Abstract 703P
Background
Chemotherapy combined with immunotherapy before radical cystectomy (RC) is anticipated to improve survival of muscle-invasive bladder cancer (MIBC) patients(pts). We investigated the efficacy and safety of camrelizumab in combination with gemcitabine plus cisplatin (GC) as neoadjuvant therapy in MIBC pts.
Methods
This prospective, multicenter, study enrolled histopathological confirmed urothelial bladder cancer pts (cT2-T4aN0-1M0). The eligible pts should tolerate cisplatin and plan to undergo RC. The neoadjuvant therapy included 3 cycles of camrelizumab (200mg, on day 1 of a 21-day cycle) in combination of GC (1,000mg/m2 gemcitabine on days 1 and 8, 70mg/m2 cisplatin on day 2 of a 21-day cycle). The primary endpoint was pathological complete response (pCR, pT0N0). The secondary endpoints included pathological downstaging response (≤pT1N0) and safety. This was a Simon’s two-stage design, if more than 5 out of 20 evaluable pts in stage one had pCR, 51 more pts will be enrolled in stage two, otherwise, this study will be terminated.
Results
By April 2021, 19 eligible pts were enrolled. Twelve pts completed 3 cycles of neoadjuvant therapy. Eleven pts underwent cystectomy (10 RC and 1 partial cystectomy due to lung metastases). The median time to cystectomy was 4.3 weeks. pCR (pT0N0) was achieved in 6 pts (54.5 %), pathological downstaging (≤pT1N0) was achieved in 7 pts (63.6 %). Adverse Events of any grade occurred in 18 pts (95 %). Grade ≥ 3 treatment emergent AEs occurred in 8 pts (42 %), 3 pts (17%) reported treatment related hospitalization/prolonged hospitalization. No grade ≥ 3 immune-related AEs occurred. Two pts (11 %) had grade 1 reactive cutaneous capillary endothelial proliferation. Table: 703P
Baseline characteristic (n=19)
| Age, Years | |
| Median (Min, Max) | 69.00 (50.0, 79.0) |
| Age, n (%) | |
| ＜65 | 7 (36.8) |
| ≥65 | 12 (63.2) |
| Sex, n (%) | |
| Male | 14 (73.7) |
| ECOG PS, n (%) | |
| 0 | 10 (52.6) |
| 1 | 9 (47.4) |
| Tumor stage (T), n (%) | |
| T2 | 11 (57.9) |
| T3-T4a | 8(42.1) |
| Tumor stage (N), n (%) | |
| N0 | 18 (94.7) |
| N1 | 1 (5.3) |
Conclusions
Camrelizumab in combination with gemcitabine plus cisplatin as neoadjuvant therapy for MIBC pts was tolerable and the efficacy met the criteria to enter the second stage.
Clinical trial identification
ChiCTR2000032359.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.