Table 1.
Infection outcomes for frontline bendamustine plus anti‐CD20 mAbs according to the standard schedule a in patients with follicular lymphoma (FL) and/or other indolent B‐cell lymphomas (i‐BCLs), reported by the three trials analyzed in the present manuscript
| Author, year | Type of study | Type of underlying hematological disease (number of cases) | Median age, (range) | Features for start immunochemotherapy (percentage of patients) | Antimicrobial prophylaxis (percentage of patients) | Nadir, ANC cells/ul, median count (range) | Outcomes reported |
|---|---|---|---|---|---|---|---|
| Djebbari et al, 2020 3 | Retrospective (single‐center) | FL, 41 | 56 y (28‐83) |
Ann Arbor stages III‐IV (98) Anemia (27) Bone marrow involved (63) LDH > 240 U/L (39) FLIPI intermediate/high risk (71) |
Acyclovir (100) G‐CSF (22) |
1900 (0‐6100) |
Infections, 63.4% (including all grades) b High‐grade documented infection episodes, 23; Deaths from infection, 2 |
| Cerchione et al, 2017 5 | Prospective (interventional, single‐center) |
FL, 42 i‐BCLs, 19 |
45.4 y (33‐77) |
Ann Arbor stages III‐IV (98) B symptoms (31) Bone marrow involved (69) Extranodal involvement (74) LDH > 240 U/L (34) FLIPI intermediate risk (31) FLIPI high risk (57) |
Primary prophylaxis with pegfilgrastim (100) | 1734 (880‐2110) |
Infections, 11.4% (including FN, 2 cases; FN with clinically documented infection at the lower respiratory tract, 3 cases; FN with microbiologically documented infection, 2 cases [1 Gram‐positive, 1 serum CMV‐DNA positivity]; Infectious complication‐related hospitalizations, 4.9%. Chemotherapy disruptions, 1.6% |
| Giordano et al, 2019 6 | Prospective (interventional, single‐center) | FL, 67 | 63 y (60‐82) |
Ann Arbor stages III‐IV (90) B symptoms (31) Bulky disease (30) Bone marrow involved (59) Extranodal involvement (70) FLIPI intermediate risk (41) FLIPI high risk (60) |
Primary prophylaxis with long acting G‐CSF, trimethoprim‐sulfamethoxazole, and acyclovir (100) | 1646 (980‐2990) |
Infections, 6% (including FN with clinically documented infection at the lower respiratory tract [1 case] and gastrointestinal tract [2 cases]; FN with microbiologically documented infection, 1 case [bacteremia due to Gram‐negative]; Infectious complication‐related hospitalizations, 3%. Chemotherapy disruptions, 3% |
Primary antimicrobials prophylaxis: pegfilgrastim/lipegfilgrastim (6 mg, s.c.) on day 4 of each immunochemotherapy cycle (from the first until the last 4‐wk cycle); trimethoprim‐sulfamethoxazole (960 mg bid die, twice a week) and acyclovir (400 mg bid die) from day 1 until 6 mo after the last cycle in all patients.
Stage III, defined as multiple lymph node groups on both sides of the diaphragm; stage IV, defined as multiple extranodal sites or lymph nodes and extranodal disease. 2
FLIPI score. Five factors included were as follows: age older than 60 y, serum lactate dehydrogenase (LDH) above normal, Ann Arbor stage III or IV, nodal involvement at more than 4 sites, and hemoglobin level <12 gr/dL. Each factor gets 1 point, and possible scores range from 0 to 5. A higher score indicates poorer prognosis. 2
ANC, absolute neutrophil count.
G‐CSF, granulocyte colony‐stimulating factors.
FN, febrile neutropenia is one of the most important clinical signs of infection during chemotherapy treatment and is characterized by an absolute neutrophil count (ANC) <1000/mm3 and at least one temperature measuring of ≥38°C.
mAbs, monoclonal antibodies.
Chemotherapy disruptions: If the leukocyte count was less than 2000/mm3 before a scheduled cycle, treatment cycle was delayed for at least 1‐wk (time disruption), or bendamustine dose was reduced to 70 mg/m2 if leukocyte count less than 1000/mm3 was noted on two consecutive days between cycles (dose disruption).
Immunochemotherapy treatment included intravenous bendamustine (90 mg/m2 given over 30‐60 min on days 1 and 2 of each cycle) plus rituximab (375 mg/m2 on day 1 of each cycle), every 4 wk for up to 6 cycles 2 in the Cerchione et al's study 5 and Giordano et al's study 6 ; in the Djebbari et al's study 3 32 patients received rituximab‐bendamustine, while 9 patients received obinutuzumab‐bendamustine (number of cycles and dosages are not reported).
According to the Common Terminology Criteria for Adverse Events (version 4).