Bladder Cancer Treatment Regimens |
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Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced health care team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are provided only to supplement the latest treatment strategies. These Guidelines are a work in progress that may be refined as often as new significant data become available. The NCCN Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. |
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Note: All recommendations are category 2A unless otherwise indicated. |
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▶Intravesical Therapy for Bladder Cancer1,a |
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REGIMEN |
DOSING |
Immediate Postoperative Intravesical Chemotherapya |
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Gemcitabine (Category 1)2-5 |
Day 1: Gemcitabine 2,000mg intravesical within 24 hours of TURBT (ideally within 6 hours). Administer for 1 dose after surgery. OR Days 1,8,15,22,29,36: Gemicitabine 2,000mg intravescial or percutaneous. Repeat cycle every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles, conditionally followed by: Day 1: Gemcitabine 2,000mg intravescial. Repeat cycle every 4 weeks for 12 cycles. |
Mitomycin (Category 1)6-9 |
Day 1: Mitomycin 40mg intravesical within 24 hours of TURBT (ideally within 6 hours). Administer for 1 dose after surgery. OR Days 1,8,15,22,29,36: Mitomycin 40mg intravesical or intraurethral or percutaneous. Repeat cycle every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles, conditionally followed by: Day 1: Mitomycin 40mg intravesical. Repeat cycle every 4 weeks for 5-11 cycles based on risk group (5 for intermediate risk; 11 for high risk). |
Induction (Adjuvant) Intravesicular Chemotherapy or BCGd |
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BCG |
If TICE BCG product is used: Days 1,8,15,22,29,36: BCG 50mg intravesical or intraurethral or percutaneous. Administer every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles, followed by maintenance therapy: Days 1 of every month: BCG 50mg intravesical Repeat cycle every 4 weeks for at least 6-12 months after completion of adjuvant BCG therapy. Ideally maintenance should be given for 1 year for intermediate-risk and 3 years for high-risk disease. |
Docetaxel14-16,b Docetaxel requires premedication. |
Days 1,8,15,22,29,36: Docetaxel 75mg intravesical. Repeat cycle every 6 weeks beginning 3-4 weeks following surgery for a maximum of 2 cycles, conditionally followed by maintenance therapy with: Day 1: Docetaxel 75mg intravesical. Repeat cycle every 4 weeks for 9 cycles starting 3 months after adjuvant therapy. |
Epirubicin17,19 |
Days 1,8,15,22,29,36: Epirubicin 50mg intravesical. Repeat cycle every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles, conditionally followed by maintenance therapy with: Days 1,8,15 of months 3,6,12,18,24,30, and 36 from initiation of adjuvant therapy: Epirubicin 50mg intravesical. |
Gemcitabine2-5 |
Day 1: Gemcitabine 2,000mg intravesical within 24 hours of TURBT (ideally within 6 hours). Administer for 1 dose after surgery. OR Days 1,8,15,22,29,36: Gemcitabine 2,000mg intravesical or percutaneous. Repeat cycle every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles, conditionally followed by: Day 1: Gemcitabine 2,000mg intravesical. Repeat cycle every 4 weeks for 12 cycles. |
Gemcitabine / Docetaxel12,14,20,b Docetaxel requires premedication. |
Days 1,8,15,22,29,36: Gemcitabine 1,000mg intravesical, followed by: Days 1,8,15,22,29,36: Docetaxel 37.5mg intravesical. Repeat cycle every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles. |
Gemcitabine / Mitomycin2,6,21 |
Days 1,8,15,22,29,36: Gemcitabine 1,000mg intravesical, followed by: Days 1,8,15,22,29,36: Mitomycin 40mg intravesical Repeat cycle every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles, conditionally followed by maintenance therapy with: Day 1: Gemcitabine 1,000mg intravesical, followed by: Day 1: Mitomycin 40mg intravesical. Repeat cycle every 4 weeks for 12 cycles. |
