Re: Revlimid: too good to be true?

[Guest guest]

This is the difference between a news story/press release and the

medical literature published in a peer-reviewed medical journal.

This is a common occurance. One would expect the discovery of

little green men on Mars to be shouted on the news; however the

scientific papers published in Nature or Science would be quite a

bit more restrained.

I wouldn't read anything into the difference. One needs to cautious

about any treatment. Time will tell on this treatment just like any

other.

>

> Blank

> Watch the language

>

> Read the following abstract and compare it to message #8845,

posted to this list on Dec. 12. 2006, discussing the same phase II

trial. The reports are almost the same, but pay close attention to

the language.

>

> The report from Medical News, titled " New Hope For Patients With

Chronic Lymphocytic Leukemia, " says,

>

> " In this phase II study -- the first to report clinical activity of

> lenalidomide in patients with CLL -- 45 patients with

> immunophenotypically diagnosed B-CLL were treated with a daily dose

> of 25 mg of lenalidomide. Major clinical responses were seen in 21

> (47%) of the patients, with four achieving complete response and 17

> achieving a partial response; all with a predictable and manageable

> safety profile. The most common side effects included fatigue,

> neutropenia and thrombocytopenia.

>

> " " Collectively, these data provide strong support for further

pursuit

> of lenalidomide in confirmatory clinical studies that are now open

at

> Roswell Park and other cancer centers in the country, " notes Dr.

Chanan-Khan. "

>

> It sounds great, but keep reading.

>

> The original abstract published in PubMed, titled " Clinical

efficacy of lenalidomide in patients with relapsed or refractory

chronic lymphocytic leukemia: results of a phase II study "

summarizes the results as follow:

>

> " Forty-five patients were enrolled, with a median age of 64 years.

Sixty-four percent of the patients had Rai stage III or IV disease,

and 51% were refractory to fludarabine. The overall response rate

was 47%, with 9% of the patients attaining a complete remission.

Fatigue, thrombocytopenia, and neutropenia were the most common

adverse effects noted in 83%, 78%, and 78% of the patients,

respectively. These findings are encouraging and warrant further

investigation of this agent in the treatment of this disorder. "

>

> Pretty much the same, except for the language. The Med News

version uses phrases like " new hope, " " predictable and manageable

safety profile, " and " strong support for further pursuit, " while the

PubMed version is more restrained and mentions such details as the

fact that a single course of revlimid caused thrombocytopenia in 78%

of the patients, neutropenia in 78% and clinical fatigue in 83%.

These were the most common adverse effects; the abstract doesn't say

how serious and how common other side effects were.

>

> This may sound " predictable " and " manageable, " - specially to

those who suffered the equally serious side effects of fludara, the

current U.S. " gold standard, - but it doesn't make me so hopeful.

Specially, since 24 of 45 trial patients achieved no improvement and

it's not known how long the remissions of the rest will last.

>

> I realize this is only a preliminary trial, but it may be better

not to be seduced by hyperboles and get our hopes up too high.

>

> Andy Gach

>

>

>

>

> J Clin Oncol. 2006 Dec 1;24(34):5343-9. Epub 2006 Nov 6.

> Clinical efficacy of lenalidomide in patients with relapsed or

refractory chronic lymphocytic leukemia: results of a phase II study.

> a.. Chanan-Khan A,

> b.. KC,

> c.. Musial L,

> d.. Lawrence D,

> e.. Padmanabhan S,

> f.. Takeshita K,

> g.. Porter CW,

> h.. Goodrich DW,

> i.. Bernstein ZP,

> j.. Wallace P,

> k.. Spaner D,

> l.. Mohr A,

> m.. Byrne C,

> n.. -Ilizaliturri F,

> o.. Chrystal C,

> p.. Starostik P,

> q.. Czuczman MS.

> Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY

14263, USA. asher.chanan-khan@...

>

> PURPOSE: Patients with relapsed or refractory chronic lymphocytic

leukemia (CLL) have profound immune defects and limited treatment

options. Given the dramatic activity of lenalidomide in other B-cell

malignancies and its pleotropic immunomodulatory effects, we

conducted a phase II trial of this agent in CLL. PATIENTS AND

METHODS: Patients with relapsed or refractory B-cell CLL (B-CLL)

were eligible if they required treatment as per the National Cancer

Institute Working Group 1996 guidelines. Lenalidomide was

administered orally at 25 mg on days 1 through 21 of a 28-day cycle.

Response was assessed after each cycle. Patients were to continue

treatment until disease progression, unacceptable toxicity, or

complete remission. Rituximab was added to lenalidomide on disease

progression. RESULTS: Forty-five patients were enrolled, with a

median age of 64 years. Sixty-four percent of the patients had Rai

stage III or IV disease, and 51% were refractory to fludarabine. The

overall response rate was 47%, with 9% of the patients attaining a

complete remission. Fatigue, thrombocytopenia, and neutropenia were

the most common adverse effects noted in 83%, 78%, and 78% of the

patients, respectively. CONCLUSION: Lenalidomide is clinically

active in patients with relapsed or refractory B-CLL. These findings

are encouraging and warrant further investigation of this agent in

the treatment of this disorder.

>

> PMID: 17088571 [PubMed - indexed for MEDLINE]

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