A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer

Stacey M. Stein, Amy Tiersten, Howard S. Hochster, Stephanie V. Blank, Bhavana Pothuri, John Curtin, Ilan Shapira, Benjamin Levinson, Percy Ivy, Benson Joseph, Achuta Kumar Guddati, Franco Muggia

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background: Phase 2 trials suggest that prolonged intravenous (IV) infusion of the topoisomerase 1 inhibitor topotecan may be less toxic than when given by standard IV bolus 5-day administration. Oxaliplatin exhibits efficacy in platinum-pretreated disease and shows preclinical synergy with topoisomerase 1 inhibitors.We sought to determine the efficacy and safety of oxaliplatin plus infusion topotecan in recurrent platinum-pretreated ovarian cancer. Methods: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers previously treated with 1 to 2 prior regimens including platinum and taxane received oxaliplatin (85 mg/m2 day 1 and day 15) and topotecan (0.4 mg/m2 per day) by continuous IV infusion over 14 days every 4 weeks. The primary objective of the trialwas to estimate the objective response rate in platinum-resistant disease (stratum 1) and in platinum-sensitive disease (stratum 2). Toxicities were assessed in all patients. Results: Thirty-eight patients received 144 cycles of therapy (median, 4; range, 1-6). The most common grade 3 and grade 4 toxicities included thrombocytopenia (grade 3, 37%; and grade 4, 19%), neutropenia (grade 3, 37%; grade 4, 11%), and anemia (grade 3, 15%). Response occurred in 4 of 19 patients in stratum I (21%; 95% confidence intervals, 6%-46%) and 9 of 19 patients in stratum 2 (47%; 95% CI, 24%-71%). Three in each stratum had lengthy complete responses. Conclusions: Biweekly oxaliplatin plus a 14-day continuous IV infusion of topotecan, given monthly, is an active regimen in platinum-pretreated ovarian cancer and merits additional evaluation.

Original languageEnglish (US)
Pages (from-to)1577-1582
Number of pages6
JournalInternational Journal of Gynecological Cancer
Volume23
Issue number9
DOIs
StatePublished - Dec 2 2013
Externally publishedYes

Fingerprint

oxaliplatin
Topotecan
Platinum
Ovarian Neoplasms
Intravenous Infusions
Topoisomerase I Inhibitors
Fallopian Tubes
Poisons
Neutropenia
Anemia

Keywords

  • Continuous infusion
  • Ovarian cancer
  • Oxalipatin
  • Phase 2
  • Topotecan

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Cite this

A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer. / Stein, Stacey M.; Tiersten, Amy; Hochster, Howard S.; Blank, Stephanie V.; Pothuri, Bhavana; Curtin, John; Shapira, Ilan; Levinson, Benjamin; Ivy, Percy; Joseph, Benson; Guddati, Achuta Kumar; Muggia, Franco.

In: International Journal of Gynecological Cancer, Vol. 23, No. 9, 02.12.2013, p. 1577-1582.

Research output: Contribution to journalArticle

Stein, SM, Tiersten, A, Hochster, HS, Blank, SV, Pothuri, B, Curtin, J, Shapira, I, Levinson, B, Ivy, P, Joseph, B, Guddati, AK & Muggia, F 2013, 'A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer', International Journal of Gynecological Cancer, vol. 23, no. 9, pp. 1577-1582. https://doi.org/10.1097/IGC.0b013e3182a809e0
Stein, Stacey M. ; Tiersten, Amy ; Hochster, Howard S. ; Blank, Stephanie V. ; Pothuri, Bhavana ; Curtin, John ; Shapira, Ilan ; Levinson, Benjamin ; Ivy, Percy ; Joseph, Benson ; Guddati, Achuta Kumar ; Muggia, Franco. / A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer. In: International Journal of Gynecological Cancer. 2013 ; Vol. 23, No. 9. pp. 1577-1582.
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abstract = "Background: Phase 2 trials suggest that prolonged intravenous (IV) infusion of the topoisomerase 1 inhibitor topotecan may be less toxic than when given by standard IV bolus 5-day administration. Oxaliplatin exhibits efficacy in platinum-pretreated disease and shows preclinical synergy with topoisomerase 1 inhibitors.We sought to determine the efficacy and safety of oxaliplatin plus infusion topotecan in recurrent platinum-pretreated ovarian cancer. Methods: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers previously treated with 1 to 2 prior regimens including platinum and taxane received oxaliplatin (85 mg/m2 day 1 and day 15) and topotecan (0.4 mg/m2 per day) by continuous IV infusion over 14 days every 4 weeks. The primary objective of the trialwas to estimate the objective response rate in platinum-resistant disease (stratum 1) and in platinum-sensitive disease (stratum 2). Toxicities were assessed in all patients. Results: Thirty-eight patients received 144 cycles of therapy (median, 4; range, 1-6). The most common grade 3 and grade 4 toxicities included thrombocytopenia (grade 3, 37{\%}; and grade 4, 19{\%}), neutropenia (grade 3, 37{\%}; grade 4, 11{\%}), and anemia (grade 3, 15{\%}). Response occurred in 4 of 19 patients in stratum I (21{\%}; 95{\%} confidence intervals, 6{\%}-46{\%}) and 9 of 19 patients in stratum 2 (47{\%}; 95{\%} CI, 24{\%}-71{\%}). Three in each stratum had lengthy complete responses. Conclusions: Biweekly oxaliplatin plus a 14-day continuous IV infusion of topotecan, given monthly, is an active regimen in platinum-pretreated ovarian cancer and merits additional evaluation.",
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