title: Activity and toxicity of paclitaxel in pretreated metastatic penile cancer patients.
abstract: 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.
authors.affiliation: University Federico II, Naples, Italy. giuseppedilorenzoncol@hotmail.com
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: Giacomo
authors.initials: G
authors.lastname: Cartenì
authors.forename: Riccardo
authors.initials: R
authors.lastname: Autorino
authors.forename: Antonio
authors.initials: A
authors.lastname: Gonnella
authors.forename: Sisto
authors.initials: S
authors.lastname: Perdonà
authors.forename: Matteo
authors.initials: M
authors.lastname: Ferro
authors.forename: Nicola
authors.initials: N
authors.lastname: Longo
authors.forename: Pasquale
authors.initials: P
authors.lastname: Rescigno
authors.forename: Francesca
authors.initials: F
authors.lastname: Doria
authors.forename: Adriana
authors.initials: A
authors.lastname: Faiella
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Altieri
authors.forename: Giovannella
authors.initials: G
authors.lastname: Palmieri
authors.forename: Ciro
authors.initials: C
authors.lastname: Imbimbo
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Mirone
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
mesh_terms: 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
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel; D002945:Cisplatin