Related Experiment Videos
Phase II study with docetaxel (Taxotere) in advanced soft tissue sarcomas of the adult. EORTC Soft Tissue and Bone
Q G van Hoesel1, J Verweij, G Catimel
1St. Radboud University Hospital, Nijmegen, The Netherlands.
Background:
Current regimens for treatment of distant metastases of soft tissues sarcomas result in response rates of about 25%. Therefore the search for active drugs remains a task for investigational groups. Taxoids offer a new class of cytostatic drugs. Docetaxel has been studied as a second line chemotherapy in advanced soft tissue sarcomas of the adult.
Patients And Methods:
In a multi-center non-randomized phase II study docetaxel was administered at a dose of 100 mg/m2 in a 1-hour i.v. infusion q 3 weeks.
Results:
Twenty-nine patients (pts), median age 52 yr, performance status WHO 0: 16 pts, WHO 1: 11 pts, WHO 2: 2 pts, were eligible. One patient had early death due to malignant disease, 1 patient died due to toxicity and progression, 1 pt refused after 1 course. Five partial responses (5/29 = 17%, C.I. 6%-36%) have been observed. Grade > or = 3 leucopenia occurred in 76% of patients and grade > or = 3 thrombopenia did not occur. Median nadir of neutrophils was 0.23 x 10(9)/l. Episodes of fever and documented infection have been observed in 10 and 5 pts respectively. Anaphylactoid type reactions occurred in 5 patients: ranging from flushing in 5 pts to cardiovascular symptoms in 1 pt. Sensory neurotoxicity was observed in 14 pts grade 1: 10 pts, grade 2: 3 pts, grade 3: 1 pt). Grade 1 motor neurotoxicity was experienced by 3 pts. Skin reactions (pruritus, erythema, urticaria, exfoliation grade 1: 11 pts, grade 2: 7 pts, grade 3: 1 pt, grade 4: 1 pt) in 20 pts, among them 9 patients with nail changes. Peripheral edema and fluid retention has been observed in 12 pts.
Conclusion:
Taxotere has activity in adult soft tissue sarcoma in second line, warranting studies on first line efficacy.
Insights
Docetaxel shows activity in treating advanced adult soft tissue sarcomas as a second-line chemotherapy, with a 17% partial response rate. Further studies are recommended for first-line efficacy.
Area of Science:
- Oncology
- Pharmacology
Background:
- Current treatments for advanced soft tissue sarcomas yield limited response rates (~25%).
- Taxoids represent a promising class of cytostatic drugs for cancer therapy.
Purpose of the Study:
- To evaluate the efficacy and safety of docetaxel as a second-line chemotherapy in adult patients with advanced soft tissue sarcomas.
Main Methods:
- A multi-center, non-randomized phase II study was conducted.
- Docetaxel was administered intravenously at 100 mg/m² every 3 weeks.
Main Results:
- Five partial responses (17%) were observed in 29 eligible patients.
- Common toxicities included grade > or = 3 leucopenia (76%), sensory neurotoxicity (14%), and skin reactions (20%).
- Anaphylactoid reactions occurred in 5 patients.
Conclusions:
- Docetaxel demonstrates activity in adult soft tissue sarcomas when used as second-line therapy.
- These findings support further investigation into docetaxel's first-line efficacy.