MAINSAIL trial: comparator-arm data with Halabi 2014 risk scores
Description
Baseline characteristics and Halabi (2014) prognostic linear predictor for
the 520 patients randomised to the comparator arm (docetaxel plus prednisone)
of the MAINSAIL trial (NCT00988208), a phase III study in metastatic
castration-resistant prostate cancer (mCRPC). The dataset is used in
XOMultinom to illustrate the sequential recalibration-alarm
procedure described in Section~5.2 of the package paper.
Usage
mainsailmainsail
Format
A data frame with 520 rows and 21 variables:
- RPT
-
Character. Zero-padded patient identifier (e.g.\
"00468"). - ENROLLDAY
-
Numeric. Randomisation day on the study-day scale (day 0 = study start). Ranges from
to; used to deriveentry_order. - entry_order
-
Integer. Patient's rank by ascending
ENROLLDAY, from 1 (earliest randomised) to 520 (latest). Ties inENROLLDAYare broken arbitrarily. - ecog
-
Numeric. Eastern Cooperative Oncology Group (ECOG) performance status at baseline: 0 (fully active), 1 (restricted in strenuous activity), or 2 (ambulatory, capable of self-care only).
- disease_site
-
Character. Halabi (2014) disease-site classification:
"ln_only"(lymph-node involvement only,) or"visceral"(any liver or lung metastasis,).NAfor 81 patients for whom disease site could not be determined from the available tumour-assessment records; all such patients havehas_bone = 0. - has_ln
-
Integer. Binary indicator: 1 if lymph-node metastases were recorded at the screening visit, 0 otherwise.
- has_bone
-
Integer. Binary indicator: 1 if bone metastases were recorded at the screening visit, 0 otherwise.
- has_visceral
-
Integer. Binary indicator: 1 if visceral (liver or lung) metastases were recorded at the screening visit, 0 otherwise.
- opioid
-
Integer. Binary indicator: 1 if the patient was receiving opioid analgesics (ATC code
N02A*) at the time of randomisation, 0 otherwise. - ldh
-
Numeric. Lactate dehydrogenase (LDH) at baseline, in U/L. Missing for 8 patients.
- ldh_uln
-
Numeric. Upper limit of normal for LDH as recorded in the trial laboratory data. Constant at 250 U/L for all patients in this dataset.
- ldh_gt_uln
-
Integer. Binary indicator: 1 if
ldh > ldh_uln, 0 otherwise. Complete for all 520 patients (missingldhvalues were treated as not exceeding the ULN). - albumin
-
Numeric. Serum albumin at baseline, in g/dL. Missing for 5 patients.
- hgb
-
Numeric. Haemoglobin at baseline, in g/dL. Missing for 16 patients.
- psa
-
Numeric. Prostate-specific antigen (PSA) at baseline, in ng/mL. Missing for 6 patients.
- alp
-
Numeric. Alkaline phosphatase (ALP) at baseline, in U/L. Missing for 8 patients.
- ln_psa
-
Numeric. Natural logarithm of
psa. Missing for the same 6 patients aspsa. - ln_alp
-
Numeric. Natural logarithm of
alp. Missing for the same 8 patients asalp. - halabi2014_lp
-
Numeric. Halabi (2014) linear predictor computed by strict listwise deletion:
NAfor any patient missing at least one of the ten model covariates (99 patients). Identical tohalabi2014_lp_rawfor the 421 complete cases. - halabi2014_lp_raw
-
Numeric. Halabi (2014) linear predictor computed under partial listwise deletion: available for the 498 patients with complete laboratory values, regardless of
disease_siteavailability. For the 77 patients with missingdisease_sitebut complete labs, both disease-site indicators are set to zero (equivalent to assigning the lymph-node-only reference category).NAfor the 22 patients missing at least one laboratory value. - halabi2014_lp_imputed
-
Numeric. Halabi (2014) linear predictor after single imputation: complete for all 520 patients. Continuous covariates (
albumin,hgb,ln_psa,ln_alp) are imputed at their sample median;disease_siteis imputed at its sample mode ("visceral"). Used as the risk score in the sequential recalibration-alarm illustration of Section~5.2.
Details
The MAINSAIL trial randomised 1059 patients with chemotherapy-naive mCRPC to
docetaxel/prednisone with or without lenalidomide. Only the 520 patients on
the comparator arm are included here. Patient entry order was determined by
ENROLLDAY extracted from assignmt.sas7bdat in the Project Data
Sphere release; all other covariates were extracted at or closest to the
baseline visit. Full details of variable construction are given in
Appendix~A of the package paper.
The Halabi (2014) linear predictor is defined as
where the regression coefficients are the
log-hazard ratios from Table~2 of Halabi et al.\ (2014); see
vignette("recalibration", package = "XOMultinom") for the full
specification.
Source
Project Data Sphere, dataset identifier
Prostat\_Celgene\_2009\_90 (https://data.projectdatasphere.org/).
Access requires registration and acceptance of the Project Data Sphere
terms of use.
References
Halabi, S., Lin, C.-Y., Kelly, W.K., Fizazi, K.S., Moul, J.W., Kaplan, E.B., Morris, M.J. and Small, E.J. (2014). Updated prognostic model for predicting overall survival in first-line chemotherapy for patients with metastatic castration-resistant prostate cancer. Journal of Clinical Oncology, 32(7), 671–677. doi:10.1200/JCO.2013.52.3696
Fizazi, K., Higano, C.S., Nelson, J.B., et al.\ (2013). Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. Journal of Clinical Oncology, 31(14), 1740–1747. doi:10.1200/JCO.2012.46.4149