PHASE II STUDY OF AMRUBICIN (AMR) COMBINED WITH CARBOPLATIN (CBDCA) FOR REFRACTORY RELAPSED SMALL CELL LUNG CANCER (SCLC): NORTH JAPAN LUNG CANCER GROUP 0802

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Abstract

Background

AMR, a new anthracycline agent, has achieved some promising results for advanced SCLC both in the first-line and the second-line setting. However, the efficacy of AMR alone against refractory relapsed SCLC was relatively low in previous studies. This study was conducted to evaluate the safety and efficacy of the combination of AMR–CBDCA in patients with refractory relapsed SCLC.

Methods

Patients with advanced SCLC who relapsed within 90 days after the completion of first-line chemotherapy received AMR (30 mg/m2, day 1–3) and CBDCA (AUC 4.0, day 1) every 3 weeks. The primary end point of this study was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival, and toxicity profile. Assuming that ORR of 45% in eligible patients would indicate potential usefulness while ORR of 20% would be the lower limit of interest, with alpha = 0.10 and beta = 0.10, at least 24 patients were required.

Results

From September 2008 to May 2011, 30 patients were enrolled from 10 institutions. One patient was excluded because of ineligible histology. Patient characteristics were male/female 26/3; median age 67 (range 50–81); and performance status 0/1/2 9/16/4. The median number of treatment cycles were 4 (range 1–7). The objective responses evaluated by RECIST were CR 0, PR 10, SD 14, and PD 5. The ORR was 34% and the disease control rate was 83%. The median PFS was 3.5 months and the median survival time was 7.3 months. Grade 3–4 neutropenia was observed in 23 patients (79%) and grade 3–4 thrombocytopenia was observed in 7 patients (24%). One patient (3%) suffered from grade 3 to 4 febrile neutropenia. Other grade 3 non-hematological toxic effects such as infection, interstitial lung disease, hyponatremia, and hypoglycemia were observed in 7 patients (24%). No treatment related death was observed.

Conclusions

This is the first prospective study of AMR combined with CBDCA for refractory relapsed SCLC, which was effective and well tolerated. Further investigation of this treatment is warranted.

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