ASCO--Non-small-cell lung cancer (NSCLC) patients receiving paclitaxel(Drug information on paclitaxel) (Taxol) plus cisplatin(Drug information on cisplatin) (Platinol) had longer survival and achieved high-er rates of response than patients receiving a current standard chemotherapy regimen of cisplatin plus etoposide(Drug information on etoposide) (VePesid) in a multicenter phase III trial, Phillip Bonomi, MD, reported at a scientific session of the American Society of Clinical Oncology (ASCO) annual meeting in Philadelphia.
Average survival times were increased 25% to 30% in patients receiving pacli-taxel in combination with cisplatin as initial therapy in the Eastern Cooperative Oncology Group (ECOG) trial, said Dr. Bonomi, associate professor of oncology, Rush University Medical Center, Chicago.
ECOG undertook the current study based on previous promising phase II trial results in which response rates achieved with paclitaxel hovered at between 21% and 24%, and 1-year survival, at 40%, Dr. Bonomi said. It was the survival data that caught the eye of the NSCLC doctors, he said.
"The study enrollment came in like a tidal wave," Dr. Bonomi noted. "There were 600 patients accrued in 16 months with about 190 ultimately in each arm." Inclusion criteria included histologically confirmed stage IIIb-IV NSCLC; no previous chemotherapy; adequate bone marrow, renal, and hepatic function; and no brain metastases.
Patients were randomized to one of three arms: a standard chemotherapy regimen of etoposide and cisplatin; a high 250 mg/m² dose of paclitaxel with cisplatin plus G-CSF (Neupogen); or a low 135 mg/m² dose of paclitaxel with cisplatin, Dr. Bonomi said. Primary study endpoints included survival, response to therapy, and toxicity.
Compared with standard chemotherapy, paclitaxel/cisplatin extended survival by 2 to 3 months, Dr. Bonomi noted. Survival averaged 7.4 months for patients receiving etoposide/cisplatin, 9.6 months among those receiving low-dose pacli-taxel/cisplatin, and 10.1 months among those receiving high-dose paclitaxel with cisplatin plus G-CSF.
Response rates for groups receiving paclitaxel were also significantly better than for those on the standard etoposide/cisplatin regimen, he said. The response rate for the etoposide/cisplatin arm of the study was 12% while that for the low-dose paclitaxel/cisplatin combination was 26%. The high-dose paclitaxel group response rate was 31%.