Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-26.

PURPOSE: Paclitaxel is an active drug for the treatment of breast cancer; however, the appropriate duration of administration is unknown. We assessed and compared the response rate, event-free survival, survival, and toxicity of paclitaxel 250 mg/m(2) delivered every 3 weeks as a 3-hour or 24-hour infusion. PATIENTS AND METHODS: A total of 563 women with stage IV or IIIB breast cancer were randomized into one of two groups: 279 received 3-hour paclitaxel and 284 received 24-hour paclitaxel. Patients were stratified by age, stage of disease, and prior therapy. RESULTS: A significantly higher rate of tumor response occurred in the first four cycles of therapy in patients who received the 24-hour infusion of paclitaxel (51% v 41%, respectively; P =.025). Tumor response over all cycles was also significantly higher in the group that received 24-hour infusion (54% v 44%, respectively; P =.023). There were no significant differences in event-free survival or survival between the two arms of the study (P =.9 and.8, respectively). No treatment by stage or by age interactions were observed. During the first four cycles of therapy, at least one episode of >/= grade 3 toxicity (excluding nadir hematologic values, alopecia, and weight change) occurred in 45% of patients who received the 3-hour paclitaxel infusion and in 50% of those who received the 24-hour paclitaxel infusion. Febrile neutropenia, >/= grade 3 infection, and >/= grade 3 stomatitis were less frequent, and severe neurosensory toxicity was more frequent in those who received the 3-hour paclitaxel infusion. Ten treatment-related deaths occurred in the first four cycles. Age, stage, and prior chemotherapy did not influence the effect of treatment. CONCLUSION: When administered as a continuous 24-hour infusion, high-dose paclitaxel results in a higher tumor response rate than when administered as a 3-hour infusion but does not significantly improve event-free survival or survival. Paclitaxel as a 24-hour infusion results in increased hematologic toxicity and decreased neurosensory toxicity.

Historical ties between otolaryngology-head and neck surgery and aviation and space medicine.

Otolaryngology-head and neck surgeons have been involved in the development of aviation and space medicine since the beginning of this century. More than 75 years ago, otolaryngologists revised the physical examination for pilots, organized "boards of medical examiners" to test pilot applicants, coined the term "flight surgeon," and helped organize the first medical research laboratories at Hazelhurst Field in New York. These laboratories were transformed in 1922 into the School of Aviation Medicine at Brooks Field, Texas, which in turn subsequently was relocated to Randolph Field, Texas. During World War II the Director of Research at the school was Colonel Paul A. Campbell, MD, an otolaryngologist. In 1959, the school moved back to Brooks Air Force Base and was renamed the Aerospace Medical Center. Since manned space flight began in the 1960s there have been many joint research efforts between principal investigators in otolaryngology-head and neck surgery and NASA. Several otolaryngology-head and neck surgeons have served or currently serve as consultants and advisors to many of NASA's standing committees. The space environment offers a new frontier for development and research in the specialty and for better understanding of vestibular function and related disorders.

Historical ties between otolaryngology--head and neck surgery and space medicine.

Otolaryngologist--head and neck surgeons have been involved in the development of aviation and space medicine since the beginning of this century. In the late 1910s, otolaryngologists revised the physical examination for pilots, organized "Boards of Medical Examiners" to test pilot applicants, coined the term "flight surgeon," and helped organize the Medical Research Laboratories at Hazelhurst Field in New York. These laboratories were transformed into the School of Aviation Medicine at Brooks Field, Texas, which was relocated to Randolph Field, Texas, in 1934. During World War II, the director of research at the school was Colonel Paul A. Campbell, MD, an otolaryngologist. In 1959 the school moved back to Brooks Air Force Base and was renamed the Aerospace Medical Center. In 1962, Dr. Campbell served as the director. Since manned space flight began in the 1960s, there have been many joint research efforts between principal investigators in otolaryngology--head and neck surgery and NASA. Currently, many otolaryngologist--head and neck surgeons serve as consultants and advisors to many of NASA's standing committees. The space environment offers a new frontier for specialty development and research in otolaryngology--head and neck surgery.

Benign parotid diseases of childhood.

A 25-year retrospective study of 63 pediatric surgical cases of benign parotid disease was done. Inflammatory disorders accounted for 34 of the cases. The remaining 29 non-inflammatory conditions included vasoformative, solid, and cystic lesions and were nearly always asymptomatic.