caa a22 4500 39756497X CHVBK 20180308164826.0 cr unu---uuuuu 161202e19961218xx s 000 0 eng 10.1093/jnci/88.24.1834 doi (NATIONALLICENCE)oxford-10.1093/jnci/88.24.1834 Preliminary Results From the Cancer Research Campaign Trial Evaluating Tamoxifen Duration in Women Aged Fifty Years or Older With Breast Cancer [Elektronische Daten] Background Although trials of postsurgical tamoxifen therapy for patients with breast cancer have convincingly demonstrated reductions in relapse rates and improvements in survival, the optimal duration of therapy is as yet unclear. Purpose: Our objective is to determine whether 2 or 5 years of tamoxifen therapy (20mg/day orally) is preferable in the treatment of patients with early breast cancer. Methods A randomized trial that was pragmatic in policy, allowing flexibility in primary treatment (i.e., type of surgery) and adjuvant therapy other than tamoxifen (i.e., radiotherapy or chemotherapy), was used to encourage maximum participation of clinicians and patients. This design allowed comparison of the two durations of tamoxifen therapy under conditions in which they would subsequently be applied in clinical practice. The patients were recruited from the oncology departments of participating hospitals in the U.K., Belgium, Poland, and Hong Kong. Those women who had completed an initial 2year course of tamoxifen therapy after primary surgery and had not experienced a recurrence of breast cancer were asked to consider random assignment either to no further therapy or to an additional 3 years of tamoxifen. Follow-up reports (every 6 months for 3 years after random assignment and then annually) were required for all surviving study subjects. These reports recorded all breast cancer-related events (i.e., locoregional relapse and distant metastasis) or the development of new primary tumors (in the opposite breast or at any other site). For patients who died, the date and cause of death were recorded. Event-free survival; overall survival; and time to locoregional relapse, distant metastasis, or the development of new primary cancers were end points for the analysis. Survival comparisons were made by use of life tables and the logrank test. Reported P values are two-sided. Results By December 31, 1994, 2937 patients had accepted random assignment to treatment; 1470 were assigned to stop tamoxifen therapy after having received it for 2 years and 1467 were assigned to continue therapy for an additional 3 years (total, 5 years). An analysis was performed when the target for patient accrual had been reached, although the trial remains open. At a median follow-up of 2 years since the randomization, no difference in survival between the two treatment groups was detected (relative risk = 0.89; 95% confidence interval = 0.69-1.15), but a statistically significant delay in the time to relapse for patients receiving the longer treatment was demonstrated (relative risk = 0.81; 95% confidence interval = 0.69-0.98). Conclusions and Implications Our results suggest that 5 years may be better than 2 years of tamoxifen therapy, but more evidence regarding the optimal duration of tamoxifen therapy must be obtained. [J Natl Cancer Inst 1996; 88: 1834-9] © Oxford University Press REPORTS nationallicence JNCI: Journal of the National Cancer Institute Oxford University Press 88/24(1996-12-18), 1834-1839 0027-8874 88:24<1834 1996 88 jnci https://doi.org/10.1093/jnci/88.24.1834 text/html Onlinezugriff via DOI 1 brief-communication jats NATIONALLICENCE 856 40 https://doi.org/10.1093/jnci/88.24.1834 text/html Onlinezugriff via DOI NATIONALLICENCE 773 0- JNCI: Journal of the National Cancer Institute Oxford University Press 88/24(1996-12-18), 1834-1839 0027-8874 88:24<1834 1996 88 jnci Metadata rights reserved CC BY-NC-4.0 http://creativecommons.org/licenses/by-nc/4.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-oxford