A phase II study to assess the efficacy of combined preoperative irinotecan (I)/cisplatin (C) chemotherapy and conformal radiotherapy (RT) followed by surgery for potentially resectable esophageal cancer
Bibliographic record
Abstract
4063 Background: Five-year survival for locally advanced esophageal cancer is < 20%. Whereas primary surgery is generally recommended, preoperative chemotherapy-RT (CRT) has shown potential to impact on survival. In combination with RT, I and C appear well tolerated. Efficacy is assessed in this phase II trial. Methods: Eligible patients with squamous cell (SCC) or adenocarcinoma of the thoracic esophagus or gastroesophageal junction, technically resectable, without distant metastases, were treated with induction CRT and a RT boost. I (65 mg/m2) plus C (30 mg/m2) were given weeks 1, 2, 4, 5, 7 and 8 with concurrent RT (40 Gy/20) during weeks 4–8. The RT boost was either conformal (10 Gy) or brachytherapy (5 Gy). After a 4–8 week interval and re-staging, the patients underwent resection. Quality of life (QOL) was evaluated using the FACT-E scale. Results: Twenty-one of a planned 30 patients have been entered, 16 have completed CRT and 14 have had their surgery so far. There were 15 men and 6 women, mean age of 58 ±10 yrs, 16 adenocarcinoma and 5 SCC. Twelve out of 14 patients (80%) with baseline severe dysphagia reported resolution after the first 2 weeks of chemotherapy eliminating the need for feeding tube support. There have been no treatment-related deaths. Grade 3 neutropenia was seen in 31% but no patients experienced febrile neutropenia. There was no grade 3/4 GI toxicity. Operative mortality was 0 % and 13/14 patients had R0 resections. Postoperative complications included anastomotic leak (3/14), atrial fibrillation and pneumonia (2/14). Clinical RRs: 1 CR, 5 PR, 8 SD and no PD by RECIST criteria. Pathological responses (histological evaluation of entire tumor site) include 3 pCRs and 10 PRs, 2 of which were minimal residual disease. Conclusions: Induction therapy with concurrent irinotecan / cisplatin and RT was well tolerated and did not appear to prevent resection, or increase operative morbidity and mortality. The overall pathological RR of 92% is encouraging and updated clinical, pathological and QOL data will be presented. Generously supported by Pfizer 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 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| 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".