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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID
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To: Maurice Winn who wrote (1468)2/5/1998 10:01:00 PM
From: Gregory Rasp   of 1762
 
Here is the ECOG trial published 3/1995 in abstract form.

An ECOG Randomized Phase III Trial of CHOP vs CHOP + Radiotherapy (XRT)
for Intermediate Grade Early Stage NHL

Glick, Kim, Earle, O'Connell

Between 10/84 and 8/92, 345 eligible patients (pts)
with previously untreated bulky or
extranodal Stage I and pts with Stage II
intermediate grade NHL were treated on an ECOG trial that randomized pts to either
induction CHOP x 8 cycles or
CHOP x 8 followed by consolidation low-dose (LD)
XRT
3000 cGy to sites of pretreatment involvement for pts in complete response (CR).
All pts in partial response (PR)
after CHOP
received high-dose (HD) XRT to 4000 cGy.
Prognostic factors include: 32% Stage I, 68% Stage II; bulky
disease 30%;
median age 59. All pts had residual disease present as
an on-study requirement. After 8 cycles of CHOP, the CR
rate was 61% and PR rate was 28%. Of pts in PR at end
of CHOP, 28% converted to CR after HD XRT. With a
median followup of 6 years, the 6 year results are:

CHOP + XRT
DFS 58% 73%
Overall Survival 70% 84%

Overall survival for all patients entered is 65%. Although
Grade 4 hematologic toxicity was common (45%), there
were only 4 toxic deaths on CHOP and no
XRT-related deaths.

Summary: Low-dose XRT in consolidation for CR's after induction
CHOP was significantly better than CHOP alone for 6-yr DFS and
FFS and marginally significant for overall survival.

Greg -
I left out a little about prognostic factors and study design
but all the important stuff is there.
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