Efficacy and safety of gefitinib in chemonaive patients with advanced non-small cell lung cancer treated in an Expanded Access Program.

Chemotherapy (CT) is recommended in numerous clinical guidelines for advanced non-small cell lung cancer (NSCLC) and offers improved survival over best supportive care. However, many patients with advanced NSCLC never receive CT because of advanced age, poor performance status, comorbidities, or patient refusal. The epidermal growth factor receptor tyrosine kinase inhibitor gefitinib has shown antitumor activity and a favorable toxicity profile in pretreated patients with recurrent advanced NSCLC and was made available in a worldwide Expanded Access Program (EAP) to >37,000 patients who did not respond to standard treatment or were ineligible for or refused CT. A retrospective chart review of 1671 consecutive patients enrolled at 11 sites in the US arm of the EAP identified 198 patients with advanced NSCLC who had not received previous CT. All patients were treated with gefitinib 250 mg/d until treatment failure or toxicity occurred. Patients were treated for a mean of 4.7 months. The most common adverse events were diarrhea (31.3%) and rash (31.3%). Complete and partial response rates were 0.7 and 5.6%, respectively, and 40.6% had stable disease. Median survival was 6 months, and estimated 1-year survival was 29.7%. The majority of patients did not receive subsequent CT.

Colonic perforation following intraoperative temporary pacemaker implantation.

This report describes the case of a 73-year-old man who was referred for consultation for increasing abdominal free air 1 week after he underwent surgery for aortic valve replacement and coronary artery bypass grafting with intraoperative pacemaker implantation. Laparoscopic exploration revealed that the pacemaker wires had passed through the left transverse colon. Although no previous reports of colonic perforation due to pacemaker lead placement was found, this experience suggests that physicians should suspect this complication in patients with increasing free intraabdominal air and peritoneal signs who have recently undergone placement of a temporary cardiac pacing system.

Necessity of axillary dissection in elderly women with early breast cancer.

The need for axillary dissection for staging and treating early breast cancer has been questioned recently. Can a patient forego axillary dissection, with its associated costs, risks, and morbidity, if it does not affect survival? The study attempted to find a subset of patients with early breast cancer in whom disease-free survival was independent of axillary lymph node status. If survival does not depend on lymph node status, axillary dissection could be omitted in the care of these patients. This study included 378 women over age 70 with T1 breast cancer diagnosed and treated during January 1992 to December 1999 at both of our institutions: a large tertiary teaching hospital in Columbus, Ohio and a breast cancer treatment center in West Columbia, South Carolina. We compared the disease-free survival, using the Kaplan-Meier estimate, in 334 node-negative patients and 44 node-positive patients with T1 breast cancer. The 3- and 5-year survival rates of patients with T1N0 tumors were 86% and 77%, respectively; and the 3- and 5-year survival rates for T1 node-positive tumors were 81% and 69%, respectively (p = 0.0673). There was no statistical difference between the node-negative and node-positive groups. Axillary dissection in women over 70 years of age with early breast cancer may be unnecessary, as the presence of lymph node metastases does not appear to affect disease-free survival rates significantly in this patient group.