Amrubicin for extensive-disease small-cell lung cancer: Does it work?

By Naveed Saleh, MD, MS, for MDLinx
Published November 5, 2018

Key Takeaways

Amrubicin plus cisplatin for extensive-disease small-cell lung cancer (ED-SCLC) offered no survival benefit but boosted overall response rate (ORR), according to research published in the Asia-Pacific Journal of Clinical Oncology.

Amrubicin is a synthetic anthracycline that has outperformed doxorubicin in animal models, and it is used as first-line treatment in patients with SCLC. Unlike doxorubicin, it has no adverse cardiac effects.

Between 60% and 70% of patients with SCLC, however, have ED-SCLC—a rapidly progressive iteration that carries a particularly dire prognosis, despite the advent of targeted and novel chemotherapies in recent years.

“Given that multiple trials observed controversial clinical outcomes of amrubicin-based treatment, it is vital to understand the full impact of the amrubicin therapy on the survival and safety outcomes,” wrote authors, led by Chun-Quan Liu, Department of Thoracic Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing.

In the current systematic review and meta-analysis, researchers mined various medical databases for randomized-controlled trials (RCTs) assessing the efficacy and safety of amrubicin-based treatment regimens in patients with ED-SCLC. In total, four RCTs (N=740) met inclusion criteria. Endpoints analyzed included progression-free survival (PFS), overall survival (OS), ORR, and adverse events.

In patients with ED-SCLC, the investigators found that an amrubicin-based regimen was not significantly correlated with either prolonged PFS (HR: 1.07; 95% CI: 0.90–1.30; P=0.463) or OS (HR: 1.07; 95% CI: 0.89–1.29; P=0.443). However, this regimen significantly improved ORR (RR: 1.14; 95% CI: 1.04–1.25; P=0.008).

On subgroup analysis, the authors found that neither amrubicin alone nor amrubicin with cisplatin lengthened PFS and OS. Only combination therapy offered a significant improvement in ORR.

The incidence of grade ≥ 3 adverse events was similar in amrubicin-containing and other treatment groups (RR: 1.42; 95% CI: 0.78–2.58; P=0.248). However, amrubicin-based therapy yielded a higher incidence of febrile neutropenia, anemia, leukopenia, neutropenia, and interstitial lung disease.

The authors acknowledged that the current study had certain limitations. For instance, only four RCTs were analyzed, of which some were low power. In addition, due to limited data the investigators could not analyze the effects of amrubicin treatment in elderly (aged > 70 years) patients, but prior research has suggested that amrubicin monotherapy is toxic and not tolerated in older patients.

“Considering the potential limitations in this meta-analysis, more well-conducted, large-scale RCTs are needed to identify our findings, and explore the effects of amrubicin-based regimen in elderly patients,” concluded the authors.

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