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| |  Paclitaxel, Cisplatin, Gemcitabine Combination Safe, Effective for Male Germ Cell Tumours: Presented at ASCO-GU By Fred Gebhart SAN FRANCISCO -- March 8, 2010 -- A combination of paclitaxel, cisplatin, and gemcitabine (TPG) may be safe and effective as third-line treatment and may be useful in an earlier treatment setting, according to researchers here on March 7 at the 2010 ASCO Genitourinary Cancers Symposium (ASCO-GU). Male germ cell tumours can usually be treated successfully, but tumours reappear or progress after first-line treatment in about 20% of patients. Various rescue therapies have been tried, but success has been limited and mixed. Different combinations of paclitaxel and gemcitabine with cisplatin or oxaliplatin have produced response rates of about 40%, but few data are available on long-term outcomes. Andrea Necchi, MD, Fondazione IRCCS Istituto Nazionale dei Tumor, Milan, Italy, was the lead author of the retrospective Italian study. TPG has been used at IRCCS since the late 1990s as salvage therapy for patients who relapsed after multiple lines of chemotherapy or who were resistant to cisplatin. Promising results from a pilot study were published in 2008, Dr. Necchi noted. The current report updates those initial findings. Researchers reviewed clinical records and identified a total of 72 patients treated with TPG between April 1999 and March 2009, including 41 patients who received the regimen as third-line treatment. Treatment consisted of paclitaxel 80 mg/m2 in a 2-hour intravenous infusion followed by cisplatin 50 mg/m2 over 30 minutes, and gemcitabine 800 mg/m2 over 30 minutes. Drug was administered on days 1 and 8 every 3 weeks for a total of 8 doses over 4 cycles. Patients could receive prophylactic dosing of granulocyte-colony-stimulating factor (G-CSF) on days 10-14 or longer if needed. Treating physicians could add additional G-CSF on days 4 and 5 and substitute pegylated G-CSF for G-CSF on day 9, if desired. Patients with a partial remission were scheduled for surgery to remove all resectable masses within 4-6 weeks after the final TPG dose. Patients in the study received a median of 7 doses of TPG and had a response rate of 51% to third-line treatment, 12% complete response, and 39% partial response. Another 12% of patients showed stable disease, and 37% showed disease progression. Median progression-free survival was 5 months. The progression-free survival rate at 2 years was 26%, and the overall survival rate at 2 years was 35%. Univariate analysis did not show any statistically significant prognostic variables, according to Dr. Necchi, and no treatment-related deaths occurred. Grade 3 and 4 haematologic toxicity occurred in 63% of patients, and 7% had febrile neutropenia, including 1 episode related to a central catheter infection. Grade 1 and 2 neurologic toxicity was almost universal (primarily peripheral neuropathy and ototoxicity), but none of the adverse events caused significant treatment delays or dose reductions. The researchers concluded that TPG deserves further investigation in a randomised clinical trial in an earlier treatment setting. The conference is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Therapeutic Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO). [Presentation title: Updated Results of the Combination of Paclitaxel, Cisplatin and Gemcitabine (TPG) Followed by Surgery as Third-Line Therapy for Male Germ Cell Tumors. Abstract 261]
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