Urothelial carcinoma

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Neoadjuvant chemotherapy

Cisplatin & Gemcitabine (GC)

GC: Gemcitabine, Cisplatin

Regimen #1, Dash, et al. 2008 - single-dose cisplatin

• Cisplatin (Platinol) 70 mg/m2 IV once on day 1
• Gemcitabine (Gemzar) 1000 mg/m2 IV once daily on days 1 & 8

21-day cycles x 4 cycles

Regimen #2, Dash, et al. 2008 - split-dose cisplatin

• Cisplatin (Platinol) 35 mg/m2 IV once daily on days 1 & 8
• Gemcitabine (Gemzar) 1000 mg/m2 IV once daily on days 1 & 8

21-day cycles x 4 cycles

References

1. Dash A, Pettus JA 4th, Herr HW, Bochner BH, Dalbagni G, Donat SM, Russo P, Boyle MG, Milowsky MI, Bajorin DF. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer. 2008 Nov 1;113(9):2471-7. doi: 10.1002/cncr.23848. link to original article contains verified protocol PubMed

CMV

CMV: Cisplatin, Methotrexate, Vinblastine

Regimen

• Methotrexate (MTX) 30 mg/m2 IV bolus once daily on days 1 & 8
• Vinblastine (Velban) 4 mg/m2 IV bolus once daily on days 1 & 8
• Cisplatin (Platinol) 100 mg/m2 IV once on day 2, before hydration
• Folinic acid (Leucovorin) 15 mg PO/IV every 6 hours x 4 doses (total daily dose: 60 mg/m2) on days 2 & 9; given after hydration, with the first dose 24 hours after the previous day's dose of methotrexate

21-day cycles x 3 cycles

References

1. International Collaboration of Trialists; Medical Research Council Advanced Bladder Cancer Working Party (now the National Cancer Research Institute Bladder Cancer Clinical Studies Group); European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group; Australian Bladder Cancer Study Group; National Cancer Institute of Canada Clinical Trials Group; Finnbladder; Norwegian Bladder Cancer Study Group; Club Urologico Espanol de Tratamiento Oncologico Group, Griffiths G, Hall R, Sylvester R, Raghavan D, Parmar MK. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol. 2011 Jun 1;29(16):2171-7. doi: 10.1200/JCO.2010.32.3139. Epub 2011 Apr 18. link to original article contains verified protocol PubMed

MVAC

MVAC: Methotrexate, Vinblastine, Adriamycin, Cisplatin

Regimen

• Methotrexate (MTX) 30 mg/m2 IV once daily on days 1, 15, 22
• Vinblastine (Velban) 3 mg/m2 IV once daily on days 2, 15, 22
• Doxorubicin (Adriamycin) 30 mg/m2 IV once on day 2
• Cisplatin (Platinol) 70 mg/m2 IV once on day 2

28-day cycles x 3 cycles

References

1. Grossman HB, Natale RB, Tangen CM, Speights VO, Vogelzang NJ, Trump DL, deVere White RW, Sarosdy MF, Wood DP Jr, Raghavan D, Crawford ED. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003 Aug 28;349(9):859-66. link to original article contains verified protocol PubMed

Concurrent chemotherapy & radiation

Cisplatin & RT

Regimen, Shipley, et al. 1998 - RTOG 89-03

Induction therapy

• Cisplatin (Platinol) 100 mg/m2 IV once daily on days 1 & 22
• Concurrent radiation therapy, 1.8 Gy fractions x 22 fractions, given 5 times per week (total dose: 39.6 Gy)

21-day cycles x 2 cycles; patient is restaged 4 weeks after completion of radiation with "examination under anesthesia, cystoscopy with tumor-site biopsy, and urinary cytology." Patients not in complete remission usually proceeded to cystectomy. Patients in compete remission usually proceeded to consolidation therapy:

Consolidation therapy

• Cisplatin (Platinol) 100 mg/m2 IV once on day 1
• Concurrent radiation therapy, 1.8 Gy fractions x 14 fractions, given 5 times per week (total dose in consolidation phase: 39.6 Gy; total overall dose in induction and consolidation phases: 64.8 Gy)