Mitomycin6-9 |
Day 1: Mitomycin 40mg intravesical within 24 hours of TURBT (ideally within 6 hours). Administer for 1 dose after surgery. OR Days 1,8,15,22,29,36: Mitomycin 40mg intravesical or intraurethral or percutaneous. Repeat cycle every 6 weeks beginning 3-4 weeks after surgery for a maximum of 2 cycles, conditionally followed by: Day 1: Mitomycin 40mg intravesical. Repeat cycle every 4 weeks for 5-11 cycles based on risk group (5 for intermediate risk; 11 for high risk). |
Valrubicin22,23 |
Days 1,8,15,22,29,36: Valrubicin 800mg intravesical. Repeat every 6 weeks beginning 3-4 weeks after surgery for 2 cycles, conditionally followed by: Day 1: Valrubicin 800mg intravesical. Repeat cycle every 4 weeks for 10 cycles. |
Maintenance Intravesical BCGf |
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BCG10-13 |
If TICE BCG product is used: Day 1 of every month: BCG 50mg intravesical. Administer a monthly cycle for at least 6-12 months after completion of adjuvant BCG therapy. Ideally maintenance should be given for 1 year for intermediate-risk and 3 years for high-risk disease. |
▶Neoadjuvant Chemotherapy1,a,c |
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Preferred |
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DDMVAC24-31d-f |
Day 1: Methotrexate 30mg/m2 IV push Day 1 OR Day 2: Vinblastine 3mg/m2 IV over 5-10 minutes Day 1 OR Day 2: Doxorubicin 30mg/m2 IV push Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 2 weeks for 3-6 cycles. |
Other Recommended Regimens |
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Gemcitabine / Cisplatin2,27,32-34,f |
Days 1,8,15: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks for 4 cycles. OR Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks for 4 cycles. |
▶Adjuvant Chemotherapy1,a,c |
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No Previous Platinum-Based Neoadjuvant Therapy (pT3, pT4a, pN+) |
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Preferred Regimen |
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DDMVAC with growth factor support for 3-6 cycles24-32,d-f |
Day 1: Methotrexate 30mg/m2 IV push Day 1 OR Day 2: Vinblastine 3mg/m2 IV over 5-10 minutes Day 1 OR Day 2: Doxorubicin 30mg/m2 IV push Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 2 weeks for 3-6 cycles. |
Other Recommended Regimens |
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Gemcitabine / Cisplatin2,27,32-34,f |
Days 1,8,15: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks for 4 cycles. OR Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks for 4 cycles. |
Nivolumab35-38,g |
Day 1: Nivolumab 240mg IV over 30 minutes. Repeat cycle every 2 weeks up to 1 year or disease recurrence. OR Day 1: Nivolumab 480mg IV over 30 minutes. Repeat cycle every 4 weeks up to 1 year or disease recurrence. |
Previous Platinum-Based Neoadjuvant Therapy (ypT2-ypT4a or ypN+)1,a |
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Other Recommended Regimen |
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Nivolumab35-38,g |
Day 1: Nivolumab 240mg IV over 30 minutes. Repeat cycle every 2 weeks up to 1 year or disease recurrence. OR Day 1: Nivolumab 480mg IV over 30 minutes. Repeat cycle every 4 weeks up to 1 year or disease recurrence. |
▶First-Line Systemic Therapy for Locally Advanced or Metastatic Disease (Stage IV)1,a |
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Cisplatin Eligible Patients |
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Preferred |
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DDMVAC with growth factor support (Category 1) followed by Avelumab Maintenance Therapy (Category 1)24-32,39,d-h Avelumab requires premedication. |
