Table 3.

Effect of type and duration of drug therapy for chronic GVHD on the risk for squamous-cell carcinoma (SCC)


Risk factors

Case patients, no.

Control patients, no.

RR

95% CI

P
Model 1: chronic GVHD therapy      
   None   21   84   1.00   Reference   -  
   AZA, CSP, steroids, ± other therapy*  16   9   18.61   4.00-86.62   <.001  
   AZA, steroids, no CSP  9   14   2.77   0.93-8.25   .07  
   CSP, no AZA, ± steroids  7   28   0.99   0.35-2.84   .99  
   Steroids/other drugs, no CSP, no AZA§  4   17   0.88   0.25-3.10   .84  
   Unknown AZA/CSP therapy   1   3   -   -   -  
Model 2: duration of chronic GVHD therapy for specific drugs      
   a: AZA, CSP, steroids, ± other therapy       
      1-11 mo   2   3   5.43   0.63-46.60   .12  
      12 mo or more   14   6   38.71   4.69-319.5   <.001  
         12-23 mo   1   1   Infinite   -   -  
         14 mo or more   13   5   37.59   4.53-311.9   <.001  
   b: AZA, steroids, no CSP       
      1-11 mo   1   8   0.67   0.08-6.02   .72  
      12 mo or more   8   6   5.05   1.37-18.65   .02  
         12-23 mo   5   4   4.99   1.00-24.97   .05  
         24 mo or more   3   2   5.14   0.80-33.13   .09  
   c: CSP, no AZA ± steroids       
      1-11 mo   3   16   0.73   0.19-2.82   .64  
      12 mo or more   4   12   1.52   0.39-5.90   .54  
         12-23 mo   3   10   1.22   0.26-5.64   .80  
         24 mo or more
 
1
 
2
 
3.41
 
0.23-50.77
 
.37
 

Risk factors

Case patients, no.

Control patients, no.

RR

95% CI

P
Model 1: chronic GVHD therapy      
   None   21   84   1.00   Reference   -  
   AZA, CSP, steroids, ± other therapy*  16   9   18.61   4.00-86.62   <.001  
   AZA, steroids, no CSP  9   14   2.77   0.93-8.25   .07  
   CSP, no AZA, ± steroids  7   28   0.99   0.35-2.84   .99  
   Steroids/other drugs, no CSP, no AZA§  4   17   0.88   0.25-3.10   .84  
   Unknown AZA/CSP therapy   1   3   -   -   -  
Model 2: duration of chronic GVHD therapy for specific drugs      
   a: AZA, CSP, steroids, ± other therapy       
      1-11 mo   2   3   5.43   0.63-46.60   .12  
      12 mo or more   14   6   38.71   4.69-319.5   <.001  
         12-23 mo   1   1   Infinite   -   -  
         14 mo or more   13   5   37.59   4.53-311.9   <.001  
   b: AZA, steroids, no CSP       
      1-11 mo   1   8   0.67   0.08-6.02   .72  
      12 mo or more   8   6   5.05   1.37-18.65   .02  
         12-23 mo   5   4   4.99   1.00-24.97   .05  
         24 mo or more   3   2   5.14   0.80-33.13   .09  
   c: CSP, no AZA ± steroids       
      1-11 mo   3   16   0.73   0.19-2.82   .64  
      12 mo or more   4   12   1.52   0.39-5.90   .54  
         12-23 mo   3   10   1.22   0.26-5.64   .80  
         24 mo or more
 
1
 
2
 
3.41
 
0.23-50.77
 
.37
 

Other drug therapy indicates chronic GVHD therapy other than CSP, AZA, or steroids. There were 58 case patients and 155 control patients.

*

Eleven of the 16 case patients who had AZA-CSP-steroid therapy had other chronic GVHD drug therapy (mainly cyclophosphamide [4], thalidomide [3]). In addition, 4 case patients had PUVA skin irradiation and 2 case patients had limited field radiation for GVHD. Two of the 9 control patients with AZA-CSP-steroids had other chronic drug therapy (cyclophosphamide [1], thalidomide [2]), and 2 had PUVA skin irradiation. All but 1 patient (control) in the AZA-CSP-steroids group had steroids for chronic GVHD therapy

Two of the 9 case patients with AZA-steroids (no CSP) had other drug therapy; 2 of the 14 control patients had other drug therapy; none had PUVA skin irradiation or limited field radiation

Four of the 7 case patients with CSP (no AZA) also had steroid therapy, and the remaining 3 case patients had CSP alone (none of the case patients had other drugs, PUVA skin irradiation, or limited field radiation therapy). Twenty-two of the 28 control patients with CSP (no AZA) also had steroid therapy, and the remaining 6 case patients had CSP alone. Three of the control patients with CSP (no AZA) had other drugs in addition to CSP and steroids, and 2 of the control patients had additional therapy with steroids and PUVA skin irradiation

§

Three of the 4 case patients in the steroids-other drugs (no CSP, no AZA) group received steroids alone, and the fourth case patient received another drug plus limited field irradiation; 14 of the 17 control patients in this therapy group received steroids, including 4 with steroids and other drugs; the other 3 control patients were treated with other drugs, no steroids

Models 2a-c have as the reference group patients with no chronic GVHD therapy (21 case patients and 84 control patients). Models are also adjusted for the other drug groups (4 variables), as shown in model 1. Duration for model 2a is based on the combined duration of CSP and AZA, accounting for overlap in therapy, whereas the duration for model 2b is based on duration of AZA therapy and the duration for model 2c is based on duration of CSP therapy

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