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 Chi-Chung 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

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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

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Small Cell Lung Carcinoma
Etoposide
Platinum
Survival
Carboplatin
Cisplatin
Area Under Curve
RRx-001
Clinical Trials
Safety
Drug Therapy
Therapeutics
Population

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Morgensztern, Daniel ; Rose, Michal ; Waqar, Saiama N. ; Morris, John ; Ma, Patrick Chi-Chung ; Reid, Thomas ; Brzezniak, Christina E. ; Zeman, Karen G. ; Padmanabhan, Arvinda ; Hirth, Jo Ann ; I. Spira, Alexander ; Trepel, Jane B. ; Padda, Sukhmani K. / RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer. In: British Journal of Cancer. 2019 ; Vol. 121, No. 3. pp. 211-217.
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title = "RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer",
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.",
author = "Daniel Morgensztern and Michal Rose and Waqar, {Saiama N.} and John Morris and Ma, {Patrick Chi-Chung} and Thomas Reid and Brzezniak, {Christina E.} and Zeman, {Karen G.} and Arvinda Padmanabhan and Hirth, {Jo Ann} and {I. Spira}, Alexander and Trepel, {Jane B.} and Padda, {Sukhmani K.}",
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Morgensztern, D, Rose, M, Waqar, SN, Morris, J, Ma, PC-C, Reid, T, Brzezniak, CE, Zeman, KG, Padmanabhan, A, Hirth, JA, I. Spira, A, Trepel, JB & Padda, SK 2019, 'RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer', British Journal of Cancer, vol. 121, no. 3, pp. 211-217. https://doi.org/10.1038/s41416-019-0504-8

RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer. / Morgensztern, Daniel; Rose, Michal; Waqar, Saiama N.; Morris, John; Ma, Patrick Chi-Chung; Reid, Thomas; Brzezniak, Christina E.; Zeman, Karen G.; Padmanabhan, Arvinda; Hirth, Jo Ann; I. Spira, Alexander; Trepel, Jane B.; Padda, Sukhmani K.

In: British Journal of Cancer, Vol. 121, No. 3, 30.07.2019, p. 211-217.

Research output: Contribution to journalArticle

TY - JOUR

T1 - RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer

AU - Morgensztern, Daniel

AU - Rose, Michal

AU - Waqar, Saiama N.

AU - Morris, John

AU - Ma, Patrick Chi-Chung

AU - Reid, Thomas

AU - Brzezniak, Christina E.

AU - Zeman, Karen G.

AU - Padmanabhan, Arvinda

AU - Hirth, Jo Ann

AU - I. Spira, Alexander

AU - Trepel, Jane B.

AU - Padda, Sukhmani K.

PY - 2019/7/30

Y1 - 2019/7/30

N2 - 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.

AB - 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.

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