Weekly <i>nab</i>-paclitaxel in combination with carboplatin as first-line therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC): Analysis of patient-reported neuropathy and taxane-associated symptoms.
Bibliographic record
Abstract
TPS7618 Background: Neuropathy and its associated symptoms are dose-limiting toxicities of taxane-based regimens. Measuring disease symptoms has utility for maintaining a balance between the benefits and costs of treatment. In a phase III trial nab-paclitaxel (nab-P, 130 nm albumin-bound paclitaxel particles) + carboplatin (C) vs solvent-based paclitaxel (sb-P) + C significantly improved the primary endpoint of overall response rate (ORR) (25% vs 33%, P = 0.005), with a 1-month improvement in median overall survival (OS; P = NS), and an improved tolerability profile in pts with advanced NSCLC. Here we report on patient-assessed neuropathy and taxane-associated symptoms, important factors in a palliative patient setting. Methods: Pts with untreated stage IIIB/IV NSCLC were randomized 1:1 to C AUC 6 day 1 and either nab-P 100 mg/m2 on days 1, 8, 15 (n = 521) or sb-P 200 mg/m2 day 1 (n = 531) q 21 days. Treatment was continued until disease progression. Safety was assessed per the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. The mean change from baseline to day 1 of each cycle for the neuropathy, pain, and hearing subscales of Functional Assessment of Cancer Therapy (FACT)‑Taxane v 4.0 were assessed. Results: 1031 (98%) pts completed FACT-Taxane at baseline, and 987 (94%) during follow-up or at completion of treatment. Baseline scores for neuropathy and pain were well balanced. Significant treatment effects favoring nab-P/C were noted for patient-reported neuropathy (P < 0.001), neuropathic pain hands/feet (P < 0.001), and hearing loss (P = 0.002). Physician-assessed rates of neuropathy were significantly lower in the nab-P/C arm vs the sb-P/C arm: 47% vs 63%, P < 0.001, all grades; 3% vs 12%, P < 0.001, grade 3/4, respectively. More pts treated with nab-P/C vs sb-P/C had no neuropathy (53% vs 47%, P < 0.001). Conclusions: nab-P/C was associated with statistically and clinically significant reductions in patient-reported neuropathy, neuropathic pain in the hands and feet, and hearing loss compared with sb-P/C. Patient-reported outcomes for neuropathy were consistent with physician assessment.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 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".