Day 1: Methotrexate 30mg/m2 IV push Day 1 OR Day 2: Vinblastine 3mg/m2 IV over 5-10 minutes Day 1 OR Day 2: Doxorubicin 30mg/m2 IV push Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 2 weeks for 4-6 cycles, conditionally followed by maintenance therapy with: Day 1: Avelumab 800mg IV over 60 minutes. Repeat cycle every 2 weeks. |
Gemcitabine / Cisplatin (Category ) followed by Avelumab Maintenance Therapy (Category 1)2,27,32-34,39,f,h |
Days 1,8,15: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks for 4-6 cycles, conditionally followed by maintenance therapy with: Day 1: Avelumab 800mg IV over 60 minutes. Repeat cycle every 2 weeks. OR Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 or on Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 3 weeks for 4-6 cycles, conditionally followed by maintenance therapy with: Day 1: Avelumab 800mg IV over 60 minutes. Repeat cycle every 2 weeks. |
Cisplatin Ineligible Patients |
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Preferred Regimens |
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Gemcitabine / Carboplatin followed by Avelumab Maintenance Therapy (Category 1)2,32,39,41-44,g,h Avelumab requires premedication. |
Days 1,8: Gemcitabine 1,000-1250mg/m2 IV over 30 minutes Day 1: Carboplatin AUC 5-6 IV over 30 minutes. Repeat cycle every for 4-6 cycles, conditionally followed by maintenance therapy with: Day 1: Avelumab 800mg IV over 60 minutes. Repeat cycle every 2 weeks. |
Pembrolizumab (for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for ant platinum-containing chemotherapy)45-48,g |
Day 1: Pembrolizumab 200mg IV over 30 minutes. Repeat cycle every 3 weeks up to 2 years of therapy. OR Day 1: Pembrolizumab 400mg IV over 30 minutes. Repeat cycle every 6 weeks up to 2 years of therapy. |
Other Recommended Regimens |
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Atezolizumab (only for patients whose tumors express PD-L1) (Category 2B)49,50,g |
Day 1: Atezolizumab 840mg IV. Repeat cycle every 2 weeks. OR Day 1: Atezolizumab 1,200mg IV. Repeat cycle every 3 weeks. OR Day 1: Atezolizumab 1,680mg IV. Repeat cycle every 4 weeks. |
Gemcitabine2,51,52 |
Days 1,8,15: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 4 weeks. OR Days 1, 8: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Gemcitabine / Paclitaxel2,53,54,i |
Day 1: Paclitaxel 175mg/m2 IV over 3 hours, followed by: Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Useful Under Certain Circumstances |
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Atezolizumab (only for patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 expression) (Category 3)49,50,g |
Day 1: Atezolizumab 840mg IV. Repeat cycle every 2 weeks. OR Day 1: Atezolizumab 1,200mg IV. Repeat cycle every 3 weeks. OR Day 1: Atezolizumab 1,680mg IV. Repeat cycle every 4 weeks. |
Ifosfamide / Doxorubicin / Gemcitabineb (for patients with good kidney function and good PS)2,55-57,d,e,j |
Days 1-4: Ifosfamide 1,500mg/m2 IV over 3 hours daily Mesna 300mg/m2 IV over 15 minutes 3 times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Day 3: Doxorubicin 45mg/m2 IV push Days 2,4: Gemcitabine 150mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks for 3 cycles. |
▶Second-Line Systemic Therapy for Locally Advanced or Metastatic Disease (Stage IV) (Post-Platinum or Other Chemotherapy)1,a |
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Preferred Regimen |
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Pembrolizumab (Category 1 for post-platinum)45-48,g |
Day 1: Pembrolizumab 200mg IV over 30 minutes. Repeat cycle every 3 weeks up to 2 years of therapy. OR Day 1: Pembrolizumab 400mg IV over 30 minutes. Repeat cycle every 6 weeks up to 2 years of therapy. |
Alternative Preferred Regimens |
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Avelumab39,58,59,g,h Avelumab requires premedication. |
Day 1: Avelumab 800mg IV over 60 minutes. Repeat cycle every 2 weeks. |
Enfortumab vedotin-ejfv60-63,k |
