A Combination of Cisplatin and 5-Fluorouracil With a Taxane in Patients Who Underwent Lymph Node Dissection for Nodal Metastases From Squamous Cell Carcinoma of the Penis: Treatment Outcome and Survival Analyses in Neoadjuvant and Adjuvant Settings.
The role of chemotherapy in nodal metastases from penile squamous cell carcinoma is not defined. We evaluated the efficacy of a combination of T-PF (a taxane, cisplatin, and 5-fluorouracil) in neoadjuvant and adjuvant settings.



Since June of 2004, T-PF was administered to stage N2 to 3 patients. With time, neoadjuvant chemotherapy administration prevailed with respect to use in the adjuvant setting. Primary end points were progression-free (PFS) and overall (OS) survival. Secondary objectives were tolerability and activity in the neoadjuvant setting. Nonparametric tests, Kaplan-Meier, and regression analyses were performed.



As of October of 2012, 47 consecutive N2 to 3 M0 patients had undergone neoadjuvant (n = 28) or adjuvant (n = 19) T-PF: 18 patients (38.3%) remain disease-free after a median follow-up of 22 months (interquartile range, 17-42 months). The 2-year disease-free survivals were 36.8% (95% confidence interval [CI], 15.2-58.5) versus 7.1% (95% CI, 0-16.7) after adjuvant and neoadjuvant therapy, respectively. N3 metastases were associated with a poorer PFS, and bilateral metastases and mutated p53 were associated with a poorer OS. After neoadjuvant treatment, 43% clinical responses and 14% complete pathologic remissions were recorded, but responses were not associated with survival. Neutropenia (25.5%) was the most frequent Grade ≥ 2 toxicity.



The T-PF regimen is well tolerated and compares with other regimens in terms of activity and efficacy in the neoadjuvant setting, and very long survivals have been recorded after adjuvant administration. The role of perioperative treatment in these patients remains controversial. Some caution in administering preemptive treatment in patients with resectable disease is needed.
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: nicola.nicolai@istitutotumori.mi.it.
Nicola
N
Nicolai
MOX - Department of Mathematics, Politecnico di Milano, Milan, Italy.
Laura Maria
LM
Sangalli
Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Andrea
A
Necchi
Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Patrizia
P
Giannatempo
MOX - Department of Mathematics, Politecnico di Milano, Milan, Italy.
Anna Maria
AM
Paganoni
Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Maurizio
M
Colecchia
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Luigi
L
Piva
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Mario Achille
MA
Catanzaro
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Davide
D
Biasoni
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Silvia
S
Stagni
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Tullio
T
Torelli
Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Daniele
D
Raggi
Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Elena
E
Faré
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Giorgio
G
Pizzocaro
Urology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Roberto
R
Salvioni
D000328:Adult; D000368:Aged; D001952:Bridged-Ring Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010412:Penile Neoplasms / Q000628:therapy*; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D002945:Cisplatin; D005472:Fluorouracil
Adjuvant chemotherapy; Drug therapy; Lymph node excision; Neoadjuvant chemotherapy; Penile neoplasms