Bevacizumab (B) plus erlotinib (E) for patients (pts) with recurrent ovarian (OC) and fallopian tube (FT) cancer: Preliminary results of a multi-center phase II trial
Bibliographic record
Abstract
5018 Background: The epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are commonly over-expressed in OC and correlate with poor prognosis. The anti-VEGF antibody B and the EGFR tyrosine kinase inhibitor E have each demonstrated activity in OC. Dual inhibition with BE may overcome mechanisms of resistance encountered with either agent alone. Methods: We are conducting a 2-stage phase II trial of BE in pts with recurrent OC, primary peritoneal, and FT cancer. Eligible pts had ≤ 2 prior chemo regimens for recurrent or refractory disease; no prior VEGF or EGFR inhibitors; ECOG performance status (PS) 0–2; measurable disease; normal organ function; no proteinuria (<1000 mg/24 hours). B 15 mg/kg was given IV on day 1 every 21 days and daily E 150 mg PO was given continuously. CT scans were obtained every 9 weeks. 2 responses are required in the first stage to justify accrual into a second stage. Results: 13 pts enrolled at 3 centers from 7/05 to 10/05. Median age: 56 (range 45–70). PS (N with 0/1/2): 6/4/3. Primary site (N): OC 11, FT 2. Primary platinum response (N): refractory 4, resistant (<12 mo PFS) 2, sensitive (≥12 mo) 7. Total prior chemo regimens (N with 1/2/3): 1/8/4. 55 cycles of BE have been delivered (median 4, range 1–8). 12 pts are evaluable for response (1 too early). There has been 1 major response (8%). 8 patients (67%) had stable disease (SD). 1 pt with SD met 75% CA-125 response criteria. 8 pts remain on study. Median PFS has not been reached (median f/u 2.2 months). Attributable toxicities (N with grade 1/2/3/4): rash 4/7/0/0, diarrhea 6/1/2/0, stomatitis 3/1/0/0, myalgias 4/0/0/0, proteinuria 3/0/0/0, bilirubin 0/2/0/0. There were 2 bowel perforations (grade 3/4): both had 2 prior regimens, peritoneal implants >1 cm, 3 doses of B (last was 10 and 42 days prior), and small bowel obstructions in the preceding 28 days. Conclusions: The first stage of accrual is complete and further enrollment is on hold pending continued efficacy evaluation. There appeared to be an increased rate of bowel perforation, and identification of potential risk factors for this event would be critical for further development of this combination. Updated results will be presented. Supported by NCI Grant N01-CM-17102. [Table: see text]
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".