Days 1, 8, 15: Enfortumab vedotin-ejfv 1.25mg/kg (maximum 125mg) IV over 30 minutes. Repeat cycle every 4 weeks. |
Erdafitinb (for patients with susceptible FGFR2 / FGFR3 alterations)64,65 |
Days 1-14 (Cycle 1): Erdafitinib 8mg orally once daily, followed by: Days 15-18 (Cycle 1): Erdafininib 9mg orally once daily (increase dose based on tolerability after 14 to 21 days if serum phosphate is <5.5 mg/dL and no ocular disorders or ≥grade 2 toxicity), followed by: Days 1-28 (beginning with Cycle 2): Erdafitinib 9mg (if tolerated) orally once daily. Repeat cycle every 4 weeks. |
Nivolumab35-38 |
Day 1: Nivolumab 240mg IV over 30 minutes. Repeat cycle every 2 weeks. OR Day 1: Nivolumab 480mg IV over 30 minutes. Repeat cycle every 4 weeks. |
Other Recommended Regimens |
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Docetaxel14,66,b |
Day 1: Docetaxel 100mg/m2 IV over 60 minutes. Repeat cycle every 3 weeks. |
Gemcitabine2,51,52 |
Days 1,8,15: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 4 weeks. OR Days 1,8: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Paclitaxel53,67-69,I Paclitaxel requires premedication. |
Days 1,8,15,22: Paclitaxel 80mg/m2 IV over 60 minutes. Repeat cycle every 4 weeks. OR Day 1: Paclitaxel 200mg/m2 IV over 3 hours. Repeat cycle every 3 weeks. |
Useful in Certain Circumstances Based on Prior Medical History |
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DDMVAC (with growth factor support)24-32,d-f |
Day 1: Methotrexate 30mg/m2 IV push Day 1 OR Day 2: Vinblastine 3mg/m2 IV over 5-10 minutes Day 1 OR Day 2: Doxorubicin 30mg/m2 IV push Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 2 weeks for 4-6 cycles. |
Gemcitabine / Cisplatin2,27,32-34,f |
Days 1,8,15: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks 4-6 cycles. OR Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 3 weeks for 4-6 cycles. |
Gemcitabine / Paclitaxel2,53,54,i |
Day 1: Paclitaxel 175mg/m2 IV over 3 hours, followed by: Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Ifosfamide / Doxorubicin / Gemcitabine2,55-57,d,e,j |
Days 1-4: Ifosfamide 1,500mg/m2 IV over 3 hours daily Mesna 300mg/m2 IV over 15 minutes 3 times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Day 3: Doxorubicin 45mg/m2 IV push Days 2,4: Gemcitabine 150mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks for 3 cycles. |
▶Second-Line Systemic Therapy for Locally Advanced or Metastatic Disease (Stage IV) (Post-Checkpoint Inhibitor)1,a |
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Preferred Regimen For Cisplatin Ineligible and Chemotherapy Naïve Patients |
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Enfortumab vedotin-ejfv60-63 |
Days 1, 8, 15: Enfortumab vedotin-ejfv 1.25mg/kg (maximum 125mg) IV over 30 minutes. Repeat cycle every 4 weeks. |
Gemcitabine / Carboplatin2,41-44 |
Days 1,8: Gemcitabine 1,000-1250mg/m2 IV over 30 minutes Day 1: Carboplatin AUC 5-6 IV over 30 minutes. Repeat cycle every for 4-6 cycles, |
Preferred Regimen For Cisplatin Eligible and Chemotherapy Naïve Patients |
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DDMVAC (with growth factor support)24-32,d-f |
Day 1: Methotrexate 30mg/m2 IV push Day 1 OR Day 2: Vinblastine 3mg/m2 IV over 5-10 minutes Day 1 OR Day 2: Doxorubicin 30mg/m2 IV push Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 2 weeks for 4-6 cycles. |
Gemcitabine / Cisplatin2,27,32-24,f |
Days 1,8,15: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks for 4-6 cycles. OR Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 3 weeks 4-6 cycles. |
Other Recommended Regimens |
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Docetaxel14,66,b |
Day 1: Docetaxel 100mg/m2 IV over 60 minutes. Repeat cycle every 3 weeks. |
Erdafitinb (for patients with susceptible FGFR2 / FGFR3 alterations)64,65 |
