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15 -year advantage of early rituximab for asymptomatic follicular lymphoma

Therefore,

15 -year advantage early rituximab:

Studies relating to asymptomatic low grade lymphomas. Moreover, at an advanced stage, with low tumor load have shown no reduction in overall survival when the treatment was postponed to symptomatic progression. For example, Vigilant expectation is therefore an accepted standard of care, allowing many patients to postpone treatment. In addition, Will 15-year follow-up of a phase 3 study change the situation?

In a randomized phase 3 study. Nevertheless, the authors compared early monotherapy by Rituximab, either in induction alone, either in induction followed by maintenance, with vigilant expectations until treatment is necessary for patients with asymptomatic follicular lymphoma with low tumor load. Meanwhile, After first results at 4 years of follow -up. Nevertheless, having shown that the Rituximab was delaying the period for establishing a new treatment (time to initiation new treatment or TTNT) compared to the vigilant wait, the study was extended to assess 15 -year advantage early rituximab the TTNT with longer follow -up.

Monitoring at 15 years of 455 patients

Eligible patients (n = 455) were over 18 years old. Similarly, bearers of a follicular lymphoma of grade 1-3A, stage II-IV, not previously treated, without B symptoms, with normal LDH, without mass> 7 cm, at the maximum of 3 ganglionary sites, no effusion, no organ compression, a splendor <16 cm, less than 5 × 10⁹ cells circulating tumor.

Patients were randomized between attentive observation until the need for treatment (“vigilant waiting” group. Moreover, n = 183), induction by Rituximab alone (group “Rituximab induction”, n = 82) and induction by Rituximab followed by maintenance treatment (group “Rituximab maintenance”, n = 190). For example, Rituximab induction included rituximab IV weekly x 4 doses of 375 mg/m². Rituximab maintenance was given every 8 weeks for 12 doses. The characteristics of the patients were well balanced between the 3 groups.

A very delayed initiation 15 -year advantage early rituximab of treatment in the group “Rituximab interview”

The median TTNT was 5.6 years in the Vigilante waiting group, 14.8 years in the Rituximab induction group and not reached in the Rituximab maintenance group.

Long -term follow -up data were obtained for 87 % of patients alive at the end of the study. Median follow -up was 14.7 years.

At 15. 65 % of patients in the Rituximab maintenance group had not started again treatment, compared to 48 % in the Rituximab induction group and 34 % in the Vigilante waiting group. For patients in the vigilant waiting group, 48 % started a new treatment within 5 years of randomization.

Of the 203 patients who started a first new treatment, 175 (86 %) began new systemic treatment and 28 (14 %) received radiotherapy.

No difference for the establishment of a 2th new treatment

A second new treatment was introduced in 32 (18 %) patients in the Vigilante 15 -year advantage early rituximab waiting group. 12 (15 %) of the Rituximab induction group and 20 (11 %) of the Rituximab maintenance group. At 15. 86 % of patients in the Rituximab maintenance group, 85 % of the Rituximab induction group and 79 % of the Vigilante waiting group had not started a second new treatment.

No difference in survival. transformation, rare undesirable effects

The overall survival at 15 was 73 % for the Rituximab maintenance group, 66 % for the Rituximab induction group and 68 % for the Vigilante waiting group, without significant difference.

There was no difference in the risk of transformation into high grade lymphoma between the groups of the test. The rates at 15 were 17 % in the Rituximab maintenance group, 15 % in the Rituximab induction group and 20 % in the Vigilante waiting group.

Grave side effects (grade ≥ 3) linked to rituximab were infrequent (5 infections in the Rituximab maintenance 15 -year advantage early rituximab group, 3 allergies and 4 episodes of neutropenia). A second primitive neoplasia occurred in 90 (20 %) of the 455 randomized patients, with no significant difference between groups.

Early rituximab could avoid chemotherapy to many patients

With 14.7 -year -old median follow -up. this data shows Improvements of TTNT in patients with asymptomatic follicular lymphoma with low tumor load at an advanced stage that have received early monotherapy in Rituximab. Almost 2/3 of patients who received rituximab in maintenance had not started again at 15 years old. against only 1/3 of patients pending vigilant. The median age at the time of the diagnosis of follicular lymphoma being more than 65 years. this data suggests that early rituximab in monotherapy could increase the proportion of patients who will never need chemotherapy.

Although these results have shown a clear improvement in TTNT in groups with Rituximab compared to the Vigilante waiting group. there was no 15 -year advantage early rituximab significant improvement in patients who received maintenance treatment compared to those who received an induction alone. It is therefore not possible to conclude that maintenance by Rituximab has an additional advantage in this context.

In total. these data demonstrate that early monotherapy by Rituximab considerably increases the proportion of patients with asymptomatic follicular lymphoma with low tumor load at an advanced stage which does not require new treatment over 15 years, without negative impact on 2th New treatment, and without effect on the incidence of transformation into high grade lymphoma or overall survival. Early monotherapy by Rituximab could therefore be considered as a standard treatment option for these patients.

15 -year advantage early rituximab — 15 -year advantage early rituximab: Studies relating to asymptomatic low grade lymphomas. at an advanced stage, with low tumor load have shown no reduction in overall survival when the treatment was postponed to symptomatic progression. Vigilant 15 -year advantage early rituximab expectation is therefore an accept.

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briar.mckenzie
briar.mckenzie
Briar’s Seattle climate-tech dispatches blend spreadsheet graphs with haiku about rain.
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