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Maintenance: Regularly Scheduled Rituxan following initial treatment
with
chemotherapy, Rituxan, or Rituxan-based chemotherapy
Last update: 05/26/2008
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Consolidation / Maintenance Rituxan Treatment:
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Rituxan maintenance for indolent
lymphomas? - AshEducationBook
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New:
Expert Commentary: Areas of Confusion in Oncology
What Is the Role of Maintenance Rituximab in Follicular NHL? cancernetwork.com/
David G. Maloney, Reviewed
by John D. Hainsworth and Bertrand Coiffier
Should rituximab maintenance become standard therapy for
follicular lymphoma?
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Follicular lymphoma:
chemotherapy and/or antibodies?
Michele Ghielmini ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND
- http://www.bloodjournal.org/cgi/content/full/108/10/3235
... "Because follicular lymphoma (FL) is usually not curable, FL patients in remission have been candidates for maintenance trials with alkylating agents first and with interferon later. Alkylators were too toxic and interferon, despite prolonging remission, failed to demonstrate a survival advantage in the meta-analysis and never entered general use because of the negative impact on quality of life.
The advent of rituximab, an agent with little toxicity and good single-agent activity in FL, reopened the maintenance issue. Several studies proved that rituximab maintenance can consistently prolong a remission obtained with single-agent rituximab or with chemotherapy.1-3
The question was still open if rituximab maintenance could be effective when the antibody had been previously administered in combination with induction chemotherapy.
In this issue of Blood, an intergroup study presented by van Oers and colleagues provides a positive answer: rituximab maintenance after rituximab-CHOP (R-CHOP) induction produces the same benefit that it does after CHOP only. The antitumor effect of rituximab is therefore not exhausted during induction but continues with further treatment. A German trial confirms the data on a smaller sample size.4
The authors also find a survival advantage in favor of maintenance, a very encouraging observation that will need substantiation by longer follow-up and data from other maintenance trials.
Although the route to rituximab maintenance is nicely paved, some unanswered questions remain.
* Do these data obtained in relapse also apply to first-line patients?
* Which of the so-far published maintenance schedules is the optimal one (weekly x 4 every 6 months or 1 single infusion every 2-3 months)?
* Would a longer maintenance be even more effective?
Ongoing trials will answer some of these questions.
As to the issue of long-term maintenance, the potential harm of prolonged B-cell depletion after long-term exposure to rituximab must be solved: although a 2-year maintenance appears to be devoid of relevant subjective toxicity and causes an infection rate just slightly higher than controls, an even longer exposure to rituximab could cause further yet unknown complications.
The van Oers et al paper is finally a chance to sum up some evidence on the differential efficacy of aggressive chemotherapy and single-agent antibodies in indolent lymphoma: in this trial CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) obtains remissions of approximately 1-year duration, whereas the adjunction of rituximab (with and after chemotherapy) adds 3 further years. In another trial in relapsed indolent lymphoma, single-agent rituximab followed by 2-year maintenance demonstrated a median progression-free survival (PFS) of almost 3 years.1
Finally, preliminary data from a small randomized trial in first-line indolent lymphoma patients, where single-agent rituximab was compared with CNOP (cyclophosphamide, vincristine, mitoxantrone, prednisone) or R-CNOP, suggest no difference in response rate or in 2-year PFS for the 3 arms, whereas the only significant difference was a higher toxicity for the chemotherapy-containing treatments.5 In this era of highly effective antibodies, do all FL patients deserve the burden of aggressive chemotherapy?
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First line Rituxan
for CLL: Single-agent rituximab as first-line and
maintenance treatment for patients with chronic lymphocytic
leukemia or small lymphocytic lymphoma: a phase II trial of the
Minnie Pearl Cancer Research Network. J Clin Oncol. 2003 May
1;21(9):1746-51. PMID:
12721250
Single-agent rituximab, used at a standard dose and schedule,
is active in the first-line treatment of patients with CLL/SLL,
producing substantially higher response rates than previously
reported in relapsed or refractory patients (51% v 13%,
respectively). Re-treatment with rituximab at 6-month intervals is
well tolerated. The PFS time of 18.6 months in patients with
CLL/SLL seems shorter than the 36- to 40-month median PFSs
previously reported with first-line plus maintenance rituximab in
patients with follicular lymphoma. Additional follow-up is
required to fully assess the impact of this treatment strategy.
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| Rituximab as first-line and maintenance therapy for
patients with indolent non-hodgkin's lymphoma.
J Clin Oncol. 2002 Oct 15;20(20):4261-7. PMID:
12377971 | Related
articles
CONCLUSION: Rituximab is highly active and extremely well
tolerated as first-line single-agent therapy for indolent NHL.
