Dose Reduction versus Dose-interval Prolongation in Eribulin Mesilate Monotherapy in Patients with Metastatic Breast Cancer: A Retrospective Comparative Study
It is often necessary to modify the dose or schedule of eribulin mesilate (Eri) because of adverse events. Therefore, we retrospectively investigated the optimal approach for Eri dose adjustment and/or dosage interval adjustment. Patients who received Eri at the institutions affiliated with the Divi...
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| Published in | YAKUGAKU ZASSHI Vol. 136; no. 7; pp. 1023 - 1029 |
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| Main Authors | , , , , , , , , , , |
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| Language | Japanese |
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The Pharmaceutical Society of Japan
01.07.2016
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| Abstract | It is often necessary to modify the dose or schedule of eribulin mesilate (Eri) because of adverse events. Therefore, we retrospectively investigated the optimal approach for Eri dose adjustment and/or dosage interval adjustment. Patients who received Eri at the institutions affiliated with the Division of Oncology of the Aichi Prefectural Society of Hospital Pharmacists between July 2011 and November 2013 were enrolled in this study. We compared the group that underwent dose reduction without changes to their dosage interval (dose reduction group) with the group that had a change in their dosage interval (dose-interval prolongation group). The primary end-point was time to treatment failure (TTF), and the secondary end-points were overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and adverse events. The TTF and OS of the dose reduction group were approximately two times longer than those of the dose-interval prolongation group. In addition, the dose reduction group had significantly improved ORR and CBR, which together indicate an antitumor effect (p=0.013 and 0.002, respectively). Although peripheral neuropathy occurred significantly more frequently in the patients in the dose reduction group (p=0.026), it was grade 1 and controllable in most of the cases. There were no differences in the occurrence of other adverse effects between the two groups. Therefore, we suggest that dose reduction with maintenance of the dosage interval is the preferred treatment approach in cases where Eri dose or schedule modification is necessary. |
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| AbstractList | It is often necessary to modify the dose or schedule of eribulin mesilate (Eri) because of adverse events. Therefore, we retrospectively investigated the optimal approach for Eri dose adjustment and/or dosage interval adjustment. Patients who received Eri at the institutions affiliated with the Division of Oncology of the Aichi Prefectural Society of Hospital Pharmacists between July 2011 and November 2013 were enrolled in this study. We compared the group that underwent dose reduction without changes to their dosage interval (dose reduction group) with the group that had a change in their dosage interval (dose-interval prolongation group). The primary end-point was time to treatment failure (TTF), and the secondary end-points were overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and adverse events. The TTF and OS of the dose reduction group were approximately two times longer than those of the dose-interval prolongation group. In addition, the dose reduction group had significantly improved ORR and CBR, which together indicate an antitumor effect (p=0.013 and 0.002, respectively). Although peripheral neuropathy occurred significantly more frequently in the patients in the dose reduction group (p=0.026), it was grade 1 and controllable in most of the cases. There were no differences in the occurrence of other adverse effects between the two groups. Therefore, we suggest that dose reduction with maintenance of the dosage interval is the preferred treatment approach in cases where Eri dose or schedule modification is necessary. It is often necessary to modify the dose or schedule of eribulin mesilate (Eri) because of adverse events. Therefore, we retrospectively investigated the optimal approach for Eri dose adjustment and/or dosage interval adjustment. Patients who received Eri at the institutions affiliated with the Division of Oncology of the Aichi Prefectural Society of Hospital Pharmacists between July 2011 and November 2013 were enrolled in this study. We compared the group that underwent dose reduction without changes to their dosage interval (dose reduction group) with the group that had a change in their dosage interval (dose-interval prolongation group). The primary end-point was time to treatment failure (TTF), and the secondary end-points were overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and adverse events. The TTF and OS of the dose reduction group were approximately two times longer than those of the dose-interval prolongation group. In addition, the dose reduction group had significantly improved ORR and CBR, which together indicate an antitumor effect (p=0.013 and 0.002, respectively). Although peripheral neuropathy occurred significantly more frequently in the patients in the dose reduction group (p=0.026), it was grade 1 and controllable in most of the cases. There were no differences in the occurrence of other adverse effects between the two groups. Therefore, we suggest that dose reduction with maintenance of the dosage interval is the preferred treatment approach in cases where Eri dose or schedule modification is necessary.It is often necessary to modify the dose or schedule of eribulin mesilate (Eri) because of adverse events. Therefore, we retrospectively investigated the optimal approach for Eri dose adjustment and/or dosage interval adjustment. Patients who received Eri