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Attempting to Compare Outcomes from Protocols to Treat Follicular Lymphoma - a work in progress

It's challenging to compare therapy protocols because of differences in the populations (such as treatment histories, risk factors, eligibility requirement),
small sample sizes, variation in how results are reported, and significant variation (deficiencies?) in follow-up - ranging from 2 to 10 years. 
Even reported CR rates can depend on how you define a CR, and how it's assessed.

Clearly, our ability to make reliable comparisons of treatment protocols is vital to patients and researchers ...
to guiding clinical and research decisions.
 

Last update: 11/14/2011

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 12.788.9)
64% NS http://bit.ly/g7quw1  Long-term Responses
defined as 12 mo or more: 
Median DR= 31.1 mo
(12.187.8+) 12 of 59 ongoing

No recurrance in 21 of 59 
Median DR = 62 mo. (range, 4887+)
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.

 

 
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