James E. Krook

Prognostic value of c-erbB2 overexpression in axillary lymph node positive breast cancer. Results from a randomized adjuvant treatment protocol

Background. This study was designed to evaluate the prognostic importance of c‐erbB2 overexpression in a standardized cohort of patients with axillary lymph node positive breast cancer.

Patterns of tumor relapse following mastectomy and adjuvant systemic therapy in patients with axillary lymph node‐positive breast cancer. Impact of clinical, histopathologic, and flow cytometric factors

Background. This analysis was conducted to evaluate the impact of selected clinical, histopathologic, and flow cytometric factors on sites of initial tumor relapse after postmastectomy adjuvant systemic therapy.

A phase II study of paclitaxel plus carboplatin as first-line chemotherapy for women with metastatic breast carcinoma.

This Phase II multicenter study evaluated the efficacy and toxicity of paclitaxel (200 mg/m2 by 3‐hour infusion) with carboplatin (area under the curve 6 mg/mL per minute) administered every 3 weeks as first‐line therapy for women with metastatic breast carcinoma.

A randomized trial of tamoxifen alone or combined with octreotide in the treatment of women with metastatic breast carcinoma

Tamoxifen (TAM) is generally considered the hormonal agent of choice for postmenopausal women with hormone receptor positive breast carcinoma. The somatostatin analogues, including octreotide, have demonstrated inhibition of breast carcinoma cell lines and multiple endocrinologic actions, including reduction of insulin‐like growth factor I (IGF‐I), a potent mitogen for breast carcinoma cells. In an attempt to improve the efficacy of TAM, this randomized trial was performed.

Results of combined-modality therapy for limited-stage small cell lung carcinoma in the elderly

A Phase III trial was conducted by the North Central Cancer Treatment Group to determine whether chemotherapy (etoposide and cisplatin) plus either twice‐daily radiotherapy (BIDRT) or once‐daily radiotherapy (QDRT) resulted in a better outcome for patients with limited‐stage small cell lung carcinoma (LD‐SCLC). No difference in survival was identified between the two arms. The current analysis examined the relation between age and outcome for patients treated during this trial.

Comparison of estrogen receptor determinations by a biochemical ligand-binding assay and immunohistochemical staining with monoclonal antibody ER1D5 in females with lymph node positive breast carcinoma entered on two prospective clinical trials

The measurement of estrogen receptors (ER) in breast cancer specimens has traditionally been assessed with a dextran‐coated charcoal assay (DCCA). More recently the immunohistochemical staining (IHC) method has gained increasing popularity because of its ability to use fixed tissue, assess needle biopsies, and reduce cost. Controversy exists over the accuracy of IHC compared with that of DCCA in determining ER. We compared these two techniques using tumor tissue obtained from a large group of females with lymph node positive breast carcinoma with long term follow‐up.

A phase III evaluation of a somatostatin analogue (octreotide) in the treatment of patients with asymptomatic advanced colon carcinoma

Background. The purpose of this study was to determine by randomized, controlled, double‐blind evaluation whether therapy with the somatostatin analogue, octreotide, would delay tumor progression and improve survival of patients with metastatic colorectal carcinomas who were ambulatory with no significant symptoms.

Randomized trial of cyclophosphamide, methotrexate, and 5-fluorouracil with or without estrogenic recruitment in women with metastatic breast cancer

Background. The fraction of breast cancer cells undergoing DNA synthesis at any one time is relatively low, which is problematic because most chemotherapeutic agents are most effective against dividing cells. Estrogens administered in vitro and in vivo can increase breast cancer cell proliferation. A randomized clinical trial was performed to determine if estrogenic recruitment could increase the effectiveness of combination chemotherapy.

A north central cancer treatment group Phase II trial of 9‐aminocamptothecin in previously untreated patients with measurable metastatic colorectal carcinoma

Topoisomerase I inhibitors have demonstrated clinical activity in patients with metastatic colorectal carcinoma. The authors performed a Phase II study to evaluate the objective tumor response rate of 2 different doses and schedules of 9‐aminocamptothecin (9‐AC) in previously untreated patients with measurable recurrent metastatic colorectal carcinoma.

A randomized phase II trial of amonafide or trimetrexate in patients with advanced non-small cell lung cancer : a trial of the North Central cancer Treatment Group

Background. In an effort to identify new active chemotherapeutic agents against non‐small cell lung cancer (NSCLC), the authors conducted a randomized Phase II trial to evaluate the efficacy of amonafide or trimetrexate in patients with Stage IV disease.