Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer: KMBOG0610B

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• 作者：Hidetoshi Hayashi (1)
  Junji Tsurutani (1)
  Taro Satoh (1)
  Norikazu Masuda (2)
  Wataru Okamoto (1)
  Ryotaro Morinaga (1)
  Masaaki Terashima (1)
  Masaki Miyazaki (1)
  Isamu Okamoto (1)
  Yukihiro Nishida (3)
  Shusei Tominaga (3)
  Yukihiko Tokunaga (4)
  Masahide Yamaguchi (5)
  Junichi Sakamoto (6)
  Takahiro Nakayama (7)
  Kazuhiko Nakagawa (1)
  
• 关键词：Metastatic breast cancer ; Irinotecan ; Phase II trial ; Topoisomerase I inhibitor ; HER2 ; negative
• 刊名：Breast Cancer
• 出版年：2013
• 出版时间：April 2013
• 年：2013
• 卷：20
• 期：2
• 页码：131-136
• 全文大小：201KB
• 参考文献：1. Hamilton A, Hortobagyi G. Chemotherapy: what progress in the last 5?years? J Clin Oncol. 2005;23(8):1760-5.
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  4. Taguchi T, Tominaga T, Ogawa M, Ishida T, Morimoto K, Ogawa N. A late phase II study of CPT-11 (irinotecan) in advanced breast cancer. CPT-11 Study Group on Breast Cancer. Gan To Kagaku Ryoho. 1994;21(7):1017-4.
  5. Taguchi T, Yoshida Y, Izuo M, Ishida T, Ogawa M, Nakao I, et al. [An early phase II study of CPT-11 (irinotecan hydrochloride) in patients with advanced breast cancer]. Gan To Kagaku Ryoho. 1994;21(1):83-0.
  6. Perez EA, Hillman DW, Mailliard JA, Ingle JN, Ryan JM, Fitch TR, et al. Randomized phase II study of two irinotecan schedules for patients with metastatic breast cancer refractory to an anthracycline, a taxane, or both. J Clin Oncol. 2004;22(14):2849-5. CrossRef
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  8. Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, et al. Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 2001;92(7):1759-8. CrossRef
  9. Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999;17(2):485-3.
  10. Fumoleau P, Largillier R, Clippe C, Dieras V, Orfeuvre H, Lesimple T, et al. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer. 2004;40(4):536-2. CrossRef
  11. Reichardt P, Von Minckwitz G, Thuss-Patience PC, Jonat W, Kolbl H, Janicke F, et al. Multicenter phase II study of oral capecitabine (Xeloda(-) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol. 2003;14(8):1227-3. CrossRef
  12. Shimada Y, Yoshino M, Wakui A, Nakao I, Futatsuki K, Sakata Y, et al. Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. CPT-11 Gastrointestinal Cancer Study Group. J Clin Oncol. 1993;11(5):909-3.
  13. Ando Y, Saka H, Ando M, Sawa T, Muro K, Ueoka H, et al. Polymorphisms of UDP-glucuronosyltransferase gene and irinotecan toxicity: a pharmacogenetic analysis. Cancer Res. 2000;60(24):6921-.
  14. Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol. 2004;22(8):1382-. CrossRef
  15. Gagne JF, Montminy V, Belanger P, Journault K, Gaucher G, Guillemette C. Common human UGT1A polymorphisms and the altered metabolism of irinotecan active metabolite 7-ethyl-10-hydroxycamptothecin (SN-38). Mol Pharmacol. 2002;62(3):608-7. CrossRef
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• 作者单位：Hidetoshi Hayashi (1)
  Junji Tsurutani (1)
  Taro Satoh (1)
  Norikazu Masuda (2)
  Wataru Okamoto (1)
  Ryotaro Morinaga (1)
  Masaaki Terashima (1)
  Masaki Miyazaki (1)
  Isamu Okamoto (1)
  Yukihiro Nishida (3)
  Shusei Tominaga (3)
  Yukihiko Tokunaga (4)
  Masahide Yamaguchi (5)
  Junichi Sakamoto (6)
  Takahiro Nakayama (7)
  Kazuhiko Nakagawa (1)
  
  1. Department of Medical Oncology, Kinki University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka, 589-8511, Japan
  2. Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, Osaka, 540-0006, Japan
  3. Department of Breast Surgery, Higashiosaka City General Hospital, 3-4-5 Nishi-Iwata, Higashiosaka, Osaka, 578-8588, Japan
  4. Department of Surgery, Osaka Kita Posts and Telecommunications Hospital, 1-1-6 Nakazaki, Kita-ku, Osaka, Osaka, 530-8798, Japan
  5. Department of Surgery, Matsushita Memorial Hospital, 5-55 Sotojima-cho, Moriguchi, Osaka, 570-8540, Japan
  6. Young Leaders Program of Health Care Administration, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan
  7. Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
  

文摘

Background A trial was conducted to evaluate the feasibility, efficacy, and safety of biweekly administration of irinotecan, a novel topoisomerase I inhibitor, for patients with metastatic breast cancer (MBC) previously treated with either anthracycline-based or taxane-based chemotherapy. Methods Eligible patients were HER2-negative, had a performance status of 0 to 2, and had been treated previously with either anthracyclines or taxanes for MBC. Patients received irinotecan intravenously at 150?mg/m2 on days 1 and 15 every 4?weeks. The primary end-point was feasibility, and the treatment was considered feasible if a patient was able to receive three administrations of irinotecan within the first 8?weeks, as pre-specified in the protocol. Results Eighteen patients (median age 60?years) were enrolled. Fifteen patients received irinotecan more than 3 times within the first 8?weeks, with resulting feasibility of 83.3%. The median number of treatment cycles was 2 (range 1-6) during this period, and the relative dose intensity was 91.2%. Partial response was observed for one patient, so overall response rate was 5.6%. Nine patients (50.0%) had stable disease, and overall disease control was 50.0%. Median progression-free survival and overall survival periods were 3.2 and 9.6?months, respectively. The only grade 3/4 hematological toxicity was neutropenia (22.2%). Grade 3/4 non-hematological toxicities were anorexia (11.2%), diarrhea (11.2%), and fatigue (5.6%). No treatment-related death occurred. Conclusions This study demonstrated that biweekly administration of 150?mg/m2 irinotecan was feasible for patients with MBC treated previously with anthracyclines or taxanes.