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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 10:15:00 PM
From: Gregory Rasp   of 1762
 
SWOG

Three Cycles of CHOP plus radiotherapy (RT is Superior
to eight Cycles of CHOP alone for localized intermediate
and high grade NHL: A SWOG study.

Miller, Dahlberg, Cassady

Localized NHL (Stage I, non-bulky II) is frequently a systemic
disease and requires initial treatment with doxorubicin-
containing chemotherapy. To better define the best treatment
we randomized 401 eligible patients with localized intermediate
and high grade NHL to CHOP x3 followed by involved field RT or
to CHOP x8 alone between 3/88 and 3/95. RT included all sites
of initial disease (prior to biopsy or resection). A minimum of
4000 cGy was delivered to the tumor volume with an optional
boost to a maximum of 5500 cGy for residual overt disease
(daily dose 180-200 cGy). Overall survival (OS) including deaths
from any cause favors CHOP x3 + RT. 4 yr survival estimates are
75% for CHOP x8 vs 87% for CHOP x3 plus RT.

A survival-tree analysis identified 127 patients (32%) characterized
by Stage I disease, normal performance status and age <60 having
a 4 yr survival of 97%. Therefore, future studies should focus on
symptomatic patients, patients >60 years, or those with stage II
disease. We conclude CHOP x3 plus RT is more effective and less
toxic than CHOP x8 alone.

________________

SO, for non-bulky Stage I disease in a young patient I think it is far from
clear that radiation is required. The ECOG trial did not have
non-bulky stage I patients in it and the SWOG trial had very
good results regardless of RT use.

Greg
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