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Median PFS Not Yet Reached After 6 Years in Rituximab/CHOP Trial

Median PFS Not Yet Reached After 6 Years in Rituximab/CHOP Trial

BUFFALO, New York—Median progression-free survival has still not been
reached after 6 years median follow-up of 40 patients with low-grade or
follicular non-Hodgkin’s lymphoma (NHL) treated in the first clinical
trial of rituximab (Rituxan) in combination with CHOP (cyclophosphamide
[Cytoxan, Neosar], doxorubicin HCl, vincristine [Oncovin], and prednisone),
Myron S. Czuczman, MD, reported.

First Clinical Trial of Rituximab/CHOP

In a poster presented at the 43rd Annual Meeting of the American Society
of Hematology, Dr. Czuczman reported that 38 patients received treatment and
were evaluable for efficacy, 35 of whom had received all six infusions of
rituximab and six cycles of CHOP. Two patients were enrolled in the trial
but not treated. CHOP was administered at standard doses every 3 weeks for
six cycles along with six infusions of rituximab (375 mg/m²/dose). Two doses
of rituximab were given both at the beginning and end of therapy, as well as
single doses before the third and fifth cycles of CHOP.

Dr. Czuczman said that the overall response rate using intent-to-treat
analysis was 95% (55% complete response [CR], 40% partial response [PR]). In
patients who completed all therapy the response rate was 100% (63% CR, 37%

Prolonged Progression-Free Survival

"The median duration of response and progression-free survival have
not been reached after 63.6+ and 65.1+ months of observation,
respectively," Dr. Czuczman reported. "Twenty-one patients are
still in remission at 46.8+ and up to 86.3+ months."

Of eight patients who were bcl-2 positive, seven had molecular complete
remissions (converted to polymerase chain reaction [PCR] negativity in blood
and marrow). Three of these patients remain PCR negative and in CR at 71+,
79+, and 84+ months. Four patients converted to negative and then reverted
to positive. Three of these patients remain in CR at 68+, 81+, and 86+
months, and one developed progressive disease at 29 months.


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