Days 1-14 (Cycle 1): Erdafitinib 8mg orally once daily, followed by: Days 15-18 (Cycle 1): Erdafininib 9mg orally once daily cycle 1 (increase dose based on tolerability after 14 to 21 days if serum phosphate is <5.5 mg/dL and no ocular disorders or ≥grade 2 toxicity), followed by: Days 1-28 (beginning with Cycle 2): Erdafitinib 9mg (if tolerated) orally once daily. Repeat cycle every 4 weeks. |
Gemcitabine2,51,52 |
Days 1,8,15: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 4 weeks. OR Days 1, 8: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Paclitaxel53,67-69,I |
Days 1,8,15,22: Paclitaxel 80mg/m2 IV over 60 minutes. Repeat cycle every 4 weeks. OR Day 1: Paclitaxel 200mg/m2 IV over 3 hours. Repeat cycle every 3 weeks. |
Useful in Certain Circumstances Based on Prior Medical History |
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Gemcitabine / Paclitaxel2,53.54,i |
Day 1: Paclitaxel 175mg/m2 IV over 3 hours, followed by: Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Ifosfamide / Doxorubicin / Gemcitabine2,55-57,d,e,j |
Days 1-4: Ifosfamide 1,500mg/m2 IV over 3 hours daily Mesna 300mg/m2 IV over 15 minutes 3 times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Day 3: Doxorubicin 45mg/m2 IV push Days 2,4: Gemcitabine 150mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks for 3 cycles. |
▶Subsequent Line Systemic Therapy for Locally Advanced or Metastatic Disease (Stage IV)1,a,n,o |
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Preferred Regimens |
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Enfortumab vedotin-ejfv (Category 1)60-63 |
Days 1, 8, 15: Enfortumab vedotin-ejfv 1.25mg/kg (maximum 125mg) IV over 30 minutes. Repeat cycle every 4 weeks. |
Erdafitinb (for patients with susceptible FGFR2 / FGFR3 alterations)64,65 |
Days 1-14 (Cycle 1): Erdafitinib 8mg orally once daily, followed by: Days 15-18 (Cycle 1): Erdafininib 9mg orally once daily (increase dose based on tolerability after 14 to 21 days if serum phosphate is <5.5 mg/dL and no ocular disorders or ≥grade 2 toxicity), followed by: Days 1-28 (beginning with Cycle 2): Erdafitinib 9mg (if tolerated) orally once daily. Repeat cycle every 4 weeks. |
Other Recommended Regimens |
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DDMVAC (with growth factor support)24-32,39,d-f |
Day 1: Methotrexate 30mg/m2 IV push Day 1 OR Day 2: Vinblastine 3mg/m2 IV over 5-10 minutes Day 1 OR Day 2: Doxorubicin 30mg/m2 IV push Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 2 weeks for 4-6 cycles. |
Docetaxel14,66,b |
Day 1: Docetaxel 100mg/m2 IV over 60 minutes. Repeat cycle every 3 weeks. |
Gemcitabine2,51.52 |
Days 1,8,15: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 4 weeks. OR Days 1,8: Gemcitabine 1,000-1,250mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Gemcitabine / Cisplatin2,27,33,34,f |
Days 1,8,15: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 4 weeks 4-6 cycles. OR Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes, followed by: Day 1 OR Day 2: Cisplatin 70mg/m2 IV over 2 hours. Repeat cycle every 3 weeks for 4-6 cycles. |
Gemcitabine / Paclitaxel2,53,54,i Paclitaxel requires premedication. |
Day 1: Paclitaxel 175mg/m2 IV over 3 hours, followed by: Days 1,8: Gemcitabine 1,000mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
Ifosfamide / Doxorubicin / Gemcitabine2,55-57,d,e,j |
Days 1-4: Ifosfamide 1,500mg/m2 IV over 3 hours daily Mesna 300mg/m2 IV over 15 minutes 3 times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Day 3: Doxorubicin 45mg/m2 IV push Days 2,4: Gemcitabine 150mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks for 3 cycles. |
Paclitaxel53,-67-69,I |
Days 1,8,15,22: Paclitaxel 80mg/m2 IV over 60 minutes. Repeat cycle every 4 weeks. OR Day 1: Paclitaxel 200mg/m2 IV over 3 hours. Repeat cycle every 3 weeks. |
Sacituzumab govitecan-hziy70,71,l,m |
Days 1,8: Sacituzumab govitecan-hziy 10mg/kg IV. Repeat cycle every 3 weeks. |
▶Radiosensitizing Chemotherapy Regimens for Organ-Preserving Chemoradiation1,a,p |
