The combined therapy of nedaplatin and amrubicin showed promising effect for advanced non-small-cell lung cancer patients in our previous phase I/II study (Ogawara et al. Chemotherapy. 2014;60(3):180-4.). In the phase I study, nedaplatin 100 mg/m2 and amrubicin 25 mg/m2 was recommended. In the phase II study, 17 out of 35 patients achieved a partial response, and the ORR was 48.6%. In the study, nedaplatin and amrubicin tend to be effective especially for the patients with squamous cell lung cancer (Sq-LC). Therefore, we assessed the efficacy and safety of the combination chemotherapy for patients with untreated, advanced or relapsed Sq-LC.
We did a single-armed, open-label, phase II study at 6 institutions in Nagasaki, Japan. Eligibility criteria included pathologically proven squamous cell lung cancer with stage IIIB/IV or postoperative recurrence, age 20 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, adequate organ function. Primary endpoint was overall response rate (ORR) and the secondary endpoints were safety, progression-free survival (PFS), and overall survival (OS). This trial was registered with the UMIN Clinical Trials Registry, number UMIN000007587, and is closed to new participants.
Between November 2012 and March 2016, 21 patients were enrolled. The patients were administered nedaplatin (100 mg/m2, day 1) plus amrubicin (25mg/m2, day 1-3) every 4 weeks. ORR was 33.3%, disease control rate was 71.4%, median duration of PFS was 4.2 months, median duration of OS was 14.6 months. Adverse events of grade 3/4 were neutropenia (38.1%), thrombocytopenia (9.5%), anemia (9.5%), febrile neutropenia (9.5%).
Combination therapy of nedaplatin and amrubicin could be an effective and tolerable first-line treatment option for patients with advanced or relapsed Sq-LC.
UMIN000007587.
Nagasaki University Hospital.
Has not received any funding.
All authors have declared no conflicts of interest.