PharmaSUG2010 - Paper AD03

Tips for Creating Oncologic Efficacy Summary Tables using PROC LIFETEST and PROC PHREG Scott Michael Ward, i3 Statprobe, Cary, North Carolina
Survival statistics are used frequently within Oncologic Efficacy Summary tables. They are used to measure several types of outputs including Progression Free Survival, Time to Treatment Failure, Time to Disease Progression, Duration of Survival, and Duration of Response. This paper will show how to achieve the following types of outputs with PROC LIFETEST and PROC PHREG by offering some tips and techniques for fast and efficient results and outputs.


To create these Oncologic Efficacy Summary Tables use the SAS procedures PROC LIFETEST and PROC PHREG. Some commonly created efficacy outputs used for these analyses are: • Progression Free Survival is the length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works. Time to Treatment Failure is the time from the start of a new drug regimen to the end of time where the drug regimen is no longer taken because of disease progression, study endpoint, or death. Time to Disease Progression is defined as time from randomization to first event of disease progression. Disease progression is a composite end point. Duration of Survival is the time from diagnosis date to the date of death. Duration of Response is the time from first Stable Disease (SD) or Partial Regression (PR) or Complete Regression (CR) until death or disease progression.

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EXAMPLE – Basic Syntax to create any of the analyses listed above. This particular example use Progression Free Survival data points.
The common statistics that you output from PROC LIFETEST are Median, 95% Confidence Intervals, 25th-75th percentiles, Minimum and Maximum, and p-values for Log-Rank and Wilcoxon. Additionally, you can use PROC PHREG to create Hazard Ratios and 95% Confidence Intervals.

(Note – again to see the name of the output datasets.) *** Create mean. See Figure 1. you can turn on ODS Trace=ON and to see what the names of the statistical datasets created in the SAS Log.Sample Kaplan-Meier Curve (Note – Adding the option plot=(s) with create a simple Kaplan-Meier Curve. ***. ODS TRACE ON. Run. 95% C.05 ties=EFRON time pfstm*pfscen(1). max. ODS TRACE OFF. ODS OUTPUT CensoredSummary =_censorsum Means =_mean Quartiles =_quartiles. time pfstm*pfscen(1). strata treatment. PROC PHREG data=test1dts. 25th-75th percentile.I. PROC LIFETEST data=test1dts outsurv=_surv alphaqt=0. min. ODS OUTPUT CLOSE.05 ties=EFRON. PROC LIFETEST data=test1dts.) *** Create Kaplan-Meier Curve ***. ODS OUTPUT ParameterEstimates=_parmests. median. ODS OUTPUT CLOSE. strata treatment. where trtnum = 0. model pfstm*pfscen(1)= trtnum / rl alpha = 0. Run. PROC LIFETEST data=test1dts outsurv=_surv alphaqt=0. .(Note – to see the name of the output datasets. you can turn on ODS Trace=ON and to see what the names of the statistical datasets created in the SAS Log.05 ties = EFRON.1). plot=(s). ODS TRACE ON. ODS TRACE ON. ODS TRACE OFF. strata treatment. Run. ODS OUTPUT WilUniChiSq =_wilcox1 LogUniChiSq =_logrank1.) *** Create Hazard Ratio for Stratified Analysis ***. where trtnum in (0. *** Create Log-Rank and Wilcoxon p-values ***. time pfstm*pfscen(1).

