GU cancers
Neoadjuvant MVAC | 2003 | Bladder - advanced |
BC2001 trial, RT w/wo chemo | 2012 | Bladder - advanced |
Keynote 045 | 2017 | Bladder - advanced |
Checkmate 275 | 2017 | Bladder - advanced |
Erdafitinib trial | 2019 | Bladder - advanced |
JAVELIN Bladder 100 Trial | 2020 | Bladder - advanced |
Keynote 052 | 2020 | Bladder - advanced |
EV 301 trial (Enfortumab Vedotin) | 2021 | Bladder - advanced |
Intermittent Androgen suppression | 2012 | Prostate - advanced |
Hero Trial | 2020 | Prostate - advanced |
ENACT Trial, enza vs active surveillance | 2022 | Prostate - early stage |
Docetaxel and Estramustine vs Mitoxantrone | 2004 | Prostate - metastatic |
Neoadjuvant MVAC
Grossman HB et al, NEJM, 2003, PMID: 12944571
Bladder - advanced
Background: Randomized phase 3 trial included 317 patients with muscle-invasive bladder cancer to either neoadjuvant chemotherapy and cystectomy vs cystectomy alone in 1:1 ratio
Arm A: Neoadjuvant chemotherapy with 3 cycles M-VAC (Methotrexate, Vinblastine, Doxorubicin, Cisplatin)
Arm B: Cystectomy alone
Primary Endpoint: Overall Survival
mFollow up: 8.7 months
Median Survival: 77 months vs 46 months, Arm A vs B
5-yr OS: 57% vs 43%, P=.06
Disease specific survival: 54 deaths vs 77 deaths, HR 1.66 (95% CI 1.22-2.45); P=.002
Main Adverse events: Post Cystectomy, Grade 3 or higher adverse events: GI effects: 8 vs 10 patients, Arm A vs B, GU side effects 8 vs 8 patients, Arm A vs B.
Amongst 150 patients with neoadjuvant chemotherapy, grade 3 or higher events were mainly granulocytopenia 85 patients, Anemia 10 patients, thrombocytopenia 7 patients, stomatitis 15 patients.
Conclusions: Neoadjuvant chemotherapy has improved survival and less likelihood of residual cancer in cystectomy specimens when compared to patients who underwent cystectomy alone.
Summarized by Pragnan Kancharla, MD