Penile cancer

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9 regimens on this page 10 variants on this page

Guidelines

ESMO

• Penile cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. PubMed

NCCN

• NCCN Guidelines - Penile Cancer

Neoadjuvant chemotherapy

TIP

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TIP: Taxol (Paclitaxel), Ifosfamide, Platinol (Cisplatin)

Regimen

Study	Evidence
Pagliaro et al. 2010	Phase II

Chemotherapy

• Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1
• Ifosfamide (Ifex) 1200 mg/m² IV over 2 hours once per day on days 1 to 3
• Cisplatin (Platinol) 25 mg/m² IV over 2 hours once per day on days 1 to 3
  • Administered intravenously in 250 mL of normal saline containing 12.5 g of mannitol

Supportive medications

• Mesna (Mesnex) as follows:
  • 400 mg/m² IV once before each dose of Ifosfamide (Ifex)
  • 200 mg/m² IV given twice, at 4 and 8 hours after each dose of Ifosfamide (Ifex)
• After Cisplatin (Platinol), hydration with 3 liters of a solution of 5% dextrose, sodium chloride, potassium chloride, magnesium sulfate, and mannitol
• One of the following dexamethasone doses:
  • Dexamethasone (Decadron) 8 mg IV once 1 hour before Paclitaxel (Taxol)
  • Dexamethasone (Decadron) 20 mg PO given twice, at 12 and 6 hours before Paclitaxel (Taxol)
• Diphenhydramine (Benadryl) 50 mg IV once prior to Paclitaxel (Taxol)
• One of the following H2 blockers:
  • Cimetidine (Tagamet) 300 mg IV once prior to Paclitaxel (Taxol)
  • Ranitidine (Zantac) 50 mg IV once prior to Paclitaxel (Taxol)
  • Famotidine (Pepcid) 20 mg IV once prior to Paclitaxel (Taxol)
• "The use of prophylactic G-CSF was allowed but not required"

21 to 28-day cycle for 4 cycles; "cycle was repeated on day 22 if the patient's ANC was at least 1400/uL and platelet count was at least 100 x 10⁹/L"

References

1. Pagliaro LC, Williams DL, Daliani D, Williams MB, Osai W, Kincaid M, Wen S, Thall PF, Pettaway CA. Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study. J Clin Oncol. 2010 Aug 20;28(24):3851-7. Epub 2010 Jul 12. link to original article contains verified protocol link to PMC article PubMed

VBM

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VBM: Vincristine, Bleomycin, Methotrexate

Regimen

Study	Evidence
Pizzocaro et al. 1988	Pilot, <20 pts

Note: The NCCN, Penile Cancer version 1.2013, says that "bleomycin-containing regimens were associated with unacceptable toxicity and are no longer recommended. Adjuvant therapy starts 2 to 4 weeks after surgery."

Chemotherapy

• Bleomycin (Blenoxane) 15 mg IM twice per week, 6 hours and 24 hours after vincristine
• Vincristine (Oncovin) 1 mg IV once per week
• Methotrexate (MTX) 30 mg PO once per week, 48 hours after vincristine

12-week course

References

1. Pizzocaro G, Piva L. Adjuvant and neoadjuvant vincristine, bleomycin, and methotrexate for inguinal metastases from squamous cell carcinoma of the penis. Acta Oncol. 1988;27(6b):823-4. link to original article contains verified protocol PubMed
2. Review: Pagliaro LC, Crook J. Multimodality therapy in penile cancer: when and which treatments? World J Urol. 2009 Apr;27(2):221-5. Epub 2008 Aug 6. link to original article contains verified protocol link to PMC article PubMed

Adjuvant chemotherapy

TIP

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Note: No primary reference available, but the NCCN, Penile Cancer version 1.2013, says that "it is reasonable to give 4 courses of TIP in the adjuvant setting if it was not given preoperatively and the pathology shows high-risk features." (see neoadjuvant chemotherapy section)

TPF (Taxotere)

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TPF: Taxotere (Docetaxel), Platinol (Cisplatin), Fluorouracil

Regimen

Study	Evidence
Necchi et al. 2011	Case report

Chemotherapy

• Docetaxel (Taxotere) 75 mg/m² IV once on day 1
• Cisplatin (Platinol) 75 mg/m² IV once on day 1
• Fluorouracil (5-FU) 750 mg/m²/day IV continuous infusion on days 1 to 4

