2017 Section 7 Green Book

HRQOL Before and After HNSCC/Rettig et al

TABLE 1. Study Population Characteristics a

combined for this analysis. Individuals who had histology other than squamous cell carcinoma (SEER histology codes 8050-8089) or multiple primary head and neck cancers were excluded. Oropharyngeal squamous cell carcinoma (OPSCC) was compared with nonoropharyngeal HNSCC (non-OPSCC) for some analyses. Statistical Analysis Summary statistics were reported as the number and per- centage, mean and standard deviation, or median and interquartile range. For individuals with multiple surveys, time-varying demographic information (eg, age) was taken from the survey most proximal to HNSCC diagnosis for summarizing population characteristics. In the absence of a noncancer control group, HRQOL was described in rela- tion to the time from HNSCC diagnosis, and HRQOL scores at various times relative to diagnosis were compared. Multilevel linear regression 17 with restricted cubic splines 18 was used to model trends in HRQOL as a dependent vari- able over time relative to HNSCC diagnosis, accounting for clustering by individual and MAO with random-effects intercepts. Spline terms for the time from diagnosis were selected as recommended by Harrell. 19 Models were selected by a comparison of fit to lowess smoothing func- tions, residuals, and Akaike Information Criteria. Similar models were applied after stratification for survival group, with 3 knots each for < 2-year and 2-year to 5-year survi- vors and 6 knots for > 5-year survivors. HRQOL at differ- ent times and absolute changes in HRQOL over given time intervals (denoted by “ D ”), were reported with 95% confidence intervals (CIs). The overall model was then used to examine the association of variables of interest with HRQOL, account- ing for the time from diagnosis. Differences in HRQOL relative to the reference group were reported with 95% CIs. For variables that interacted significantly with time from diagnosis, changes in HRQOL relative to the refer- ence group at 3 different time points ( 2 24, 13, and 60 months) were reported. A multivariable model also was constructed using variables that were significantly associ- ated with HRQOL after adjustment for other factors and/or were deemed clinically relevant. Survival analysis was limited to individuals who completed surveys within 5 years before HNSCC diagno- sis. Survival rates were estimated using the Kaplan-Meier method. 20 Overall survival (OS) was calculated as the time from diagnosis to death, with censoring at the last known vital status. Survival curves were compared using log-rank tests. Risk factors for mortality were explored using univariable and multivariable Cox proportional

Characteristic

No. of Individuals (%)

Total no.

1653

No. of surveys per individual 1

1006 (61) 546 (33)

2 3 4

58 (4) 43 (3)

MHOS cohort 1998-1999

456 (28) 379 (23) 183 (11) 156 (9) 179 (11) 300 (18)

2000-2001 2002-2003 2004-2005 2006-2007 2008-2009

Age at diagnosis: Mean 6 SD, y

71.7 6 8.5

Sex

Men

1175 (71) 478 (29)

Women

Smoking status Former/never

1103 (74) 387 (26)

Current

Marital status Married

917 (57) 318 (20) 372 (23) 498 (31) 506 (32) 597 (37) 595 (36) 573 (35) 178 (11) 307 (19)

Divorced/separated/never married

Widowed

Education

< High school

High school graduate/GED

> High school

Household income, US$ < $19,999

$20,000-49,999

$50,000

Do not know/missing

Race

White Other

1299 (79) 354 (21)

Recent depressive symptoms No

1134 (70) 483 (30)

Yes

No. of comorbidities 0-1

557 (35) 573 (36) 478 (30) 380 (23) 367 (22) 265 (22) 311 (19) 230 (14) 625 (38) 385 (23) 198 (12) 295 (18)

2-3

4

Calendar period of diagnosis 1988-1997

1998-2000 2001-2003 2004-2006 2007-2009

Primary site Larynx

Oral cavity

Lip

Oropharynx Hypopharynx

71 (4) 79 (5)

Nasopharynx, nasal cavity, paranasal sinuses

SEER stage In situ

94 (6)

Local

822 (56) 426 (29) 119 (8)

Regional

Distant

Radiotherapy No

661 (41) 963 (59)

Yes

Abbreviations: GED, General Educational Development; MHOS, Medicare Health Outcomes Survey; SD, standard deviation; SEER, Surveillance, Epi- demiology, and End Results. a For individuals who completed multiple surveys, time-varying demo- graphic information is from the survey most proximal to the time of head and neck cancer diagnosis.

Cancer

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