Penile cancer

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Neoadjuvant chemotherapy

TIP

TIP: Taxol, Ifosfamide, Platinol

Regimen, Pagliaro et al. 2010

• 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, Methotrexate & Bleomycin

Regimen, Haas et al. 1999

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

21-day cycles, continued until evidence of disease progression, or 6 cycles

Supportive medications:

• Normal saline infused IV at 250 cc/hr started 1 hour before administration of cisplatin and continued at least 6 hours after administration.
• Furosemide 40 mg IV was administered just before cisplatin was initiated.

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

Irinotecan & Cisplatin

Regimen, Theodore et al. 2008

• Irinotecan (Camptosar) 60 mg/m2 IV over 30 minutes on days 1, 8 and 15
• Cisplatin (Platinol) 80 mg/m2 IV as a 1-3 hour infusion on day 1
  • Administered in keeping with guidelines at each investigator site, to insure that adequate hydration was given.

28-day cycles, with a maximum of four cycles before surgery in the neo-adjuvant setting for T3 or N1–N2 or up to 8 cycles for T4 or N3 or M+ distant metastatic disease

Supportive medications:

• Antiemetic medication was that prescribed locally in routine 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

Paclitaxel (Taxol)

Regimen, Di Lorenzo et al. 2011

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

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

Supportive medications:

• GCSF permitted if the patient developed febrile neutropenia in any treatment cycle
• Dexamethasone (Decadron) 8 mg PO was given 12 h before, immediately before, and 12 h after the paclitaxel infusion

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