First-line treatment with scheduled maintenance at 6-month
intervals produces high overall and complete response rates and a
longer progression-free survival (34 months) than has been
reported with a standard 4-week treatment.
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Rituxan following R-FCM
in Relapsed follicular NHL: Maintenance therapy with rituximab
leads to a significant prolongation of response duration after
salvage therapy with a combination of rituximab, fludarabine,
cyclophosphamide and mitoxantrone (R-FCM) in patients with
relapsed and refractory follicular and mantle cell lymphomas -
results of a prospective randomized study of the German low grade
lymphoma study group (GLSG). Blood. 2006 Aug 31; PMID:
16946304
Response duration was significantly prolonged by R-maintenance
after R-FCM with the median not being reached versus 16 months
(p=0.001). This beneficial effect was also observed when analyzing
FL (p=0.035) and MCL (p=0.049) separately.
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Maintenance Rituxan following Relapse of
follicular NHL
* Maximizing Therapeutic Benefit of Rituximab: Maintenance Therapy Versus Re-Treatment at Progression in Patients With Indolent Non-Hodgkin's Lymphoma—A Randomized Phase II Trial of the Minnie Pearl Cancer Research Network
Journal of Clinical Oncology, Vol 23, No 6 (February 20), 2005: pp. 1088-1095
© 2005 American Society of Clinical Oncology.
John D. Hainsworth, Sharlene Litchy, Don W. Shaffer, Van L. Lackey, Manuel Grimaldi, F. Anthony Greco
From the Sarah Cannon Cancer Center and Tennessee Oncology PLLC, Nashville, TN; Northwest Georgia Oncology Centers, Marietta, GA; Jackson Oncology Associates, Jackson, MS; and Consultants in Blood Disorders and Cancer, Louisville, KY
PURPOSE: To compare the benefit of maintenance rituximab therapy versus rituximab re-treatment at progression in patients with previously treated indolent non-Hodgkin's lymphoma.
PATIENTS AND METHODS:
Between June 1998 and August 2002, 114 patients who had received previous chemotherapy for indolent non-Hodgkin's lymphoma were treated with a standard 4-week course of rituximab.
Patients with objective response or stable disease were randomly assigned to receive either maintenance rituximab therapy (standard 4-week courses administered at 6-month intervals) or rituximab re-treatment at the time of lymphoma progression.
The duration of rituximab benefit was measured from the date of first rituximab treatment until the date other treatment was required.
RESULTS: Ninety (79%) of 114 patients had objective response or stable disease after initial rituximab treatment, and were randomly assigned to treatment. Progression-free survival was prolonged in the maintenance group (31.3 v 7.4 months; P = .007).
Final overall and complete response rates were higher in the maintenance group.
Duration of rituximab benefit was similar in the maintenance and re-treatment groups (31.3 v 27.4 months, respectively).
More maintenance patients remain in continuous remission, and more are currently in complete remission. Both treatment approaches were well tolerated.
CONCLUSION: In patients who have objective response or stable disease with single-agent rituximab therapy, duration of rituximab benefit is substantially prolonged with either scheduled maintenance treatment or rituximab re-treatment at the time of progression.
At present, the magnitude of benefit with either approach appears similar.
However, additional follow-up of this trial is required, and completion of phase III randomized trials is necessary to definitively answer this question.
Supported in part by grants from Genentech Inc and the Minnie Pearl Foundation.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
source: http://www.jco.org/cgi/content/abstract/23/6/1088
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Rituximab maintenance improves clinical outcome
of relapsed/resistant follicular non-Hodgkin's lymphoma, both in
patients with and without rituximab during induction: results of a
prospective randomized phase III intergroup trial. Blood.
2006 Jul 27; PMID:
16873669
"We evaluated the role of rituximab (R) both in remission induction and maintenance treatment of relapsed/resistant follicular lymphoma (FL). A total of 465 patients were randomized to induction with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (every 3 weeks) or R-CHOP (R: 375 mg/m2 intravenously, day 1).
Those in complete remission (CR) or partial remission (PR) were randomized to maintenance with R (375 mg/m2 intravenously once every 3 months for a maximum of 2 years) or observation.
R-CHOP induction yielded an increased overall response rate
(CHOP, 72.3%; R-CHOP, 85.1%; P < .001) and
CR rate (CHOP, 15.6%; R-CHOP, 29.5%; P < .001).
Median progression-free survival (PFS) from first randomization was
20.2 months after CHOP versus
33.1 months after R-CHOP (hazard ratio [HR], 0.65; P < .001).
