Activity and toxicity of paclitaxel in pretreated metastatic penile cancer patients.
The objective of this study was to evaluate the use of paclitaxel in patients with advanced squamous cell penile cancer previously treated with neoadjuvant cisplatin-based chemotherapy. This was a single-arm, phase II, multicenter study. Patients were treated with 175 mg/m paclitaxel at a 3-week interval, until disease progression or irreversible toxicity. The primary end point was the objective response rate. Secondary end points were safety, progression-free survival, and overall survival. Twelve patients were enrolled. Partial responses were observed in 25% (3 of 12) of patients (95% confidence interval: 12-40%). Grade 3 neutropenia and oral mucositis were the most common side effects, each noted in three patients. Median progression-free survival was 4 months (range 2-6 months) and median overall survival was 6 months (range 3-10 months). Paclitaxel is well tolerated and associated with promising efficacy. Further trials, also in a neoadjuvant setting, are needed to corroborate our preliminary findings.
Di Lorenzo
Giuseppe
G
University Federico II, Naples, Italy. giuseppedilorenzoncol@hotmail.com
Cartenì
Giacomo
G
Autorino
Riccardo
R
Gonnella
Antonio
A
Perdonà
Sisto
S
Ferro
Matteo
M
Longo
Nicola
N
Rescigno
Pasquale
P
Doria
Francesca
F
Faiella
Adriana
A
Altieri
Vincenzo
V
Palmieri
Giovannella
G
Imbimbo
Ciro
C
Mirone
Vincenzo
V
De Placido
Sabino
S
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000503:physiopathology; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000627:therapeutic use; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D010412:Penile Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D013280:Stomatitis / Q000139:chemically induced; D015996:Survival Rate; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel; D002945:Cisplatin