A phase I/II study of OGX-011 and a gemcitabine (GEM)/platinum regimen as first-line therapy in 85 patients with advanced non-small cell lung cancer
Bibliographic record
Abstract
7596 Background: OGX-011 is a second-generation antisense oligonucleotide designed to knockdown expression of the cytoprotective chaperone, clusterin, thereby facilitating apoptosis and sensitization of many human cancer cell-lines to chemotherapy. Methods: Eligibility criteria: stage IIIB/IV NSCLC; no prior chemotherapy; =1 measurable lesion; ECOG =1; adequate organ function; no active CNS metastasis. Treatment: infusion of OGX-011 initial loading doses (3 in 1 week), followed by weekly OGX-011 with standard chemotherapy: GEM (1,250 mg/m2) Days 1+8 and either cisplatin (75 mg/m2) or carboplatin (AUC=5) Day 1 q21 days, (maximum 6 cycles). Results: 85 pts (phase I=10 and phase II=75) enrolled between Dec 04 and Nov 06. Based on phase I results, dose of OGX-011 was 640 mg. Data is available on the first 53 pts; all received =1 dose of OGX-011 and were considered evaluable for safety and efficacy. Demographics: female (47%); stage IV (87%); median age 61 (45–79) yrs; ECOG PS =1 (62%); median no. of cycles delivered was 4. Principal grade 3/4 toxicities were hematologic: neutropenia (32%) + thrombocytopenia (17%). Other common toxicities included fatigue, nausea, vomiting, fever, chills, constipation, + anorexia. Two serious adverse events previously reported as associated with GEM/platinum therapy were documented: acute cortical blindness with stroke + thrombotic thrombocytopenic purpura. Responses: 12 confirmed PR (ORR = 23%). Median PFS is 101 days (53–260+). Of the first 24 patients who have all been followed for =1 yr, median survival is 383 days (19–751+); 14/24 (58%) survived >1 yr; 10/14 remain alive as of 12/13/06. Conclusions: 1-yr survival rate =50% may justify a phase III randomized trial. Survival data on 46 pts followed for =1 yr will be presented. OGX-011 is being developed by OncoGenex Technology Inc. + Isis Pharmaceuticals Inc. No significant financial relationships to disclose.
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 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".