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Preferred Regimens (Doublet Chemotherapy is Preferred When Feasible) |
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Cisplatin27,72-74,f |
Days 1-2,8-9,15-16 of Cycle 1 (Induction): Cisplatin 20mg/m2 IV over 60 minutes daily, followed by: Days 1-2,8-9 of Cycle 2 (Consolidation): Cisplatin 20mg/m2 IV over 60 minutes daily. Repeat cycle every 6 weeks for 1-2 cycles with concurrent RT. |
Fluorouracil / Mitomycin6,75,76 |
Day 1: Mitomycin 12mg/m2 IV push Days 1-5,22-26: Fluorouracil 500mg/m2 IV continuous infusion over 24 hours daily. Administer for one 28- to 45-day cycle with concurrent RT. |
Low-dose Gemcitabine2,77 |
Days 1,4,8,11,15,18,22,25 (induction): Gemcitabine 27mg/mg2 IV over 30 minutes Administer for one 4-week cycle with concurrent RT, followed by: Days 1,4,8,11,15 (Consolidation): Gemcitabine 27mg/mg2 IV over 30 minutes. Administer for one 3-week cycle with concurrent RT. |
Other Recommended Regimens |
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Cisplatin / Fluorouracil27,75,77,78,f |
Days 1-3,15-17 of Cycle 1 (Induction): Fluorouracil 400mg/m2 IV continuous infusion over 24 hours daily, followed by: Days 1-3, and 8-10 of Cycle 2 (Consolidation): Fluorouracil 400mg/m2 IV continuous infusion over 24 hours daily Days 1-3,8-10,15-17 of Cycle 1 (Induction): Cisplatin 15mg/m2 IV over 60 minutes, followed by: Days 1-2,8-9 of Cycle 2 (Consolidation): Cisplatin 15mg/m2 IV over 60 minutes. Repeat cycle every 8 weeks for 1-2 cycles with concurrent twice daily RT. OR Days 1-3, 8-10, and 15-17 of Cycle 1 (Induction): 400 mg/m2 IV continuous infusion over 24 hours daily, followed by: Days 1-3, and 8-10 of Cycle 2 (Consolidation): 400 mg/m2 IV continuous infusion over 24 hours daily Days 1-3,8-10,15-17 of Cycle 1 (Induction): Cisplatin 15 mg/m2 IV over 60 minutes daily, followed by: Days 1-2,8-9 of Cycle 2 (Consolidation): Cisplatin 15 mg/m2 IV over 60 minutes daily. Repeat cycle every 8 weeks for 1-2 cycles with concurrent twice daily radiation. |
Cisplatin / Paclitaxel27,53,78,79,f,i,m |
Days 1,8,15 of Cycle 1 (Induction): Paclitaxel 50mg/m2 IV over 60 minutes, followed by: Days 1,8 of Cycle 2 (Consolidation): Paclitaxel 50mg/m2 IV over 60 minutes. Days 1-3,8-10,15-17 of Cycle 1 (Induction): Cisplatin 15mg/m2 IV over 60 minutes, followed by: Days 1-2,8-9 of Cycle 2 (Consolidation): Cisplatin 15mg/m2 IV over 60 minutes. Repeat cycle every 8 weeks for 1-2 cycles with concurrent twice daily RT. |
Useful in Certain Circumstances (not generally reserved for curative-intent chemoradiotherapy for organ preservation) |
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Capecitabine (Category 3)80,81 |
Days 1-5: Capecitabine 600-900mg/m2 orally twice daily and administered on days of RT. Repeat cycle weekly with concurrent RT. |
Docetaxel (Category 2B)14,b |
See NCCN Bladder Cancer Guidelines1 |
Fluorouracil (Category 2B)75,76 |
Days 1-5; 22-26: Fluorouracil 500mg/m2 IV continuous infusion over 24 hours daily. Administer for one 28- to 45-day cycle with concurrent RT. |
Paclitaxel (Category 2B)53,82,I Paclitaxel requires premedication. |
Days 1,8,15,22,29,36,43: Paclitaxel 50mg/m2 IV over 60 minutes. Administer for one 49-day cycle with concurrent RT. |
▶Systemic Therapy for Bladder Cancer Characterized by Non-Urothelial and Urothelial with Variant Histology1,a |
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Pure Squamous Histology |
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ITP (Paclitaxel / Ifosfamide / Cisplatin) for selected patients27,53,55,83,d,f,I,j |
Days 1-3: Ifosfamide 1,500mg/m2 IV over 3 hours daily Days 1-3: Mesna 300mg/m2 IV over 15 minutes three times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Day 1: Cisplatin 70mg/m2 IV over 2 hours Day 1: Paclitaxel 200mg/m2 IV over 3 hours. Repeat cycle every 3 or 4 weeks for a maximum of 6 cycles. |
Pure Adenocarcinoma Including Urachal Carcinoma |
