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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID -- Ignore unavailable to you. Want to Upgrade?

To: Maurice Winn who wrote (1468)	2/4/1998 8:13:00 PM
From: Gregory Rasp	Read Replies (2) \| Respond to of 1762

Yttrium 90 does look much more promising than Rituxan according to the recent Mayo Clinic trial. As for life extension that would seem like a no-brainer to me also but I can tell you that there are several sites where the addition of radiation improves median survival but is rarely offered to the patient under the thought that 6 months is not worth $6-10K. The real problem for Rituxan is proof that it improves survival. I am not aware of any. Since we first started talking the drug is now being marketed aggressively in Ohio. All of the advertising claims tumor response but no mention of its use in the adjuvant setting. I will get those two abstracts for you. Greg BTW - IMHO Stanford is the preeminent lymphoma center in the US. Dr. Hoppe as a radiation oncologist is hard to beat.

To: Maurice Winn who wrote (1468)	2/5/1998 10:01:00 PM
From: Gregory Rasp	Respond to 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.

To: Maurice Winn who wrote (1468)	2/5/1998 10:15:00 PM
From: Gregory Rasp	Respond to 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