Carboplatin & gemcitabine in all diseases

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Bladder cancer

Source: Carboplatin & gemcitabine for unresectable or metastatic bladder cancer

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GC: Gemcitabine, Carboplatin

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) 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

21-day cycles

Patients who achieved complete response were given two additional cycles of treatment.

Variant #2, AUC 5/1250

Study Evidence Comparator Efficacy ORR Comparator ORR
Dogliotti et al. 2006 Randomized Phase II (E) 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

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