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Node-Positive Disease |
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GemFLP (Fluorouracil / Leucovorin / Gemcitabine / Cisplatin2,27,84-86,d,f |
Days 1-5: Fluorouracil 200mg/m2 IV continuous infusion over 24 hours daily Days 1-5: Leucovorin 10mg/m2 IV daily Days 1-5: Cisplatin 20mg/m2 IV over 60 minutes daily Day 1: Gemcitabine 200mg/m2 IV over 30 minutes, followed by: Day 5: Gemcitabine 200mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
mFOLFOX675,85-88,m,q,r |
Day 1: Oxaliplatin 85mg/m2 IV over 2 hours, concurrent with: Day 1: Leucovorin 400mg/m2 IV over 2 hours, followed by: Day 1: Fluorouracil 400mg/m2 IV push, followed by: Days 1-2: Fluorouracil 1,200mg/m2 IV continuous infusion over 24 hours daily (2,400mg/m2 IV over 46-48 hours). Repeat cycle every 2 weeks. |
Advanced Disease |
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GemFLP (Fluorouracil / Leucovorin / Gemcitabine / Cisplatin) for selected patients2,27,84-86,f |
Days 1-5: Fluorouracil 200mg/m2 IV continuous infusion over 24 hours daily Days 1-5: Leucovorin 10mg/m2 IV daily Days 1-5: Cisplatin 20mg/m2 IV over 60 minutes daily Day 1: Gemcitabine 200mg/m2 IV over 30 minutes, followed by: Day 5: Gemcitabine 200mg/m2 IV over 30 minutes. Repeat cycle every 3 weeks. |
ITP (Paclitaxel / Ifosfamide / Cisplatin) for selected patients27,53,55,83,d,f,I,j |
Days 1-3: Ifosfamide 1,500mg/m2 IV over 3 hours Days 1-3: Mesna 300mg/m2 IV over 15 minutes three times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Day 1: Cisplatin 70mg/m2 IV over 2 hours Day 1: Paclitaxel 200mg/m2 IV over 3 hours. Repeat cycle every 3 or 4 weeks for a maximum of 6 cycles. |
mFOLFOX6 for selected patients75,85-88,m,q,r |
Day 1: Oxaliplatin 85mg/m2 IV over 2 hours, concurrent with: Day 1: Leucovorin 400mg/m2 IV over 2 hours, followed by: Day 1: Fluorouracil 400mg/m2 IV push, followed by: Days 1-2: Fluorouracil 1,200mg/m2 IV continuous infusion over 24 hours daily (2,400mg/m2 IV over 46-48 hours). Repeat cycle every 2 weeks. |
Alternatively combination paclitaxel and platinum may be considered. |
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Any Small-Cell Component (or Neuroendocrine Features) |
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Neoadjuvant Chemotherapy |
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See regimens recommended in NCCN Small Cell Lung Cancer Guidelines |
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Alternating Ifosfamide / Doxorubicin With Etoposide / Cisplatin27,55,56,89-92,d-f,j |
Days 1-4: Ifosfamide 2000mg/m2 IV over 3 hours. Days 1-4: Mesna 300mg/m2 IV over 15 minutes three times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Days 1-3: Doxorubicin 25mg/m2 IV push. Repeat cycle every 3 weeks for 2 cycles, alternating with: Days 1-5: Etoposide 80mg/m2 IV over 2 hours daily Days 1-5: Cisplatin 20mg/m2 IV over 60 minutes daily. Repeat cycle every 3 weeks for 2 cycles. |
Metastatic Chemotherapy |
|
See regimens recommended in NCCN Small Cell Lung Cancer Guidelines |
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Alternating Ifosfamide / Doxorubicin With Etoposide / Cisplatin27,55,56,89-92,d-f,j |
Days 1-4: Ifosfamide 2000mg/m2 IV over 3 hours. Days 1-4: Mesna 300mg/m2 IV over 15 minutes three times daily (one dose before Ifosfamide, then at 4 and 8 hours from the start of each Ifosfamide dose) Days 1-3: Doxorubicin 25mg/m2 IV push. Repeat cycle every 3 weeks for 2 cycles beyond maximal response, alternating with: Days 1-5: Etoposide 80mg/m2 IV over 2 hours daily Days 1-5: Cisplatin 20mg/m2 IV over 60 minutes daily. Repeat cycle every 3 weeks for 2 cycles beyond maximal response. |
Primary Bladder Sarcoma |
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See NCCN Soft Tissue Sarcoma Guidelines.93 |
|