References

1. Shipley WU, Winter KA, Kaufman DS, Lee WR, Heney NM, Tester WR, Donnelly BJ, Venner PM, Perez CA, Murray KJ, Doggett RS, True LD. Phase III trial of neoadjuvant chemotherapy in patients with invasive bladder cancer treated with selective bladder preservation by combined radiation therapy and chemotherapy: initial results of Radiation Therapy Oncology Group 89-03. J Clin Oncol. 1998 Nov;16(11):3576-83. link to original article contains verified protocol PubMed

Fluorouracil, Mitomycin, RT

Regimen

• Fluorouracil (5-FU) 500 mg/m2/day IV continuous infusion x 10 total days (total dose: 5000 mg/m2) during radiation fractions 1 to 5, 16 to 20
• Mitomycin (Mutamycin) 12 mg/m2 IV bolus once on day 1
• Radiation therapy given according to one of the following plans:
  • Concurrent radiation therapy, 2.75 Gy fractions x 20 fractions (total dose: 55 Gy) over 4 weeks
  • Concurrent radiation therapy, 2 Gy fractions x 32 fractions (total dose: 64 Gy) over 6.5 weeks

References

1. James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Sizer B, Sreenivasan T, Hendron C, Lewis R, Waters R, Huddart RA; BC2001 Investigators. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med. 2012 Apr 19;366(16):1477-88. doi: 10.1056/NEJMoa1106106. link to original article contains verified protocol PubMed

Chemotherapy for locally advanced or metastatic disease

Carboplatin & Gemcitabine (GC)

GC: Gemcitabine, Carboplatin

Regimen

• 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 daily on days 1 & 8

21-day cycles x up to 6 cycles, until progression of disease, unacceptable toxicity, or physician discretion based on patient's best interests

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

Carboplatin & Paclitaxel

Regimen

• Carboplatin (Paraplatin) AUC 6 IV once on day 1
• Paclitaxel (Taxol) 225 mg/m2 IV over 3 hours once on day 1

21-day cycles x up to 6 cycles

References

1. Vaughn DJ, Manola J, Dreicer R, See W, Levitt R, Wilding G. Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896): a trial of the Eastern Cooperative Oncology Group. Cancer. 2002 Sep 1;95(5):1022-7. link to original article contains protocol PubMed

CISCA

CISCA: CISplatin, Cyclophosphamide, Adriamycin

Regimen

• Cyclophosphamide (Cytoxan) 650 mg/m2 IV once on day 1
• Cisplatin (Platinol) 100 mg/m2 IV once on day 2
• Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 2

21-day cycles x up to 6 cycles

Supportive medications:

• Forced mannitol diuresis with cisplatin

References

1. Logothetis CJ, Dexeus FH, Finn L, Sella A, Amato RJ, Ayala AG, Kilbourn RG. A prospective randomized trial comparing MVAC and CISCA chemotherapy for patients with metastatic urothelial tumors. J Clin Oncol. 1990 Jun;8(6):1050-5. link to original article contains verified protocol PubMed

Cisplatin & Gemcitabine (GC/GP)

GC: Gemcitabine, Cisplatin
GP: Gemcitabine, Platinol

Regimen #1, von der Maase, et al. 2000 & Bellmunt, et al. 2012

• Cisplatin (Platinol) 70 mg/m2 IV once on day 2
• Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 to 60 minutes once daily on days 1, 8, 15

28-day cycles x 6 cycles, given until progression of disease or unacceptable toxicity

Regimen #2, Dogliotti, et al. 2007

• Cisplatin (Platinol) 70 mg/m2 IV once on day 2
• Gemcitabine (Gemzar) 1250 mg/m2 IV over 30 to 60 minutes once daily on days 1 & 8

21-day cycles x up to 6 cycles, until progression of disease, unacceptable toxicity, or physician discretion based on patient's best interests

Regimen #3, Soto Parra, et al. 2002 - 3-week schedule

Only a minority of patients in Soto Parra, et al. 2002 had bladder cancer. The majority of patients had non-small cell lung cancer.

