A Phase II Trial of Erlotinib as Maintenance Treatment After Gemcitabine Plus Platinum-based Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma
Bibliographic record
Abstract
BACKGROUND: Despite the efficacy of gemcitabine-platinum regimen, the outcome of patients with recurrent and/or metastatic nasopharyngeal carcinoma (RM NPC) is poor. A phase II trial was conducted to determine the efficacy of erlotinib, given as maintenance therapy after gemcitabine-platinum chemotherapy in patients with RM NPC. PATIENTS AND METHODS: Patients were treated with gemcitabine 1000 mg/m on days 1 and 8 as well as cisplatin 70 mg/m on day 1 (or carboplatin area under curve 5 on day 1, if contraindication to cisplatin) 3 weeks. After 6 chemotherapy cycles (or before in case of progression), patients were switched to erlotinib 150 mg/d 4 weeks. Primary end point was time to progression in patients without progressive disease after 6 chemotherapy cycles and treated with maintenance erlotinib. Epstein-Barr virus DNA plasma levels, measured using quantitative real-time polymerase chain reaction, were correlated with outcome. RESULTS: Of 20 enrolled patients, 19 patients received 96 chemotherapy cycles. Fifteen patients were switched to erlotinib and received 36 cycles (range: 1 to 6 cycles). Safety profiles observed with the chemotherapy combination and erlotinib were those expected. Of 12 patients evaluable for response to erlotinib, all progressed except 3 patients (25%) who had stable disease for 3, 4, and 7 months, respectively. Median time to progression was 6.9 months for 13 patients without progressive disease after 6 chemotherapy cycles and treated with erlotinib. No correlation was identified between Epstein-Barr virus DNA plasma levels and clinical outcome. CONCLUSIONS: Maintenance or second-line therapy with erlotinib after chemotherapy was not effective in RM NPC. Historical comparison with patients treated with the same chemotherapy alone until progression suggests that it may be detrimental to stop chemotherapy after 6 cycles if disease did not progress.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".