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Phase II study of paclitaxel in patients with relapsed or cisplatin-refractory testicular cancer
C Bokemeyer1, J Beyer, B Metzner
1Eberhard Karls University, Department of Internal Medicine II, Hematology/Oncology, Tubingen, Germany.
Background:
Despite generally high cure rates in patients with metastatic testicular cancer, patients with incomplete responses to cisplatin-based first-line therapy or with relapsed disease have an extremely poor prognosis. Paclitaxel represents an antitumor agent with demonstrated activity in cisplatin-sensitive tumors. In addition, responses to paclitaxel have been observed in patients with platin-refractory ovarian cancers. The current phase II trial evaluates the role of paclitaxel in male patients with cisplatin-refractory or relapsed malignant germ cell tumors.
Patients And Methods:
Twenty-four patients with relapsed, mostly cisplatin-refractory metastatic testicular cancer were treated with paclitaxel as three-hour infusions of 225 mg/m2 at 3-weekly intervals. The patients had received a median of 7 platinum-containing treatment cycles (range 3-12) prior to paclitaxel and 12 patients (50%) had previously received high-dose carboplatin/etoposide-based salvage therapy with autologous stem cell support.
Results:
Six patients (25%) achieved major responses to paclitaxel with 2 CR (8%) and 4 PR with marker normalisation (17%). In addition, 5 patients (21%) showed disease stabilisation. Median duration of responses to paclitaxel was 8 months (3-16+). Toxicity was tolerable, with mainly granulocytopenia occurring in 50% of patients and peripheral neuropathy > or = grade II in 29%.
Conclusion:
Paclitaxel demonstrates significant antitumor activity in 25% of patients with relapsed or cisplatin-refractory testicular cancer. Combination regimens including paclitaxel may be warranted.