Anastrozole versus tamoxifen as adjuvant therapy f

Authors: Tomohiko Aihara Isao Yokota Yasuo Hozumi Kenjiro Aogi Hiroji Iwata Motoshi Tamura Atsushi Fukuuchi Haruhiko Makino Ryungsa Kim Masashi Andoh Koichiro Tsugawa Shinji Ohno Takuhiro Yamaguchi Yasuo Ohashi Toru Watanabe Yuichi Takatsuka Hirofumi Mukai

Publish Date: 2014/10/16

Volume: 148, Issue: 2, Pages: 337-343

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Abstract

Aromatase inhibitors are superior to tamoxifen as adjuvant therapy in postmenopausal patients with hormoneresponsive breast cancer We report the followup efficacy results from the NSAS BC 03 trial UMIN CTRID C000000056 where anastrozole was compared with tamoxifen as adjuvant therapy in postmenopausal Japanese patients with hormoneresponsive early breast cancer The full analysis set contained 696 patients anastrozole arm n = 345 tamoxifen arm n = 351 The logrank test was used to compare the two groups in terms of diseasefree survival DFS and relapsefree survival RFS Kaplan–Meier estimates were calculated The treatment effects were estimated by Cox’s proportional hazards model To examine timevarying effect of hazard ratios we estimated timevarying hazard ratios at time t HRt using data from time t up to 12 months After a median followup of 985 months hazard ratios 95  CIs were 090 065–124 logrank p = 0526 for DFS and 083 056–123 logrank p = 0344 for RFS Hazard ratios 95  CIs for DFS and RFS up to 36 months were 069 040–117 and 054 027–106 and those after 36 months were 106 070–159 and 105 064–173 respectively Timevarying hazard ratios for both DFS and RFS showed that hazard ratios were initially in favor of anastrozole and approached 10 at around 36 months Superior efficacy of anastrozole to tamoxifen suggested by the initial analysis was not confirmed in the present analysis after a longterm followup period Advantage of anastrozole was the greatest immediately after switching from tamoxifen and then decreased thereafterWe thank Yumiko Nomura and her team for the excellent data management We are indebted to all the patients and the investigators who participated in this trial especially to the investigators who have contributed to the data updating listed in the Appendix This study was funded by the Comprehensive Support Project for Oncology Research CSPOR of Public Health Research Foundation The corporate and individual sponsors of this study are listed on the CSPOR website http//wwwcsporjp/cspor/kyousan ehtml The pharmaceutical manufacturer/distributor who provided financial contribution as a corporate sponsor took no part in this study other than providing information relevant to the proper use of study drugs All decisions concerning the planning implementation and publication of this study were made by the executive committee of this study This clinical trial complies with the current laws in JapanK Aogi NHO Shikoku Cancer Center Y Hozumi Jichi Medical University Hospital N Wada National Cancer Center Hospital East C Egawa Kansai Rosai Hospital H Iwata Aichi Cancer Center Hospital Y Fujiwara National Cancer Center Hospital K Nakagami Shizuoka General Hospital M Takahashi NHO Hokkaido Cancer Center T Ito Rinku General Medical Center N Ogino Osaka Saiseikai Tondabayashi Hospital M Funakoshi Hiroshima City Asa Hospital S Mitsuyama Kitakyushu Municipal Medical Center H Abe Shiga University of Medical Science N Masuda NHO Osaka National Hospital H Tokura Ashikaga Red Cross Hospital S Maeda NHO Nagasaki Medical Center S Kamigaki Sakai Municipal Hospital S Ohno NHO National Kyushu Cancer Center H Yagata St Luke’s International Hospital H Arioka Yokohama Rosai Hospital S Karamatsu Toyokawa City Hospital H Kawaguchi Matsuyama Red Cross Hospital A Fukuuchi Mitsui Memorial Hospital T Sugimoto Kochi Medical School Hospital Y Katayose Akita City Hospital N Yamamoto Chiba Cancer Center S Kuze Chutoen General Medical Center M Okada Hiroshima University Hospital H Matsumoto Saitama Cancer Center T Saito Saitma Red Cross Hospital Y Tokuda Tokai University Hospital H Tomita Niigata Prefectural Sakamachi Hospital S Hojo Osaka Saiseikai Senri Hospital R Nishimura Kumamoto Municipal Hospital G Amano Nihonkai General Hospital M Yoshida Seirei Hamamatsu General Hospital Y Park Toho University Sakura Medical Center T Toyama Nagoya City University Hospital Y Komoike Kinki University Hospital Faculty of Medicine F Tsukamoto Osaka Koseinenkin Hospital T Kunihisa Yodogawa Christian Hospital M Ochi Miyoshi Central Hospital A Matsui NHO Tokyo Medical Center M Inaba Kanagawa Cancer Center S Nakano Aichi Medical University Hospital K Hashimoto Shimane Prefectural Central Hospital H Doihara Okayama University Hospital T Watanabe Sendai Medical Center H Tahara The Institute of Medical Science The University of Tokyo Y Tamaki Osaka Medical Center for Cancer and Cardiovascular Diseases S Ozaki Kochi Prefectural Hata Kenmin Hospital M Kitada Asahikawa Medical University Hospital K Kuroi Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital M Iguchi Kanazawa University Hospital F Tanaka Fukui Red Cross Hospital N Sonoda Yurin Koseikai Fuji Hospital A Naito Nagoya Kyouritsu Hospital K Kobayashi Kinki Central Hospital Y Maehara Kyushu University Hospital M Hashimoto Iizuka Hospital H Kimura Okayama Saiseikai General Hospital S Imoto School of Medicine Kyorin University T Ri Kyoto First Red Cross Hospital S Hara Sasebo Municipal General Hospital K Okada Uwajima City Hospital J Ando Tochigi Cancer Center K Sakakibara Nagoya City West Medical Center M Kuranami Yamato Municipal Hospital

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