Following is a summary of findings from the preliminary investigation by the National Cancer Institute (NCI) on 23 of 29 patients enrolled by the Memorial Cancer Research Foundation of Southern California in the study of lumpectomy and mastectomy by the National Surgical Adjuvant Breast and Bowel Project (NSABP):
Patient 1 had a type of breast cancer for which a lumpectomy was not “the appropriate operation,” according to the NCI report. The patient developed a second tumor two years later and died of metastatic breast cancer three years after that. She was not enrolled until after her surgery, violating the statistical integrity of the study and rendering her ineligible. Nor did she sign a written consent prior to enrollment and surgery, as required by study regulations.
Patient 2 also had a form of breast cancer that made her “clearly ineligible” for a lumpectomy and thus for enrollment in the study. It is unclear whether she gave written consent before enrollment and surgery, or whether she was enrolled before surgery, as required by study guidelines. The patient suffered a recurrence of cancer one year after her operation.
Patient 3 received a lumpectomy, but the NCI notes that surgeons were unable to remove all the malignant tissue under the adjacent arm, making the woman “clearly ineligible” for the study. It is unclear whether the patient consented to join the study before enrollment and surgery. Although she later developed metastasis and died, her death was not reported to the NSABP.
Patient 4 received a lumpectomy even though her laboratory tests were “not definitive for breast cancer.” Nor was the patient’s tumor size recorded or reported at the time of her enrollment, as required. Although the woman explicitly refused to participate in the study, the NCI says reports of her subsequent progress apparently were sent to NSABP “against her expressed wishes.”
Patient 5 was ineligible because her cancer had spread beyond her breast. She suffered a recurrence of cancer a year after her mastectomy and died the year after that. It is unclear whether the patient consented to join the study, or whether she was enrolled before her surgery, as required by regulations. Although the patient’s file contains little medical information, regular progress reports apparently were forwarded to NSABP.
Patient 6 apparently was assigned to receive a mastectomy and then reassigned to the group of lumpectomy patients, violating the statistical integrity of the study and rendering her ineligible according to study guidelines. She did not provide written consent before enrollment and surgery. NCI notes the patient later was reported to NSABP as “alive and well,” although the same follow-up report listed the chemotherapy she was then receiving for metastatic breast cancer.
Patient 7 was first assigned to receive a mastectomy, then assigned the following day to the lumpectomy group, something NCI terms “a significant irregularity in the randomization process” and one that would invalidate the data collected on this patient. It also is unclear whether the patient was enrolled, or provided written consent, before surgery.
Patient 8 did not sign a written consent form until two months after receiving a mastectomy. Although she died in 1992, the woman was reported to NSABP last year as “alive and well.”
Patient 9 was enrolled by NSABP despite the failure to record or report the size of her tumor, as required by study regulations. Her written consent form, originally dated several days after surgery, was changed with correction fluid to match the date of her operation.
Patient 10 chose a lumpectomy before she was enrolled in the study, a violation of the study guidelines that should have rendered her ineligible. She did not give written consent to join the study until three weeks after enrollment and surgery. It also is unclear whether she was enrolled before surgery.
Patient 11 was enrolled in the study one month after receiving a lumpectomy. She did not give written consent to join the study until more than two years after her operation, although data on her progress was reported to NSABP during that period.
Patient 12 apparently was enrolled in the study after receiving a lumpectomy. NCI was unable to determine whether the woman consented to join the study before surgery.
Patient 13 apparently was enrolled in the study following a mastectomy. Medical records also indicate the woman had previously existing colloid cancer, another potential disqualification.
Patient 14 was enrolled in the study one month after surgery. She also received what was described as an “extensive”-and, therefore, possibly disqualifying-lumpectomy.
Patient 15. NCI was unable to determine whether the patient was enrolled or consented to join the study before surgery. The patient apparently signed two written consent forms; however neither form was dated or signed by her physician, as required, and each form was witnessed by different individuals.
Patient 16 also appears to have signed two consent forms, one dated the day of her mastectomy by someone other than the patient, the other undated. The NCI noted that the date on the first form was in a different ink and handwriting than any of the signatures, suggesting post-dating. The NCI also was unable to confirm whether the patient agreed to join the study before receiving a mastectomy or whether she was eligible for the study.
Patient 17 was enrolled in the study despite the presence of two widely separated tumors in her breast, making her ineligible under study guidelines.
Patient 18. NCI was unable to determine whether this patient was eligible for the study, whether she was enrolled before receiving a lumpectomy, and whether she consented to join the study prior to enrollment and surgery.
Patient 19 received a lumpectomy of the left breast five days before enrollment. The NCI states that the possibility of cancer in the patient’s right breast “had not been ruled out” at the time of her operation, another potential disqualification. It is also unclear whether the patient consented to join the study before surgery.
Patient 20. NCI was unable to determine whether this patient was eligible for the study, or whether she was enrolled before receiving a lumpectomy.
Patient 21. NCI was unable to determine whether this patient was eligible for the study, or whether she was enrolled prior to receiving a mastectomy.
Patient 22 was enrolled in the study following a mastectomy.
Patient 23 received post-operative radiation therapy that violated study guidelines. Her consent form was undated, making it unclear whether she agreed to join the study prior to enrollment and surgery.
