|
Protocol |
N
FL |
Population Characteristics
(Treatment history and risk factors) |
Median
Duration of response
(TTP, DR, PFS) |
Median
Follow-up |
CR |
MDS
NS - not stated |
Based on Report |
Notes
|
CHOP-RIT vs.
CHOP-R
randomized
OliverPress et al |
554 |
Untreated
follicular
Median age balanced but not specified
Advanced stage (bulky stage II, III or IV) evaluable FL of any
grade (1, 2, or 3)
|
CHOP-RIT:
80% PFS at 2 yr
CHOP-R 78% PFS at 2 yr
|
4.9 yr
~58 mo |
CHOP-RIT 46%
CHOP-R
41%
|
CHOP-RIT:
7 (2.7%)CHOP-R:
3 (1.1%) |
http://bit.ly/uIhYKf |
Author conclusion: "PFS and OS are outstanding with either
of the two regimens with median times to progression not yet
reached for either treatment"
|
R-CHOP
randomized
Meta Analysis, Siddhartha |
223 |
Untreated
follicular, age > 60 = 82; 36.8%
b-symptoms: 80 (35.9%)
advanced stage III/IV: 223; 100% |
87% (195 / 223)
continue without treatment failure at: |
1.5 yr
18 mo |
20%
44/223 |
NS |
http://bit.ly/hbYG0W |
CR rate lower than
comparator CVP-R:
CVP-R 41% 66/162
CHOP-R 20% (44/223) |
R-chemo -
R maintenance
for 2 yrs
randomized
PRIMA Salles et al |
505 |
Untreated
follicular
Median age 56 yrs;
FLIPI 0-1 (21%),
FLIPI 2 (36%), FLIPI 3-5 (43%).
Induction: 74% had R-CHOP
22% R-CVP, 4% R-FCM). |
82% PFS at:
60.3% PFS at:
(95% CI 55.8 - 64.5%) |
2 yr
3 yr
36 mo |
75%
|
NS |
http://bit.ly/eOxR8q |
Data on ongoing remissions
not specified in ASH abstract
52% in PR converted to CR/Cru
at the end of 2-yr R maint.,
vs. 30% for observation |
Fludara - Bexxar
single-arm
Martin, et al |
38 |
Untreated
follicular
Median age 53 yrs; 43% high FLIPI |
51% PFS at:
59% PFS at:
|
10.6 yr
5.1 yr |
NS |
4 MDS
1 to AML |
http://bit.ly/dTfS6c |
OS = 69% at 10 yrs
A drop in PFS of only 8% in 5 yrs - is this evidence of a
plateau? |
Zevalin
single-arm
Scholz et al |
59 |
Untreated
follicular
Advanced stage; Grade I-IIIA |
17.9 mo. PFS at:
|
~2 yr
23 mo |
52% |
|
http://bit.ly/gutP7h |
Among 33 pts who reached follow up of more than 18 mo,
52% continue in CR |
Chemo - Zevalin
randomized
vs. chemo
Hagenbeek et al |
207 |
Untreated
follicular
Advanced stage; |
47% PFS at:
|
5 yr
92 mo |
57%
CR/CRu |
6 (3%)
MDS / AML |
http://bit.ly/dOHojf |
In pts achieving CR/CRu,
5-year PFS = 57%;
median PFS not yet reached at 92 mo. |
R-CVP
randomized
Marcus et al |
162 |
Untreated
follicular , age > 60 = 41; 25.3%
b-symptoms: 65; 40.1%
advanced stage III/IV: 160; 98.8%
bulky - 63 (39%) ;
FLIPI 0-2 49% / 3-5 44% |
Median disease-free survival
not reached at: |
2.5 yr
30 mo |
41%
66/162 |
NS |
http://bit.ly/gT04Q6 |
Clearly established superiority of
Rituxan-based chemo - in this case
CVP-Rituxan over CVP:
CR rate 30% v. 8%
Median duration of response
35 mo v. 14 mo |
Bexxar
single-arm
Kaminski |
76 |
Untreated
follicular |
38% PFS at:
59% PFS at:
|
10 yr
5.1 yr |
75% |
1 MDS |
http://bit.ly/gPIvrD |
OS rate = 83%;
for pts with CR,
median PFS was 9.2 yrs. |
CVP - Bexxar
single-arm
Link et al |
30 |
Untreated
follicular |
Median PFS Not reached at:
(range, 3 to 111+ mo) |
8.4 yr |
93% |
2 MDS/AML |
http://bit.ly/chKTgk |
Five-yr PFS and OS rates were
56% / 83%, respectively |
R-Chemo
single-arm
Czucman |
40 |
Untreated AND
Previously TREATED
follicular
63% - non-bulky
2 Untreated
29/38 -
previously TREATED
3, 3, 1 , 2 had
1, 2, 3 , >4 prior treatments, respectively |
The median TTP and
Duration of Response
82.3 mo and 83.5 mos (~7 yr),
respectively at: |
9 yr |
55%
22/40 |
|
http://bit.ly/hbYG0W |
16 / 38 pts still in remission
6 to 9 years after treatment;
3 of these 16 pts had prior treatment |
CHOP - Bexxar
single-arm
Press et al |
90 |
Untreated
follicular
Advanced stage |
67% PFS at: |
5.1 yr |
69% |
MDS (1%)
AML (0%) |
http://bit.ly/cng3S8 |
|
Bexxar
single-arm
Kaminski, et al |
60 |
Previously TREATED
indolent lymphoma
(transformed = 23, MCL = 1)
chemo-refractory or transformed with at least 2 chemo and had
either not responded to (72%) or had progressed within 6 mo.
