | 0.009 |
NR=not reached.
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