Rituximab maintenance yielded a median PFS from second randomization of
51.5 months versus
14.9 months with observation (HR, 0.40; P < .001).
Improved PFS was found both after induction with CHOP (HR, 0.30; P < .001) and R-CHOP (HR, 0.54; P = .004).
R maintenance also improved overall survival from second randomization:
85% at 3 years versus
77% with observation (HR, 0.52; P = .011).
This is the first trial showing that in relapsed/resistant FL rituximab maintenance considerably improves PFS not only after CHOP but also after R-CHOP induction.
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CONSOLIDATION OF CHEMO: Rituximab (anti-CD20 monoclonal
antibody) as consolidation of first-line CHOP chemotherapy in
patients with follicular lymphoma: a phase II study. Eur J
Haematol. 2002 Jul;69(1):21-6. PMID: 12270058 - PubMed
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Extended use of Rituxan in Newly diagnosed and relapsed
follicular NHL
Prolonged treatment with rituximab in patients with follicular
lymphoma significantly increases event-free survival and response
duration compared with the standard weekly x 4 schedule. Blood
2004;. PubMed
The potential benefits of extended rituximab treatment have been investigated in a randomized trial comparing the standard schedule with prolonged treatment in 202 patients with newly diagnosed or refractory/relapsed follicular lymphoma (FL). All patients received standard treatment (rituximab 375 mg/m2 weekly x 4).
In 185 evaluable patients, the overall response rate was
67% in chemotherapy-naive patients and
46% in pretreated cases (P < .01).
Patients responding or with stable disease at week 12 (n = 151) were randomized to no further treatment or prolonged rituximab administration (375 mg/m2 every 2 months for 4 times).
At a median follow-up of 35 months, the median event-free survival (EFS) was
12 months in the no further treatment versus
23 months in the prolonged treatment arm (P = .02),
the difference being particularly notable in chemotherapy-naive patients
(19 vs 36 months; P = .009)
and in patients responding to induction treatment
(16 vs 36 months; P = .004).
The number of t(14;18)-positive cells in peripheral blood (P = .0035) and in bone marrow (P = .0052) at baseline was predictive for clinical response.
Circulating normal B lymphocytes and immunoglobulin M (IgM) plasma levels decreased for a significantly longer time after prolonged treatment, but the incidence of adverse events was not increased. In patients with FL, the administration of 4 additional doses of rituximab at 8-week intervals significantly improves the
EFS.
Source: http://www.ncbi.nlm.nih.gov
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| NEW: Rituxan
maintenance for DLBCL following CHOP-R? ASCO
2007
Maintenance rituximab (MR) compared to observation (OBS) after
R-CHOP or CHOP in older patients (pts) with diffuse large B-cell
lymphoma (DLBCL): An Intergroup E4494/C9793 update.
MR after CHOP, but not after R-CHOP, significantly prolongs TTF,
but fails to prolong OS, possibly due to a delayed pattern of
relapse and/or the efficacy of rituximab in the salvage
setting.
As 6-yr FFS declined to <50% among R-CHOP responders, with or
without MR, there is a need for more effective treatment
strategies in older DLBCL pts.
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| Rituximab long-term maintenance therapy after autologous
stem cell transplantation in patients with B-cell
non-Hodgkin’s lymphoma springerlink.com
"Rituximab maintenance therapy after autologous peripheral
blood stem cell transplantation (PBSCT) might represent an
improvement in NHL therapy. We therefore retrospectively analyzed
the efficacy and side effects of monthly long-term Rituximab
maintenance therapy after PBSCT in 27 patients with NHL.
In median 10 infusions of Rituximab were given after PBSCT in time
intervals of 1 month. Molecular monitoring of t(14;18) was
performed using nested as well as quantitative real time
polymerase chain reaction (RT-PCR) based on the LightCycler
technology. Side effects according to common toxicity criteria (CTC)
> II did mainly affect the hematopoietic system. In total, 10
patients (37%) suffered form grade III-IV hematotoxicity. Except
for two patients with cutaneous Varicella-Zoster infection no
serious infectious complications (CTC grade III/IV) occurred. No
patient died because of treatment-related causes. This adverse
event data compared favorably to the published data. Three
patients had t(14;18) nested RT-PCR positive results before
Rituximab therapy and converted to negativity after Rituximab
therapy. We conclude that a prolonged Rituximab maintenance
therapy after PBSCT with monthly administration is reliable and
safe.
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ASH 2002: Proleukin® Plus Rituxan® may Reduce
Recurrences Following Stem Cell Transplant in Non-Hodgkin’s
Lymphoma - CancerConsultants.com
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