Abstract
We enrolled 28 eligible patients with relapsed chronic lymphocytic leukemia (CLL) to a phase II study of single agent thalidomide (200 mg/ d, with dose escalation up to 1000- mg/d over 60 days). The median age was 66 years and 71% were males. Study participants received a median of 2 (range 1-7) prior treatment regimens and 61% had Rai stage 3-4 disease at enrollment. Grade 3 or higher hematologic toxicity was observed in 13 (46%) and 16 (57%) had grade 3 or higher non-hematologic toxicity. Grade 3-4 tumor flare was observed in five (18%) patients. The overall response rate was 11% (3 of 28) with one (4%) complete remission and two (7%) partial remissions. Duration of response for these three responders was 3, 14 and 15 months. Fourteen (50%) patients had stabilisation of disease for a median duration of 8 months (95% CI: 7-16 months). Median time to progression for all 28 patients was 7.3 months. Although thalidomide appears to have modest clinical activity in pretreated/ relapsed CLL primarily based on reduction of the absolute lymphocyte count, in our opinion the toxicity profile precludes it from more active investigation in CLL.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 588-592 |
| Number of pages | 5 |
| Journal | Leukemia and Lymphoma |
| Volume | 50 |
| Issue number | 4 |
| DOIs | |
| State | Published - 2009 |
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Keywords
- Angiogenesis
- CLL
- Relapsed
- Thalidomide
- Treatment
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research
Cite this
N9986 : A phase II trial of thalidomide in patients with relapsed chronic lymphocytic leukemia. / Kay, Neil Elliot; Shanafelt, Tait D.; Call, Timothy G.; Wu, Wenting; Laplant, Betsy R.
In: Leukemia and Lymphoma, Vol. 50, No. 4, 2009, p. 588-592.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - N9986
T2 - A phase II trial of thalidomide in patients with relapsed chronic lymphocytic leukemia
AU - Kay, Neil Elliot
AU - Shanafelt, Tait D.
AU - Call, Timothy G.
AU - Wu, Wenting
AU - Laplant, Betsy R.
PY - 2009
Y1 - 2009
N2 - We enrolled 28 eligible patients with relapsed chronic lymphocytic leukemia (CLL) to a phase II study of single agent thalidomide (200 mg/ d, with dose escalation up to 1000- mg/d over 60 days). The median age was 66 years and 71% were males. Study participants received a median of 2 (range 1-7) prior treatment regimens and 61% had Rai stage 3-4 disease at enrollment. Grade 3 or higher hematologic toxicity was observed in 13 (46%) and 16 (57%) had grade 3 or higher non-hematologic toxicity. Grade 3-4 tumor flare was observed in five (18%) patients. The overall response rate was 11% (3 of 28) with one (4%) complete remission and two (7%) partial remissions. Duration of response for these three responders was 3, 14 and 15 months. Fourteen (50%) patients had stabilisation of disease for a median duration of 8 months (95% CI: 7-16 months). Median time to progression for all 28 patients was 7.3 months. Although thalidomide appears to have modest clinical activity in pretreated/ relapsed CLL primarily based on reduction of the absolute lymphocyte count, in our opinion the toxicity profile precludes it from more active investigation in CLL.
AB - We enrolled 28 eligible patients with relapsed chronic lymphocytic leukemia (CLL) to a phase II study of single agent thalidomide (200 mg/ d, with dose escalation up to 1000- mg/d over 60 days). The median age was 66 years and 71% were males. Study participants received a median of 2 (range 1-7) prior treatment regimens and 61% had Rai stage 3-4 disease at enrollment. Grade 3 or higher hematologic toxicity was observed in 13 (46%) and 16 (57%) had grade 3 or higher non-hematologic toxicity. Grade 3-4 tumor flare was observed in five (18%) patients. The overall response rate was 11% (3 of 28) with one (4%) complete remission and two (7%) partial remissions. Duration of response for these three responders was 3, 14 and 15 months. Fourteen (50%) patients had stabilisation of disease for a median duration of 8 months (95% CI: 7-16 months). Median time to progression for all 28 patients was 7.3 months. Although thalidomide appears to have modest clinical activity in pretreated/ relapsed CLL primarily based on reduction of the absolute lymphocyte count, in our opinion the toxicity profile precludes it from more active investigation in CLL.
KW - Angiogenesis
KW - CLL
KW - Relapsed
KW - Thalidomide
KW - Treatment
UR - http://www.scopus.com/inward/record.url?scp=68449101813&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=68449101813&partnerID=8YFLogxK
U2 - 10.1080/10428190902777467
DO - 10.1080/10428190902777467
M3 - Article
C2 - 19373657
AN - SCOPUS:68449101813
VL - 50
SP - 588
EP - 592
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
SN - 1042-8194
IS - 4
ER -