Evaluation of AJCC, UICC, and Brigham and Women's Hospital Tumor Staging for Cutaneous Squamous Cell Carcinoma

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1 Evaluation of AJCC, UICC, and Brigham and Women's Hospital Tumor Staging for Cutaneous Squamous Cell Carcinoma Karia, et al Methods Details of data collectionfeatures of primary tumors including anatomic location, tumor depth, tumor differentiation, and presence of perineural or lymphpovascular invasion were obtained from pathology reports. Clinical tumor diameter was obtained from clinic notes. Medical records were reviewed to determine whether outcomes of interest occurred including local recurrence (LR), nodal metastasis (NM), disease-specific death (DSD), and overall death (OD). For patients with multiple primary CSCCs, each tumor was considered separately since each may have distinct high-risk factors which carry their own risk of poor outcomes. Tumor differentiation was graded based on areas of worst differentiation visualized histologically within each tumor. Patient gender, race, ethnicity, skin cancer history, immune status, and cause of death as noted in medical records were also recorded. LR was considered to have occurred if a pathology report documented invasive CSCC in the same anatomic location as a prior CSCC and the medical record indicated this lesion was considered a recurrence of the index primary tumor. NM was defined as histologically or radiologically confirmed disease in a draining nodal basin of the primary CSCC considered to be CSCC metastasis of the primary tumor by the treatment team. DSD was considered to have occurred if the treatment team documented that a patient died due to a 1

2 specific CSCC or complications directly arising from it. OD was determined by review of medical records and the Social Security Death Index. Survival time for each outcome of interest was defined as the time between primary CSCC tumor diagnosis and time of outcome occurrence arising from the tumor. For those tumors which did not result in any outcome of interest, survival time was censored on the date of death or date of medical record review if patient was alive at time of data collection. Statistical analysis Baseline patient demographic characteristics and CSCC tumor clinical characteristics were analyzed using descriptive statistics and frequency tabulation. Competing-risks analysis according to the method of Fine and Gray 21,22 was used to examine univariate and multivariate associations between risk factors and development of LR, NM, and DSD. Models incorporating competing risk data using the Fine and Gray method enable estimation of cause-specific hazard functions (yielding sub-distribution hazard ratios [SHRs] which are interpreted similarly to hazard ratios) and cumulative incidence functions. Competing risk models take into account risks of other events which compete with the outcomes of interest. Such models were chosen for this analysis since in an elderly population with rare events from CSCC, risk of other more common events (such as death from other causes) should be taken into account. Cox modeling was used for OD. Multivariate models were built through forward stepwise selection and backward elimination. Variables were added based on their relative effect estimates on univariate 2

3 modeling and retained if the Wald test comparing the smaller model with the larger model was significant at p 0.05 or if the p value comparing the 2 models was borderline (>0.05 to ) and addition of the variable changed the SHR by at least 10%. Models were corrected for intra-patient correlation using the robust variance estimate since the analysis was tumor case-based, rather than patient-based. The robust variance estimate was obtained in Stata using the robust option when fitting time to event models. Pair-wise comparison tests were utilized to determine whether cumulative incidence and Kaplan-Meier curves for each BWH tumor stage differed significantly from one another (Gray s test for cumulative incidence function curves and log-rank test for Kaplan-Meier curves). Results Validation of the BWH T staging system One additional risk factor, tumor location on ear, was significantly associated with poor outcomes in this study but not the prior study (LR: SHR 3.2 [95% CI and DSD: 10.3 [ ]). It was decided that this risk factor would not be incorporated into BWH staging for the following reasons: 1) Hazard ratios for the multivariate models of each outcome of interest did not change significantly between models incorporating and not incorporating ear location (data not shown) and 2) the current study cohort includes patients treated at two large tertiary care centers for advanced head and neck tumors (Massachusetts Eye and Ear Institute and Dana-Farber/Brigham and Women s Head and 3