• Cisplatin (Platinol) 70 mg/m2 IV over 30 to 60 minutes once on day 2
• Gemcitabine (Gemzar) 1000 mg/m2 IV once daily on days 1 & 8

21-day cycles x up to 6 cycles, until progression of disease, unacceptable toxicity, or physician discretion based on patient's best interests

Supportive medications:

• 2 liters of fluid and "appropriate antiemetic therapy" given with cisplatin
• "blood-product transfusion and the administration of antibiotics, antiemetics and analgesics, as appropriate"

Regimen #4, Soto Parra, et al. 2002 - 4-week schedule

Only a minority of patients in Soto Parra, et al. 2002 had bladder cancer. The majority of patients had non-small cell lung cancer.

• Cisplatin (Platinol) 70 mg/m2 IV over 30 to 60 minutes once on day 2
• Gemcitabine (Gemzar) 1000 mg/m2 IV once daily on days 1, 8, 15

28-day cycles x up to 6 cycles, until progression of disease, unacceptable toxicity, or physician discretion based on patient's best interests

Supportive medications:

• 2 liters of fluid and "appropriate antiemetic therapy" given with cisplatin
• "blood-product transfusion and the administration of antibiotics, antiemetics and analgesics, as appropriate"

References

1. von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000 Sep;18(17):3068-77. link to original article contains verified protocol PubMed
2. Soto Parra H, Cavina R, Latteri F, Sala A, Dambrosio M, Antonelli G, Morenghi E, Alloisio M, Ravasi G, Santoro A. Three-week versus four-week schedule of cisplatin and gemcitabine: results of a randomized phase II study. Ann Oncol. 2002 Jul;13(7):1080-6. link to original article contains verified protocol PubMed
3. 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
4. Bellmunt J, von der Maase H, Mead GM, Skoneczna I, De Santis M, Daugaard G, Boehle A, Chevreau C, Paz-Ares L, Laufman LR, Winquist E, Raghavan D, Marreaud S, Collette S, Sylvester R, de Wit R. Randomized Phase III Study Comparing Paclitaxel/Cisplatin/ Gemcitabine and Gemcitabine/Cisplatin in Patients With Locally Advanced or Metastatic Urothelial Cancer Without Prior Systemic Therapy: EORTC Intergroup Study 30987. J Clin Oncol. 2012 Feb 27. [Epub ahead of print] link to original article contains verified protocol PubMed

Cisplatin, Gemcitabine, Paclitaxel (PCG)

PCG: Paclitaxel, Cisplatin, Gemcitabine

Regimen, Bellmunt, et al. 2012 - EORTC 30987

• Cisplatin (Platinol) 70 mg/m2 IV once on day 1
• Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 to 60 minutes once daily on days 1 & 8
• Paclitaxel (Taxol) 80 mg/m2 IV once daily on days 1 & 8, given first

21-day cycles x up to 6 cycles

References

1. Bellmunt J, von der Maase H, Mead GM, Skoneczna I, De Santis M, Daugaard G, Boehle A, Chevreau C, Paz-Ares L, Laufman LR, Winquist E, Raghavan D, Marreaud S, Collette S, Sylvester R, de Wit R. Randomized Phase III Study Comparing Paclitaxel/Cisplatin/ Gemcitabine and Gemcitabine/Cisplatin in Patients With Locally Advanced or Metastatic Urothelial Cancer Without Prior Systemic Therapy: EORTC Intergroup Study 30987. J Clin Oncol. 2012 Feb 27. [Epub ahead of print] link to original article contains verified protocol PubMed

Gemcitabine & Paclitaxel

Regimen

• Gemcitabine (Gemzar) 1000 mg/m2 IV once daily on days 1, 8, 15
• Paclitaxel (Taxol) 200 mg/m2 IV over 3 hours once on day 1

21-day cycles x up to 6 cycles

References

1. Meluch AA, Greco FA, Burris HA 3rd, O'Rourke T, Ortega G, Steis RG, Morrissey LH, Johnson V, Hainsworth JD. Paclitaxel and gemcitabine chemotherapy for advanced transitional-cell carcinoma of the urothelial tract: a phase II trial of the Minnie pearl cancer research network. J Clin Oncol. 2001 Jun 15;19(12):3018-24. link to original article PubMed

