Combination lurbinectedin and doxorubicin did not improve overall survival (OS) in patients with relapsed small-cell lung cancer (SCLC), according to trial results presented at the IASLC 2021 World Conference on Lung Cancer (WCLC).

The phase 3 ATLANTIS trial (ClinicalTrials.gov Identifier: NCT02566993) was designed to compare lurbinectedin plus doxorubicin with cyclophosphamide, doxorubicin, and vincristine (CAV) or topotecan in patients with SCLC.

Enrolled patients had limited- or extensive-stage SCLC, had progressed on 1 previous line of platinum chemotherapy, had a chemotherapy-free interval (CTFI) of 30 days or more, and had an Eastern Cooperative Oncology Group performance status of 2 or less.


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The patients were randomly assigned to receive lurbinectedin plus doxorubicin (307 patients) or CAV/topotecan (306 patients) until disease progression or unacceptable toxicity. Baseline characteristics — including age, gender, and smoking status — were well balanced between the treatment arms.

The study’s primary endpoint was OS. In the intention-to-treat population, the median OS was 8.6 months in the lurbinectedin arm and 7.6 months in the control arm (hazard ratio [HR], 0.967; P =.7032).

None of the variables used for stratification — including CTFI after first-line treatment, performance status, and baseline central nervous system involvement — predicted superior OS in either treatment arm.

The median progression-free survival (PFS) was 4.0 months in each arm, but there was a significant difference in favor of the lurbinectedin arm (HR, 0.831; P =.0437). The 12-month PFS rate was 10.8% in the lurbinectedin arm and 4.4% in the control arm (P =.0129).

PFS was superior in the lurbinectedin arm among patients with a CTFI after first-line treatment of at least 180 days (HR, 0.469) and among patients with no baseline central nervous system involvement (HR, 0.788).

The overall response rate was 31.6% in the lurbinectedin arm and 29.7% in the control arm. The median duration of response was 5.7 months and 3.8 months, respectively (HR, 0.581; P =.0012).

Patients in the control arm were more likely to have grade 3 or higher adverse events than those in the lurbinectedin arm — 75.4% and 47.2%, respectively — as well as an adverse event leading to death — 3.5% and 0.3%, respectively.

Disclosures: This research was supported by PharmaMar. One study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Paz-Ares L, Ciuleanu TE, Navarro A, et al. Lurbinectedin/doxorubicin versus CAV or topotecan in relapsed SCLC patients: Phase III randomized ATLANTIS trial. Presented at: IASLC 2021 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer; September 8-14, 2021; Abstract PL02.03.

This article originally appeared on Cancer Therapy Advisor