a Abbreviations: BCG, Bacillus Calmette-Guerin; CSF, colony-stimulating factor; DDMVAC, dose dense Methotrexate / Vinblastine / Doxorubicin / Cisplatin; GemFLP, Fluorouracil / Leucovorin / Gemcitabine / Cisplatin; FOLFOX, Fluorouracil / Leucovorin / Oxaliplatin; RT, radiation therapy; PD-1, programmed cell death-1; PS, performance status. b For Docetaxel: Premedication with dexamethasone for fluid retention is required. One recommended dosing strategy is: Dexamethasone 8mg orally twice daily for three consecutive days starting 1 day prior to Docetaxel administration. c For patients who are not candidates for Cisplatin, there are no data to support a recommendation for perioperative chemotherapy. d Myeloid growth factor therapy is recommended with administration of DDMVAC. e Doxorubicin is an anthracycline. Cumulative anthracycline dosage should be monitored. f Hydration is required with supplemental electrolytes pre- and post-administration of Cisplatin. g Early- and late-onset immune-related adverse events affecting multiple organ systems can occur in patients receiving immune checkpoint inhibitors. Patients with neurologic or life-threatening autoimmune disorders as well as receiving high levels of immunosuppression for their underlying disease should be approached with caution when considering immunotherapy. All patients will require extensive resources including ongoing intensive monitoring and supportive care. h For Avelumab: Premedication for infusion reactions is required prior to the first 4 infusions and as clinically indicated thereafter. The recommended dosing is: Diphenhydramine 12.5-50mg IV or orally 30-60 minutes pre-avelumab AND acetaminophen 650-1000mg orally 30-60 minutes pre-avelumab. i For PACLitaxel: Premedication for hypersensitivity is required: H2 antagonist: Famotidine 20 mg IV or orally (or equivalent H2 blocker) 30 – 60 minutes pre-PACLitaxel AND H1 antagonist: DiphenhydrAMINE 12.5 – 50 mg IV/PO 30 – 60 minutes pre-PACLitaxel AND Dexamethasone: Dexamethasone 20 mg orally approximately 12 and 6 hours pre-PACLitaxel OR Dexamethasone 20 mg IV 30 minutes pre-PACLitaxel. j Hydration is required pre- and post-administration of Ifosfamide. k Indicated for cisplatin ineligible patients who have received one or more prior lines of therapy. l Consider premedication for infusion reactions. The recommended dosing is: DiphenhydrAMINE 25 – 50 mg IV or orally 15 – 60 minutes pre-sacituzumab govitecan-hziy AND Famotidine 20 mg IV or orally (or equivalent H2 blocker) 15 – 60 minutes pre-sacituzumab govitecan-hziy AND Acetaminophen 650 – 1000 mg orally 15 – 60 minutes pre- sacituzumab govitecan-hziy. m CSFs may be considered for primary prophylaxis based on the febrile neutropenia (FN) risk of the chemotherapy regimen. n Patients should have already received platinum and a checkpoint inhibitor, if eligible. o These therapies are appropriate for patients who received a first-line platinum-containing chemotherapy followed by Avelumab maintenance therapy. p Carboplatin is not an effective radiosensitizer and should not be substituted for cisplatin in the perioperative setting. (Rodel C, Grabenbauer GG, Kuhn R, et al. Combined modality treatment and selective organ preservation in invasive bladder cancer: long-term results. J Clin Oncol. 2002;20:3061.) q Discontinuation of Oxaliplatin should be strongly considered after 3-4 months of therapy (or sooner if neurotoxicity grade 2 or greater develops) while maintaining other agents until time of tumor progression. Oxaliplatin may be reintroduced if it was discontinued for neurotoxicity rather than for disease progression. r Leucovorin infusion time should match infusion time of Oxaliplatin when these agents are given concurrently |
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References |
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(Revised 2/2023; NCCN Bladder Cancer Guidelines v1.2023) © 2023 by Haymarket Media, Inc. |
This article originally appeared on Cancer Therapy Advisor