RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer

Daniel Morgensztern, Michal Rose, Saiama N. Waqar, John Morris, Patrick C. Ma, Thomas Reid, Christina E. Brzezniak, Karen G. Zeman, Arvinda Padmanabhan, Jo Ann Hirth, Alexander I. Spira, Jane B. Trepel, Sukhmani K. Padda

Research output: Contribution to journalArticle

Abstract

Background: This exploratory single-arm phase II study evaluated the efficacy and safety of RRx-001 followed by reintroduction of platinum plus etoposide in patients with previously treated small-cell lung cancer (SCLC). Methods: Patients were treated with RRx-001 4 mg IV on day 1 of each week of a 21-day cycle followed at progression by re-challenge with etoposide 80–100 IV mg/m2 on days 1, 2 and 3 and cisplatin 60–80 mg/m2 IV on day 1 or carboplatin AUC 5–6 IV on day 1, every 21 days. The primary end points were overall survival (OS) and overall response rate to platinum regimen. Results: Twenty-six patients were enroled and received at least one dose of RRx-001. The median number of prior lines of therapy was 2 (range 1–9) and 19 (73.1%) patients had platinum-resistant disease. In the intention-to-treat population, one patient (3.8%) had complete response and six (23.1%) had partial response on platinum plus etoposide. The estimated median and 12-month OS from enrolment were 8.6 months and 44.1%, respectively. The most common treatment-emergent adverse event from RRx-001 was mild discomfort at the infusion site (23%). Conclusions: RRx-001 followed by re-challenge with platinum plus etoposide chemotherapy is feasible and associated with promising results. Clinical trial registration: NCT02489903.

Original languageEnglish (US)
Pages (from-to)211-217
Number of pages7
JournalBritish journal of cancer
Volume121
Issue number3
DOIs
StatePublished - Jul 30 2019

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Morgensztern, D., Rose, M., Waqar, S. N., Morris, J., Ma, P. C., Reid, T., Brzezniak, C. E., Zeman, K. G., Padmanabhan, A., Hirth, J. A., I. Spira, A., Trepel, J. B., & Padda, S. K. (2019). RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer. British journal of cancer, 121(3), 211-217. https://doi.org/10.1038/s41416-019-0504-8