Erratum: Phase I/II Study of Amrubicin and Nedaplatin in Patients with Untreated, Advanced, Non-Small Cell Lung Cancer
Ogawara D.
Nakamura Y.
Fukuda M.
Nakatomi K.
Yamaguchi H.
Motoshima K.
Mizoguchi K.
Nakano H.
Takemoto S.
Gyotoku H.
10.6084/m9.figshare.5241766.v1
https://karger.figshare.com/articles/dataset/Erratum_Phase_I_II_Study_of_Amrubicin_and_Nedaplatin_in_Patients_with_Untreated_Advanced_Non-Small_Cell_Lung_Cancer/5241766
A phase I/II study of combination chemotherapy with amrubicin and nedaplatin for patients with untreated, advanced, non-small cell lung cancer (NSCLC) was conducted. Amrubicin was given on days 1-3, with nedaplatin given on day 1. The treatment was repeated every 3 weeks. In the phase I trial, the initial amrubicin dose of 25 mg/m<sup>2</sup> was escalated in 5-mg/m<sup>2</sup> increments until the maximum tolerated dose was reached, with the dose of nedaplatin fixed at 100 mg/m<sup>2</sup>. In the phase II trial, the primary endpoint was the overall response rate (ORR), assuming 20% for a standard therapy and 40% for a target therapy (α = 0.05 and β = 0.20), and the estimated required total number of patients was 35. In the phase I study, nedaplatin 100 mg/m<sup>2</sup> and amrubicin 25 mg/m<sup>2</sup> was recommended. In the phase II study, 17 out of 35 patients achieved a partial response, and the ORR was 48.6%. Grade 3/4 neutropenia, grade 3 anemia and grade 3/4 thrombocytopenia occurred in 62.9, 11.4 and 11.4% of cycles, respectively. Febrile neutropenia occurred in 5 cycles (3.9%) and all cases were manageable. The recommended dose of this combination is well tolerated and effective in patients with advanced NSCLC.
2017-07-25 13:55:15
Non-small cell lung cancer
Phase I/II trials
Nedaplatin
Amrubicin
First-line therapy