_quartiles. Some additional options in PROC LIFETEST AND PROC PHREG The BY statement is to obtain separate analyses on observations in groups defined by the BY variables. Run. if treatment = 1 then call symput('total1'. tables treatment / out=dentot. The timing variable (PFSTM) is the Time to First Event. FREQ statement identifies a variable containing the frequency of occurrence of each observation. A Label field should be created to display a statistic label for each outputted statistics. you will have to do a DO Loop to run for each treatment arm. Run. USEFUL TIPS AND OTHER CONSIDERATIONS FOR USING PROC LIFETEST AND PROC PHREG The trtnum variable is used if there is more than one treatment group. ODS OUTPUT CLOSE. ID variables should be created for grouping and ordering purposes. ODS TRACE OFF. set dentot. ID variable values are used to label the observations of the product-limit survival function estimates. strata treatment. _wilcox1.compress(count)). A PROC FREQ or a PROC SQL can be used to create the denominator for the denominator for each column: PROC FREQ data= test1dts noprint. The alphaqt option set the significance level of the confidence limits. _parmests. ♦ CONCLUSION All the datasets that are created in PROC LIFETEST and PHREG(_censorsum. The censor variable (PFSCEN) is Event Occurred (0/1). The alpha option set the significance level of the confidence limits. _mean. The test option specifies a list of numeric (continuous) covariates that you want tested for association with the failure time. The strata option tells what variable should be stratified (optional). Data dentot.test trtnum. if treatment = 2 then call symput('total2'. Run. The statistic columns should be labeled by TREATMENT number in each dataset to ensure proper concatenation of all outputs.compress(count)). The ties option specifies how to handle ties in the failure time. . The censored value (1) is to show if an Event occurred. and _logrank1) all need to be manipulated and combined.

define statord / order order=internal noprint. define grp / order order=internal noprint. Run.Progression Free Survival . define label / display flow width=50 left ' '. break after grp / skip. define treatment1 / width=20 center. See Table 1.A PROC FREQ or PROC SUMMARY can be used to the top section of the output for the following categories: – – Number of patients with an event Earliest contributing event • Progressive Disease • Death Number of patients without an event – A PROC REPORT can be used to output your statistics: PROC Report data=final_ds center headskip headline missing nowindows spacing=2 split='|'. column grp order label (“PHARMA_1|(n=&total1” treatment1) (“PHARMA_2|(n=&total2” treatment2). define treatment2 / width=20 center.

0+ .Progression Free Survival . OF PATIENTS 275 225 NO. 0.818) 0.963. 894.OUTPUT RESULTS Progression Free Survival Intent to Treat PharmaSUG 2010 PHARMA_1 PHARMA_2 (n=275) (n=225) ƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒƒ NO.0 .9%) 120 (43.0008 828. 966.816) 0. OF PATIENTS WITH AN EVENT EARLIEST CONTRIBUTING EVENT: PROGRESSIVE DISEASE DEATH NO.0 (905.0.0 .0 2.0+ .963.607 (0.1%) Table 1.0 2.0 96 24 155 (56.966. 0.4%) 54 16 155 (68.0 947.0009 0. OF PATIENTS WITHOUT AN EVENT PROGRESSION-FREE SURVIVAL (DAYS) MEDIAN (95% CI) 25TH-75TH PERCENTILE RANGE UNSTRATIFIED ANALYSIS HAZARD RATIO (RELATIVE TO PHARMA_1) (95% CI) P-VALUE (LOG-RANK) STRATIFIED ANALYSIS HAZARD RATIO (RELATIVE TO PHARMA_1) (95% CI) P-VALUE (LOG-RANK) 0.0 (776.0.0) 552.965.0) 689.451.450.6%) 70 (31.606 (0.

00 0.50 0.Kaplan-Meier Graph 1.Sample Kaplan-Meier Curve .75 Survival Distribution Function 0.00 0 200 400 600 800 1000 Days to Event STRATA: treatmnt=1 Censored treatmnt=1 treatmnt=2 Censored treatmnt=2 Figure 1.25 0.

CONTACT INFORMATION Your comments and questions are valued and SAS and all other SAS Institute Inc. ® indicates USA registration. Contact the author at: Scott Michael Ward Senior Statistical Programmer I3 Statprobe Weston One 1001 Winstead Drive Suite 200 Cary. Other brand and product names are trademarks of their respective companies. North Carolina 27513 Work Phone: 919-678-4725 E-mail: scott. in the USA and other countries. . product or service names are registered trademarks or trademarks of SAS Institute Inc.ACKNOWLEDGEMENTS I would like to thank my colleagues at i3 Statprobe for reviewing and providing feedback on this paper.

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