4 Neck Cancer Group) and it is likely that advanced ear tumors were over-represented in this cohort compared to the general CSCC population. Multivariate analysis Due to small numbers, a p-value of <0.1 was considered significant for PNI. Wald tests were significant for LR, NM, and DSD (p). Harrell s C statistics were 0.89 (CI ) for LR, 0.91 (CI ) for NM, 0.93 (CI ) for DSD, and 0.55 (CI ) for OD indicating accurate prediction with the exception of OD. Comparison of AJCC, UICC, and BWH T staging systems Twenty-one and four tumors could not be classified by UICC and AJCC T stage, respectively, because tumor diameter data and/or tumor depth data were unavailable. One tumor could not be classified by the BWH T stage because of missing tumor diameter and PNI nerve diameter. Pair-wise comparison tests indicate that BWH T stages are statistically distinct with regard to all outcomes with the exception of and a being equivalent for OD (Table S4). 4

5 Table S1. Univariate Analysis for Outcomes of Interest Characteristic LR NM DSD OD SHR (95% CI) p SHR (95% CI) p SHR (95% CI) p HR (95% CI) p Age < >80 Gender Female Male Tumor Diameter <2cm 2cm Tumor Differentiation Well/Moderate Poor Tumor Depth Dermis/Fat Beyond Fat PNI Invasion No Yes Caliber of Nerve Invasion No PNI <0.1mm 0.1mm Tumor Location Other Head/Neck Ear Lip 2.4 ( ) 1.8 ( ) ( ) ( ) 7.7 ( ) 18.8 ( ) 10.4 ( ) 5.6 ( ) 10.4 ( ) 4.4 ( ) 3.8 ( ) 4.3 (-19.0) ( ) 0.9 ( ) (-5.1) ( ) 14.9 ( ) 31.3 ( ) 12.8 ( ) No Events 18.9 ( ) 4.1 ( ) 2.4 (0.5-1) 6.7 ( ) ( ) 0.7 ( ) ( ) ( ) 18.8 ( ) 36.4 ( ) 15.5 ( ) No Events 21.1 ( ) 3.8 ( ) 6.3 ( ) 5.8 ( ) ( ) 2.3 ( ) 1.9 ( ) 1.1 ( ) ( ) 2.0 ( ) ( ) ( ) 2.3 ( ) 1.2 ( ) 1.4 ( ) 0.6 ( )

6 Table S2. Multivariate Analysis for Outcomes of Interest Characteristic LR NM DSD OD SHR (95% CI) p SHR (95% CI) p SHR (95% CI) p HR (95% CI) p Diameter 2cm 5.6 ( ) 9.5 ( ) 19.1 ( ) ( ) Poorly differentiated histology 4.5 ( ) 8.3 ( ) 10.0 ( ) 1.4 ( ) Depth beyond fat 8.0 ( ) 7.0 ( ) 11.1 ( ) 1.5 ( ) PNI 0.1mm 2.3 ( ) ( ) ( ) ( ) Ear location 3.2 ( ) ( ) ( ) ( )

