AZD2171 (Cediranib) is active in first line metastatic renal cell carcinoma (RCC): Interim results of a phase II trial. A trial of the PMH Phase II Consortium.
Bibliographic record
Abstract
A10 Background: AZD2171 is a potent VEGF signaling inhibitor of all 3 VEGF receptors, with additional activity against c-Kit. It has been shown in preclinical models to inhibit angiogenesis and block tumor growth.Agents targeting the VEGFR have been shown to be particularly active in first-line metastatic RCC. Methods: In this phase II study, AZD 2171 45 mg daily was administered to pts with adv/met RCC, ECOG 0-2, who had no prior cytokine or anti-angiogenic therapy. The primary endpt was tumor control rate (OR+SD). Secondary endpts were median and 6mo PFS, MS, OS, and toxicity. DCE-MRI used to assess changes in blood flow and permeability during treatment. pK studies were done on d8, 15, 28. Pre and post rx levels of soluble markers of angiogenic growth factors and receptors and CEC have been collected for analysis at study completion. Results: 32 pts. (M: F 3:29; PS 0:1 17:15, prior RT 7pts) were accrued from Jan/06-Apr/07. Twenty-nine pts. were evaluable for response (2 too early, 1 never received drug). Best objective response by independent review: 9 confirmed PR (incl. 1 unconfirmed CR), 2 unconfirmed PR, 11 SD (8 had shrinkage >20% not sufficient for PR), 4 PD, 3 inevaluable. Median PFS 8.7mo and 6mo was PFS 55%. Most common AE (32 evaluable pts) fatigue, diarrhea, hypertension, inc. creatinine, voice changes. Grade 3+ AE hypertension, fatigue, joint pain, abdominal pain, and dyspnea. 22/29 pts required dose reductions to 30mg(13pts) and 20mg (9pts) respectively. 13 pts remain on treatment with accrual ongoing to target 37 evaluable pts. Conclusions: AZD2171 (Cediranib) shows activity in first-line metastatic RCC with an OR of 9/29=31%(14-48%), and clinical benefit rate (PR+SD) 22/29=76%(56-89%). Updated information including pK and DCE-MRI results will be available at time of presentation.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".