SUNCAP, a phase II study with sunitinib and capecitabine in patients with metastatic colorectal cancer (MCRC) refractory to previous treatment with 5FU/irinotecan/oxaliplatin.
Bibliographic record
Abstract
545 Background: Patients (pts) with MCRC refractory/resistant to Irinotecan and Oxaliplatin have a poor prognosis. Sunitinib is an oral TKI that selectively inhibits the VEGFR 1, 2, 3, PDGFR and FLT3, CSF-1R, RET. Phase II studies with single agent sunitinib in patients with MCRC did not demonstrate a meaningful ORR but showed acceptable safety profile and warranted further study. Methods: We conducted a phase II escalating dose of sunitinib (S) and capecitabine (C) to assess the efficacy of this oral treatment given on a 2 wks every 3 wks schedule, (level 0, S: 37,5 mg, C: 2,000mg/m2, level +1, S: 50 mg, C: 2,000 mg/m2, level +2, S: 50 mg, C: 2,500 mg/m2 and level -1:S: 25 mg, C: 1,500 mg/m2. Treatment was initiated at level 0 and increased at level +1 and +2 at cycle 3 and 5 if no grade 2/3 toxicity was observed. Between 02.2009 and 06.2010, 15 pts previously exposed to oxaliplatin/irinotecan/bevazizumab were enrolled, all of them had progressive disease at the time of study entry. Primary objective was ORR. Treatment was given until PD or unacceptable toxicity. Results: Pts characteristics were: sex: 12M/3F, median age: 65 years [41-75], primary tumors: colon: 13, rectum: 2, ECOG PS 0/1: 8/7, median nb of metastatic sites: 3, KRAS status: WT/MT/Unknown: 1/9/5. Escalating to level +1:53%, level +2: 7%. Median nb of cycles received/pt: 5. All pts were evaluable for toxicity (tox): SAEs: 40%, any tox. grade 1/2/3(%): 93/60/ 40. Neutropenia gr. 1/2/3(%): 13/13/7, thrombocytopenia gr.1/2/3(%): 13/20/7. Fatigue gr.1/2/3(%): 27/20/7. Nausea gr.1: 27%. Diarrhea gr.1: 13%. Hand foot syndrome gr. 1/2/3 (%): 13/13/27. Mucositis gr. 1/2/3(%): 7/20/7. Hypertension gr.2: 13%. Thyroïd gr.1: 27%. ORR (CR+PR): 0%, confirmed SD: 7/15: 47%, PD: 8/15: 53%. Median PFS: 137 days [95%CI: 112-162], median OS: 291 days [95%CI: 99-482]. Conclusions: In this heavily pretreated patients, sunitinib in combination with capecitabine appears feasible, with acceptable toxicity. 47% of patients had a confirmed stable disease. Although no objective response was observed, the high level of stable disease may suggest a role of this combination for maintenance therapy. [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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 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 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| 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".