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Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.


ABSTRACT: PURPOSE:Chemotherapy-induced thrombocytopenia (CIT) leads to delay or reduction in cancer treatment. There is no approved treatment. METHODS:We conducted a phase II randomized trial of romiplostim versus untreated observation in patients with solid tumors with CIT. Before enrollment, patients had platelets less than 100,000/?L for at least 4 weeks, despite delay or dose reduction of chemotherapy. Patients received weekly titrated romiplostim with a target platelet count of 100,000/?L or more, or were monitored with usual care. The primary end point was correction of platelet count within 3 weeks. Twenty-three patients were treated in a randomization phase, and an additional 37 patients were treated in a single-arm, romiplostim phase. Resumption of chemotherapy without recurrent CIT was a secondary end point. RESULTS:The mean platelet count at enrollment was 62,000/?L. In the randomization phase, 14 of 15 romiplostim-treated patients (93%) experienced correction of their platelet count within 3 weeks, compared with one of eight control patients (12.5%; P < .001). Including all romiplostim-treated patients (N = 52), the mean platelet count at 2 weeks of treatment was 141,000/?L. The mean platelet count in the eight observation patients at 3 weeks was 57,000/?L. Forty-four patients who achieved platelet correction with romiplostim resumed chemotherapy with weekly romiplostim. Only three patients (6.8%) experienced recurrent reduction or delay of chemotherapy because of isolated CIT. CONCLUSION:This prospective trial evaluated treatment of CIT with romiplostim. Romiplostim is effective in correcting CIT, and maintenance allows for resumption of chemotherapy without recurrence of CIT in most patients.

SUBMITTER: Soff GA 

PROVIDER: S-EPMC6823892 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Romiplostim Treatment of Chemotherapy-Induced Thrombocytopenia.

Soff Gerald A GA   Miao Yimei Y   Bendheim Gemma G   Batista Jeanette J   Mones Jodi V JV   Parameswaran Rekha R   Wilkins Cy R CR   Devlin Sean M SM   Abou-Alfa Ghassan K GK   Cercek Andrea A   Kemeny Nancy E NE   Sarasohn Debra M DM   Mantha Simon S  

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20190923 31


<h4>Purpose</h4>Chemotherapy-induced thrombocytopenia (CIT) leads to delay or reduction in cancer treatment. There is no approved treatment.<h4>Methods</h4>We conducted a phase II randomized trial of romiplostim versus untreated observation in patients with solid tumors with CIT. Before enrollment, patients had platelets less than 100,000/μL for at least 4 weeks, despite delay or dose reduction of chemotherapy. Patients received weekly titrated romiplostim with a target platelet count of 100,000  ...[more]

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