Updated survival analysis of JBR.10: A randomized phase III trial of vinorelbine/cisplatin versus observation in completely resected stage IB and II non-small cell lung cancer (NSCLC)
Bibliographic record
Abstract
7501 Background: JBR.10 was one of a number of phase III trials that established adjuvant cisplatin based chemotherapy as a recommended treatment in completely resected NSCLC . Long-term follow-up of these trials is important to document persistent benefit and potential late toxicities of adjuvant therapy. We report the updated survival data for JBR.10 with more than 9 years median follow up. Methods: Patients with completely resected stage IB (T2N0) or II (T1–2N1) NSCLC were randomized to receive 4 cycles of vinorelbine/cisplatin or observation.. Kaplan-Meier curves were generated for overall (OS) and disease specific survival (DSS). Log-rank test was used to compare survival distribution and to test cause specific hazard. For the competing risk analysis, the Gray test was used to test the difference in cause specific incidences. All efficacy analyses were done on an ITT basis. Results: 482 patients were randomized. Data cut-off for this update was July 2008. Median follow-up is 9.3 years (3.2–13.8 y). 12 patients were lost to follow up, a median 4.9 years from randomization (1.5–12 years). 271 deaths have occurred, 73% due to lung cancer or its treatment. Survival analysis continues to show a benefit for chemotherapy: HR .78 (CI .61-.99, p=.04). The benefit appears to be confined to N1 patients: median OS 6.8 y versus 3.6 y, HR .68 (CI .5-.92, p=.01). N0 patients did not appear to benefit: HR 1.03 (CI .7–1.52, p=.87). Chemotherapy significantly prolonged DSS, HR.73 (CI .55-.97, p=.03) Competing risk analysis showed observation to be associated with significantly higher risk of death from lung cancer (p=.02) with no difference in incidences of death from other causes between arms (p=.62). Conclusions: Prolonged follow-up of patients in the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy. This benefit appears to be confined to N1 patients. There was no increase in death from other causes in the chemotherapy arm. [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 | 0.008 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 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".