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 C.
AU - Reid, Thomas
AU - Brzezniak, Christina E.
AU - Zeman, Karen G.
AU - Padmanabhan, Arvinda
AU - Hirth, Jo Ann
AU - Spira, Alexander
AU - Trepel, Jane
AU - Padda, Sukhmani Kaur
N1 - Publisher Copyright:
© 2019, The Author(s), under exclusive licence to Cancer Research UK.
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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Azetidines/administration & dosage
KW - Carboplatin/administration & dosage
KW - Cisplatin/administration & dosage
KW - Etoposide/administration & dosage
KW - Female
KW - Humans
KW - Lung Neoplasms/drug therapy
KW - Male
KW - Middle Aged
KW - Nitro Compounds/administration & dosage
KW - Small Cell Lung Carcinoma/drug therapy
UR - http://www.scopus.com/inward/record.url?scp=85067847142&partnerID=8YFLogxK
U2 - 10.1038/s41416-019-0504-8
DO - 10.1038/s41416-019-0504-8
M3 - Article
C2 - 31231122
SN - 0007-0920
VL - 121
SP - 211
EP - 217
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 3
ER -
