Penile cancer

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Adjuvant chemotherapy

TIP

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)

Neoadjuvant chemotherapy

TIP

TIP: Taxol, Ifosfamide, Platinol

Regimen, Pagliaro, et al. 2010

Level of Evidence: Phase II

• 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
• Mesna (Mesnex) 400 mg/m2 IV once before each dose of ifosfamide
• Mesna (Mesnex) 200 mg/m2 IV given twice, at 4 and 8 hours after each dose of ifosfamide

21 to 28-day cycles x 4 cycles; "cycle was repeated on day 22 if the patient's absolute neutrophil count was at least 1,400/μL and platelet count was at least 100,000/μL"

Supportive medications:

• After cisplatin, hydration with 3 liters of a solution of 5% dextrose, sodium chloride, potassium chloride, magnesium sulfate, and mannitol
• Either Dexamethasone (Decadron) 8 mg IV once 1 hour before paclitaxel, or Dexamethasone (Decadron) 20 mg PO given twice, at 12 and 6 hours before the paclitaxel
• Diphenhydramine (Benadryl) 50 mg IV once prior to paclitaxel
• One of the following H2 blockers:
  • Cimetidine (Tagamet) 300 mg IV once prior to paclitaxel
  • Ranitidine (Zantac) 50 mg IV once prior to paclitaxel
  • Famotidine (Pepcid) 20 mg IV once prior to paclitaxel
• "The use of prophylactic granulocyte colony-stimulating factor was allowed but not required"

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. doi: 10.1200/JCO.2010.29.5477. Epub 2010 Jul 12. link to original article contains verified protocol PubMed

Metastatic or unresectable disease

Cisplatin & Fluorouracil

Regimen, Shammas, et al. 1992

Level of Evidence: 8 patients reported, 2 with partial response

• 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

Regimen, Theodore, et al. 2008 (EORTC 30992)

Level of Evidence: Phase II

• 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

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

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."

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

Cisplatin, Methotrexate, Bleomycin

Regimen, Haas, et al. 1999 (SWOG 8520)

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

Level of Evidence: Phase II

• 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
• Methotrexate (MTX) 25 mg/m2 IV bolus once per day on days 1 & 8
• 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

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

Supportive medications:

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

References

1. 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

Paclitaxel (Taxol)

Regimen, Di Lorenzo, et al. 2011

Level of Evidence: Phase II

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

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

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

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 original article contains verified protocol PubMed

TIP

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

TPF: Taxol, Platinol, Fluorouracil

Regimen, Pizzocaro, et al. 2009

Level of Evidence: 6 patients reported

• 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

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

Supportive medications:

• "Corticosteroids, antihistamines, and an H2 antagonist were administered before starting paclitaxel"
• "Antiemetic drugs and glutathione were administered before cisplatin"
• 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

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. doi: 10.1016/j.eururo.2008.07.014. Epub 2008 Jul 14. link to original article contains verified protocol PubMed