MVAC

MVAC: Methotrexate, Vinblastine, Adriamycin, Cisplatin

Regimen #1, Sternberg, et al. 2001 & Sternberg, et al. 2006 - dose-dense EORTC 30924

• Methotrexate (MTX) 30 mg/m2 IV once on day 1
• Vinblastine (Velban) 3 mg/m2 IV once on day 2
• Doxorubicin (Adriamycin) 30 mg/m2 IV once on day 2
• Cisplatin (Platinol) 70 mg/m2 IV once on day 2

14-day cycles, given until progression of disease or unacceptable toxicity; in contrast to Sternberg, et al. 2001, Sternberg, et al. 2006 specified 15-day cycles

Supportive medications:

• G-CSF 240 ug/m2 SC once daily on days 4-10 (additional use up to a total of 14 consecutive days if needed), injected at alternating sites, discontinued if ANC >30 x 10⁹/L. In contrast to Sternberg, et al. 2001, Sternberg, et al. 2006 said G-CSF was given on days 3-7.

Regimen #2, Logothetis, et al. 1990; Sternberg, et al. 2001; Sternberg, et al. 2006; Han, et al. 2008

• Methotrexate (MTX) 30 mg/m2 IV once daily on days 1, 15, 22
• Vinblastine (Velban) 3 mg/m2 IV once daily on days 2, 15, 22
• Doxorubicin (Adriamycin) 30 mg/m2 IV once on day 2
• Cisplatin (Platinol) 70 mg/m2 IV once on day 2

28-day cycles x 6 cycles (number of cycles and criteria to continue therapy varies depending on reference)

References

1. Logothetis CJ, Dexeus FH, Finn L, Sella A, Amato RJ, Ayala AG, Kilbourn RG. A prospective randomized trial comparing MVAC and CISCA chemotherapy for patients with metastatic urothelial tumors. J Clin Oncol. 1990 Jun;8(6):1050-5. link to original article contains verified protocol PubMed
2. Sternberg CN, de Mulder PH, Schornagel JH, Théodore C, Fossa SD, van Oosterom AT, Witjes F, Spina M, van Groeningen CJ, de Balincourt C, Collette L; European Organization for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group. Randomized phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors: European Organization for Research and Treatment of Cancer Protocol no. 30924. J Clin Oncol. 2001 May 15;19(10):2638-46. link to original article contains verified protocol PubMed
3. Han KS, Joung JY, Kim TS, Jeong IG, Seo HK, Chung J, Lee KH. Methotrexate, vinblastine, doxorubicin and cisplatin combination regimen as salvage chemotherapy for patients with advanced or metastatic transitional cell carcinoma after failure of gemcitabine and cisplatin chemotherapy. Br J Cancer. 2008 Jan 15;98(1):86-90. Epub 2007 Dec 18. link to original article contains verified protocol PubMed
4. Sternberg CN, de Mulder P, Schornagel JH, Theodore C, Fossa SD, van Oosterom AT, Witjes JA, Spina M, van Groeningen CJ, Duclos B, Roberts JT, de Balincourt C, Collette L; EORTC Genito-Urinary Cancer Group. Seven year update of an EORTC phase III trial of high-dose intensity M-VAC chemotherapy and G-CSF versus classic M-VAC in advanced urothelial tract tumours. Eur J Cancer. 2006 Jan;42(1):50-4. Epub 2005 Dec 5. link to original article contains verified protocol PubMed

Pemetrexed (Alimta)

Regimen

• Pemetrexed (Alimta) 500 mg/m2 IV over 10 minutes once on day 1

21-day cycles

References

1. Sweeney CJ, Roth BJ, Kabbinavar FF, Vaughn DJ, Arning M, Curiel RE, Obasaju CK, Wang Y, Nicol SJ, Kaufman DS. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol. 2006 Jul 20;24(21):3451-7. link to original article contains protocol PubMed