Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1

Combination Therapy

Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.

Droga: Rituximab

Otros nombres:

• MabThera

Radiación: Quimioterapia

Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE

The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.

Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)

Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.

Percentage of Participants With CR According to International Working Group Response Criteria for NHL

Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.

Percentage of Participants Alive at 1, 2, and 3 Years

Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as [number of participants alive divided by the number analyzed] multiplied by 100.