Carboplatin & gemcitabine in all diseases
Bladder cancer
Source: Carboplatin & gemcitabine for unresectable or metastatic bladder cancer
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GC: Gemcitabine, Carboplatin
Regimen variant #1, AUC 4.5/1000
| Study | Evidence | Comparator | Efficacy | Toxicity | ORR | Comparator ORR |
|---|---|---|---|---|---|---|
| De Santis et al. 2009 (EORTC 30986) | Randomized Phase II/III (E-de-esc) | M-CAVI | Seems not superior | Lower toxicity than M-CAVI | Intention to treat: 38% (2009) 41.2% (2012) |
Intention to treat: 20% (2009) 30.3% (2012) |
Chemotherapy
- Carboplatin (Paraplatin) AUC 4.5 IV over 60 minutes once on day 1, given second
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8, given first
21-day cycles
Patients who achieved complete response were given two additional cycles of treatment.
Regimen variant #2, AUC 5/1250
| Study | Evidence | Comparator | Efficacy | ORR | Comparator ORR |
|---|---|---|---|---|---|
| Dogliotti et al. 2006 | Randomized Phase II (E-switch-ic) | Cisplatin & Gemcitabine | Seems not superior | Intention to treat: 40% (95% CI NR) Evaluable patients only: 56% (95% CI: 40–72) |
Intention to treat: 49% (95% CI NR) Evaluable patients only: 66% (95% CI: 49–80) |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 30 to 60 minutes once on day 2
- Gemcitabine (Gemzar) 1250 mg/m2 IV over 30 to 60 minutes once per day on days 1 & 8
21-day cycle for up to 6 cycles
References
- Dogliotti L, Cartenì G, Siena S, Bertetto O, Martoni A, Bono A, Amadori D, Onat H, Marini L. Gemcitabine plus cisplatin versus gemcitabine plus carboplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium: results of a randomized phase 2 trial. Eur Urol. 2007 Jul;52(1):134-41. Epub 2006 Dec 26. link to original article contains verified protocol PubMed
- EORTC 30986: De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Skoneczna I, Marreaud S, de Wit R, Sylvester R. Randomized phase II/III trial assessing gemcitabine/ carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: phase II--results of EORTC study 30986. J Clin Oncol. 2009 Nov 20;27(33):5634-9. link to original article link to PMC article contains verified protocol PubMed
- Update: De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Gil T, Marreaud S, Daugaard G, Skoneczna I, Collette S, Lorent J, de Wit R, Sylvester R. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol. 2012 Jan 10;30(2):191-9. link to original article link to PMC article contains verified protocol PubMed