at the institutions affiliated with the Division of Oncology of the Aichi Prefectural Society of Hospital Pharmacists between July 2011 and November 2013 were enrolled in this study. We compared the group that underwent dose reduction without changes to their dosage interval (dose reduction group) with the group that had a change in their dosage interval (dose-interval prolongation group). The primary end-point was time to treatment failure (TTF), and the secondary end-points were overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and adverse events. The TTF and OS of the dose reduction group were approximately two times longer than those of the dose-interval prolongation group. In addition, the dose reduction group had significantly improved ORR and CBR, which together indicate an antitumor effect (p=0.013 and 0.002, respectively). Although peripheral neuropathy occurred significantly more frequently in the patients in the dose reduction group (p=0.026), it was grade 1 and controllable in most of the cases. There were no differences in the occurrence of other adverse effects between the two groups. Therefore, we suggest that dose reduction with maintenance of the dosage interval is the preferred treatment approach in cases where Eri dose or schedule modification is necessary. |
| Author | Ban, Akiko Hisada, Tatsuya Mizutani, Mitsuhiro Sasaki, Toshinori Mishima, Etsuko Itakura, Yukari Nagamatsu, Hidetsugu Tsukiyama, Ikuto Katsuragawa, Kenji Yoshioka, Yuki Oshima, Yumiko |
| Author_xml | – sequence: 1 fullname: Sasaki, Toshinori organization: Department of Pharmacy, Mikawa Breast Cancer Clinic – sequence: 2 fullname: Oshima, Yumiko organization: Department of Pharmacy, Ichinomiya Municipal Hospital – sequence: 3 fullname: Mishima, Etsuko organization: Department of Pharmacy, Handa City Hospital – sequence: 4 fullname: Ban, Akiko organization: Department of Pharmacy, Nishichita General Hospital – sequence: 5 fullname: Katsuragawa, Kenji organization: Department of Pharmacy, TOYOTA Memorial Hospital – sequence: 6 fullname: Nagamatsu, Hidetsugu organization: Department of Pharmacy, Handa City Hospital – sequence: 7 fullname: Yoshioka, Yuki organization: Department of Pharmacy, Nishichita General Hospital – sequence: 8 fullname: Tsukiyama, Ikuto organization: Department of Pharmacy, Aichi Medical University Hospital – sequence: 9 fullname: Hisada, Tatsuya organization: Department of Pharmacy, TOYOTA Memorial Hospital – sequence: 10 fullname: Itakura, Yukari organization: Department of Pharmacy, Hekinan Municipal Hospital – sequence: 11 fullname: Mizutani, Mitsuhiro organization: Department of Breast Surgery, Mikawa Breast Cancer Clinic |
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| References_xml | – reference: 15) Dezső Z., Oestreicher J., Weaver A., Santiago S., Agoulnik S., Chow J., Oda Y., Funahashi Y., PLoS One, 9, e106131 (2014). – reference: 10) Aogi K., Iwata H., Masuda N., Mukai H., Yoshida M., Rai Y., Taguchi K., Sasaki Y., Takashima S., Ann. Oncol., 23, 1441-1448 (2012). – reference: 2) Greenberg P. A., Hortbagyi G. N., Smith T. L., Ziegler L. D., Frye D. K., Buzdar A. U., J. Clin. Oncol., 14, 2197-2205 (1996). – reference: 7) Cortes J., O'Shaughnessy J., Loesch D., Blum J. L., Vahdat L. T., Petrakova K., Chollet P., Manikas A., Diéras V., Delozier T., Vladimirov V., Cardoso F., Koh H., Bougnoux P., Dutcus C. E., Seegobin S., Mir D., Meneses N., Wanders J., Twelves C., EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators, Lancet, 377, 914-923 (2011). – reference: 1) Hortbagyi G. N., N. Engl. J. Med., 339, 974-984 (1998). – reference: 12) Jordan M. A., Wilson L., Nat. Rev. Cancer, 4, 253-265 (2004). – reference: 4) Paterson A. H. G., Szafran O., Cornish F., Lees A. W., Hanson J., Breast Cancer Res. Treat., 1, 357-363 (1981). – reference: 3) Fossati R., Confalonieri C., Torri V., Ghislandi E., Penna A., Pistotti V., Tinazzi A., Liberati A., J. Clin. Oncol., 16, 3439-3460 (1998). – reference: 11) Hattori M., Fujita T., Sawaki M., Kondo N., Horio A., Ushio A., Gondo N., Idota A., Ichikawa M., Iwata H., Jpn. J. Cancer Chemother., 40, 737-741 (2013). – reference: 13) Funahashi Y., Okamoto K., Adachi Y., Semba T., Uesugi M., Ozawa Y., Tohyama O., Uehara T., Kimura T., Watanabe H., Asano M., Kawano S., Tizon X., McCracken P. J., Matsui J., Aoshima K., Nomoto K., Oda Y., Cancer Sci., 105, 1334-1342 (2014). – reference: 9) Partridge A. H., Rumble R. B., Carey L. A., Come S. E., Davidson N. E., Di Leo A., Gralow J., Hortobagyi G. N., Moy B., Yee D., Brundage S. B., Danso M. A., Wilcox M., Smith I. E., J. Clin. Oncol., 32, 3307-3329 (2014). – reference: 6) Ghersi D., Wilcken N., Simes R. J., Br. J. Cancer, 93, 293-301 (2005). – reference: 14) Yoshida T., Ozawa Y., Kimura T., Sato Y., Kuznetsov G., Xu S., Uesugi M., Agoulnik S., Taylor N., Funahashi Y., Matsui J., Br. J. Cancer, 110, 1497-1505 (2014). – reference: 5) A'Hern R. P., Smith I. E., Ebbs S. R., Br. J. Cancer, 67, 801-805 (1993). – reference: 8) Kanda Y., Bone Marrow Transplant., 48, 452-458 (2013). |
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| SubjectTerms | Adult Aged Breast Neoplasms - drug therapy Breast Neoplasms - mortality dose adjustment Drug Administration Schedule Endpoint Determination eribulin mesilate Female Furans - administration & dosage Furans - adverse effects Humans Ketones - administration & dosage Ketones - adverse effects metastatic breast cancer Middle Aged Neoplasm Recurrence, Local Peripheral Nervous System Diseases - chemically induced Peripheral Nervous System Diseases - epidemiology relative dose intensity Retrospective Studies Survival Rate Treatment Failure Treatment Outcome |
| Title | Dose Reduction versus Dose-interval Prolongation in Eribulin Mesilate Monotherapy in Patients with Metastatic Breast Cancer: A Retrospective Comparative Study |
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