Results from a randomized study of carboplatin and etoposide (CE) with or without palifosfamide (Pa) in extensive stage small cell lung cancer (ES-SCLC): The MATISSE study.
Bibliographic record
Abstract
7504 Background: Extensive stage small cell lung cancer (ES-SCLC) is a disease with high mortality. SCLC is initially exquisitely sensitive to chemotherapy with carboplatin and etoposide (CE), considered the standard first-line regimen in ES-SCLC in the US. In a previous phase III trial, the combination of cisplatin, etoposide, and ifosfamide (VIP) improved overall survival (OS) as compared to cisplatin and etoposide in ES-SCLC but with increased toxicity (JCO 13: 2594-2599,1995). Palifosfamide (Pa), a bi-functional DNA alkylator is the active metabolite of Ifosfamide that does not generate toxic metabolites facilitating its combination with CE. This trial was therefore pursued comparing CE with or without Pa in ES SCLC. Methods: This was a multi-center, open-label trial in chemotherapy-naive patients (pts) with ES SCLC with planned enrollment of 548 pts. Pts were randomized 1:1 to receive CE (C at AUC 5mg/mL/min day 1 with E 100mg/m2/day days 1-3) or PaCE (Pa at 130mg/m2/day, E at 100mg/m2/day both on days 1-3 and C at AUC 4mg/mL/min day 1). The primary endpoint was overall survival (OS). The secondary endpoints included progression-free survival, objective response rate, and quality of life assessment. Pts were stratified based on age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status. Results: The MATISSE trial closed prematurely in light of the negative phase III trial evaluating the addition of Pa to doxorubicin in sarcoma (PICASSO). ES-SCLC pts (N = 188) were randomized to CE (n = 94) or PaCE (n = 94). Pt characteristics were well balanced with median age of 61 and the majority of pts having an ECOG PS of 0-1. Median OS in the Intent to treat population was 10.0 months (95% CI: 7.7-10.5) with PaCE and 10.4 months (95% CI: 8.7-13.4) with CE (p value 0.096). Serious treatment-related adverse events were observed in 28.3% pts receiving PaCE and 27.5% pts receiving CE with febrile neutropenia occurring in 4.3% of pts on PaCE arm and 5.5% of pts on CE arm. Conclusions: The addition of Pa to CE did not improve survival in ES-SCLC. The safety profile was as anticipated and the addition of Pa did not lead to increased toxicity. Clinical trial information: NCT01555710.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".