Presentation
Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage breast cancer

Presented at the Sixth Annual Meeting of the American Society of Breast Surgeons, Los Angeles, California, March 16–20, 2005
https://doi.org/10.1016/j.amjsurg.2005.06.024Get rights and content

Abstract

Background

Historically, fewer than 5% of cancer patients enroll in clinical trials and lack of physician participation is a contributing factor. In 1999, the American College of Surgeons Oncology Group (ACOSOG) conducted a multicenter breast cancer trial evaluating the prognostic value of sentinel lymph node (SLN) and bone marrow micrometastases. This report elucidates factors influencing patient accrual.

Methods

Demographics of investigators (N = 198) and their success in accruing patients (N = 5327) were reviewed. ACOSOG Breast Committee members (N = 1136) were surveyed to identify factors influencing participation.

Results

Surgeons from 126 institutions participated in Z0010 (academic [48%], teaching-affiliated [20%], and community [29%] practices), and 28% of surgeons accrued 75% of the subjects. Twenty-four percent of surgeons accrued 75% of minority patients. Female surgeons accrued 24% of patients and accounted for 30% of investigators. On survey, 16% of respondents reported no prior experience with clinical trials and a number of factors were identified that influenced participation.

Conclusions

ACOSOG successfully accrued 5327 patients to a SLN trial with surgeon participation from all practice settings. However, significant barriers to participation remain.

Section snippets

Methods

The primary objectives of the Z0010 trial were (1) to estimate the prevalence of and evaluate the prognostic significance of sentinel node micrometastases detected by immunohistochemistry (IHC); (2) to estimate the prevalence of and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry (ICC); and (3) to determine the hazard rate for regional recurrence in women whose sentinel nodes were negative by hematoxylin and eosin (H&E) staining in women with

Results

Surgeons from 126 institutions located in 37 states of the United States, and in Ireland and Australia, participated in Z0010. These surgeons were located at academic (48.4%), teaching-affiliated (19.8%), and community (28.6%) practices. Overall, approximately 50% of Z0010 investigators were at community or teaching-affiliated institutions compared with 41% of all ACOSOG investigators (chi-square = 6.1838, P = .0129). Surgeons accrued a median of 12 patients to study (range 1 to 290). The 10

Conclusions

The ACOSOG Z0010 trial was successful in attracting a large cadre of surgeons for study participation despite a stringent credentials documentation requirement (≥20 cases of SLNB followed by ALND). This is in contrast to the National Surgical Adjuvant Breast and Bowel Project (NSABP) B32 trial that allowed surgeon participation after a study sponsored training with only five cases of SLND followed by ALND [1]. ACOSOG investigators were successful in completing accrual to the Z0010 trial with

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