7 Table S3. Life Tables for Local Recurrence (LR), Nodal Metastasis (NM), Disease-Specific Death (DSD), and Overall Death (OD) by AJCC, UICC, and BWH Tumor Stage Clinical Stage Number at Risk (Number of Events) 1y 2y 3y 4y 5y 6y 7y 8y 9y 10y AJCC (1,814 tumors) LR NM DSD OD UICC (n=1,796 tumors) LR NM 1,361 (6) 447 (22) 3 (2) 1, (14) 3 (2) 1, (2) 1,361 (83) 447 (37) 1,597 (21) 154 (5) 43 (3) 3 (2) 1,597 (6) 154 (4) 1, (6) 1,216 (1) 354 (8) 1,216 (0) 364 (3) 1,276 (81) 409 (44) 1,391 (2) 120 (3) 27 (3) 1,405 (6) 120 (1) 1,028 (2) 277 (4) 1, (3) 1,034 (0) 295 (3) 1,139 (65) 351 (25) 1,178 (3) 96 (3) 1,189 (3) 97 (0) 834 (0) 224 (1) (2) 842 (0) 239 (1) 934 (50) 277 (23) (0) (2) 77 (0) (0) (1) 760 (58) 209 (9) (0) 767 (0) (0) (0) 114(0) (38) 151 (8) (0) 7 (1) 565 (0) 35 (0) (0) (0) 354 (0) 81 (2) 439 (30) 108 (9) 396 (0) 2 4 (0) 399 (0) (0) 52 (0) 227 (0) 52 (0) (0) 291(17) 74 (4) 252 (0) 256 (0) 157 (0) 34 (0) (0) 36 (0) 204 (7) 52 (2) (0) 2 (0) 175 (0) 14 (0) (0) 92 (0) 19 (0) 141 (4) 33 (3) 99 (0) 99 (0) 7

8 DSD OD BWH (1,817 tumors) LR a b NM a b DSD a b OD a b 43 (7) 1,597 (1) 154 (1) 4 1,597 (103) 154 (11) 43 (7) 1,393 (7) 332 (11) 86 (10) 6 (1) 1, (6) 86 (8) 6 (3) 1, (1) 6 (1) 1,393 (83) 332 (27) 86 (12) 6 (1) 27 (2) 1, (3) 1,493 (97) 141 (16) 36 (9) 1,229 (1) 266 (2) 59 (4) 4 (3) 1,236 (1) 270 (2) 64 (6) 1,236 (0) 275 (0) 68 (3) 5 (2) 1,262 (80) 285 (27) 72 (18) 5 (2) 1,196 (1) 99 (1) 2 1,334 (80) 118 (7) 26 (3) 1,050 (1) 216 (2) 38 (3) 1,057 (0) (2) 1,057 (0) 225 (0) 46 (3) 1,078 (73) 233 (11) 49 (7) 12 (0) 979 (1) 7 16 (1) 1,090 (69) 95 (3) 19 (2) (0) 27 (1) 856 (0) 187 (0) 27 (2) 856 (0) 190 (1) 34 (0) 2 (2) 876 (61) 192 (11) 35 (1) 2 (2) 9 (0) 775 (0) 55 (1) (64) 70 (3) 16 (0) (0) (0) 686 (0) (55) 138 (12) 3 7 (0) (0) 669 (43) 49 (3) (1) 19 (0) 504 (0) 89 (0) 504 (0) 9 24 (0) 516 (36) 96 (8) 24 (1) 4 (0) 404 (2) 24 (0) 5 (0) 497 (38) 36 (1) 12 (0) 355 (0) 56 (0) 14 (0) (0) (0) 18 (2) 366 (35) 60 (1) 18 (3) (0) 4 (0) 329 (20) 25 (1) (0) (0) 45 (0) (0) 47 (0) 12 (0) 228 (17) 48 (3) 1 2 (0) 177 (0) 15 (0) 230 (9) 17 (0) 154 (0) 29 (0) 155 (0) 29 (0) 7 (0) 155 (0) 3 9 (0) 157 (5) 32 (3) 9 (1) 10 2 (0) 156 (5) 12 (2) 89 (0) 2 (0) 89 (0) 89 (0) 19 (0) 92 (4) 20 (2) 8

9 Table S4. Pair Wise Comparison Tests of BWH T Stages BWH T Stage LR NM DSD OD Gray s Test p Gray s Test p Gray s Test p Log Rank Test p vs. a a vs. b b vs

10 Table S5. Results of McNemar s Test of CSCC Outcomes by Staging System Staging System LR NM DSD OD McNemar s Test p McNemar s Test p McNemar s Test p McNemar s Test AJCC / vs. BWH /a UICC / vs. BWH /a AJCC / vs. BWH b/ UICC / vs. BWH b/ p 10

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