Patients with advanced germ cell tumors who received cisplatin, etoposide and bleomycin chemotherapy demonstrated comparable PFS as those who underwent sequential high-dose chemotherapy with stem-cell rescue, according to results of a randomized, phase 2 study.
Andrea Necchi, MD, of the department of medical oncology at Istituto Nazionale dei Tumori, and colleagues evaluated data from 85 patients with advanced germ cell tumors who had a poor prognosis.
Researchers assigned 43 patients to receive four cycles of cisplatin, etoposide and bleomycin (PEB) chemotherapy every 3 weeks. The other 42 patients received two PEB cycles followed by a high-dose sequence of cyclophosphamide, cisplatin, etoposide with stem-cell support and carboplatin. These patients then underwent autologous stem cell transplantation.
PFS served as the primary endpoint.
Median follow-up was 114.2 months (interquartile range, 87.7-165.8).
Researchers reported overall response rates of 65.1% (95% CI, 49.1-79) in the PEB arm and 69.1% (95% CI, 52.9-82.4) in the high-dose sequence arm. The difference was not statistically significant (P=.81). These data included two (4.6%) complete responses in the PEB arm and four (9.5%) in the high-dose sequence arm.
A similar proportion of patients in the PEB and high-dose sequence arms achieved 5-year PFS (55.8% vs. 54.8%; P=.72) and 5-year OS (62.8% vs. 59.3%; P=.68).
Multivariate analyses indicated the presence of liver, bone and brain metastases was significantly associated with PFS (HR=2.21; 95% CI, 1.04-4.7).
More patients in the high-dose sequence arm experienced grade 3 to grade 4 infection/sepsis (90.1% vs. 6.9%), gastrointestinal toxicity (59.6% vs. 11.6%) and neurologic toxicity (9.5% vs. 2.3%). One patient in the PEB arm died due to a treatment-related adverse event.
“These results represent a further step toward the allocation of high-dose chemotherapy in the therapeutic strategy of germ cell tumors,” Necchi and colleagues wrote. “Until new drugs or new concepts become available, further attempts using high-dose chemotherapy to improve response in this patient category should be discouraged.”
Disclosure: The researchers report no relevant financial disclosures.