Carboplatin & gemcitabine in all diseases

Bladder cancer

Source: Carboplatin & gemcitabine for unresectable or metastatic bladder cancer

back to top

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

1. 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
2. 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
   1. 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