Quality of life (QOL) in a phase III randomized trial of standard fractionation radiotherapy (SFX) with concurrent cisplatin (CIS) versus accelerated fractionation radiotherapy (AFX) with panitumumab (PMab) in patients (pts) with locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN): NCIC Clinical Trials Group HN.6 (NCT00820248).
Bibliographic record
Abstract
6053 Background: Addition of concurrent anti-EGFR monoclonal antibody to radiotherapy alone did not worsen QOL (Curran 2007). We compared standard chemoradiotherapy (cRT) to bioradiotherapy (bRT). Methods: Pts with T any N+M0 or T3-4N0M0 untreated LA-SCCHN were randomized 1:1 to receive SFX (70Gy/35/7 weeks) plus CIS at 100 mg/m2intravenous (IV) for 3 doses on weeks 1, 4 and 7 versus AFX (70Gy/35/6 weeks) plus the anti-EGFR monoclonal antibody PMab at 9 mg/kg IV for 3 doses on weeks -1, 3 and 6. QOL was collected at baseline, end of RT, and 2, 4, 6, 12, 24 and 36 months post-RT using validated instruments FACT-H&N, MDADI and SWAL-QOL. All analyses were intent-to-treat. We hypothesized a 6-points more favourable change in FACT-H&N score from baseline to 1 year post-treatment in the bRT arm relative to cRT. Results: From 12/2008 to 11/2011, 320 pts were randomized, 160 to cRT and 160 to bRT, with median follow-up of 46.4 (range: 0.1-64.3) months. Median age 56, 84% male, ECOG PS 0 (71%), 1 (29%). Primary site was oropharynx in 81% (p16 +68%, - 11%, missing 21%), larynx (11%), hypopharynx (6%), oral cavity (2%). Smoking history was > 10 pack-years in 58%, < = 10 in 12%; 28% were never-smokers. All compliance exceeded 80%. Baseline scores did not differ by arm (cRT/bRT): FACT-H&N 110/110, MDADI Global 83/77, SWAL-QOL General 67/68. At 1 year, no statistically or clinically significant difference was seen between arms in FACT-H&N change from baseline: cRT 4.23, bRT 1.88, p = 0.129. Differences were only seen during the last week of radiotherapy, for (cRT: bRT): FACT-Physical Well-Being (-11.6, -10, p = 0.049), MDADI Physical subscale (-40.4, -33.9, p = 0.045), and SWAL-QOL Eating Duration (-61.2, -51.2, p = 0.02), Eating Desire (-53.3, -43.9, p = 0.031) and Mental Health (-42, -32.6, p = 0.009). No differences by arm on any scale were seen post-treatment. Conclusions: Despite transient benefits at the end of RT, the combination of PMab with AFX did not durably improve QOL as compared to SFX with CIS. Clinical trial information: NCT00820248.
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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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.005 | 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".