Table 1.
Trial Characteristics | No. Trials with Complete BMEC/Total | Percent | P-valuea | |
---|---|---|---|---|
Industry funding of trial | Yes | 141/361 | 39.1 | P = 0.02 |
No | 27/101 | 26.7 | ||
Cooperative group trial | Yes | 35/112 | 31.3 | P = 0.20 |
No | 132/348 | 37.9 | ||
Enrollment start year | 1995–2000 | 4/8 | 50 | P = 0.02 |
2001–2005 | 41/90 | 45.6 | ||
2006–2010 | 96/258 | 37.2 | ||
2011–2015 | 26/102 | 25.5 | ||
Disease siteb | Breast | 32/75 | 42.7 | P < 0.001 |
Gastrointestinal | 43/76 | 56.6 | ||
Genitourinary | 35/55 | 65.5 | ||
Head & Neck | 4/23 | 17.4 | ||
Melanoma | 5/20 | 25.0 | ||
Thoracic | 18/95 | 18.9 | ||
Treatment modalityc | Systemic therapy | 137/334 | 41.0 | P = 0.01 |
Radiotherapy | 1/6 | 16.7 | ||
Surgery | 1/2 | 50.0 | ||
Supportive care | 26/112 | 23.2 | ||
Systemic therapy subgroupd | Targeted therapy | 106/257 | 41.2 | P = 0.88 |
Cytotoxic chemotherapy | 31/77 | 40.3 | ||
Completed planned accrual | Yes | 90/240 | 37.5 | P = 0.56 |
No | 37/108 | 34.3 | ||
Trial success (primary endpoint met) | Yes | 72/198 | 36.4 | P = 0.53 |
No | 70/177 | 39.5 |
a P-value reflects Pearson’s chi-squared tests for all except enrollment start year, for which P-value reflects results of binary logistic regression analysis by year.
bLimited to trials with a defined single disease site.
cPrimary intervention as part of the randomization. Systemic therapy includes cytotoxic chemotherapy, targeted systemic agents, and similar, with primary endpoint aimed at improved disease-related outcomes. Supportive care trials aimed to reduce disease- or treatment-related toxicity.
dSystemic therapy trials subdivided further into those assessing a targeted therapy (including small molecule inhibitors, monoclonal antibodies, and similar) and those assessing cytotoxic chemotherapy.