21-day cycle for 3 cycles

References

1. Necchi A, Nicolai N, Colecchia M, Catanzaro M, Torelli T, Piva L, Salvioni R. Proof of activity of anti-epidermal growth factor receptor-targeted therapy for relapsed squamous cell carcinoma of the penis. J Clin Oncol. 2011 Aug 1;29(22):e650-2. Epub 2011 May 31. link to original article contains verified protocol PubMed

Metastatic or unresectable disease

BMP

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BMP: Bleomycin, Methotrexate, Platinol (Cisplatin)
MPB: Methotrexate, Platinol (Cisplatin), Bleomycin

Regimen #1

Study	Evidence
Haas et al. 1999 (SWOG 8520)	Phase II

Chemotherapy

• Bleomycin (Blenoxane) 10 units/m² IV bolus once per day on days 1 & 8
  • Chemotherapy with bleomycin was discontinued when a total cumulative dose of 200 units/m² was reached
• Methotrexate (MTX) 25 mg/m² IV bolus once per day on days 1 & 8
• Cisplatin (Platinol) 75 mg/m² at a concentration of 1 mg/mL normal saline IV given at a rate of 1 mg/min once on day 1

Supportive medications

• Normal saline IV at 250 mL/hour, starting 1 hour before Cisplatin (Platinol) and continued at least 6 hours after completion of Cisplatin (Platinol)
• Furosemide (Lasix) 40 mg IV once prior to Cisplatin (Platinol)

21-day cycles, given until disease progression; patients who achieved complete remission discontinued therapy after 6 cycles

Regimen #2

The NCCN, Penile Cancer version 1.2013, says that "bleomycin-containing regimens were associated with unacceptable toxicity and are no longer recommended."

Study	Evidence
Corral et al. 1998	Phase II

21 of 29 evaluable patients in Corral et al. 1998 had penile cancer. Please see the paper for additional variations in the protocol, including some patients being treated with intraarterial therapy.

Chemotherapy

• Bleomycin (Blenoxane) 10 mg/m² IV once per day on days 2 to 6
  • Note: Pagliaro et al. 2009 lists a "dosage of 50 mg/m² on days 2 to 6," which could be misinterpreted as 50 mg/m² for each dose, which is in contrast to the 50 mg/m² for each cycle that Corral et al. 1998 describes.
• Methotrexate (MTX) 200 mg/m² IV once per day on days 1, 15, 22
• Cisplatin (Platinol) 20 mg/m² IV over 3 hours once per day on days 2 to 6
  • Note: Corral et al. 1998 does not specify which days cisplatin is given on. Pagliaro et al. 2009 specifies that cisplatin is given on days 2 to 6. For Corral et al. 1998, the 5 day course is inferred based on the paper saying that the total dosage--presumably per cycle--was 100 mg/m².

Supportive medications

• Folinic acid (Leucovorin) 25 mg PO every 6 hours x 12 doses, starting 24 hours after each dose of Methotrexate (MTX)

28-day cycles

References

1. Corral DA, Sella A, Pettaway CA, Amato RJ, Jones DM, Ellerhorst J. Combination chemotherapy for metastatic or locally advanced genitourinary squamous cell carcinoma: a phase II study of methotrexate, cisplatin and bleomycin. J Urol. 1998 Nov;160(5):1770-4. link to original article contains verified protocol PubMed
2. Haas GP, Blumenstein BA, Gagliano RG, Russell CA, Rivkin SE, Culkin DJ, Wolf M, Crawford ED. Cisplatin, methotrexate and bleomycin for the treatment of carcinoma of the penis: a Southwest Oncology Group study. J Urol. 1999 Jun;161(6):1823-5. link to original article contains verified protocol PubMed content property of HemOnc.org
3. Review: Pagliaro LC, Crook J. Multimodality therapy in penile cancer: when and which treatments? World J Urol. 2009 Apr;27(2):221-5. Epub 2008 Aug 6. link to original article contains verified protocol link to PMC article PubMed

Cisplatin & Fluorouracil

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Regimen

Study	Evidence
Shammas et al. 1992	Pilot, <20 pts

Chemotherapy

• Cisplatin (Platinol) 100 mg/m² IV once once on day 1
• Fluorouracil (5-FU) 1000 mg/m²/day IV continuous infusion on days 1 to 5

References

1. Shammas FV, Ous S, Fossa SD. Cisplatin and 5-fluorouracil in advanced cancer of the penis. J Urol. 1992 Mar;147(3):630-2. contains protocol PubMed

Cisplatin & Irinotecan

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Regimen

Study	Evidence
Theodore et al. 2008 (EORTC 30992)	Phase II

Chemotherapy

• Cisplatin (Platinol) 80 mg/m² IV over 1 to 3 hours once on day 1, given second
• Irinotecan (Camptosar) 60 mg/m² IV over 30 minutes once per day on days 1, 8, 15, given first

Supportive medications

• Adequate hydration with cisplatin, per guidelines at each investigator's site
• Antiemetic medication per routine local practice.
• "Systematic premedication with atropine as of the first cycle of treatment was at the investigator's discretion but was not recommended."

