Safety and use of bendamustine from the Bendamustine Expanded Access Trial in Canada (Bend-ACT).
Bibliographic record
Abstract
e19542 Background: Bendamustine (B) is widely used in the treatment of indolent non-Hodgkin’s lymphoma (iNHL) and chronic lymphocytic leukemia (CLL). Methods: An expanded access trial with the primary objective of safety was conducted at 16 centres across Canada and enrolled patients (pts) from March 2012 to June 2013. Eligible pts were at least 18 years old, able to provide informed consent with relapsed/refractory iNHL and were previously treated with a rituximab-containing regimen or previously untreated for CLL, and had an ECOG performance status 0-2 and good organ function. Pts with iNHL received up to 8 cycles of B (120mg/m2) on days 1 and 2 every 21 or 28 days; pts with CLL were given B 100 mg/m2on days 1 and 2 every 28 days for up to 6 cycles. Dose adjustment algorithms were followed for toxicities. Pts were followed for up to 6 weeks after completion of treatment. Results: Ninety pts started on treatment (74 iNHL;16 CLL). The mean age was 64(range 40–90), 44% of the CLL pts were at least 70 years old. For iNHL pts, 77% were treated on a 28-day schedule, with a median of 6 cycles of treatment and 24.3% of pts received 8 cycles. Median time on treatment was 137 days (28–224 days). For CLL pts the majority received at least 3 cycles and median time on treatment was 91 days (28–168 days). All pts reported at least one adverse event (AE). Grade 3 or 4 toxicities resulted in dose delays in 31.1% of pts, with hematological toxicities being the most common reason (24.4%). Serious AEs were reported in 36.7% of pts and included fever (10%), gastrointestinal events (6.6%), febrile neutropenia (5.6%), pneumonia (5.5%), renal failure (3.3%), hypotension (2.2%), syncope (2.2%) and tumor lysis syndrome (2.2%). Overall mortality was 4.4%. AEs associated with death included Pneumocystis jiroveci pneumonia, multi-organ failure (the only fatal AE deemed probably related to treatment), cardiac arrest, respiratory failure, and abdominal pain. Conclusions: In this expanded access trial, hematological toxicities were the most frequent reason for dose delays whereas infections or fever were the most common reason for serious AEs. Overall, the toxicity and safety profile of single agent B is consistent with other published studies in a similar pt population. Clinical trial information: NCT01500083.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".