Revlimid: too good to be true?

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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]