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Giuseppe Di Lorenzo,
Carlo Buonerba, Adriana Faiella,
Pasquale Rescigno,
Mimma Rizzo,
Riccardo Autorino,
Sisto Perdonà,
Nando Riccardi,
Sarah Scagliorini,
Florinda Scognamiglio,
Daniele Masala,
Matteo Ferro,
Giovannella Palmieri,
Michele Aieta,
Alfredo Marinelli,
Vincenzo Altieri,
Sabino De Placido,
Giacomo Cartenì
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ABSTRACT: To determine the activity and tolerability of docetaxel re-treatment after first-line therapy with docetaxel in castration-resistant prostate cancer (CRPC).
Between November 2005 and January 2009, 45 patients initially responding to docetaxel and then experiencing disease progression after a period of biochemical remission of at least 5 months were enrolled in a prospective multicenter study and re-treated with docetaxel. The primary endpoint was the biochemical response (biochemical partial response defined as > 50% prostate-specific antigen [PSA] decline); secondary endpoints were objective response, toxicity, progression-free survival (PFS) and overall survival (OS).
Partial PSA responses were observed in 11 patients (24.5%), 4 (25%) of whom also had an objective response. The treatment was well tolerated, with grade 1-2 neutropenia, thrombocytopenia, vomiting and peripheral neuropathy noted in 18 (40%), 11 (24.5%), 8 (17.8%), and 6 (13.3%) patients, respectively. The most common grade 3 toxicity was neutropenia, which was observed in 8 patients (17.8%). Median PFS was 5 months and median OS was 13 months.
Docetaxel re-treatment preserves anti-tumour activity and is well tolerated in a selected population of pretreated patients with CRPC. Further randomized trials are needed to confirm our preliminary results.
BJU International 01/2011; 107(2):234-9. · 2.84 Impact Factor
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PhD Giuseppe Di Lorenzo MD,
Sisto Perdonà MD,
Rocco Damiano MD,
Adriana Faiella MD,
Francesco Cantiello MD,
Sandro Pignata MD,
Paolo Ascierto MD,
Ester Simeone MD,
PhD Marco De Sio MD,
PhD Riccardo Autorino MD,
Giuseppe Di Lorenzo,
Sisto Perdonà,
Rocco Damiano, Adriana Faiella,
Francesco Cantiello,
Sandro Pignata,
Paolo Ascierto,
Ester Simeone,
Marco De Sio,
Riccardo Autorino
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ABSTRACT: BACKGROUND:The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC).METHODS:In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated.RESULTS:Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P < .008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated.CONCLUSIONS:Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients. Cancer 2010. © 2010 American Cancer Society.
Cancer 04/2010; 116(8):1893 - 1900. · 4.77 Impact Factor
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ABSTRACT: The efficacy of intravesical gemcitabine was evaluated compared with repeated administration of bacille Calmette-Guérin (BCG) after BCG failure in high-risk, non-muscle-invasive bladder cancer (BC).
In this multicenter, prospective, randomized, phase 2 trial, eligible patients were those with high-risk non-muscle-invasive BC, failing 1 course of BCG therapy. All patients were randomly allocated to Group A, receiving intravesical gemcitabine (at a dose of 2000 mg/50 mL) twice weekly for 6 consecutive weeks and then weekly for 3 consecutive weeks at 3, 6, and 12 months, or Group B, receiving intravesical BCG (Connaught strain, 81 mg/50 mL) over a 6-week induction course and each week for 3 weeks at 3, 6, and 12 months. Outcome measures were recurrence rate, time to first recurrence, and progression rate. Treatment-related complications were also evaluated.
Eighty participants were enrolled, 40 for each group 52.5% in Group A developed disease recurrence versus 87.5% of those in Group B (P = .002). There was no statistically significant difference in mean time to the first recurrence (Group A, 3.9 months; Group B, 3.1 months; P = .09). Kaplan-Meier analysis of 2-year recurrence-free survival showed significant differences between Group A and B (19% and 3%, respectively, P < .008). Seven of 21 (33%) patients in Group A and 13 of 35 (37.5%) patients in Group B had disease progression and underwent radical cystectomy (P = .12). Both intravesical administrations were generally well tolerated.
Gemcitabine might represent a second-line treatment option after BCG failure in high-risk non-muscle-invasive BC patients.
Cancer 02/2010; 116(8):1893-900. · 4.77 Impact Factor
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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
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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.
Anti-cancer drugs 05/2009; 20(4):277-80. · 2.23 Impact Factor
