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Posted by on May 12, 2018 in Non-Hodgkin lymphoma | 0 comments

In a nutshell

This study investigated the outcomes of patients with indolent (painless) refractory (does not respond to treatment) non-Hodgkin’s lymphoma (NHL) after G-B (obinutuzumab, bendamustine) treatment. This study concluded that G-B improved survival outcomes for NHL patients with similar side effects as bendamustine (Treanda) monotherapy.

Some background

Follicular lymphoma (FL) is the most common type of non-Hodgkin’s lymphoma (NHL). The current standard first-line treatment for these patients is immunochemotherapy. This type of treatment combines immunotherapy and chemotherapy to stimulate the immune system to attack and destroy cancer cells. Rituximab (Rituxan) is often the first immunotherapy choice.

However, many patients relapse or develop refractory disease after initial treatment. These patients have limited options, and outcomes remain poor. Obinutuzumab (G) plus bendamustine (B) is a new combination under investigation for patients with rituximab-refractory NHL. Whether this treatment is safer and more effective than bendamustine alone is unclear.

Methods & findings

This study involved 413 patients with NHL. The most common subtype was follicular lymphoma (FL; 81.1%) of grade 1 – 2 (61.5%). All patients had disease that did not respond to prior rituximab treatment. Patients received G-B (49.4%) or bendamustine alone (B monotherapy, 50.6%). G-B patients who did not have disease progression also received G (obinutuzumab; Gazyva) maintenance for up to 2 years. The average follow-up period of the study was 31.8 months.

For all patients, the average progression-free survival (PFS; time from treatment before disease progression) at follow-up was 25.8 months (G-B) and 14.1 months (B monotherapy). For FL patients, the average PFS was 25.3 months (G-B) and 14.0 months (B monotherapy). G-B treatment decreased risk of disease progression by 43% (all patients) and 48% (FL patients).

Overall survival (OS; time from treatment until death of any cause) data was not available. At follow-up, 25.5% (G-B) and 34.9% (B monotherapy) had died, most commonly due to disease progression. G-B treatment decreased mortality risk by 33% (all patients) and 42% (FL patients). This difference was statistically significant.

72.5% (G-B) and 65.5% (B monotherapy) of patients reported moderate, severe, or life-threatening side effects. The most common side effects included low white blood cell count (G-B, 34.8%; B monotherapy, 27.1%), low platelet count (G-B, 10.8%; B-monotherapy, 15.8%), and anemia (7.4%, G-B; 10.8%, B monotherapy). Fever with low white blood cell count (G-B, 5.4%), pneumonia (G-B, 3.4%; B monotherapy, 5.9%, and sepsis (3.4%) also reported. 20.1% (G-B) and 17.2% (B monotherapy) discontinued treatment due to side effects.

The bottom line

This study concluded that G-B improved survival outcomes for NHL patients with similar side effects as bendamustine monotherapy. The authors suggested that G-B is the preferred treatment option for FL patients with rituximab-refractory disease.

Published By :

Journal of clinical oncology

Date :

Mar 27, 2018

Original Title :

Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study.

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