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A phase II trial of paclitaxel in refractory germ cell tumors
A B Sandler1, A Cristou, S Fox
1Genitourinary Oncology Program, Indiana University Cancer Center, Indianapolis, USA.
Background:
A significant percentage of patients with refractory germ cell tumors will not respond to standard salvage regimens. Thus there is a need for new active agents. Paclitaxel has demonstrated activity against a variety of solid tumors in both laboratory and clinical studies.
Methods:
Eighteen patients with refractory germ cell tumors who failed initial cisplatin-based chemotherapy and a maximum of 2 salvage regimens were enrolled into a Phase II trial of paclitaxel at a dose of 170 mg/m2 by intravenous infusion over 24 hours every 21 days without growth factor support. The median age of the patients was 32.5 years (range, 18-49 years). The testis was the primary site of tumor for 13 patients (72%) and the tumor was extragonadal in 5 patients (28%). Six patients (33%) were late recurrences. Twelve patients (67%) had > or = 2 metastatic sites. The median number of previous chemotherapy cycles was six (range, four to nine). Three patients (17%) previously had undergone autologous bone marrow transplantation.
Results:
Two patients (11%) responded to paclitaxel. Major toxicities were Grade 3-4 neutropenia (55% of patients) and Grade 3-4 neurotoxicity (2 patients). Neutropenic fever occurred in 3 patients (17%).
Conclusions:
Paclitaxel demonstrated minimal activity in heavily pretreated patients with multiple, poor risk clinical features. These results in part may be due to the unfavorable characteristics of the patients in the current study, specifically the high percentage of patients with late recurrences and extragonadal primary tumors, both of which are known to respond poorly to salvage therapy. Other trials with different patient populations and doses of paclitaxel reported response rates ranging from 13.3%-26%. The role of paclitaxel in the treatment of patients with refractory germ cell tumors remains to be defined in future studies.
Insights
Paclitaxel showed limited effectiveness in patients with advanced germ cell tumors who had not responded to prior treatments. Further research is needed to determine its role in treating this difficult-to-treat cancer.
Area of Science:
- Oncology
- Medical Oncology
- Clinical Trials
Background:
- Refractory germ cell tumors often resist standard salvage chemotherapy.
- New therapeutic agents are needed for patients with treatment-resistant germ cell tumors.
- Paclitaxel has shown promise in various solid tumor treatments.
Purpose of the Study:
- To evaluate the efficacy and safety of paclitaxel in patients with refractory germ cell tumors.
- To assess paclitaxel's activity in heavily pretreated patients who failed cisplatin-based chemotherapy.
Main Methods:
- A Phase II clinical trial was conducted involving 18 patients with refractory germ cell tumors.
- Patients received paclitaxel at 170 mg/m2 intravenously every 21 days without growth factor support.
- Patient characteristics included median age of 32.5, primary tumor sites (testicular or extragonadal), recurrence status, metastatic sites, and prior treatments.
Main Results:
- Two patients (11%) demonstrated a response to paclitaxel treatment.
- The primary toxicities observed were Grade 3-4 neutropenia (55%) and Grade 3-4 neurotoxicity (2 patients).
- Neutropenic fever occurred in 17% of the patients.
Conclusions:
- Paclitaxel exhibited minimal activity in heavily pretreated germ cell tumor patients with poor-risk features.
- Patient characteristics, including late recurrences and extragonadal tumors, may have influenced the low response rate.
- The precise role of paclitaxel in refractory germ cell tumor treatment requires further investigation in diverse patient populations and dosages.