Bendamustine HCl (TREANDATM) Treatment Results in High Rates of Objective Response in Patients with Rituximab-Refractory and Alkylator-Refractory Indolent B-Cell Non-Hodgkin’s Lymphoma (NHL): Results from a Phase II Multicenter Single-Agent Study (SDX-105-01).
Bibliographic record
Abstract
Abstract Background: Bendamustine HCl (TreandaTM) is a multifunctional, alkylating agent with novel mechanisms of action. Unlike other commonly used chemotherapeutic agents, bendamustine in vitro induces durable cell damage resulting in rapid cell death in apoptosis-resistant cancer cell lines through the apoptosis independent pathway of mitotic catastrophe. European studies have reported single-agent activity in patients with relapsed/refractory NHL, chronic lymphocytic leukemia, multiple myeloma, and breast cancer. Aim: This study evaluated the efficacy and toxicity of bendamustine in patients with NHL who have relapsed or are refractory to previous chemotherapy regimens. Patients refractory to Rituximab had disease progression within 6 months of treatment. Methods: This Phase II multicenter trial enrolled patients with relapsed indolent or transformed rituximab-refractory B-cell NHL from 17 sites in the US and Canada. Indolent histologic phenotype was seen in 84% of patients, while 16% had transformed disease. Median age of patients was 63 years (range: 38–84) and 88% had Stage III/IV disease. Patients received bendamustine 120 mg/m2 IV over 30–60 minutes, days 1 and 2, every 21 days for up to 6 cycles. Response was measured using the International Working Group criteria. Results: The intent-to-treat (ITT) population consisted of 75 heavily pretreated patients with a median of 2 prior chemotherapies. The overall objective response rate (ORR) in the ITT population was 74%; 25% had a complete response, 49% had a partial response, 12% had stable disease, and 14% had disease progression. Of 15 patients who were refractory to prior alkylator treatment (patients who progressed after at least one prior alkylator-containing therapy), 10 (67%) experienced an objective response to bendamustine. The median duration of response was 6.6 months for all patients, 9.3 months for indolent patients, and 2.4 months for transformed patients. The most frequent nonhematologic adverse events were nausea (63%), fatigue (39%), vomiting (38%), fever (25%), and diarrhea (22%). Most of these events were grade 1 or 2; alopecia and hemorrhagic cystitis were not observed. Grade 3 or 4 reversible hematologic toxicities seen included neutropenia (47%), thrombocytopenia (24%), and anemia (11%). Conclusions: Single-agent bendamustine produced durable objective responses with acceptable toxicity, despite unfavorable prognostic features, in heavily pretreated rituximab-refractory indolent and transformed NHL patients. Durable response has been seen in alkylator-resistant patients. A Phase III trial with bendamustine as a single agent in patients with rituximab-refractory indolent NHL is ongoing.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".