Mark Kris, MD, Memorial-Sloan Kettering Cancer Center, and Howard
Burris, MD, director of clinical research, Cancer Therapy and
Research Center, San Antonio, presented data on the use of docetaxel
in NSCLC. Of 248 chemotherapy-naive patients in six separate studies,
they found a 21% to 32% response rate, which lasted for 4 to 6
On average, the survival rate was 2 months longer than survival
after treatment with etoposide (VePesid) and vinorelbine tartrate
(Navelbine), both administered in conjunction with cisplatin (Platinol).
In addition, they found that patients given Taxotere had a significant
diminution of disease-associated pain.
Dr. Burris said that there is no established second-line treatment
for NSCLC after platinum-based therapy has failed. In the 88 patients
in his trial of Taxotere in platinum failures, 17% responded for
a median of 7 months. One year after the first Taxotere dose,
38% were alive.
Side effects included neutropenia in about 80% of patients, mild
neurotoxicity, GI symptoms such as nausea and vomiting, skin toxicity,
In an interview with Oncology News International, Dr. Burris said
he thought that the safety profile of Taxotere is much higher
than that suggested by the data presented by the company. "In
the 1,600 patients who have ever received docetaxel in a clinical
trial, the death rate as a result of drug toxicity was less than
2%, but that didn't come across in the company's presentation,"
Moreover, Dr. Burris said, during the course of the clinical trials,
which have been going on since 1990, "we have learned how
to manage the side effects, and thus now have a much lower incidence
of serious toxicity problems."
Phase III Trials Ongoing
After the initial vote rejecting the recommendation to approve
the drug for use in breast cancer, several panel members proposed
recommending approval conditionally, pending results of phase
III trials. These trials are comparing Taxotere with paclitaxel
(Taxol) in breast cancer patients previously treated with doxorubicin,
to determine time to disease progression, as well as quality of
life for the patients who respond. Due to a tie vote, this proposal
was not approved.