Efficacy, safety, and cost efficiency of rituximab, gemcitabine, dexamethasone, and oxaliplatin (RGDOx) in B-cell NHL: Report of the prospective multicentric trial NCT01019863.
Bibliographic record
Abstract
8581 Background: Cisplatinum-based 2nd line therapy is poorly tolerated. We evaluated the activity and toxicity of an outpatient RGDOx regimen Methods: Patients (pts) with CD20+ NHL, without limitation of age, general condition or prior treatments, were eligible for up to 8 biweekly cycles of rituximab 375 mg/m², gemcitabine 1000 mg/m², oxaliplatin 100 mg/m² on day 1 and dexamethasone 40mg/day orally on day 1- 3. Toxicity was reported according to NCI criteria. Response was assessed at mid and end of treatment. Pts were followed up to 24 months. Costs were collected on per diem canadian interprovincial rates and hospital pharmacy medication costs as of Oct. 2011. Results: The planned 50 pts were included from 2009 to Jan. 2013. Two died before starting therapy and were not included in this analysis; 17 females, 31 males, median age 70 (47 - 86) yrs with relapsed (37) or refractory (11) B-NHL (DLBCL 25, FL 8, MCL 11, Richter 2 and CLL 2). 83% had stage III/IV disease, aaIPI / FLIPI ≥2 (85%), median Charlson co-morbidity score of 4, average 2 (1-8) previous treatment lines, 47 previously treated with rituximab and 9 with cisplatin. A total of 250 cycles were given. This was well tolerated. Common grade I-II AE: Sensory neuropathy 66%, diarrhea 36% asthenia 35%, and bone pain 18%. Grade III/IV: Lymphopenia 12%, neutropenia 3% and thrombocytopenia 4%. Two died after 1 and 3 cycles, before documenting response. The overall response was 57% (n=46, CR 40%, PR 17%, PD: 43%). DLCBL (40%, 8%, 52%), FL (38%, 25%, 38%), MCL (50%, 20%, 30%). The median survival was 18.4 months (n=48) and disease-free median survival among responders was 15.7 months (n=27). Refractoriness to previous treatment or response lasting less than 12 months was associated with poorer outcome. Previous cisplatin therapy tended to predict lower response. Average 6-cycle course was associated with 4.8 days of hospitalization, 0.7 medical visits for iatrogenic side effects and 7.3 visits for additional laboratory tests. Mean cost for 6 cycles of RGDOX was $Can 54,991 with a median cost per life year of $Can 35,863. Conclusions: RGDOx is safe, effective and cost-effective for relapsing/refractory B-Cell NHL. Clinical trial information: NCT01019863.
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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 | 0.008 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".