(28%) of their last regimen |
8% PFS at:
|
10 yrs |
20% |
4 MDS |
http://bit.ly/fICJfh |
Challenging heavily pretreated population
5 of 12 pts (1 transformed) with
CR still in remission ≥ 10 yrs |
Zevalin
Single center;
historical data
Zinzani et al |
57 |
Previously TREATED
follicular; 2 MZL; 2 SLL
median prior treatment = 3 (range 1-9)
6 with bulky; at least 1 prior Rituxan-based chemo |
45% PFS at:
|
1.7 yr
20 mo |
70% |
NS |
http://bit.ly/i7H9Wa |
12 of 26 CR heavily pretreated
26 / 40 pts (65%) with CR are in continuous CR (CCR) (range,
10-42 mo.); 4 maintain CCR after 36 mo. |
Zevalin
single-arm; 4 trials
Witzig et al |
59
|
Previously TREATED
follicular
relapsed or refractory; 31% bulky
1/3 treated with at least 3 prior therapies; 37% had not
responded to last therapy. |
29.3 mo DR at:
|
4.6 yr
54.9 mo
(range 12.7–88.9) |
64% |
NS |
http://bit.ly/g7quw1 |
Long-term Responses
defined as 12 mo or more:
Median DR= 31.1 mo
(12.1–87.8+) 12 of 59 ongoing
No recurrance in 21 of 59
Median DR = 62 mo. (range, 48–87+) |
Zevalin
single-arm
Schilder et al |
30 |
Previously TREATED follicular
relapsed or refractory low-grade, follicular, or transformed |
11.5 mo. PFS at
(range: 1.0-53.9 months)
|
3 yr
36. 5 mo |
47% |
NS |
http://bit.ly/epWk6Y |
Median TTP was 9.4 mo.
(range: 1.7 - 55+ mo.)
TTP of 12 mo. or more in 14/30 pts (47%); 12 of 14 CR/CRu pts
(86%) |
Zevalin
retrospective
Lopci et al |
59 |
Previously TREATED
follicular
relapsed or refractory |
PFS not specified at:
|
2 yr
23 mo |
46% |
NS |
http://bit.ly/fRiKvR |
a statistically significant relation between disease extent
before RIT and response to treatment with respect to PFS (P =
0.015), |
Bendamustine-Rituxan
ramdomized
Rummel et al |
24
|
Previously TREATED
follicular
Need for treatment required
at least 1 - 3 previous treatments
risk factors specific to FL not specified
|
median PFS for FL
not reached at:
|
2 yr
24 mo |
71%
17/24
|
|
http://bit.ly/9Wvvqk |
Small study N=24
Median OS not yet been reached. |
Bexxar
single-arm;
3 trials
Kaminski et al |
117 |
Previously TREATED
follicular
Median prior chemo: 3 -
37% with 4 or more chemo
63 of 117 (54%) (Non-bulky)
27 with bulky disease (B)
27 with very bulky disease (VB) |
12.5 mo. Median PFS at:
|
2 yr |
31%
41% Not B
22% Bulky
19% Very B |
NS |
http://bit.ly/gQw5g5 |
9 of 11 (82%) patients with bulky disease who achieved a CCR
continue in CCR at 2 yr. |
Bexxar
single-arm;
5 trials
Fisher et al |
250 |
Previously TREATED
follicular
including transformed
43 % treated with > 4 therapies;
36% with no response to most recent therapy |
17% PFS at:
|
5.3 yr |
20%
-
38% |
NS |
http://bit.ly/h97CI8 |
81 (32%) of 250 pts with TTP of ≥ 1 yr
of these 44% had not progressed at ≥ 2.5 to ≥ 9.5 yrs with
median DR= 45.8 mo
at 5.3 yr.
Median duration of CR
not reached at 5.3 yrs |
Zevalin
single-arm; 7 trials
Gordon et al |
553 |
Previously TREATED
follicular |
26 mo. DR at:
|
2.3 yr
29 mo |
34% |
NS |
http://bit.ly/gDR1e2 |
on-going responses of more than four years duration have been
achieved. |