28-day cycles, with up to 4 cycles before surgery in the neoadjuvant setting for T3 or N1 to N2; up to 8 cycles for patients with T4, N3, or M+ distant metastatic disease

References

1. Theodore C, Skoneczna I, Bodrogi I, Leahy M, Kerst JM, Collette L, Ven K, Marréaud S, Oliver RD; EORTC Genito-Urinary Tract Cancer Group. A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992). Ann Oncol. 2008 Jul;19(7):1304-7. link to original article contains verified protocol PubMed

Paclitaxel monotherapy

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Regimen

Study	Evidence
Di Lorenzo et al. 2011	Phase II

Chemotherapy

• Paclitaxel (Taxol) 175 mg/m² IV over 3 hours once on day 1

Supportive medications

• G-CSF could be used in later cycles if the patient developed febrile neutropenia during treatment
• Dexamethasone (Decadron) 8 mg PO given three times, at 12 hours before, immediately before, and 12 hours after paclitaxel

21-day cycles, administered until disease progression or unacceptable toxicity

References

1. Di Lorenzo G, Federico P, Buonerba C, Longo N, Cartenì G, Autorino R, Perdonà S, Ferro M, Rescigno P, D'Aniello C, Matano E, Altieri V, Palmieri G, Imbimbo C, De Placido S, Mirone V. Paclitaxel in pretreated metastatic penile cancer: final results of a phase 2 study. Eur Urol. 2011 Dec;60(6):1280-4. link to SD article contains verified protocol PubMed

Panitumumab monotherapy

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Regimen

Study	Evidence
Necchi et al. 2011	Case report

Note: Necchi et al. 2011 is a case report referenced by the NCCN Guidelines, Penile Cancer version 1.2013.

Chemotherapy

• Panitumumab (Vectibix) 6 mg/kg IV once on day 1

14-day cycles

References

1. Necchi A, Nicolai N, Colecchia M, Catanzaro M, Torelli T, Piva L, Salvioni R. Proof of activity of anti-epidermal growth factor receptor-targeted therapy for relapsed squamous cell carcinoma of the penis. J Clin Oncol. 2011 Aug 1;29(22):e650-2. Epub 2011 May 31. link to original article contains verified protocol PubMed

TIP

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No primary reference available, but the NCCN, Penile Cancer version 1.2013, says that "TIP is a reasonable first-line treatment for patients with metastatic penile cancer." (see neoadjuvant chemotherapy section)

TPF (Taxol)

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TPF: Taxol (Paclitaxel), Platinol (Cisplatin), Fluorouracil

Regimen

Study	Evidence
Pizzocaro et al. 2009	Pilot, <20 pts

Chemotherapy

• Paclitaxel (Taxol) 120 mg/m² in 500 mL 5% glucose solution IV once on day 1, given first
• Cisplatin (Platinol) 50 mg/m² IV once per day on days 1 & 2
• Fluorouracil (5-FU) 1000 mg/m²/day in 2 liters half normal 2.5% glucose saline IV continuous infusion on days 2 to 5

Supportive medications

• "Corticosteroids, antihistamines, and an H2 antagonist were administered before starting paclitaxel"
• "Antiemetic drugs and glutathione were administered before Cisplatin (Platinol)"
• 1 liter half normal 2.5% glucose saline with 20 mEq potassium chloride and 10 mEq magnesium sulfate (MgSO4) IV given twice, before and after Cisplatin (Platinol)

21-day cycles; "two patients received more than the standard four courses"

References

1. Pizzocaro G, Nicolai N, Milani A. Taxanes in combination with cisplatin and fluorouracil for advanced penile cancer: preliminary results. Eur Urol. 2009 Mar;55(3):546-51. Epub 2008 Jul 14. link to original article contains verified protocol PubMed