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.
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Authors | Giuseppe Di Lorenzo, Giacomo Cartenì, Riccardo Autorino, Antonio Gonnella, Sisto Perdonà, Matteo Ferro, Nicola Longo, Pasquale Rescigno, Francesca Doria, Adriana Faiella, Vincenzo Altieri, Giovannella Palmieri, Ciro Imbimbo, Vincenzo Mirone, Sabino De Placido |
Journal | Anti-cancer drugs
(Anticancer Drugs)
Vol. 20
Issue 4
Pg. 277-80
(Apr 2009)
ISSN: 1473-5741 [Electronic] England |
PMID | 19262371
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
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Topics |
- Adult
- Aged
- Antineoplastic Agents, Phytogenic
(adverse effects, therapeutic use)
- Carcinoma, Squamous Cell
(drug therapy, physiopathology)
- Chemotherapy, Adjuvant
- Cisplatin
(therapeutic use)
- Disease-Free Survival
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Neoplasm Metastasis
- Neutropenia
(chemically induced)
- Paclitaxel
(adverse effects, therapeutic use)
- Penile Neoplasms
(drug therapy, physiopathology)
- Stomatitis
(chemically induced)
- Survival Rate
- Treatment Outcome
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